text:
No. 09-1156 IN THE Supreme Court of the United States ———— MATRIXX INITIATIVES INC., et al., Petitioners, v. JAMES SIRACUSANO, et al., Respondents. ———— On Writ of Certiorari to the United States Court of Appeals for the Ninth Circuit ———— BRIEF FOR THE ADVANCED MEDICAL TECHNOLOGY ASSOCIATION AS AMICUS CURIAE IN SUPPORT OF PETITIONERS ———— CHRISTOPHER L. WHITE STEVEN G. BRADBURY ANDREW VAN HAUTE STEVEN A. ENGEL ADVANCED MEDICAL Counsel of Record TECHNOLOGY ASSOC. DECHERT LLP 701 Pennsylvania Ave. N.W. 1775 I Street N.W. Suite 800 Washington, DC 20006 Washington, DC 20004 (202) 261-3300 (202) 783-8700 firstname.lastname@example.com WILLIAM K. DODDS JAMES M. BECK DAVID A. KOTLER DAVID T. JONES DECHERT LLP BRIELLE M. REY 1095 Avenue of the Americas DECHERT LLP New York, NY 10036 2929 Arch Street (212) 698-3500 Philadelphia, PA 19104 (215) 994-4000 Counsel for Amicus Curiae WILSON-EPES PRINTING CO., INC. – (202) 789-0096 – W ASHINGTON, D. C. 20002 i TABLE OF CONTENTS Page TABLE OF AUTHORITIES ................................ iii INTEREST OF THE AMICUS CURIAE ............ 1 SUMMARY OF ARGUMENT ............................. 3 ARGUMENT ........................................................ 8 I. ADVERSE EVENT REPORTS PRO- VIDE NO RELIABLE BASIS TO INFER CAUSATION ............................................. 11 A. The FDA Requires Manufacturers To Report All Adverse Events Regard- less of Causation .................................. 11 B. The FDA Recognizes that Adverse Event Reporting Is Subject to Significant Statistical Biases and Lacks Scientific Validity ..................... 13 C. Numerous Courts Have Recognized that FDA Adverse Event Reports Are Insufficient for Civil Liability ............. 20 II. THE INHERENT LIMITATIONS OF ADVERSE EVENT REPORTS PRE- CLUDE DRAWING ANY INFERENCE OF SCIENTER, ABSENT STATIS- TICAL SIGNIFICANCE ........................... 24 A. Non-Disclosure of Unreliable or Spe- culative Information to the Public Does Not Support an Inference of Scienter ................................................ 25 B. Statistically Insignificant Adverse Event Reports Can Only Support an Improper Hindsight Inference of Fraud.................................................... 28 ii TABLE OF CONTENTS—Continued Page C. It Is Prudent and Sensible for a Company To Investigate Adverse Event Reports for Statistical Significance Before Making A Public Disclosure ............................................ 31 III. THE NINTH CIRCUIT'S RULE WOULD HAVE DIRE CONSEQUENCES FOR LIFE SCIENCES COMPANIES, IN- VESTORS, AND CONSUMERS .............. 33 CONCLUSION .................................................... 36 iii TABLE OF AUTHORITIES CASES Page Allen v. Pa. Eng'g Corp., 102 F.3d 194 (5th Cir. 1996)..................... 21 Avon Pension Fund v. GlaxoSmithKline, PLC, 343 Fed. App'x 671 (2d Cir. 2009) ............ 25, 27 Basic Inc. v. Levinson, 485 U.S. 224 (1988) ................................... 25 Benkwith v. Matrixx Initiatives, Inc., 467 F. Supp. 2d 1316 (M.D. Ala. 2006) .... 22 Blue Chip Stamps v. Manor Drug Stores, 421 U.S. 723 (1975) ................................... 34 Brumbaugh v. Sandoz Pharm. Corp., 77 F. Supp. 2d 1153 (D. Mont. 1999) ....... 23 Cloud v. Pfizer, Inc., 198 F. Supp. 2d 1118 (D. Ariz. 2001) ....... 22 Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) ................................... 21, 22 Dellinger v. Pfizer Inc., 2006 WL 2057654 (W.D.N.C. July 19, 2006) ...................................................... 22 DeLuca v. Merrell Dow Pharm., Inc., 791 F. Supp.1042 (D.N.J. 1992) ............... 23 Dunn v. Sandoz Pharm. Corp., 275 F. Supp. 2d 672 (M.D.N.C. 2003) ...... 22 Ervin v. Johnson & Johnson, Inc., 2006 WL 1529582 (S.D. Ind. May 30, 2006) ...................................................... 22 iv TABLE OF AUTHORITIES—Continued Page Fort Worth Empl. Ret. Fund v. Biovail Corp., 615 F. Supp.2d 218 (S.D.N.Y. 2009)......... 25 Glastetter v. Novartis Pharm. Corp., 252 F.3d 986 (8th Cir. 2001)..................... 21 Grossman v. Novell, Inc., 120 F.3d 1112 (10th Cir. 1997) ................. 27 Haggerty v. Upjohn Co., 950 F. Supp. 1160 (S.D. Fla. 1996) .......... 23 Heckstall v. Pincus, 797 N.Y.S.2d 445 (N.Y. App. Div. 2005) .. 23 Higginbotham v. Baxter Int'l, Inc., 495 F.3d 753 (7th Cir. 2007)..................... 31, 32 Hollander v. Sandoz Pharm. Corp., 95 F. Supp.2d 1230 (W.D. Okla. 2000) ..... 22, 23 Horizon Asset Mgmt. v. H&R Block, Inc., 580 F.3d 755 (8th Cir. 2009)..................... 31 In re Accutane Prod. Liab. Litig., 2007 WL 1288354 (M.D. Fla. May 2, 2007) ...................................................... 22 In re AstraZeneca Sec. Litig., 559 F. Supp. 2d 453 (S.D.N.Y. 2008)........ 29 In re Baycol Prod. Litig., 532 F. Supp. 2d 1029 (D. Minn. 2007) ..... 22 In re Biogen Sec. Litig., 179 F.R.D. 25 (D. Mass. 1997) .................. 35 In re Breast Implant Litig., 11 F. Supp. 2d 1217 (D. Colo. 1998) ......... 22 v TABLE OF AUTHORITIES—Continued Page In re Carter-Wallace Sec. Litig., 150 F.3d 153 (2d Cir. 1998) ............. 6, 10, 26, 27 In re Carter-Wallace Sec. Litig., 220 F.3d 36 (2d Cir. 2000) ....................... passim In re Diet Drugs Prod. Liab. Litig., 2001 WL 454586 (E.D. Pa. Feb. 1, 2001) ... 22 In re Healthcare Compare Corp. Sec. Litig., 75 F.3d 276 (7th Cir. 1996)....................... 26 In re Intrabiotics Pharm., Inc. Sec. Litig., 2006 WL 2192109 (N.D. Cal. Aug. 1, 2006) ...................................................... 10 In re MedImmune, Inc. Sec. Litig., 873 F. Supp. 953 (D. Md. 1995) ................ 35 In re Medtronic, Inc. Sec. Litig., 618 F. Supp. 2d 1016 (D. Minn. 2009) ..... 10 In re Meridia Prod. Liab. Litig., 328 F. Supp. 2d 791 (N.D. Ohio 2004) ...... 22 In re Norplant Contraceptive Prod. Liab. Litig., 1997 WL 80527 (E.D. Tex. Feb. 19, 1997) ...................................................... 23 Kairalla v. Advanced Med. Optics, Inc., 2008 WL 2879087 (C.D. Cal. June 6, 2008) ...................................................... 10 Masters v. GlaxoSmithKline, 271 Fed. App'x. 46 (2d Cir. 2008) .............. 27 McClain v. Metabolife Int'l, Inc., 401 F.3d 1233 (11th Cir. 2005) ................. 21 vi TABLE OF AUTHORITIES—Continued Page Merrell Dow Pharm., Inc. v. Havner, 953 S.W.2d. 706 (Tex. 1997) ..................... 23, 28 Merrill Lynch, Pierce, Fenner & Smith, Inc. v. Dabit, 547 U.S. 71 (2006) ..................................... 33 N.J. Carpenters Pension & Annuity Funds v. Biogen IDEC Inc., 537 F.3d 35 (1st Cir. 2008) ...................... passim Novak v. Kasaks, 216 F.3d 300 (2d Cir. 2000) ...................... 29 Oran v. Stafford, 226 F.3d 275 (3d Cir. 2000) ...................... 10 Plumbers and Pipefitters Local Union 719 Pension Fund v. Zimmer Holdings, Inc., 673 F. Supp. 2d 718 (S.D. Ind. 2009) ....... 10 Ranes v. Adams Labs., Inc., 778 N.W.2d 677 (Iowa 2010) .................... 23 Reynolds v. Warthan, 896 S.W.2d 823 (Tex. App. 1995) .............. 23 Rider v. Sandoz Pharm. Corp., 295 F.3d 1194 (11th Cir. 2002) ................. 21 Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ................................... 12 Santa Fe Indust., Inc. v. Green, 430 U.S. 462 (1977) ................................... 25 Schlifke v. Seafirst Corp., 866 F.2d 935 (7th Cir. 1989)..................... 26 vii TABLE OF AUTHORITIES—Continued Page SEC v. Zandford, 535 U.S. 813 (2002) ................................... 31 Shields v. Citytrust Bancorp., 25 F.3d 1124 (2d Cir. 1994) ...................... 29 Slayton v. Am. Express Co., 604 F.3d 758 (2d Cir. 2010) ...................... 31 Smith v. Pfizer Inc., 2010 WL 1754443 (M.D. Tenn. Apr. 30, 2010) ...................................................... 22 Soldo v. Sandoz Pharm. Corp., 244 F. Supp. 2d 434 (W.D. Pa. 2003) ........ 22 State Univs. Ret. Sys. of Ill. v. AstraZeneca PLC, 334 Fed. App'x 404 (2d Cir. 2009) ............ 27 Teamsters Local 445 Freight Div. Pension Fund v. Dynex Capital, Inc., 531 F.3d 190 (2d Cir. 2008) ....................... 26 Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308 (2007) ................................... passim TMJ Implants, Inc. v. U.S. Dept. of Health & Human Servs., 584 F.3d 1290 (10th Cir. 2009) ................. 13 TSC Indus., Inc. v. Northway, Inc., 426 U.S. 438 (1976) .............................. 25, 26, 31 Winer Family Trust v. Queen, 503 F.3d 319 (3d Cir. 2007) ...................... 27 viii TABLE OF AUTHORITIES—Continued Page Wyeth v. Levine, 129 S. Ct. 1187 (2009) ............................... 13 Yanek v. Staar Surgical Co., 388 F. Supp. 2d 1110 (C.D. Cal. 2005) ..... 25 STATUTES Securities Exchange Act Section 10(b) 15 U.S.C. § 78j(b) .....................................2, 3, 31 15 U.S.C. § 78u-4(b)(2).............................. 9 21 U.S.C. § 360i(a)(1) ................................ 11 21 U.S.C. § 379aa ...................................... 25 21 U.S.C. § 379aa-1................................... 25 21 U.S.C. § 803.50(a) ................................ 11, 12 Dietary Supplement & Nonprescription Drug Consumer Protection Act, Pub. L. 109-462, 120 Stat. 3469 .................... 25 REGULATIONS Rule 10b-5, 17 C.F.R.§ 240.10b-5.......... 2, 3, 25, 33 17 C.F.R. § 230.175(a) .................................. 32 21 C.F.R. § 803.3 .......................................... 12 21 C.F.R. § 803.9(a) ...................................... 24 21 C.F.R. § 803.12(d) .................................... 15 21 C.F.R. § 803.16 ........................................ 13 21 C.F.R. § 803.20(a) .................................... 15 21 C.F.R. § 803.50(a) .................................... 12 21 C.F.R. § 314.80 ........................................ 11 ix TABLE OF AUTHORITIES—Continued Page 21 C.F.R. § 314.80(a) .................................... 13 21 C.F.R. § 314.80(c)..................................... 13 21 C.F.R. § 314.80(j) ..................................... 13 21 C.F.R. § 600.80 ........................................ 11 Protecting the Identities of Reporters of Adverse Events and Patients; Preemp- tion of Disclosure Rules, 60 Fed. Reg. 16962 (Apr. 3, 1995) .................................. 15 OTHER AUTHORITIES Brief for the United States as Amicus Curiae Supporting Respondents, Brue- sewitz v. Wyeth, Inc, No. 09-152 (U.S. July 23, 2010) ............................................ 18 Catherine Struve, The FDA & the Tort System: Postmarketing Surveillance, Com- pensation, & the Role of Litigation, 5 Yale J. Health Pol'y, L. & Ethics 587 (2005) ......................................................... 16 Edward M. Basile & Beverly H. Lorell, The Food & Drug Administration's Regulation of Risk Disclosure for Implantable Cardioverter Defibrillators: Has Technology Outpaced the Agency's Regulatory Framework?, 61 Food & Drug L.J. 251 (2006) ................................. 16, 17 FDA, Adverse Event Reporting System (Aug. 20, 2009) .......................................... 15 FDA, Center for Devices & Radiological Health, CDRH FY 2006 Annual Report 29 (2006) .................................................... 16 x TABLE OF AUTHORITIES—Continued Page FDA, Center for Devices and Radiological Health, Guidance for Industry & FDA Staff: Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials, (Feb. 5, 2010)................................. 19 FDA, Center for Devices & Radiological Health, Medical Device Reporting for Manufacturers (Mar. 1, 1997) ............. 12, 13, 24 FDA, Center for Drug Evaluation and Research, Annual Adverse Event Drug Experience Report: 1996 (Oct. 30, 1997)... 14 FDA, Center for Devices and Radiological Health, Guidance for Industry Assess- ment of Abuse Potential of Drugs 18 (Discussion Draft Jan. 2010) .................... 18 FDA, Guidance for Industry: Good Phar- macovigilance Practices & Pharmaco- epidemiologic Assessment, (Mar. 2005) ..................................................... 17, 18, 19 GAO, Medical Device Reporting: Im- provements Needed in FDA's System for Monitoring Problems with Approved Devices (Jan. 1997) ................................... 17 GAO, Medical Devices: Early Warning of Problems Is Hampered by Severe Under- reporting (Dec. 1986) ........................... 