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December 29, 2005
BETH ANN MCNELLIS, ON BEHALF OF THE ESTATE OF THEODORE DEANGELIS, DECEASED, AND IN HER OWN RIGHT, PLAINTIFFS,v.PFIZER, INC., ET AL., DEFENDANTS.
This products liability case arises from the suicide death of Theodore DeAngelis on January 30, 2003. Plaintiffs, Beth Ann McNellis, on behalf of the estate of Theodore DeAngelis, deceased, and in her own right, contend that Zoloft, an antidepressant drug manufactured by Defendant Pfizer, Inc., which Theodore DeAngelis began taking shortly before he died, was responsible for his suicide. Plaintiffs contend principally that Pfizer's warnings regarding suicide as a possible adverse reaction associated with Zoloft were inadequate. Presently before the Court is the motion for summary judgment of Defendant Pfizer, Inc., in which the issue presented is whether, in the circumstance of the ongoing regulation and scrutiny of Zoloft, the Food and Drug Administration's regulation of prescription drugs under the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq. ("FDCA") and federal regulations preempts Plaintiffs' state law tort claims arising from the alleged failure to give sufficient warning of the possibility of an increased risk of suicide in depressed patients associated with this medication. For the reasons discussed below, this motion will be denied without prejudice to renewal upon completion of a limited period of discovery.
Plaintiff Beth Ann McNellis, suing individually and as executrix of the estate of her father, Theodore DeAngelis (collectively, "Plaintiffs"), claims that (1) Zoloft, a medication prescribed for Mr. DeAngelis, can and does "drive some people to their death" by suicide; (2) Pfizer, Inc. failed to adequately warn Mr. DeAngelis's physician of that purported fact; and (3) the purported failure to warn caused Mr. DeAngelis to ingest Zoloft and become more prone to the suicide which ended his life. (Compl. at ¶¶ 10, 12, 16.)
Theodore DeAngelis ("Decedent") was a sixty-four year old retiree who, in late 2002, began to feel depressed and consulted his family doctor. Mr. DeAngelis was initially prescribed Lexapro, an anti-depressant, but disliked that medication and was prescribed Zoloft instead on January 22, 2003. Six days later, Mr. DeAngelis consulted a psychiatrist, who prescribed a higher dose of Zoloft. Two days later, on January 30, 2003, Mr. DeAngelis was found dead, having taken his own life. Mr. DeAngelis apparently had no prior history of depression or suicidal tendencies, and had not previously taken anti-depressant medications before Lexapro.
Plaintiffs filed suit in Atlantic County Superior Court and the case was removed to this Court on March 4, 2005. Plaintiffs' claims against Defendant Pfizer, Inc. ("Pfizer") include allegations of defective design, N.J.S.A. 2A:58C-2, et seq. (Count I), failure to warn (Count II), violations of the New Jersey Consumer Fraud Act, N.J.S.A. 56:8-2, et seq. (Count III), and breach of express warranty (Count IV). Plaintiffs' primary contention is that Pfizer failed to adequately warn of the risk of suicidality associated with antidepressants such as Zoloft, despite the presence of the warning label which FDA had authorized to be given verbatim. Pfizer filed the instant motion for summary judgment, arguing that Plaintiffs' state law tort claims are preempted by the federal Food, Drug and Cosmetic Act and its implementing regulations. Extensive oral argument was held and shortly thereafter Plaintiffs filed a motion for an extension of time to complete discovery pursuant to Fed. R. Civ. P. 56(f). Supplemental briefing was received from both parties as to the merits and the Rule 56(f) motion to extend discovery, which have been carefully considered.
A. Summary Judgment Standard of Review
Summary judgment is appropriate when the materials of record "show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). A dispute is "genuine" if "the evidence is such that a reasonable jury could return a verdict for the non-moving party." See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A fact is "material" only if it might affect the outcome of the suit under the applicable rule of law. Id. Disputes over irrelevant or unnecessary facts will not preclude a grant of summary judgment. Id.
In deciding whether there is a disputed issue of material fact, the court must view the evidence in favor of the non-moving party by extending any reasonable favorable inference to that party; in other words, "[T]he nonmoving party's evidence 'is to be believed, and all justifiable inferences are to be drawn in [that party's] favor.'" Hunt v. Cromartie, 526 U.S. 541, 552 (1999) (quoting Liberty Lobby, 477 U.S. at 255). The threshold inquiry is whether there are "any genuine factual issues that properly can be resolved only by a finder of fact because they may reasonably be resolved in favor of either party." Liberty Lobby, 477 U.S. at 250; Brewer v. Quaker State Oil Refining Corp., 72 F.3d 326, 329-30 (3d Cir. 1995) (citation omitted).