15, 16, 17 HHS Office of Inspector General, Adverse Event Reporting for Medical Devices (Oct. 2009) ............................................ 11, 16, 19 xi TABLE OF AUTHORITIES—Continued Page MAUDE, "Manufacturer and User Facility Device Experience" ................................... 15, 24 Jeffrey Zigler, et al., Medical Device Reporting: Issues With Class III Medical Devices, 62 Food & Drug L.J. 573 (2007) . 17 Ralph Hall, A Proposed Solution to the Notification Problem, 7 Minn. J.L. Sci. & Tech 189 (2005) ......................................... 19, 20 Richard A. Nagareda, FDA Preemption: When Tort Law Meets the Admini- strative State, 1 J. Tort Law 4 (2006) ....... 29 Tom Baker & Sean J. Griffith, How the Merits Matters: Directors' and Officers' Insurance & Securities Settlements, 157 U. Penn. L. Rev. 755 (2009) ...................... 34 IN THE Supreme Court of the United States ———— No. 09-1156 ———— MATRIXX INITIATIVES INC., et al., Petitioners, v. JAMES SIRACUSANO, et al., Respondents. ———— On Writ of Certiorari to the United States Court of Appeals for the Ninth Circuit ———— BRIEF FOR THE ADVANCED MEDICAL TECHNOLOGY ASSOCIATION AS AMICUS CURIAE IN SUPPORT OF PETITIONERS ———— INTEREST OF THE AMICUS CURIAE 1 The Advanced Medical Technology Association ("AdvaMed") is the largest medical technology associ- ation in the world, representing more than 300 medical device, diagnostic, and health information system companies. AdvaMed's members manufac- 1 The parties have filed letters with the Clerk of Court consenting to the filing of all amicus briefs. No counsel for any party to these proceedings authored this brief, in whole or in part. No other entity or person, aside from amicus AdvaMed and its counsel, made any monetary contribution for the prepa- ration or submission of this brief. 2 ture 90 percent of the $75 billion in health care technology purchased annually in the United States and over 50 percent of the $175 billion in global sales in this most vital of markets. The question presented concerns an issue of fundamental importance to AdvaMed's members and to all healthcare companies subject to the federal requirements for adverse event reporting, as well as investors, health care providers, and patients more generally. AdvaMed has a strong interest in ensur- ing that the federal securities laws are construed so as to require healthcare companies to disclose publicly meaningful and coherent information, instead of partial and anecdotal information that would more likely mislead and confuse investors, rather than assist them. In the decision below, the Ninth Circuit rejected the majority view, endorsed by three courts of appeal and numerous district courts, that a company's non- disclosure of adverse event reports to investors will not form the basis for a claim under Section 10(b) of the Securities Exchange Act and SEC Rule 10b-5, unless such reports are statistically significant. The Ninth Circuit's decision rests on an apparent misconception about the nature of the adverse event reporting system. Left in place, it would require AdvaMed's members to include statistically insignifi- cant and substantively meaningless reports in their public disclosures that would expand the information available to investors and consumers without quali- tatively improving it. AdvaMed submits this amicus curiae brief to assist the Court in considering (1) the nature and role of federal adverse event reporting; and (2) the proper impact of adverse event reports on scienter in Rule 10b-5 actions. 3 SUMMARY OF ARGUMENT The Food and Drug Administration ("FDA") requires healthcare companies, and encourages medical professionals voluntarily, to submit to the agency any and all anecdotal reports tying the use of a medical device or a pharmaceutical product to an adverse event. Although each report is typically meaningless if evaluated on its own—because the reports do not purport to show any actual causal link between the product and the adverse event—the FDA believes that, in the aggregate, the reporting of enough of these events might evidence a statistically significant link between the use of the product and some adverse condition that would merit further investigation. Prior to the Ninth Circuit's decision below, the lower courts had agreed that plaintiffs proceeding under Section 10(b) of the Securities Exchange Act and SEC Rule 10b-5 could not state a claim based solely on a company's non-disclosure of adverse event reports to investors, absent a statistically significant link between the company's product and the adverse events. Those decisions rested upon an appreciation that the FDA's adverse event reporting system provides far more noise, absent some kind of scien- tifically valid screen, than the reliable, material information suitable for disclosure to investors under the securities laws. As explained in Petitioners' opening brief, adverse event reports thus should not be regarded as material, unless they are sufficient to demonstrate a statistically significant link between the product and the adverse event. AdvaMed submits, however, that the requirements for scienter under the securities laws, as elucidated by this Court's decision in 4 Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308 (2007), provide an even more compelling reason why the Ninth Circuit's decision was in error. In Tellabs, the Court held that a strong inference of scienter "must be more than merely plausible or reasonable—it must be cogent and at least as compelling as any opposing inference of nonfrau- dulent intent." Id. at 314 (emphasis added). In view of the nature of the FDA's adverse event reporting system, it is perfectly ordinary as a matter of practice and appropriate as a matter of prudence for a health- care company to exercise caution in making public disclosures to investors unless or until the data evidences a statistically significant link. Accordingly, as a matter of law, a plaintiff cannot meet his burden of pleading facts giving rise to a strong inference of scienter "as compelling as any opposing inference" by simply pointing to a company's non-disclosure to the market of scientifically meaningless adverse event reports. In concluding that the mere "[w]ithholding [of] reports of adverse effects" supports a strong inference of scienter, regardless of the reports' statistical signi- ficance, the Ninth Circuit misapplied the controlling principles of Tellabs and the stiff pleading require- ments imposed by Congress for securities fraud claims. A careful examination of the nature and role of adverse event reporting under the relevant federal regulations compellingly exposes the flaws in the Ninth Circuit's reasoning and demonstrates why the decision should be reversed. 1. Federal regulations require companies that manufacture drugs, medical devices, vaccines, and other products to submit adverse event reports— known as Medical Device Reports ("MDRs") in the 5 medical device industry—to the FDA. MDRs, like all adverse event reports, reflect unverified anecdotal information submitted in various ways to manufac- turers by health professionals and product users. Although potentially useful in the aggregate, adverse event reports are inherently unreliable and subject to numerous biases. First, MDRs make no attempt to rule out even obvious alternative causes (let alone mere chance), because the FDA encourages submission of adverse event reports even in doubtful situations, such as cases of user error. The FDA's reporting systems often generate voluminous but questionable information that pre- cludes determinations of cause and effect. Second, adverse event reports often omit critical information such as the patient's underlying illnesses, medical history, and concomitant use of other products and therapies. Third, adverse publicity, including litigation-generated mass media attention, greatly influences—and often distorts—reporting of adverse events. Indeed, the potential for distortion is greatly magnified under passive surveillance systems, like the FDA's voluntary reporting regime for medical professionals, that are inherently prone to under- reporting. Recognizing the inherent limitations of adverse event reports, the FDA expressly disclaims using them to assess causation. At most, MDRs are individual data points—"signals" in FDA parlance— that can suggest a need for further inquiry. By themselves, they establish no medical or scientific facts. The FDA thus employs sophisticated statistical analyses of adverse events in its databases before drawing any conclusions about their significance, and it expects life sciences companies to do the same. 6 The FDA's skepticism of raw adverse event reports is shared by courts analyzing causation in civil cases. Numerous courts have held that the inherent flaws of adverse event reporting are too serious to allow their use to prove causation. 2. The nature of the FDA's adverse event system underscores why statistical significance is necessary before a court may draw any inference, much less a "strong" inference, that non-disclosure of adverse event reports to the investing public is probative of scienter. Three well-established principles of securi- ties law demonstrate why statistical significance is an appropriate minimum threshold for scienter in cases involving alleged non-disclosure of adverse events to investors: First, a court may infer scienter from the defen- dant's non-disclosure of information only if there is plausible reason to think that the defendant believes he or she has something to hide. A strong inference of scienter therefore may not reasonably be inferred when the defendant regards the undisclosed informa- tion as unreliable or inconclusive. In re Carter- Wallace Sec. Litig., 150 F.3d 153 (2d Cir. 1998), and 220 F.3d 36 (2d Cir. 2000), and its progeny among the lower courts, properly hold that the mere receipt of inconclusive adverse event reports does not support a strong inference of scienter. A defendant cannot be deemed to know of, let alone intentionally or reck- lessly ignore, a causal link between its product and an adverse event where the reports have never established such a connection. Unless and until adverse event reports reach the level of statistical significance, the most plausible inference under Tellabs will always be that the defendant reasonably believes that, in the overall context of the product's 7 history and experience in the market, the existence of the reports did not call into question the product's safety. The Ninth Circuit's contrary decision, equating raw adverse event reports with "red flags" about product safety, misunderstands that the multifarious, and sometimes conflicting, reports amount to little more than background noise in a much broader setting of product usage, unless and until subjected to statistical analysis. Second, scienter must turn on a defendant's know- ledge at the time of an alleged misstatement. "Fraud-by-hindsight" is not actionable under the securities laws. The subsequent linkage of a product to an adverse event does not demonstrate prior intent to deceive. Abandoning statistical significance as a prerequisite to a securities fraud claim would effec- tively hold a life sciences company and its officers culpable for not predicting—based on unreliable and inconclusive adverse event reports—the later emer- gence of a bona fide safety issue. The statistical significance standard protects defendants from such post hoc critiques. Indeed, the Ninth Circuit's finding of a strong inference of scienter based on non- disclosure of statistically insignificant adverse event reports (and an FDA warning letter issued some five years after the class period), raises the untenable specter of fraud-by-hindsight. Third, a defendant's decision to investigate adverse event reports before publicly disclosing them reflects prudence, not the intent to defraud. A company cannot determine the scientific implications of a series of adverse event reports without engaging in a sophisticated statistical analysis of these cumulative reports. The FDA recognizes this and thus advises life sciences companies to investigate such reports 8 carefully before drawing any conclusions. In direct conflict with that direction, the Ninth Circuit actually concluded that Petitioners' investigation supported an inference of scienter, treating such raw reports as indicia of causation. That was error. 