The moving party always bears the initial burden of showing that no genuine issue of material fact exists, regardless of which party ultimately would have the burden of persuasion at trial. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986); Country Floors v. Partnership of Gepner and Ford, 930 F.2d 1056, 1061-63 (3d Cir. 1991)(reviewing district court's grant of summary judgment in a trademark action); Lucent Info. Manage. v. Lucent Tech., 986 F. Supp. 253, 257 (D.N.J. 1997)(granting summary judgment in favor of telecommunications provider in trademark action), aff'd, 186 F.3d 311 (3d Cir. 1999); Jalil v. Avdel Corp., 873 F.2d 701, 706 (3d Cir. 1989), cert. denied, 493 U.S. 1023 (1990). However, where the nonmoving party bears the burden of persuasion at trial, as plaintiff does in the present case, "the burden on the moving party may be discharged by 'showing' --- that is, pointing out to the district court -- that there is an absence of evidence to support the nonmoving party's case." Celotex Corp., 477 U.S. at 325.
The non-moving party "may not rest upon the mere allegations or denials of" its pleading in order to show the existence of a genuine issue. Fed. R. Civ. P. 56(e). Plaintiff must do more than rely only "upon bare assertions, conclusory allegations or suspicions." Gans v. Mundy, 762 F.2d 338, 341 (3d Cir. 1985), cert. denied, 474 U.S. 1010 (1985) (citation omitted); see Liberty Lobby, 477 U.S. at 249-50. Thus, if the plaintiff's evidence is a mere scintilla or is "not significantly probative," the court may grant summary judgment. Liberty Lobby, 477 U.S. at 249-50; Country Floors, 930 F.2d at 1061-62.
B. Conflict Preemption
The Supremacy Clause, Article VI, Clause 2, of the United States Constitution preempts any state law that conflicts with the exercise of federal power. Fidelity Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 152-53 (1982). Federal law will override state law under the Supremacy Clause when (1) Congress expressly preempts state law; (2) Congressional intent to preempt may be inferred from the existence of a pervasive federal regulatory scheme; or (3) state law conflicts with federal law or its purposes. English v. General Elec. Co., 496 U.S. 72, 78-79 (1990). Defendant Pfizer argues that the third and final form of preemption, namely conflict preemption, is implicated here, and that the complaint must be dismissed.
"[I]f a state common-law claim directly conflicted with a federal regulation . . ., or if it were impossible to comply with any such regulation without incurring liability under state common law, [conflict] pre-emption would occur." Sprietsma v. Mercury Marine, 537 U.S. 51, 65 (2002). Conflict preemption occurs either "where it is impossible for a private party to comply with both state and federal law" or where "under the circumstances of [a] particular case, [the challenged state law] stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372-73 (2000) (citing Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963), and Hines v. Davidowitz, 312 U.S. 52, 66-67 (1941)). Federal regulations "have no less pre-emptive effect than federal statutes." de la Cuesta, 458 U.S. at 153. The imposition of damages under state law is a form of state action subject to preemption. Geier v. American Honda Motor Co., 529 U.S. 861, 881 (2000). Where, as in the present circumstance, federal law does not directly preempt claims for inadequate warnings upon prescription drugs, the Supreme Court has cautioned that "a court should not find pre-emption too readily in the absence of clear evidence of a conflict." Id. at 885. The Supreme Court has instructed that there is a presumption against conflict preemption, and that the court should presume "that the historic police power of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." New York Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 655 (1995)(internal quotations omitted).
C. Plaintiffs' Failure to Warn Claim (Count II)
Defendant maintains that Plaintiffs' common law failure to warn claim is preempted by federal law because the Food and Drug Administration would consider any label suggesting that Zoloft "can and does cause suicide" "false and misleading," and therefore in direct contravention of the Food, Drug and Cosmetic Act.
1. FDA Prescription Drug Approval Process
By operation of federal law, the Food and Drug Administration ("FDA") occupies the field in determining the content of labeling on prescription pharmaceuticals such as Zoloft, as now discussed. The FDA's primary purpose is to protect consumers from dangerous prescription drugs and other products. United States v. Dotterweich, 320 U.S. 277 (1943). The FDA is charged with ensuring that "human and veterinary drugs are safe and effective" and approving prescription medicines as such before they are sold in the United States. 21 U.S.C. § 393(b)(2)(B); § 355(d).