3. Adopting the Ninth Circuit's indiscriminate approach to disclosure of unverified adverse event reports would adversely affect life science companies, investors, and patients. If affirmed, the Ninth Cir- cuit's decision would push companies selling pharma- ceuticals, biotechnology, and medical technology to disclose publicly every single adverse event report— amounting to potentially hundreds of thousands of reports annually—with little regard to the strength of the causal link. Under such a regime, companies would be forced to give their imprimatur to unveri- fied and unreliable reports about their products, leading in some cases to artificially depressed stock prices and increased volatility, as confused investors seek to separate the true nuggets of value amidst a torrent of unreliable information. Disclosing such statistically insignificant adverse event reports would harm investors and consumers by distorting the information upon which they base critical investment and health care decisions. While statistical significance alone may not estab- lish the strong inference of scienter that Tellabs demands, the failure even to allege it should be grounds for dismissal. The decision below should be reversed. ARGUMENT The decision below rests upon a misunderstanding of the significance of adverse event reports for products distributed among tens of thousands, and 9 sometimes millions, of consumers throughout the country and the world. As discussed below, the FDA has long recognized that adverse event reports do not constitute reliable information upon which companies or consumers should base actual medical decisions until statistical significance suggests a pattern that merits investigation. Yet the Ninth Circuit held that adverse event reports alone, even if statistically insignificant, may create a factual question about liability under the federal securities laws. Although the lower court misapplied the principles that govern the element of materiality, as explained in Petitioners' opening brief, the Ninth Circuit's holding on scienter is premised upon an even more drastic error. It assumes an inference of fraudulent intent to be equally appropriate to a benign inference when a healthcare company prudently follows FDA recommendations—and common sense—by evaluat- ing the implications of reported adverse events through the lens of science before making a public statement. In pleading securities fraud, plaintiffs must "state with particularity facts giving rise to a strong inference that the defendant acted with the required state of mind," i.e., scienter. 15 U.S.C. § 78u-4(b)(2). 2 "To qualify as 'strong' within the intendment of § 21D(b)(2) . . . an inference of scienter must be more than merely plausible or reasonable—it must be cogent and at least as compelling as any opposing inference." Tellabs, 551 U.S. at 314. A court shall deny a motion to dismiss "only if a reasonable person 2 Scienter is "a mental state embracing intent to deceive, manipulate, or defraud." Tellabs, 551 U.S. at 319 (quotation marks and citation omitted). 10 would deem the inference of scienter cogent and at least as compelling as any opposing inference one could draw from the facts alleged." Id. at 324. Even before Tellabs, the Second Circuit had long recognized that non-disclosure of statistically insigni- ficant adverse event reports cannot give rise to a strong inference of scienter. In re Carter-Wallace, Inc. Sec. Litig., 150 F.3d 153 (2d Cir. 1998) ("Carter- Wallace I"); In re Carter-Wallace, Inc. Sec. Litig., 220 F.3d 36 (2d Cir. 2000) ("Carter-Wallace II"). Two other courts of appeals subsequently adopted this standard, see N.J. Carpenters Pension & Annuity Funds v. Biogen IDEC Inc., 537 F.3d 35 (1st Cir. 2008); Oran v. Stafford, 226 F.3d 275 (3d Cir. 2000) (Alito, J.), 3 and numerous district courts agree. 4 These courts recognize that absent statistical signi- ficance, the far more plausible inference to be drawn from non-disclosure to the public is that the adverse event reports did not yet evidence a correlation, much less a causal connection, between the product and the events. 3 While Oran was decided on materiality grounds, the court's analysis would apply equally well to scienter. Cf. Carter- Wallace II, 220 F.3d at 41 ("Not only were the financial state- ments not materially misleading before the link [between the product and an adverse event] could be made, but any inference of scienter was negated as well."). 4 See, e.g., Plumbers and Pipefitters Local Union 719 Pension Fund v. Zimmer Holdings, Inc., 673 F. Supp. 2d 718, 742 (S.D. Ind. 2009); In re Medtronic, Inc. Sec. Litig., 618 F. Supp. 2d 1016, 1026 (D. Minn. 2009); Kairalla v. Advanced Med. Optics, Inc., 2008 WL 2879087, at *10-11 (C.D. Cal. June 6, 2008); In re Intrabiotics Pharm., Inc. Sec. Litig., 2006 WL 2192109, at *13- 14 (N.D. Cal. Aug. 1, 2006). 11 In expressly rejecting statistical significance as a prerequisite, the Ninth Circuit considered neither the nature of adverse event reports under the FDA's regulatory scheme nor the importance of statistical analysis in evaluating such reports. Yet statistical significance remains the appropriate threshold for determining whether a defendant's non-disclosure of adverse event reports to investors can support any inference of scienter, much less the strong one required by the securities laws. I. ADVERSE EVENT REPORTS PROVIDE NO RELIABLE BASIS TO INFER CAUSATION. A. The FDA Requires Manufacturers To Report All Adverse Events Regardless of Causation. AdvaMed's members, and all medical device manu- facturers, must submit MDRs to the FDA for all suspected adverse incidents. 21 U.S.C. § 360i(a)(1). 5 This reporting requirement, contained in 21 C.F.R. § 803.50(a), extends to more than 20,000 companies and covers almost 100,000 medical devices, from tongue depressors to artificial heart valves. 6 5 This brief focuses on adverse event reporting requirements applicable to medical device companies. Substantially similar requirements apply to virtually all FDA-regulated products, including drugs and vaccines. See, e.g., 21 C.F.R. § 314.80 (drugs); 21 C.F.R. § 600.80 (vaccines). 6 HHS Office of Inspector General, Adverse Event Reporting for Medical Devices ("Adverse Event Reporting"), at 1 (Oct. 2009), available at http://oig.hhs.gov/oei/reports/oei-01-08-00110.pdf. All Web pages cited herein were last visited no earlier than August 23, 2010. 12 MDRs must be filed with the FDA without regard to the likelihood of causation. An "MDR Reportable Event" occurs whenever a manufacturer learns of anything "reasonably suggest[ing]" that its device: (1) "[m]ay have caused or contributed to a death or serious injury," or (2) experienced a non-injurious "malfunction" that "would be likely to cause or contribute to a death or serious injury" if it recurred. 21 C.F.R. § 803.50(a). 7 "Caused or contributed" is defined to include unknown and doubtful cases: Caused or contributed means that a death or serious injury was or may have been attributed to a medical device, or a medical device may have been a factor in the death or serious injury. 21 C.F.R. § 803.3 (emphasis added); see Riegel v. Medtronic, Inc., 552 U.S. 312, 319 (2008) (citing 21 C.F.R. § 803.50(a)). MDRs are required even for "user error." 21 C.F.R. § 803.3. Filing an MDR in no way establishes that a device had anything to do with the reported event: A report or other information . . . is not neces- sarily an admission that the device . . . caused or contributed to the reportable event. [Manufac- turers] do not have to admit and may deny that the report or information submitted . . . consti- tutes an admission that the device . . . caused or contributed to the reportable event. 7 Malfunction MDRs must be filed whenever "the chance of a death or serious injury . . . is not remote." FDA, Center for Devices & Radiological Health, Medical Device Reporting for Manufacturers ("Medical Device Reporting"), 1997 WL 33793806 § 2 (Mar. 1, 1997). For malfunctions, there is "no[] need to assess the likelihood that a malfunction will recur," as recur- rence is "presume[d]." Id. 13 21 C.F.R. § 803.16; see FDA, Medical Device Report- ing § 3 (definition of "Disclaimers"). 8 Only two circumstances are exempt from reporting: (1) if the supposed event did not happen at all, and (2) if the event involves another manufacturer's device. FDA, Medical Device Reporting § 2. 9 B. The FDA Recognizes that Adverse Event Reporting Is Subject to Signifi- cant Statistical Biases and Lacks Scientific Validity. Not surprisingly, the FDA has long recognized the limitations of adverse event reporting for medical devices and drugs, and it readily acknowledges that these limitations preclude causation assessment: 1. For any given [reported] case, there is no certainty that the suspected drug caused the [adverse event]. This is because physicians and 8 The FDA intentionally chose more reports over better ones. As the Tenth Circuit has explained: "FDA reiterated the need for an expansive reporting system and adopted regulations that require manufacturers to file an MDR if they become aware of information suggesting that a device may have caused or contributed to a death or serious injury rather than the more limited language proposed that would have required manufac- turers to file an MDR only in cases where they receive informa- tion suggesting that a device has caused or contributed to a death or serious injury." TMJ Implants, Inc. v. U.S. Dept. of Health & Human Servs., 584 F.3d 1290, 1295 (10th Cir. 2009) (citing FDA regulation). 9 A similarly broad reporting requirement exists for prescrip- tion drugs. Drug manufacturers must make reports to the FDA about "[a]ny adverse event associated with the use of a drug in humans, whether or not considered drug related." Wyeth v. Levine, 129 S. Ct. 1187, 1210 (2009) (quoting 21 C.F.R. §§ 314.80(a), (c), (j)). 14 consumers are encouraged to report all suspected [adverse events], not just those that are already known to be caused by the drug. The adverse event may have been related to an underlying disease for which the drug was given, to other concomitant drugs, or may have occurred by chance at the same time the suspect drug was administered. 2. Accumulated [adverse events] may not be used to calculate incidences or estimates of drug risk. Numbers from these data should be care- fully interpreted as reporting rates and not occurrence or incidence rates. FDA, Center for Drug Evaluation and Research, Annual Adverse Event Drug Experience Report: 1996 2 (Oct. 30, 1997). 10 The FDA's current guidance on its Web site can- didly advises that adverse event reports lack statis- tical validity: [T]here is no certainty that the reported event was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. Further, FDA does not re- ceive all adverse event reports that occur with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event. Therefore, [adverse event reports] can- 10 Available at http://druganddevicelaw.net/Annual%20Adverse %20drug%20experience%20report%201996.pdf. 15 not be used to calculate the incidence of an adverse event in the U.S. population. FDA, Adverse Event Reporting System (Aug. 20, 2009). 11 With respect to MDRs, the FDA similarly warns that "MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices." 12 The statistical biases in adverse event reports relate to the inconsistent, informal, and anecdotal nature of the FDA's reporting system. Although mandatory for the manufacturers of all medical devices and drugs, adverse event reporting is purely voluntary for healthcare professionals—who may be the primary source for reports, depending upon the device or drug in question. See In re Medtronic, Inc., 184 F.3d 807, 809 (8th Cir. 1999). Through the FDA's "MedWatch" reporting system, physicians, physician assistants, pharmacists, and nurses may submit reports "either directly to the agency or to other entities who report to the agency" (i.e., the manufacturers). Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules, 60 Fed. Reg. 16962, 16962 (Apr. 3, 1995); see 21 C.F.R. §§ 803.12(d), 803.20(a). More- over, adverse event reports from healthcare pro- fessionals are highly informal; the great majority are made orally to manufacturers. See General 11 Available at http://www.fda.gov/Drugs/Guidance Compliance RegulatoryInformation/Surveillance/AdverseDrugEffects/default. htm. 12 MAUDE, which stands for "Manufacturer and User Facility Device Experience," is the FDA's online MDR database. Availa- ble at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/ search.cfm. 16 Accounting Office, Medical Devices: Early Warning of Problems Is Hampered by Severe Underreporting ("Medical Devices") 47 (Dec. 1986) (83% are oral reports). Because the FDA requires manufacturers to submit duplicative adverse event reports for inci- dents voluntarily reported to them by healthcare providers, MedWatch "generate[s] a deluge of infor- mation." Catherine Struve, The FDA & the Tort System: Postmarketing Surveillance, Compensation, & the Role of Litigation, 5 Yale J. Health Pol'y, L. & Ethics 587, 604 (2005). For example, the FDA reported receiving 224,197 MDRs during its 2006 fiscal year. FDA, Center for Devices & Radiological Health, CDRH FY 2006 Annual Report 29 (2006). 13 A more recent report concluded that this total was even larger: This number increased steadily until 2006, when it increased more than fourfold to 443,066 events, and then stayed relatively flat with 449,978 events in 2007. HHS Office of Inspector General, Adverse Event Reporting, at 10. That sharp increase was due to one particular manufacturer's device, id., demonstrating again the volatility of the reporting system. At the same time, while MDR totals "may seem high, underreporting of adverse events" is a persis- tent problem. Edward M. Basile & Beverly H. Lorell, The Food & Drug Administration's Regulation of Risk Disclosure for Implantable Cardioverter Defibrilla- tors: Has Technology Outpaced the Agency's Regula- 13 Available at http://www.fda.gov/downloads/AboutFDA/Centers Offices/CDRH/CDRHReports/ucm129258.pdf. 17 tory Framework?, 61 Food & Drug L.J. 251, 258 (2006). In 1986 (under earlier regulations), the General Accounting Office ("GAO") estimated that health care providers voluntarily reported only one percent of reportable events to the FDA and only about half to the manufacturers. 14 A decade later, GAO found that systemic underreporting persisted. 15 "Reasons" for underreporting: include ignorance of the reporting system, com- placency, fear of medicolegal liability, personal or professional guilt about having inadvertently harmed a patient, and uncertainty as to whether the drug or device was actually the cause of the adverse event. Jeffrey Zigler, et al., Medical Device Reporting: Issues With Class III Medical Devices, 62 Food & Drug L.J. 573, 577 (2007). Chronic underreporting by healthcare providers allows extraneous factors to influence reporting rates. In 2005, the FDA concluded that adverse event reporting is "subject to substantial limitations in interpretation because of the inherent uncer- tainties in the numerator and denominator." FDA, Guidance for Industry: Good Pharmacovigilance Prac- tices & Pharmacoepidemiologic Assessment ("Good Pharmacovigilance"), 2005 WL 3628217 § IV(G) (Mar. 2005). Thus: [V]oluntary adverse event reporting systems . . . are subject to a variety of reporting biases (e.g., 14 GAO, Medical Devices, at 50-51. 15 GAO, Medical Device Reporting: Improvements Needed in FDA's System for Monitoring Problems with Approved Devices 15-17 (Jan. 1997), available at http://www.gao.gov/archive/1997/ he97021.pdf. 18 some observations could reflect concomitant treatment, not the product itself, and other factors, including the disease being treated, other co-morbidities or unrecorded confounders, may cause the events to be reported). In addition, [the] data may be affected by the submission of incomplete or duplicate reports, underreporting, or reporting stimulated by publicity or litigation. Id. § IV(E). In a brief filed with the Court this Term, the Solici- tor General similarly acknowledged that voluntary adverse event reporting in the vaccine context is "not sufficient" for "sound" decision making and requires "further investigation": Because VAERS [the vaccine adverse event reporting system] depends on self-reporting, however, its data alone are not sufficient for sound public health policy decisions. VAERS data are instead used to trigger further investigation. 16 To cull true product risk from mere reporting biases, statistical significance—not the number of reported events—is essential. As the FDA recently explained, "[i]nformation from other sources that is neither systematically acquired nor statistically significant can provide only anecdotal information." 17 16 Brief for the United States as Amicus Curiae Supporting Respondents, Bruesewitz v. Wyeth, Inc, No. 09-152, at 21-22 (U.S. July 23, 2010). 17 FDA, Center for Devices and Radiological Health, Guidance for Industry Assessment of Abuse Potential of Drugs 18 (Discussion Draft Jan. 2010), available at http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM198650.pdf. 19 The FDA neither acts, nor demands that manufac- turers act, upon raw adverse event reports of the sort at issue in the present case. Instead, the FDA employs statistical analysis—precisely what the Ninth Circuit rejected here. 18 Despite the value of the FDA's adverse event reporting system, the data contained within the database is plagued by significant flaws that prevent the information from being relied upon absent such analysis: First, no causation requirement means "that the system gets flooded with too many (generally unim- portant) reports" and generates so much noise that "[k]ey data regarding new issues can get lost in this sea of irrelevant information." Ralph Hall, A Proposed Solution to the Notification Problem, 7 Minn. J.L. Sci. & Tech. 189, 194 (2005). Second, "underreporting is a recognized problem . . . [p]articularly for low frequency events" where "every report is critical." Id. And third, the FDA's "passive systems provide only a raw number of events and not the incident rate" 18 The FDA utilizes "trend analyses . . . such as calculating occurrence rate changes for specific events." HHS Office of Inspector General, Adverse Event Reporting, at 5. The FDA's latest device guidance recommends sophisticated analysis "to mine large databases of post-market medical reports" in order to "reduce the number of falsely significant associations that are expected." FDA, Center for Devices and Radiological Health, Guidance for Industry & FDA Staff: Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials, 2010 WL 545395 § 6 (Feb. 5, 2010). Similar forms of "data mining" are recommended for evaluating adverse drug events. FDA, Good Pharmacovigilance, § V. 20 and "may not provide a valid basis for medical deci- sions." Id. In other words, the FDA's reporting system results in a database that is both overinclusive and underin- clusive, with the biases of underreporting influenced by a variety of confounding factors. Thus, sophisti- cated statistical analysis is required before the infor- mation may be relied upon to draw any meaningful conclusions. C. Numerous Courts Have Recognized that FDA Adverse Event Reports Are Insuffi- cient for Civil Liability. Respondents' attempt to rely upon adverse event reports to establish civil liability under the securities laws calls to mind more frequent attempts by plain- tiffs in products-liability cases to mine the FDA's adverse event database for evidence of causation. In that context, too, the vast majority of federal courts have concluded that, absent statistical significance, adverse event reports are insufficient to support liability. In seeking to fulfill its broad mandate to ensure the safety of drugs and medical devices, the FDA seeks to pull together as much information as possible in the adverse event databases, not to assemble a database of reliable reports sufficient to satisfy individual questions of causation. Such administrative analysis involves a much lower standard than necessary in a court of law: This methodology results from the preventive perspective that the agencies adopt in order to reduce public exposure to harmful substances. The agencies' threshold of proof is reasonably 21 lower than that appropriate in tort law, which traditionally makes more particularized inqui- ries into cause and effect. Allen v. Pa. Eng'g Corp., 102 F.3d 194, 198 (5th Cir. 1996) (citation and internal quotation marks omit- ted); see also Rider v. Sandoz Pharm. Corp., 295 F.3d 1194, 1201 (11th Cir. 2002) ("A regulatory agency such as the FDA may choose to err on the side of caution."); Glastetter v. Novartis Pharm. Corp., 252 F.3d 986, 991 (8th Cir. 2001) ("[M]ethodology employed by a government agency results from the preventive perspective that the agencies adopt."). For this reason, courts in civil litigation frequently reject the scientific validity of FDA MedWatch reporting when applying scientific reliability stan- dards under Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993). In McClain v. Metabolife Int'l, Inc., 401 F.3d 1233, 1250 (11th Cir. 2005), for instance, the court recognized that "FDA reports reflect complaints called in by product consumers without any medical controls or scientific assess- ment." Utilization of such reports to prove causation was unscientific, and admission of this testimony was an abuse of discretion: [A]necdotal reports do not prove causation . . . . Uncontrolled anecdotal information offers one of the least reliable sources to justify opinions about both general and individual causation. Id. Mere complaints "lack[] the indicia of scientific reliability." Id. at 1240. Accord Glastetter, 252 F.3d at 989-90 (voluntary reports "make little attempt to screen out alternative causes," "frequently lack anal- ysis," and "often omit relevant facts"). 22 Numerous district courts ruling on Daubert and similar evidentiary challenges have reached the same conclusion, dismissing adverse event report data as "uncontrolled anecdotal information," Benkwith v. Matrixx Initiatives, Inc., 467 F. Supp. 2d 1316, 1327 (M.D. Ala. 2006), that "suggest only a potential, untested hypothesis," In re Breast Implant Litig., 11 F. Supp. 2d 1217, 1228 (D. Colo. 1998), that lack any "known or potential rate of error," In re Baycol Prod. Litig., 532 F. Supp. 2d 1029, 1041 (D. Minn. 2007), and are simply "not probative of . . . notice." Smith v. Pfizer Inc., 2010 WL 1754443, at *5 (M.D. Tenn. Apr. 30, 2010). 19 19 Accord In re Accutane Prod. Liab. Litig., 2007 WL 1288354, at *3 (M.D. Fla. May 2, 2007) (MedWatch reports "reflect[] nothing more than an assessment of a possible relationship, not an actual relationship"); Dellinger v. Pfizer Inc., 2006 WL 2057654, at *9 (W.D.N.C. July 19, 2006) (reports "are not scientific proof of causation" and "cannot support a causation opinion"); Ervin v. Johnson & Johnson, Inc., 2006 WL 1529582, at *6 (S.D. Ind. May 30, 2006) (reports "do little more than establish a temporal association between an exposure to a drug and a particular occurrence"), aff'd, 492 F.3d 901 (7th Cir. 2007); In re Meridia Prod. Liab. Litig., 328 F. Supp. 2d 791, 807 (N.D. Ohio 2004) ("[P]roportional reporting rate analyses are incomplete and often misleading because they do not show the total distribution of reports."), aff'd, 447 F.3d 861 (6th Cir. 2006); Dunn v. Sandoz Pharm. Corp., 275 F. Supp. 2d 672, 682 (M.D.N.C. 2003) (re- ports lack "information that would be necessary to determine . . . causation"); Soldo v. Sandoz Pharm. Corp., 244 F. Supp. 2d 434, 537 (W.D. Pa. 2003) (reports "are compilations of occur- rences" and "do not demonstrate a causal link but instead represent coincidence"); Cloud v. Pfizer, Inc., 198 F. Supp. 2d 1118, 1133 (D. Ariz. 2001) (reports "are merely compilations of occurrences, and have been rejected as reliable scientific evi- dence"); In re Diet Drugs Prod. Liab. Litig., 2001 WL 454586, at *15 (E.D. Pa. Feb. 1, 2001) (reports "are universally recognized as insufficient and unreliable evidence of causation"); Hollander 23 State courts applying similar scientific validity standards concur. In Merrell Dow Pharm., Inc. v. Havner, 953 S.W.2d 706, 720 (Tex. 1997), the court excluded "case reports" because "anecdotal . . . evi- dence accomplishes no more than a false appearance of direct and actual knowledge of a causal rela- tionship." So too the Iowa Supreme Court, which recently held that FDA "[c]ase reports are merely accounts of medical events. They reflect only re- ported data, not scientific methodology." Ranes v. Adams Labs., Inc., 778 N.W.2d 677, 693 (Iowa 2010). 