In order to obtain FDA approval for a prescription drug, the drug's manufacturer must file a New Drug Application ("NDA") with the FDA. 21 U.S.C. §§ 355(a), (b), (d). The FDCA requires the FDA to approve an application to market a prescription drug unless, inter alia, (a) the application does not include adequate tests to show whether the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling; (b) the results of clinical testing show that the drug is unsafe for use under the conditions prescribed, recommended, or suggested in the proposed labeling; (c) there is insufficient information to determine whether the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling; (d) there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; or (e) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular. 21 U.S.C. §§ 355(c), (d).
FDA regulations mandate the general format and content of all sections of labels for all prescription drugs as well as the risk information each section must contain. 21 C.F.R. §§ 201.56, 201.57. The FDA sets out the product-specific labeling requirements in an "approvable" letter the FDA sends to the manufacturer. Id. at § 314.110(a) ("FDA will send the applicant an approval letter if the application . . . substantially meets the requirements of this part and the agency believes that it can approve the application . . . if . . . specific conditions (for example, certain changes in labeling) are agreed to by the applicant. The approvable letter will describe . . . the conditions the applicant is asked to meet."). Final approval of the NDA is "conditioned upon the applicant incorporating the specified labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed label prior to marketing." Id. at § 314.105(b).
If the manufacturer desires to make changes to the labeling after a drug is approved, it must generally submit a Supplemental NDA to the FDA pursuant to 21 C.F.R. § 314.70(b)(2)(v)(A). Although most labeling changes require a Supplemental NDA, a number of exceptions have been enumerated in 21 C.F.R. § 314.70(c)(6)(iii), which provides in pertinent part:
(6) The agency may designate a category of changes for the purpose of providing that, in the case of a change in such category, the holder of an approved application may commence distribution of the drug product involved upon receipt by the agency of a supplement for the change. These changes include, but are not limited to:
(iii)Changes in the labeling to accomplish any of the following:
(A) To add or strengthen a contraindication, warning, precaution, or adverse reaction;
(B) To add or strengthen a statement about drug abuse, dependence, psychological effect, or overdosage;
(C) To add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product;
(D) To delete false, misleading, or unsupported indications for use or claims for effectiveness; or
(E) Any labeling change normally requiring a supplement submission and approval prior to distribution of the drug product that FDA specifically requests be submitted under this provision.
21 C.F.R. § 314.70(c)(6)(iii). Thus, it is apparent that prior FDA approval need not be obtained, nor will a product be deemed mislabeled, if the manufacturer voluntarily or even unilaterally strengthens the approved warnings, precautions or potential adverse reactions upon the label pursuant to 21 C.F.R. § 314.70(c)(6)(iii)(A). The FDA's approved label as part of the NDA process can therefore be said to set the minimum labeling requirement, and not necessarily the ultimate label where a manufacturer improves the label to promote greater safety.
2. The FDA's Approval of Zoloft
On April 13, 1988, Pfizer submitted an NDA to the FDA seeking approval to market their drug, Zoloft, for the treatment of depression in adults. (Def.'s Ex. C, App. 49-52.) The FDA issued its approvable letter on September 30, 1991. (Def.'s Ex. F, App. 267-88.) The approvable letter contained "the Agency's proposal for the labeling of Zoloft," and requested that Pfizer "please use the proposed text verbatim." (Id. at App. 267.) The FDA-proposed labeling mentioned suicide in two locations. First, the FDA required that Pfizer include in the "Precautions" section the following language:
Suicide - The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. Close supervision of high risk patients should accompany initial drug therapy. Prescriptions for Zoloft (sertraline) should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
(Id. at App. 276.) Second, in the "Adverse Reactions" section of the labeling, the FDA required that Pfizer include a "Psychiatric Disorders" subsection that listed "suicide attempt" as an "Infrequent" occurrence, and explained that "infrequent adverse events are those occurring in 1/100 to 1/1000 patients," and that "[i]t is important to emphasize that although the events reported occurred during treatment with Zoloft (sertraline), they were not necessarily caused by it." (Id. at App. 284-85.) Pfizer followed the FDA's instructions and included the proposed labeling verbatim. Therefore, the FDA granted Pfizer final approval on December 30, 1991. (Def.'s Ex. G, App. 289-306.) Moreover, the FDA approved Zoloft for treatment of other ailments on five subsequent occasions and required the exact language with respect to suicide that has been required for initial approval.*fn1
3. Preemption Analysis
Defendant argues that Plaintiffs' inadequate warning claim, based on the notion that Pfizer should have provided a different, presumably stronger, warning before Decedent committed suicide on January 30, 2003, directly conflicts with the FDA's requirement that Pfizer provide "verbatim" the language regarding suicide in the "Precautions" and "Adverse Reactions" sections of Zoloft's labeling at that time and, therefore, is preempted. In addition, Pfizer maintains that any label suggesting that Zoloft causes suicide would be considered by the FDA to be "false and misleading," and thus it would be in direct conflict with the FDCA. See 21 U.S.C. § 355(d) (an NDA must be refused if the Secretary finds that a label is "false and misleading in any particular"). Plaintiffs allege that Pfizer was not preempted from strengthening the label regarding suicidality before the time of Mr. DeAngelis' death because Pfizer allegedly knew of an increased incidence requiring a stronger warning than the original FDA-approved version.