20 v. Sandoz Pharm. Corp., 95 F. Supp.2d 1230, 1237 (W.D. Okla. 2000) (reports "are not controlled studies and do not eliminate confounding variables"), aff'd in relevant part, 289 F.3d 1193 (10th Cir. 2002); Brumbaugh v. Sandoz Pharm. Corp., 77 F. Supp. 2d 1153, 1156 (D. Mont. 1999) (reports "don't isolate and investigate the effects of alternative causation agents," "are compilations of reported phenomena," and "reflect reported data, not scientific methodology"); In re Norplant Contraceptive Prod. Liab. Litig., 1997 WL 80527, at *1 (E.D. Tex. Feb. 19, 1997) (reports excluded because "the FDA requires [defendant] to submit all adverse events reported to it without regard to whether there is any proven causal connection"); Haggerty v. Upjohn Co., 950 F. Supp. 1160, 1164 (S.D. Fla. 1996) (reports "can be used to generate hypotheses" but "scientifically valid cause and effect determinations depend on controlled clinical trials and epidemiological studies"), aff'd mem., 158 F.3d 588 (11th Cir. 1998); DeLuca v. Merrell Dow Pharm., Inc., 791 F. Supp. 1042, 1050 (D.N.J. 1992) (reports have "inherent biases as they are second-or-third hand reports, are affected by medical or mass media attention, and are subject to other distortions"), aff'd mem., 6 F.3d 778 (3d Cir. 1993). 20 Accord Heckstall v. Pincus, 797 N.Y.S.2d 445, 447 (N.Y. App. Div. 2005) (MedWatch reports are "unverified listings and reporting of adverse reactions" and "are not generally accepted in the scientific community on questions of causation"); Reynolds v. Warthan, 896 S.W.2d 823, 828 (Tex. App. 1995) (reports only "create[] a suspicion without any medical proof"). 24 In no other case and in no other area of the law have adverse event reports carried the weight that the Ninth Circuit gave them below. II. THE INHERENT LIMITATIONS OF AD- VERSE EVENT REPORTS PRECLUDE DRAWING ANY INFERENCE OF SCIEN- TER, ABSENT STATISTICAL SIGNIFIC- ANCE. Given the inherent limitations and biases of adverse event reports, as acknowledged by the FDA and the courts, such reports are presumptively incon- clusive of a correlation—let alone a causal connec- tion—between a product and an adverse event. They are scientifically meaningless until cumulative statis- tical analysis demonstrates otherwise. In view of such limitations, there is simply no basis upon which a court could draw an inference that a company's decision not to disclose such isolated reports through a public statement to investors was suspicious in any way, much less that it supports a "strong inference" of fraudulent intent "at least as compelling as any opposing inference." Tellabs, 551 U.S. at 314. 21 21 Adverse event reports received by medical device manufac- turers are, in fact, publicly available. The FDA has authority to disclose adverse event reports to the public, see 21 C.F.R. § 803.9(a), and through the MAUDE online database, see supra, n.12, all adverse event reports involving medical devices (MDRs) are made available to the public by the FDA, subject to protection of trade secrets and patients' personal medical infor- mation. See id. § 803.9(b); see also Medical Device Reporting § 3 (explaining disclosure process). The public availability of MDRs is a separate reason why securities fraud claims against medical device manufacturers cannot be based on the alleged non-disclosure of MDRs. See, 25 A. Non-Disclosure of Unreliable or Spe- culative Information to the Public Does Not Support an Inference of Scienter. In assessing scienter in non-disclosure cases, the quality of the undisclosed information is critical. Information need not be disclosed that is inconclu- sive, speculative, or "of dubious significance." Basic Inc. v. Levinson, 485 U.S. 224, 231 (1988) (quoting TSC Indus., Inc. v. Northway, Inc., 426 U.S. 438, 448 e.g., Santa Fe Indust., Inc. v. Green, 430 U.S. 462, 474 (1977) (no actionable Rule 10b-5 claim where plaintiffs were "furnished with all relevant information on which to base their decision"); see also Avon Pension Fund v. GlaxoSmithKline, PLC, 343 Fed. App'x 671, 674 (2d Cir. 2009) (disclosure to the FDA "effectively refutes that the pleaded circumstances support the requisite inference of scienter"); Fort Worth Empl. Ret. Fund v. Biovail Corp., 615 F. Supp.2d 218, 221 (S.D.N.Y. 2009) (no scienter where allegedly undisclosed letter "was publicly available on the FDA's website throughout the putative class period, where it could have been read and assessed by any investor"); Yanek v. Staar Surgical Co., 388 F. Supp. 2d 1110, 1126 (C.D. Cal. 2005) (no scienter where "the MAUDE printouts were available through the FDA"; "the market already had the necessary information"). Unlike medical devices, the product at issue in the present case, Zicam, was an over-the-counter homeopathic product, and the FDA did not require mandatory adverse event reporting for such OTC medications until 2006. See Dietary Supplement & Nonprescription Drug Consumer Protection Act, Pub. L. 109-462, 120 Stat. 3469, codified as 21 U.S.C. §§ 379aa (OTC drug reporting requirements) and 379aa-1 (same for dietary supplements). The allegations in this case involved the non-disclosure of pre-2006 adverse events reports. But no matter whether a company is obliged to submit adverse event reports to the FDA, the scienter analysis should remain the same. In either case, as discussed below, scienter does not exist where a company has no reason to believe that the reports are statistically significant. 26 22 (1976)). Non-disclosure of such information to the market supports no inference, much less a strong inference, of intent to deceive. In these circum- stances, "the defendant did not have sufficient information at the relevant time to form an evalu- ation that there was a need to disclose certain information and to form an intent not to disclose it." N.J. Carpenters, 537 F.3d at 45 (emphasis added). Stated differently, a defendant has no "reason to believe" that non-disclosure of inconclusive or otherwise suspect information creates a danger of misleading investors. Carter-Wallace I, 150 F.3d at 157; see also Schlifke v. Seafirst Corp., 866 F.2d 935, 946 (7th Cir. 1989) ("The question is not merely whether the [defendant] had knowledge of the undisclosed facts; rather, it is the danger of misleading buyers that must be actually known or so obvious that any reasonable man would be legally bound as knowing.") (citation and internal quotation marks omitted). A company cannot have culpable knowledge of a product safety issue without a sound reason to believe that the product is causally linked to an adverse event. Yet until a statistically significant association is apparent, the company can draw no meaningful inferences from anecdotal reports and thus has no basis "to form an evaluation that there 22 See also Teamsters Local 445 Freight Div. Pension Fund v. Dynex Capital, Inc., 531 F.3d 190, 196 (2d Cir. 2008) (no inference of scienter where "[plaintiffs'] broad reference to raw data lacks even an allegation that these data had been collected into reports that demonstrated" their allegations); In re Health- care Compare Corp. Sec. Litig., 75 F.3d 276, 282-83 (7th Cir. 1996) (no duty to disclose tentative internal estimates subject to revision or verification, even though they conflict with published estimates). 27 was a need to disclose." N.J. Carpenters, 537 F.3d at 45; see also Avon, 343 Fed. App'x at 672 ("Reports or test results must yield reliable evidence of a drug's adverse effect to give rise to a duty . . . to disclose those results to potential investors."). Absent statis- tical significance, the company thus has no reason to view adverse event reports as casting doubt on product safety, and without such a belief, there is no legal basis to infer an intent to deceive the public through non-disclosure. 23 Instead, the most plausible inference is that the company continued to believe that its product—marketed only after FDA review— remained safe. 24 23 It should be emphasized that the statistical significance of adverse event reports is a necessary, but not a sufficient, con- dition to establish scienter. Scienter requires that the company also know that the reports are "sufficiently serious and frequent to affect future earnings" and threaten the "commercial viabil- ity" of the company. Carter-Wallace I, 150 F.3d at 157; see also Masters v. GlaxoSmithKline, 271 Fed. Appx. 46, 50-51 (2d Cir. 2008) (dismissing non-disclosure complaint because the statisti- cally significant test results were "financially immaterial" as the product represented less than 3% of the company's sales). Moreover, a complaint must plead particularized allegations that support imputing knowledge of non-disclosed adverse events, as well as their significance, to each defendant. See, e.g., Winer Family Trust v. Queen, 503 F.3d 319, 335-36 (3d Cir. 2007). 24 See, e.g., Carter-Wallace II, 220 F.3d at 42 ("[U]ntil a connection between [the product] and any illness could be made, we would not expect [defendant] to abandon its product on what, at the time, would have been speculation."); State Univs. Ret. Sys. of Ill. v. AstraZeneca PLC, 334 Fed. App'x 404, 407 (2d Cir. 2009) ("[P]laintiffs have not alleged anything to negate the idea that defendants were attempting to develop a drug that they thought [would be] beneficial and were so describing it to the public.") (quotation omitted). 28 The Ninth Circuit failed to appreciate the inherent inconclusiveness and unreliability of adverse event reports. Instead of viewing unverified adverse event reports with appropriate skepticism, the Ninth Circuit fell victim to their "false appearance of direct and actual knowledge of a causal relationship." Merrell Dow, 953 S.W.2d at 720. Nowhere in Respon- dents' complaint is there any allegation, much less a particularized one, that the non-disclosed adverse event reports at issue here were statistically signifi- cant. Absent that critical allegation, there is no scientific basis upon which these adverse event reports may be deemed to support causation, and thus any inference that adverse event reports were withheld with fraudulent intent is not "cogent and at least as compelling as any opposing inference of nonfraudulent intent." Tellabs, 551 U.S. at 314. B. Statistically Insignificant Adverse Event Reports Can Only Support an Improper Hindsight Inference of Fraud. This Court has observed that one recognized purpose of the "strong inference" standard for scienter is "to ward off allegations of 'fraud by hindsight.'" Tellabs, 551 U.S. at 319 (citations omitted). A plaintiff must allege particularized facts that the defendant's statements were false or misleading when they were made. A classic fraud-by-hindsight scenario assumes that "simply because the alleged misrepresentation conflicts with the current state of the facts, the charged statement must have been false" when made. Grossman v. Novell, Inc., 120 F.3d 1112, 1124 (10th Cir. 1997) (citation and quotation marks omitted). "Corporate officials need not be clairvoyant; they are only responsible for revealing 29 those material facts that are reasonably available to them." Novak v. Kasaks, 216 F.3d 300, 309 (2d Cir. 2000). Nor are they "required to take a gloomy, fearful or defeatist view of the future; subject to what current data indicates, they can be expected to be confident." Shields v. Citytrust Bancorp., 25 F.3d 1124, 1129 (2d Cir. 1994). Securities fraud cases against life sciences compa- nies commonly allege that "a promising drug or medi- cal device is approved by the FDA and then later proves to have health risks which affect the market for the [product]." N.J. Carpenters, 537 F.3d at 47. Such suits are rife with fraud-by-hindsight claims. But if the management of the company releases positive reports about the drug to the public along the way which the management honestly believes to be true, and where there is no reck- less disregard for truth, then that is not securi- ties fraud, even though at a later point some event occurs which prevents the marketing of the drug or makes it necessary to take the drug off the market. In re AstraZeneca Sec. Litig., 559 F. Supp. 2d 453, 470 (S.D.N.Y. 2008), aff'd, 334 Fed. App'x 404 (2d Cir. 2009). Carter-Wallace and its progeny cogently recognize that without statistical significance, securities claims based on non-disclosure of adverse event reports to investors inherently allege "fraud by hindsight." Carter-Wallace II, 220 F.3d at 42. 25 The defendant is 25 See also Richard A. Nagareda, FDA Preemption: When Tort Law Meets the Administrative State, 1 J. Tort Law 4, 49 (2006) ("Litigation is inherently prone to play into hindsight bias. Early, speculative information—say, from anecdotal experience 30 blamed for not identifying product safety concerns in advance of the available data. Until scientifically valid methods reveal an association between the product at issue and adverse events, a defendant is entitled to view the reports as they are: unverified anecdotal accounts that may describe events caused by any number of things, from the condition being treated, to a simultaneously used product, to operator error, to mere chance. See supra at pp. 11-20. "The eventual linking of [an adverse event] to [a product] cannot relate back to the time of the [allegedly misleading] statements . . . and reflect on [a com- pany's] reasonable belief that the reports were random." Carter-Wallace II, 220 F.3d at 41. The statistical significance standard directly protects against such fraud-by-hindsight abuses, such as occurred in the present case. Indeed, the Ninth Circuit's rejection of any requirement that the non-disclosed adverse event reports be statistically significant virtually guaran- teed fraud-by-hindsight. The court itself relied (Pet. App. at 2a n.1) on an FDA warning letter dated June 2009—more than five years after the close of the class period. Such a post hoc association plainly can have no legal bearing on Petitioners' conduct during the 2003-2004 class period. in the absence of systematic research controls—might seem the first inkling of a drug safety problem only when framed within subsequent scientific developments"). 31 C. It Is Prudent and Sensible for a Com- pany To Investigate Adverse Event Reports for Statistical Significance Before Making A Public Disclosure. Section 10(b) seeks "to achieve a high standard of business ethics in the securities industry." SEC v. Zandford, 535 U.S. 813, 819 (2002) (quotation omit- ted). "A prudent course of action . . . weakens rather than strengthens an inference of scienter." Slayton v. Am. Express Co., 604 F.3d 758, 777 (2d Cir. 2010) (quoting Horizon Asset Mgmt. v. H&R Block, Inc., 580 F.3d 755, 763 (8th Cir. 2009)). Because publicly traded companies have a duty to speak accurately when they speak to their investors, "[p]rudent managers conduct inquiries rather than jump the gun with half-formed stories as soon as a problem comes to their attention." Higginbotham v. Baxter Int'l, Inc., 495 F.3d 753, 760-61 (7th Cir. 2007) (Easterbrook, J.). Far from reflecting a guilty state of mind, it is prudent and sensible for a publicly traded life sciences company to forego disclosing raw adverse event data to investors unless and until the reports are analyzed both individually and in the aggregate. Only if the reports reveal a statistically significant product safety issue could a disclosure obligation arise. Carter-Wallace II, 220 F.3d at 42 ("[U]ntil a connection between [a] product and any illness could be made, we would not expect [a company] to aban- don its product."). Making disclosures to investors regarding unverified adverse event reports "on what, at the time, would have been speculation" about their significance, id., is unquestionably irresponsible. See TSC, 426 U.S. at 448 (disclosure of "dubious" infor- mation "may accomplish more harm than good"); 32 N.J. Carpenters, 537 F.3d at 58 (defendant "would have behaved irresponsibly (and possibly in violation of the securities laws) if it had made a public announcement which was possibly inaccurate because the situation of [adverse event] incidences had not yet been adequately investigated.") 26 The statistical significance standard avoids this no-win dilemma. Perversely, the Ninth Circuit drew an inference of scienter from Petitioners' decision to investigate the handful of adverse event reports involving Zicam. The court observed that the defendants were "suffi- ciently concerned" about the customer complaints to "call[] [a doctor] about one of her patients who had complained" and "ask if [the doctor] would participate in studies" of the drug. (Pet. App. at 32a.) But "[k]nowing enough to launch an investigation . . . is a very great distance from convincing proof of intent to deceive." Higginbotham, 495 F.3d at 758. Indeed, the far more plausible inference was that Petitioners' investigative efforts reflected compliance with the FDA's guidance simply to investigate the adverse event reports—an inference that must be drawn in Petitioners' favor under Tellabs. Absent statistical significance, the Ninth Circuit's conclusion that non-disclosure of adverse event re- ports to the public "present[ed] a danger of mis- leading buyers or sellers" (Pet. App. at 33a) is unwarranted as a matter of law. 26 See also Higginbotham, 495 F.3d at 761 (defendant "might more plausibly have been accused of deceiving investors had managers called a press conference before completing the steps necessary to determine just what happened"); 17 C.F.R. § 230.175(a) (forecasts made without a reasonable basis are not protected by safe harbor). 33 III. THE NINTH CIRCUIT'S RULE WOULD HAVE DIRE CONSEQUENCES FOR LIFE SCIENCES COMPANIES, INVESTORS, AND CONSUMERS. Over the last decade, life sciences companies have assumed that non-disclosure of statistically insignifi- cant adverse event reports (to anyone but the FDA) would not support an actionable securities claim under Rule 10b-5. The Ninth Circuit's contrary deci- sion threatens a dramatic change in the status quo. Absent a statistical significance requirement, life sciences companies will be forced to make difficult decisions whether or not to disclose each and every adverse event report to the market upon receipt, with either choice creating litigation risk. Given the hundreds of thousands of adverse event reports generated annually, that burden and risk cannot be overstated. The most obvious risk to life sciences companies from any abandonment of the statistical significance standard is present here—a securities lawsuit claiming non-disclosure of statistically insignificant adverse event reports. As all concerned with class action securities litigation are well-aware, the Rule 12(b)(6) stage carries almost "dispositive" signific- ance, as unsuccessful defendants must decide whether to settle based on a multitude of non-merits factors, including the huge cost of protracted discov- ery. See Merrill Lynch, Pierce, Fenner & Smith, Inc. v. Dabit, 547 U.S. 71, 80 (2006) ("[L]itigation under Rule 10b-5 presents a danger of vexatiousness differ- ent in degree and in kind from that which accompa- nies litigation in general . . . Even weak cases brought under the Rule may have substantial settle- ment value . . . because '[t]he very pendency of the 34 lawsuit may frustrate or delay normal business activity.'") (quoting Blue Chip Stamps v. Manor Drug Stores, 421 U.S. 723, 739 (1975)); Tom Baker & Sean J. Griffith, How the Merits Matters: Directors' and Officers' Insurance & Securities Settlements, 157 U. Penn. L. Rev. 755, 820 (2009) (motions to dismiss are "dispositive" because "essentially all securities class actions that survive a motion to dismiss are [ultimately] settled with a payment to the class"). Under the Ninth Circuit's rule, every decision not to disclose an adverse event report to investors, regardless of statistical significance, could be very costly. Overcautious companies erring on the side of mass disclosure of adverse event reports expose themselves to different, yet equally troubling, securities litigation risks. The Ninth Circuit's decision will deprive companies of the opportunity to investigate adverse event reports, or to conduct the statistical analyses recommended by the FDA, before making such disclosures. Companies opting for preemptive disclo- sure would do so on incomplete information. They would be in the precarious position of crafting disclo- sures that disclaim such events' significance, while simultaneously allowing the possibility that later analysis could reveal a different outcome. 27 Prema- 27 The food and drug laws, rather than the securities laws, already strike the appropriate balance in disclosing raw adverse event reports. As noted above, supra note 21, the FDA makes adverse event reports public for certain products through FDA databases like MAUDE, where medical professionals and any other inquiring minds can seek them out. By contrast, the Ninth Circuit's decision would thrust such raw data on the market by company disclosures that may incorrectly be perceived—no matter how carefully worded—as placing the company's imprimatur on the unverified reports. 35 ture disclosure could also harm investors by causing an unwarranted decline in stock value (or at a mini- mum, an increase in volatility) until such time as a complete investigation reveals no statistically signifi- cant link. 28 In short, companies seeking to comply with the Ninth Circuit's decision—the very companies that our society looks to research, develop and manufac- ture critical and life-saving medicines and medical devices—face an effectively no-win choice, were the decision below to be affirmed. 28 Cf. In re MedImmune, Inc. Sec. Litig., 873 F. Supp. 953, 966 (D. Md. 1995) ("Where mere disclosure of [an FDA] question might cause the company's stock to decline in value, the eventual answer to the question might cause it to rise once again. Investors who sold that stock when the FDA's question was asked but before the company's answer was given might have legitimate cause for concern."); accord In re Biogen Sec. Litig., 179 F.R.D. 25, 37 (D. Mass. 1997). 36 CONCLUSION For the reasons explained, the judgment of the United States Court of Appeals for the Ninth Circuit should be reversed. Respectfully submitted, CHRISTOPHER L. WHITE STEVEN G. BRADBURY ANDREW VAN HAUTE STEVEN A. ENGEL ADVANCED MEDICAL Counsel of Record TECHNOLOGY ASSOC. DECHERT LLP 701 Pennsylvania Ave. N.W. 1775 I Street N.W. Suite 800 Washington, DC 20006 Washington, DC 20004 (202) 261-3300 (202) 783-8700 firstname.lastname@example.com WILLIAM K. DODDS JAMES M. BECK DAVID A. KOTLER DAVID T. JONES DECHERT LLP BRIELLE M. REY 1095 Avenue of the Americas DECHERT LLP New York, NY 10036 2929 Arch Street (212) 698-3500 Philadelphia, PA 19104 (215) 994-4000 Counsel for Amicus Curiae August 27, 2010
Pages to are hidden for
"amicus brief - Dechert LLP"Please download to view full document


text:
1 Year Membership
Lifetime Membership
|Log In and Access Exclusive Members-Only Area
|Watch over 150 Hours of Streaming Videos for . . .
1 Year
|Watch New Streaming Videos Added to the Site for . . .
1 Year
|Download Source Code Demonstrated in Videos
|Download and Save .MP4 Video Files to Keep
|Ask the Instructor Questions About the Video Lessons
|Choose 1 Year
|Choose Lifetime
No automatic recurring payments. 30-day money back satisfaction guarantee.
Pricing and Sign Up FAQs
Q: What do I get when I purchase a subscription?
A: A subscription entitles you to access our members-only area where you can immediately watch the full versions of all current video tutorial lessons. Lifetime members will also learn how to access the secured download links to all current and retired video tutorial files. In many cases, the videos will have accompanying source code as demonstrated in the video. In addition to the videos there are several workbooks, cheat-sheets and more. Lifetime subscribers also receive access to our exclusive "Ask The Instructor" Q & A feature allowing them to clarify concepts discussed in the video.
Q: If I subscribe, is my credit card charged once? OR is this a recurring monthly/quarterly/yearly bill?