This Court finds no conflict to exist as a result of Pfizer's alleged inability to comply with both state and federal requirements. Defendant argues that if it had more strongly warned of an association between Zoloft and suicidality, it would have violated the FDA's order to use the FDA approved warning label language "verbatim." It should be noted that the word "verbatim" appears only in the FDA approvable letter to Pfizer, however, and not in any of the misbranding statutes or regulations. Moreover, as discussed above, the FDA's regulations at issue explicitly permit drug manufacturers to unilaterally strengthen warning labels at any time without regulatory pre-approval. See 21 C.F.R. § 314.70(c)(6)(iii)(A). Indeed, this particular regulation was promulgated precisely to allow drug manufacturers to quickly strengthen label warnings when evidence of new side effects are discovered. See 30 Fed. Reg. 993 (Jan. 30, 1965).
Since 1965, the FDA's regulations have permitted a manufacturer "[t]o add or strengthen a contraindication, warning, precaution, or adverse reaction," without prior approval by the FDA. 21 C.F.R. § 314.70(c)(6)(iii)(A). In addition, a drug manufacturer may "add or strengthen a statement about drug abuse, dependence, psychological effect, or overdosage," without prior approval (21 C.F.R. § 314.70(c)(6)(iii)(B)), and "add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product," without prior approval. 21 C.F.R. § 314.70(c)(6)(iii)(C). These regulations require a manufacturer to issue a warning whenever there is "reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved." 21 C.F.R. § 201.57(e). Thus, FDA's position regarding stronger warnings by drug manufacturers, as expressed through its own regulations, is that a manufacturer could, and should if warranted, provide stronger warnings as soon as it is evident that such a warning is appropriate.
As such, the FDCA and the FDA's regulations do not conflict with New Jersey's failure to warn law because those federal regulations merely set minimum standards with which manufacturers must comply. Indeed, this minimum standards approach is fully consistent with Congress' primary goal in enacting the FDCA, which is "to protect consumers from dangerous products," United States v. Sullivan, 332 U.S. 689, 696 (1948), as well as Congress' stated intent that the FDCA "'must not weaken the existing laws', but on the contrary 'it must strengthen and extend that law's protection of the consumer.'" United States v. Dotterweich, 320 U.S. 277 (1943).
Pfizer maintains, however, that § 314.70 gives manufacturers only temporary authority to strengthen the warning language on their labels. While the FDA's regulations do grant it the power to later disapprove a label strengthened pursuant to § 314.70, nothing in the regulation requires that the FDA take any action when a manufacturer makes a change pursuant to § 314.70(c). See 56 Fed. Reg. 59290 (Nov. 25, 1991). If the FDA does nothing, the change remains in effect. Moreover, the FDA's ultimate power to disapprove the change does not render the manufacturer's unilateral strengthening of the label language a violation of any federal law. Instead, if the FDA exercises its power to disapprove the strengthened warning, the manufacturer simply ceases the use and distribution of the new label. 21 C.F.R. § 314.70(c)(7).