A: You will only be charged once. We do not automatically charge your credit card / PayPal account subsequent times. IF you want to renew your subscription you must be pro-active and re-subscribe manually. Personally, we're annoyed by websites and other services where you forget and wind up paying hundreds of dollars for something you never use.
Q: Lifetime subscription? Is this a joke?
A: Nope. To be clear, lifetime means the life of our site. We started in February, 2002 and have enjoyed a good deal of success thanks to strong word-of-mouth advertising. If the day comes where the end is near, there will be plenty of advanced warning. At this point in time, there is no end in sight and there is a lot of new technology on its way from Microsoft, so stay tuned!
Q: What if I decide that I want my money back? What do I do?
A: Please contact us with your refund request.

subset: commoncrawl


text:
gnome-gpg package in Ubuntu
This package has 1 new bug and 0 open questions.
Package information
- Maintainer:
- Ubuntu Development Team
- Urgency:*
- Low Urgency
- Component:*
- universe
- Architectures:*
- any
- Latest upload:
- 0.6.0-1ubuntu1
*actual publishing details may vary in this distribution, these are just the package defaults.
Upstream connections
A wrapper for GnuPG that can store your passphrase in the Gnome keyring. It also uses the Gnome authentication dialog for passphrase entry.
- Bug supervisor:
- Bug tracker:
- Branch:
Packaging is up-to-date for Gnome-GPG 0.6.0 .
|The Lucid Lynx (supported)
|release (universe)


text:
Monday, March 23, 2015
Three Day Autumn Sale
Sweet William is having a quick 3 Day Autumn Sale over at hardtofind.com.au.
25% Off from 23-25 March 2015 on all products plus free shipping with in Australia!
Friday, March 13, 2015
Posted by paula mills at Friday, March 13, 2015 Links to this post
Labels: art , creative , dahlias , flowers , inspiration , painting , paula mills , studio
Thursday, March 5, 2015
A slow start to my year.
www.atly.com which have been great and I have also forced myself to get away from the computer and into my studio. I have met up with a wonderful local artist who works from her home studio and we paint together. My plan is starting to work but I need a bit more time...which seems to be running away from me. When all else fails, I go in for a bit of retail therapy, I find fresh flowers and a new cushion for my home, always manages to make me feel a little brighter! Okay so even though it's already March - here's to a great 2015 everyone!
Posted by paula mills at Thursday, March 05, 2015 Links to this post
Labels: art , bright colours , colourful , drawing , inspiration , melbourne , my creative space , painting , studio
Friday, January 23, 2015
January Sale 30% OFF!!
30% Off Sale for one week only on Sweet William products over at www.hardtofind.com.au - free shipping for all Australian orders too.
Posted by paula mills at Friday, January 23, 2015 Links to this post
Labels: art , discount , illustration , paula mills , prints , sale , sweet william prints
Tuesday, December 9, 2014
Christmas at my house!
|Christmas at my house in full colour - decorations from Poppies for Grace
Poppies for Grace were exhibiting along with us at the Big Design Market last weekend. They did the most impressive stall with a beautiful tissue paper backdrop in rainbow colours - and I thought what a brilliant idea for our Christmas decorations this year! Here are the results, what do you think?
Posted by paula mills at Tuesday, December 09, 2014 Links to this post
Labels: christmas , christmas inspiration , colourful , craft markets melbourne , crafted , design files , etsy , handmade , home sweet home , inspiration , inspirational
A little Sweet William Christmas gift guide
Clockwise: Pale Mountain Journey print from $15; Camille Colouring in book $10; Wrapping Paper Pack $9; Sweet William mixed paper pack wonderful lucky dip $15; Miniature Camille in her match box home $16. Free shipping in Australia.
How is your Christmas shopping going? If you need a little help and you live in Australia you have until Monday the 15th of December to get your orders in. Unfortunately it may be a little late for international orders but of course you may still do some online shopping! Good luck with it all.
Posted by paula mills at Tuesday, December 09, 2014 Links to this post
Labels: Camille , christmas , christmas inspiration , craft markets melbourne , design files , ephemera , etsy , handmade , illustration , interior design , nursery , pink
Friday, November 21, 2014
Brand New work for Markit at Federation Sqaure
Markit this Sunday. For one day only, Federation Square in Melbourne will become home to over 100 of Australia's best independent designers and makers, selling products ranging from ceramics to homewares, jewellery, fashion, stationery and prints. Admission is free! 10am–5pm. Pop in, get some Christmas shopping done and say hello!
Posted by paula mills at Friday, November 21, 2014 Links to this post
Labels: art , art work , cactus , federation square , flowers , illustration , melbourne , pastels , peony , proteas
Wednesday, November 12, 2014
Brand New Christmas Cards
|Pack of 6 recycled cards for $22 - from our etsy shop
We have just listed these brand new Christmas cards in our etsy shop they will also be available on hardtofind.com.au very soon. Only 6 weeks till Christmas, wow! These cards are printed locally in Melbourne by a small family run business, on recycled card with vegetable based inks. Shop local and support small businesses this Christmas xxx
Tuesday, October 28, 2014
Collaboration with Zaishu Studio
Zaishu and The Big Design Market. For Zaishu's ten year anniversary they have partnered with Melbourne artists to make up limited edition artisan stools to be sold exclusively at the Big Design Market in December. The artists involved are: Bridget Bodenham, Beth Emily, Stefan Gevers, Emily Green, Rowena Martinich and myself - Paula Mills. Thrilled!
Posted by paula mills at Tuesday, October 28, 2014 Links to this post
Labels: art , artisan furniture , beautiful , beth emily , chairs , colour , craft markets melbourne , design market , illustration , paula mills , wooden texture , zaishu stools
Tuesday, October 14, 2014
New Work to be launced at Finders Keepers Melbourne
Sweet William will be at Finders Keepers Market on Friday and Saturday at the Royal Exhibition Building in Carlton, Melbourne. We haven't done a market for a little while and we have lots of lovely new products to show everyone, so if you are in Melbourne come and say hello. Here is a sneak peek of some of the new work...
Tuesday, October 7, 2014
Subscribe and Win 3 prints!
|Subscribe to our online newsletter here
Friday, October 3, 2014
Finalist in the Etsy Design Awards - yay!
|Circle Collage Illustration nominated for Etsy Design Award
I am most flattered to be a finalist in the Australian Etsy Design Awards! My illustration, entitled Circle Collage has been nominated as one of the finalists, amongst some amazing artists! You can vote for my entry here and be in with a chance to win a $250 etsy voucher for yourself, yay! Thanks so much everyone, Paula xxx
'View the 58 finalists to vote for your favourite item or Etsy shop. Etsy Design Awards celebrate the people who make Etsy.com a destination for great design. Entrants have the chance to win a trip to Etsy's headquarters in Brooklyn, New York, and be featured in the December issue of Inside Out.
Vote now and go in the draw to win a $250.00 Etsy gift card'
Friday, September 12, 2014
It 's all about flowers.
|Sweet William Prints - available here
|Messing around in my studio with my paints
|Prettiness on my mantelpiece
|Sweet William Wooden Postcard available here
|Prettiness on my kitchen bench
Thursday, September 11, 2014
New Work
New prints available from our etsy shop here.
Friday, August 29, 2014
A little DIY in pastel pink
Monday, August 25, 2014
New Work in Pastels
instagram feed will see) but I am also very fond of soft colours, especially soft blush, pink, flesh tones which look lovely set against white... so I revisited some of my brightly coloured designs and gave them a bit of fresh pastel makeover, I love this grey and pink colour combination and I am pretty pleased with the result! These two brand new prints are now available from our Etsy shop.
Thursday, August 14, 2014
Lots of new goodies
etsy store. We are so very pleased with our brand new stationery range which we have designed, produced and packaged all in our Melbourne studio. We hope you enjoy it as much as we do!
Posted by paula mills at Thursday, August 14, 2014 Links to this post
Labels: art , cards , christmas inspiration , colorful , craft markets melbourne , etsy , finders keepers market melbourne , geometric , geometric shapes , gifts , illustration
Monday, August 11, 2014
Brand New Cards now available!
Eventually after months of planning and production I am in a position to be able to offer these brands new cards for sale in our Etsy shop - enjoy!
Monday, July 21, 2014
Sweet William Prints in three sizes
Thursday, July 17, 2014
Group Exhibition
Just Another Project Space' and Signed & Numbered in Prahan. I have this original collage called 'two worlds' in the exhibition. Opening Night Thursday, July 17th 6-9pm at 153 Greville Street, Prahran and 2A/127 Greville Street, Prahran (entry off Grattan Street). All welcome!
Subscribe to: Posts ( Atom )


text:
Burns By Gilson Tiller
zachary24May 15, 2008
I have a Burns by Gilson tiller
Model # 51011 then on over it says 43788
Serial # 57B5397
If anyone can give me information about it or maybe has the manual and would be willing to send me a copy of it please contact me. I need to know what the part numbers are so i can buy parts for it.
What i need is what i call the engage arm the pully on it the bearings are shot and its not turning like it should and need a new one but not sure what part number it is.
Any help would be appreaciated.


text:
Dwarf Hydrangea selection - opinions on my candidates?
I'm looking for a dwarf hydrangea to replace a large one that has taken over. I'm hoping to keep it 3' or less (ideally 2'). I'm not well versed in hydrangeas. Here are ones I'm considering:
Let's Dance Starlight
Color Fantasy
Proven Winners Cityline Paris
Any opinions?
I have seen some Paris shrubs and they look very nice. Locally, the cityline and Let's Dance Series have arbitrarily shown up at small or medium plant nurseries but not all the varieties showed up. Pia, being an older variety has shown up at nurseries more reliably.
The Let's Dance Series Starlight is a rebloomer. Fantasy, Paris and Pia do not rebloom so they produce the flower buds in July-August and then bloom the following Spring. Do not expect to get the purple seen on some pictures of Fantasy; that actually depends on your soil.
2' is a nice wish but in our climate, 3-4' is more likely for any of these and some perhaps even larger. I am disinclined to want to prune to maintain a specific size and you do run the risk of reducing or eliminating a bloom cycle if you do.
"reblooming" hydrangeas are a bit of a misnomer in our area as well.......any hydrangea here has a rather lengthy bloom season but unless greenhouse grown, don't expect to see flowers before midJuly. Just not warm enough to encourage earlier blooming. But they will stay in bloom well into fall and often even after several light frosts.
All that said, 'Pia' (aka Pink Elf) is a reliable plant in this area with a heavy bloom and seldom gets much above 3'x3'. And holds its pink color well regardless of soil conditions.


text:
Faculty Scholarship
TU Law Faculty publish in a wide variety of areas. Check out our Book Gallery for recent books by our faculty, our publications page for a listing of articles, chapters and other contributions to scholarly works and our Selected Works gallery for individual professors.
Scholarly Articles and Other Contributions
Books Authored by TU Law Faculty
Faculty Pages (Selected Works)
Recent Additions to Publications*
The Irrelevance of Prisoner Fault for Excessively Delayed Executions, Russell Christopher
72 Washington & Lee Law Review (2015).
Obstacles to pH1N1 Vaccine Availability: the Complex Contracting Relationship between Vaccine Manufacturers, WHO, Donor and Beneficiary Governments, Sam Halabi
in The Public Health Response to 2009 H1N1. Ed. Michael Stoto and Melissa Higdon. Oxford University Press, 2015.