Pfizer also asserts that the FDA would have regarded any unilateral label change to be "false and misleading" and thus in direct conflict with 21 U.S.C. § 355(e) by pointing to the FDA's frequent reapproval of Zoloft without any changes to its warnings or its labels both before and after Decedent committed suicide. The record reflects that the FDA comprehensively evaluated Zoloft clinical-trial data before it first found the medication safe and effective as labeled and approved it for marketing in 1991. (Def.'s Ex. C, App. 49-52; Def.'s Ex. D, App. 53-135; Def.'s Ex. G, App. 289-306; Def.'s Ex H., App. 307-65.) In addition, the FDA found Zoloft safe and effective as labeled six more times before and after January 2003. (Def.'s Ex. P., App. 800-25; Def.'s Ex. Q, App. 826-54; Def.'s Ex. R, App. 855-85; Def.'s Ex. S, App. 886-914; Def.'s Ex. T, App. 915-49; Def.'s Ex. U, App. 950-87.) In 1996, Thomas P. Laughren, M.D. of the FDA's Center for Drug Evaluation and Research submitted a detailed memo, concluding that the data presented in response to a concern about the possibility of a signal of emergent suicidality associated with sertraline use in adult and pediatric patients did not "represent a signal of risk for suicidality for either adults or children." (Def.'s Ex. X, App. 1054.) In June 2003, the FDA completed an analysis of Zoloft adverse event reports under the Best Pharmaceuticals for Children Act, including reports of suicidal ideation or behavior temporally associated with the use of Zoloft, (Def.'s Ex. KK, App. 1180-1202), and concluded that the data "do not provide any safety signals that indicate that the agency needs to do anything except continue to actively assess the evolving benefit-risk profile of these products." (Def.'s Ex. LL, App. 1203.) It was not until October of 2004, more than a year after Decedent's death, however, that the FDA "directed manufacturers of all antidepressant drugs to revise the labeling for their products to include a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents . . . ." (Def.'s Ex. EE, App. 1091.) No such expanded warning statements were required by FDA for the adult users of antidepressants.
This record evidence, however, at this early stage of the case, cannot suffice to satisfy Defendant's burden on the instant motion for summary judgment. Pfizer's assertion here fails to recognize that "FDA regulations are generally minimum standards of conduct" unless Congress has expressed clear intent to preempt state common law, which it has not done here. Hill v. Searle Laboratories, 884 F.2d 1064, 1068 (8th Cir. 1989). Rather than acting as an absolute edict on the appropriate label language, the reapprovals merely confirmed the minimum labeling required and do not prove that a label strengthened pursuant to § 314.70(c)(6)(iii)(A) would be considered "false and misleading," rendering it in conflict with 21 U.S.C. § 355(e).
In further support of its argument that Plaintiffs' state law claims are preempted by federal law, Defendant offers the amicus brief filed by the United States in support of Defendant's position in Motus v. Pfizer, 358 F.3d 659 (9th Cir. 2004).*fn2 (See Def.'s Ex. B, App. 17-48.) In Motus v. Pfizer, 127 F. Supp. 2d 1085 (C.D. Cal. 2000), the plaintiff claimed that Zoloft caused her husband to commit suicide. Defendant Pfizer moved for summary judgment on the grounds that the plaintiff's failure to warn claims were preempted by federal law. On appeal, the United States, through its amicus brief, urged that the warning of a causal relation between Zoloft and suicide would have "misbranded" the drug. (Def.'s Ex. B, App. 38-43.) The United States specifically stated that
any warning, no matter how worded, that could reasonably have been read as describing or alluding to such a relation would have been false or misleading, and therefore in conflict with federal law because there was no (and still is not) scientific support for such a warning. This is not just because FDA had rejected any link between Zoloft and suicide when, in 1991, the agency approved the drug as a treatment for depression. Subsequently, in response to petitions making similar allegations as to the related drug, Prozac, FDA found no link between antidepressants and suicide.
(Id. at App. 42-43) (emphasis in original) (internal citations omitted).
After oral argument, the Defendant submitted for this Court's consideration, the amicus brief field by the United States on September 15, 2005, in Kallas v. Pfizer, Inc., No. 2:04-CV-0998 (PGC), in the U.S. District Court for the District of Utah. The amicus brief in Kallas was submitted to the Utah court at the request of Judge Paul G. Cassell, and it was followed by a corrected amicus brief on September 30, 2005. The brief asserted the Government's position that "the state tort law claims in this case - under which plaintiffs argue that defendant Pfizer should be liable for using only the labeling for Zoloft approved by FDA - are preempted because they would punish Pfizer for not using a label that, as of November 2002, would have misbranded the drug." (Kallas Amicus Br. at 2.) The brief recited in detail why, in FDA's judgment, there was not reasonable evidence of an association between Zoloft and an increased risk of suicide or suicidality as of November, 2002. Id. at 2-3, 12-23. The brief noted that especially intensive evaluations of the data were undertaken by FDA and manufacturers of the SSRI class of antidepressants to which Zoloft belongs, focusing on the impacts of antidepressants on pediatric and adolescent patients, beginning with the FDA's July 2003 data requests, resulting in the requirement on March 22, 2004, that Zoloft and the other SSRI medications include an enhanced warning statement recommending "close observation of adult and pediatric patients treated with those drugs for worsening of depression or the emergence of suicidality." (Id. at 21, quoting FDA Public Health Advisory "Worsening Depression and Suicidality in Patients being Treated with Antidepressant Medications," dated March 22, 2004.) The amicus brief summarized the FDA's conclusions in 2002, 2003 and early 2004 that there was not reasonable evidence of an association between Zoloft (or SSRI's generally) and an increased risk of suicidality, and that suicidality had not emerged as a matter of concern based on those reviews. (Id. at 35-37.)