Selling Hospice, Sam Halabi
42 Journal of Law, Medicine, and Ethics 442 (2015).
Discovery of Medical Records in Oklahoma State Courts, Adams Charles
Discovery of Medical Records in Oklahoma State Courts, 85 Oklahoma Bar Journal 2008 (2014).
Death Delayed is Retribution Denied, Russell Christopher
99 Minnesota Law Review 421 (2014)
Penalizing and Chilling an Indigent's Exercise of the Right to Appointed Counsel for Misddemeanors, Russell Christopher
99 Iowa Law Review 1905 (2014).
Intentions, Compliance, and Fiduciary Obligations, Stephen Galoob and Ethan Leib
Abstention, Parity, and Treaty Rights: How Federal Courts Regulate Jurisdiction under the Hague Convention on the Civil Aspects of International Child Abduction, Sam Halabi
32 Berkeley J. Int'l. L. 241 (2014).
Multipolarity, Intellectual Property, and the Internationalization of Public Health Law, Sam Halabi
35 Mich. J. Int'l. L. 1 (2014).
The Project Model of Clinical Education: Eight Principles to Maximize Student Learning and Social Justice Impact, Anna Carpenter
20 Clinical Law Review 39 (2013).
*Updated as of 03/31/15.


text:
Home building questions
Building a new spec home in Austin and have some questions:
1. I have two young children at home. Am I crazy to ask for GFCI outlets everywhere? What are the tradeoffs?
2. Builder uses Trane ACs. It's been suggested to aim for a single compressor. Should I go for the XR15 or XL15i? Haven't seen where they'll go yet but I've asked to put them near the garage. How loud are these things?
3. The home is 3500sf and has 4 bathrooms. The builder uses State or AO water heaters. I think it's too big for tankless to make sense. Should I aim for a hybrid unit and if not which line?
1) GFCI is required where there is proximity to a grounding device, typically water pipes. So putting them elsewhere is not necessary.
Speaking of electrical safety, AFCI is required on certain receptacles.
And it would be advisable to have whole house surge protection.
Depending upon local code, tamper-resistant outlets could be required throughout. NEC 2008 requires all outlets be tamper resistant, which consists of little doors inside the outlet, which have to both be pushed in at the same time to open. If a child tries to push a single item into a slot, it won't go. GFCI outlets are far more expensive. BTW- Even GFCI outlets have to be tamper resistant per NEC 2008.
I'm curious to hear any responses to the OPs third question:
3. The home is 3500sf and has 4 bathrooms. The builder uses State or AO water heaters. I think it's too big for tankless to make sense. Should I aim for a hybrid unit and if not which line?
Our 5,500 sq ft has tankless heaters and work just fine. I have two Rheem (I would suggest another brand) rated at 5.5 gpm each. We can have 2 showers and a faucet on and still get hot water. Any more is more of a water pressure issue with our well and tank.
Remember that tankless is not instant, you need a recirculating system for that.


text:
NCAAB Basketball - Preview
|Lamar Cardinals vs. Central Arkansas Bears
The Lamar Cardinals and the Central Arkansas Bears will both be trying to pick up a win on Saturday when they battle at Farris Center. Lamar was a 91-74 loser in its last match on the road against Oral Roberts. In their last action, Central Arkansas was a 103-98 winner at home against McNeese State. Lamar:
Team record: 2-17 SU, 1-4 ATS
Current streak: lost 7 straight games.
Central Arkansas:
Team record: 7-10 SU, 0-0 ATS
Current streak: won 2 straight games.
Next up:
Lamar home to Northwestern State, Thursday, January 31
Central Arkansas home to Southeastern Louisiana, Thursday, January 31


text:
Check out the new, mobile-friendly WineSpectator.com!
It doesn't take a Wine Spectator Grand Award to stir excitement around wine, though. This year, a record 833 restaurants earn the Best of Award of Excellence, which recognizes a wine list for having a thoughtful selection of 400 or more wines, with solid depth or superior breadth in at least one major wine-producing region.
For the full article, check out the new issue of Wine Spectator, on newsstands July 26, 2011.
Do you have a Wine Spectator magazine subscription? Save 50% on your Online Membership right now!
Passionate about wine? Wine Spectator magazine is looking for an enthusiastic copy editor in the New York office.
Sips & Tips | Wine & Healthy Living
Video Theater | Collecting & Auctions
New! Ratings Flash | New! Unfiltered
» View samples
» Or sign up now!
» Manage my newsletter preferences
The marketplace for all your wine needs, including:
Wine Storage | Wine Clubs
Dining & Travel | Wine Auctions
Wine Shops | Wine Accessories


text:
8 Phrases That Signify Zero Respect in a RelationshipRespect is a tricky objective to achieve with a significant other. However,...
16 Ways to Bust StressThe degree of stress we experience on a daily basis might be a cultural norm...
7 Things Christians Need to Know about Depression...No one is exempt from depression or anxiety and Christians are included. We...
7 Loving Insights from Yoga GirlThe body, the mind, and the soul are actually all entwined with yoga, but to...
More great inspirational content to help you through depression
How Can I Overcome My Fear of Rejection?
11 Simple Strategies to Move Past Depression
6 Ways to Stay Effective At Work When You're Depressed
Are You Feeling Alone?


text:
Can anyone id this plant for me?
I don't remember planting it .... just wondering what it is - I hate when that happens. The blooms look like a delphinium but the leaves aren't what I remember as the leaves of a delphinium. I did attempt to grow some larkspur from seeds last year but it doesn't look like larkspur either.
Can anyone help?
Thanks FTM and ZC - It has been identified on the Name-that-plant forum as a Verbascum phoeniceum - aka purple mullein. Apparently it is a short lived perennial but propagates easily from seed so I am going to try collect some seeds for next year. It is such a pretty color!
That is so incredible, Jean! I looked at your pics the other day, and I just couldn't figure out what that was. I, too, thought maybe Delphinium/larkspur, but....yeah, just not the same.
Yesterday, Mom & I went plant shopping (holy cow, I'm an addict, I swear! LOL), and guess what I bought? A Verbascum ('Jackie') that has flowers shaped just like that, only a different color! I'm so glad you found out what it is, though. :)
Stunning photo Jeanner! Mystery solved.
I planted verbascum last year and this spring it was gone, and it was in a good garden bed. Talk about a short lived perennial. In this case also known as an annual. LOL 'Jackie' is really pretty. Good luck with it Brenda, maybe it will like Cali better!
Campanula grows well for me, the peach-leafed type the best. No luck with the shorter 'blue clips' types.
Delphiniums last two seasons in my zone 7, with decline in the second season. Just too hot for them, but boy do I love them. Raptures.
Foxgloves are great too and will grow well via re-seeding provided they like their location.
Surprising my Lobelia cardinalis is coming back gang-busters this spring. Lobelia is another plant that has to love it's location or it goes poof. It's growing on the back side of my pond in damp clay, partial morning/mid day sun. Full shade from afternoon sun. Next to several varieties of Joe Pye Weed (eupatorium). Also, great blue lobelia.
QUESTIONS for the plant people. My Lousiana iris plant (Black Gamecock) is huge, but has never bloomed. All my other iris (Siberian, species, yellow flag, Japanese) bloom with no problems. Could it want a lower Ph? My soil is clay and tends to be 8.5 and the city water here is also 8.5. Rain is about 5.5 to 6.0 It started as one small fan and is now 3 feet tall and just as wide with many fans. It's lush looking. It is on the damp left side of the pond near my other pond marginals that do bloom (those listed above). I fertilize once per year in early spring with general purpose Miracle Grow, but maybe I should try Miracid or something else? I have an Endless Summer hydrangea nearby that blooms pink (as proof of the higher Ph). I need ideas - thanks.
Thanks for the mullein info, CT! (Great to see you back here, too! :)) I can only hope it lives over, since as you said, it really is pretty.
On the other hand, my Delphinium 'Blue Butterfly' didn't make it. I sure wish I had more luck with those.
My Lobelia 'Cranberry Crush' went poof, but I think the gopher might have got carried away with it. It also probably didn't help when I blasted the top off of it with my pellet gun while running off feral chickens last fall. LOL
I've had a Campanula (Serbian bellflower, 'Dickson's Gold') for many years, but it hasn't spread, and the light blue flowers are somewhat lost amidst the golden leaves. But, hey, it's alive! LOL
Oh, my foxglove is enormous! I planted it last fall, so I was suprised when it sent up 6 or 7 stalks in early spring! LOVE those!
I don't have any Louisiana iris, but I've read that they like neutral to acid water and/or soil conditions. How long have you had it?
I just discovered that I have another verbascum, the buds look more like a bright pink. Apparently I bought several of them! I need to go root through my tub of tags (I think I have the tag for every plant that I've ever bought) - unfortunately they are not well organized.
I have been growing foxgloves from seed every year for several years, they are an easy plant to grow from seed. This is the first winter that I didn't start any, I am hoping they reseed from the plants this year. I usually avoid biennals but I can't resist the foxglove - besides the deer won't touch them so they are one of the few shade plants that I can grow.
So ladies, where are the pictures?? Huh??? You KNOW I'm going ask!


text:
Barbara's Hair-N-Body Care welcomes Erin Weum
Barbara's Hair-N-Body Care would like to welcome Erin Weum to their staff of cosmetologists.
Weum was previously employed at Tan & Tone and at a local spa before joining Barbara's Hair-N-Body where she will assume the responsibilities hair cuts, colors, treatments as well as manicures, pedicures and make up.
Are you a newspaper subscriber but you don't have a Digital Access account yet? https://secure.forumcomm.com/?publisher_ID=40&event=subscriber/lookup.
You will need your subscription account number and phone number. Not sure if you have an account? Email us at email@example.com and we can help you.


text:
Gallup, New Mexico (map) | (505) 863-5021
Sites: 134 | Latest Rate: $33.00 |
|Clean Restrooms:
|Clean Showers:
As others have said, it is a former KOA, so expect a gravel parking lot not far off the interstate. We feel that for 33 bucks a night with an escapees discount, this park is a little over priced. Check in was quick and thorough, registrar was polite. Barely enough room in pull through for our 38ft. plus truck, we had an extra vehicle that had to be parked to the side, so if you are long, make sure you let them know you need plenty of length. I think we would look for another park if coming through here again. It is okay, nothing bad, just nothing great either. - buffy
Passing through for one night, it was easy to find-right off I-40 and away from the congested traffic further in town. What we didn't realize is that it was at the end of the airport runway and during our stay the planes were landing and taking off right over our fifth wheel and were very low and loud. They did stop at 9:30 PM but started back up at 8AM. We were given a large pull-through site between several trailers that were more long term and had pet fences, boxes, and other storage items sitting around their trailers. The trailer beside us had parked at an angle and we had to take some time to arrange ourselves so that our slide outs wouldn't touch. Because of our location, it did feel like a trailer park setting and not a campground to us. All of the other trailers had dogs and evidently when someone is not occupying our spot it is used for the doggie restroom as I had to pick up several "piles". Overnight one even used our trailer tires as a hydrant (if you know what I mean). Check in was very professional, laundry facilities nice and the gift shop offered lots of choices. Looks like during the summer months there are lots of fun activities and a nice pool. We probably would consider another park next time. - The Traveling Tiedemans
This former KOA, with side-by-side hookups, is squeaky clean with level sites. The store is one of the best we've encountered, and we're full-timers. Staff is friendly and helpful. Good laundry. We spent five days here, and then put our 5th wheel into storage for a month in the park's storage area. Some noise from the nearby airport and nearby railroad tracks, but not very bad. We would come back in a heartbeat. - Ray Waugh