Plaintiff responded that material facts are in dispute whether, prior to Decedent's death in January, 2003, there was "reasonable evidence of an association of a serious hazard with a drug [for which] a causal relationship need not have been proved," within the meaning of 21 C.F.R. § 201.57(e), supra. Plaintiffs posit that the data requested by FDA from manufactures on July 22, 2003, collected over the course of years, and supports the notion that there was a link between Zoloft and suicidality prior to January, 2003, at least among the pediatric patients studied. Plaintiffs also cite to a 2000 study published by the British Journal of Psychiatry by Stuart Donovan, et al., titled "Deliberate Self-harm and Antidepressant Drugs," pointing to a significantly elevated risk of self-harm among SSRI patients (including Zoloft users) compared with the tricyclic class of antidepressants (TCA). The enhanced incidence of suicidality in clinical trials of SSRIs associated with patients treated for anxiety and depression was also reported, according to Plaintiffs, in August 2002's "Clinical Psychiatry News," in which Dr. Arif Khan was reported to conclude that from 1985 until 2000, the rate of suicides in trials for antidepressant drugs was 718/100,000 compared to 11/100,000 in the general population. Plaintiffs also presented the Declaration of Dr. Arvin Shroff, who retired in 2002 from the FDA, most recently as Deputy Director in the Office of Enforcement. (Pl.'s Letter Br. dated 10/21/2005 at Ex. H.) Dr. Shroff stated that in his FDA experience he does "not know of any case where FDA has considered a product to be 'misbranded' because if had a stricter warning on the label than FDA had originally approved.... Normally FDA has considered a drug 'misbranded' when a manufacturer promotes the drug for indications that are outside of the labeling." (Id. at ¶ 14.) Dr. Shroff's testimony is consistent with Judge Rosenbaum's opinion in Witczak v. Pfizer, Inc., 377 F. Supp. 2d 726, 729 (D. Minn. 2005), regarding the FDA's permissiveness toward voluntary strengthening of warning labels:
The FDA's regulations do grant it the power to later disapprove a label strengthened pursuant to §314.70. 21 C.F.R. § 314.70(c)(7). But the regulation "does not require that FDA take any action when a manufacturer" makes a change pursuant to [§314.70(c)]; if the FDA does nothing, the change remains in effect. See 56 Fed. Reg. 59290 (Nov. 25, 1991). Further, even if exercised, the power to disapprove does not retroactively make the manufacturer's strengthened label a violation of any law. Rather, if the FDA exercises its power to disapprove, the manufacturer simply stops distributing the new label. 21 C.F.R. § 314.70(c)(7).
Under certain situations, the FDA's position is entitled, under Supreme Court precedent, to some deference. In Geier v. American Honda Motor Co., for example, the Supreme Court placed considerable weight upon the Department of Transportation's interpretation of the regulation at issue's objectives and its conclusion that tort suits such as the one presented would stand as an obstacle to the accomplishment and execution of those objectives. 529 U.S. at 883. The Court acknowledged that "[t]he agency is likely to have a thorough understanding of its own regulation and its objectives and is 'uniquely qualified' to comprehend the likely impact of state requirements." Id. (quoting Medtronic, 518 U.S. at 496). See also Sprietsma, 537 U.S. at 67-68 (affording deference to the agency's position on preemption). That deference may be particularly appropriate when the regulatory scheme is silent as to preemption. "[W]hen a statute speaks clearly to the issue at hand, courts 'must give effect to the unambiguously expressed intent of Congress,' but when the statute 'is silent or ambiguous,' courts must defer to a reasonable construction by the agency charged with its implementation." Barnhard v. Thomas, 540 U.S. 20, 26 (2003) (quoting Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 843 (1984)).
This Court, however, declines to treat statements from the amicus legal briefs as declarations to be afforded the preemptive force of law. Notably, the propositions Pfizer cites from the Motus brief were not even addressed by the Motus court itself. See Motus, 358 F.3d at 661. The FDA was not a party nor did the Court adopt its legal position. Moreover, the premise of the brief's argument that Pfizer should be insulated from liability because the FDA rejected suicide warnings on the Zoloft label previously is no longer valid. In recommending labeling changes that reflect concerns about the association between SSRIs and suicidality, neither the FDA nor Pfizer can now claim, as they had in Motus, that no scientific basis exists for a suicide warning.
It must be noted that the issue before this Court is not one of express preemption, as presented in those cases addressing the language set forth explicitly by Congress in the Medical Device Amendments ("MDA") of 1976 to the FDCA. See, e.g., Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Indeed, the MDA's express preemption provision is considerably broader than the limiting principles of the conflict preemption doctrine in that it preempts not only when a state law actually conflicts with federal law, but even when a state law is merely "different from, or in addition to," an MDA requirement applicable to the medical device at issue. 21 U.S.C. § 360k(a). Congress did not extend such preemptive force to the regulation of pharmaceutical drugs in the FDCA.
The express preemption language of the MDA thus demonstrates that where Congress means to explicitly preempt the laws of the various states, it knows how to do so. Absent such language in the FDCA with respect to the labeling of prescription drugs, this Court's inquiry is a far narrower one, as it is limited to whether Plaintiffs' claim "would 'stand as an obstacle to the accomplishment and execution of' the objective of the safety and effectiveness" of the drug specifically and "would conflict with the federal requirements imposed" by the FDCA. Horn v. Thoratec Corp., 376 F.3d 163, 179 (3d Cir. 2004) (quoting Geier, 529 U.S. at 873). This Court is unwilling to find, as Pfizer would have it, that Congress intended to obviate the very state laws that provide remedies to consumers harmed by dangerous products and deceptive marketing in the absence of a clear and compelling Congressional statement. See Bates v. Dow Agrosciences LLC, 125 S.Ct. 1788, 1802 (2005) ("If Congress had intended to deprive injured parties of a long available form of compensation, it surely would have expressed that intent more clearly.").
In its argument that conflict preemption applies in this case, Pfizer places significant weight on the Third Circuit's decision in Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004). In Horn, the Third Circuit stated that the state tort law claims were in "severe tension" with the federal requirement regarding medical devices. Id. at 177. The court in Horn, however, was interpreting the express preemption clause of the MDA, which commands: "No State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement - (1) which is different from, or in addition to, any requirement applicable to this chapter to the device." 21 U.S.C. § 360k(a) (emphasis added); Horn, 376 F.3d at 166. Thus, by this provision, Congress has clearly expressed its intent that stricter state law requirements should not be permitted in the case of medical devices. The opposite, however, is true with prescription drugs, as discussed above. In the realm of prescription drugs regulated by the FDA under the FDCA, this Court finds that the federal labeling requirements are minimum standards; states can impose stricter requirements regarding labeling and warnings if they so choose by operation of customary tort law. The only limiting regulation is that the warnings must not be false or misleading, as that would lead ultimately to the FDA's rejection of Pfizer's labeling, and that any requirement for stricter labeling be based upon at least reasonable evidence of the association of a serious hazard with the drug, even if a causal relationship has not been proved, consistent with 21 C.F.R. §201.57(e). Here, the question of whether the FDA would have so acted can only be answered when it is clear what Pfizer knew about the link between Zoloft and suicidality, whether (as Plaintiffs allege) the company withheld crucial information on that issue from the FDA in seeking approval and reapproval of the drug, and how, if at all, its withholding of any relevant information matters.
Thus, stated differently, if Plaintiffs can demonstrate that Pfizer had knowledge of a heightened risk of suicidality, which should have resulted in enhanced labeling beyond the FDA-approved warning, then the FDCA does not preempt Plaintiffs' claim. If Plaintiffs can prove to the factfinder that Pfizer had, prior to January 2003, "reasonable evidence of an association of a serious hazard [suicidality] with a drug [Zoloft or the SSRI class generally,]" see 21 C.F.R. § 201.57(e), then the enhanced warning sought by Plaintiffs herein would not be preempted by the FDCA. There remains, at this early stage, the need for Plaintiffs to have the opportunity to obtain discovery upon this material issue before Plaintiffs can fairly be called upon to rebut Pfizer's showing on summary judgment, as requested by Plaintiffs in their Rule 56(f) motion. At this stage, therefore, summary judgment will be denied without prejudice.
D. Plaintiffs' Defective Design, Warranty and Consumer-Fraud Claims
In addition to their failure to warn claim, Plaintiffs assert claims for defective design under N.J.S.A. 2A:58C-2, et seq. (Count I); violation of the New Jersey Consumer Fraud Act, N.J.S.A. 56:8-2, et seq. (Count III); and breach of express warranty (Count IV). At oral argument, Plaintiffs' counsel clarified that the Complaint does not allege that the product was defective or adulterated when consumed by Mr. DeAngelis, as the essential basis of liability was the content of labeling and warnings. These additional claims are also not preempted for the reasons set forth above because they, like Plaintiffs' inadequate warning claim, present no conflict between federal and state law arising solely from the approved labeling of this pharmaceutical. While these claims may present Plaintiffs with an especially steep burden in the context of this case, this Court cannot agree with Pfizer that Congress implied that preemption of such claims without a more specific indication of congressional intent.
E. Plaintiffs' Rule 56(f) Motion
By agreement of the parties, no discovery has been exchanged in this case. After oral argument was heard in this case, Plaintiffs filed a motion for an extension of time to complete discovery pursuant to Rule 56(f), Fed. R. Civ. P. Rule 56(f) provides in pertinent part that
Should it appear from the affidavits of a party opposing the motion that the party cannot for reasons stated present by affidavit facts essential to justify the party's opposition, the court may refuse the application for judgment or may order a continuance to permit affidavits to be obtained or depositions to be taken or discovery to be had or may make such other order as is just.
Defendant's summary judgment motion and extensive affidavits and appendices in support were filed on May 10, 2005. Thereafter, Plaintiffs agreed by Consent Order filed May 27, 2005 to Defendant Pfizer's request for a stay of discovery while the legal issue of conflict preemption was decided. Now, however, Plaintiffs argue that while it was anticipated that the law, and not the factual record, would be the deciding factor in this Court's determination of the conflict preemption issue, it is clear that the factual record may have more relevance. (Rule 56(f) Affidavit of Gregory Spizer at ¶ 7.) What Pfizer knew and when it knew it, Plaintiffs maintain, can only be obtained through the Defendant during discovery. (Id. at ¶ 8.)
"[W]here the facts are in possession of the moving party a continuance of a motion for summary judgment for purposes of discovery should be granted almost as a matter of course." Miller v. Beneficial Mgmt. Corp., 977 F.2d 834, 846 (3d Cir. 1992) (holding in certain circumstances the incomplete state of discovery itself warrants preclusion of summary judgment on the merits) (quoting Sames v. Gable, 732 F.2d 49, 51 (3d Cir. 1984)). Here, Defendant alone is in possession of all relevant information. The studies Pfizer performed on Zoloft, the risks inherent from use of the drug, including suicidal ideation, adverse event reports related to Zoloft use, the manner in which Zoloft was sold and marketed to physicians and patients, and the communications it had with the FDA about all of these topics are all relevant to Plaintiffs' arguments.
This Court will therefore grant Plaintiffs' Rule 56(f) motion and permit a 120 day period of discovery, at the conclusion of which, Plaintiffs should be prepared to submit a competent expert report*fn3 to support its argument that there exists a prima facie basis for believing that Pfizer possessed sufficient information before January, 2003 from which it is reasonable to conclude there existed a link between Zoloft and enhanced suicidality which rendered the product warning inadequate. This period enables Plaintiffs, through prompt efforts, to seek and obtain relevant discovery within the scope of this motion, focusing on the evidence of suicidality prior to the Decedent's death in January, 2003. The period is not so lengthy, however, that Plaintiffs can embark upon a fishing expedition in hopes of obtaining something of interest.*fn4 Until Plaintiffs have this opportunity to obtain relevant discovery, the present summary judgment motion is premature.
For the reasons discussed above, Defendant's motion for summary judgment will be denied without prejudice and Plaintiffs' motion pursuant to Fed. R. Civ. P. 56(f) will be granted, and relevant discovery within the scope of this summary judgment motion may be exchanged promptly; Plaintiffs, as the parties opposing this summary judgment motion, must serve a competent expert's report within 120 days demonstrating a basis for prevailing upon its claims on all counts, alleging deficient warnings and causation and especially with regard to an analysis of data showing that the risk of suicidality as of January, 2003, associated with Zoloft was not adequately reflected on the FDA-approved label. If Plaintiffs are unable to do so, Pfizer may renew this summary judgment motion. The accompanying Order is entered.
JEROME B. SIMANDLE United States District Judge
This matter having come before the Court upon the motion of Defendant Pfizer, Inc. for summary judgment as well as the motion of Plaintiffs Beth Ann McNellis, on behalf of the Estate of Theodore DeAngelis, deceased, and in her own right, for an extension of time to complete discovery pursuant to Fed. R. Civ. P. 56(f); and the Court having considered the submissions of the parties in support thereof and in opposition thereto; and the Court having heard oral argument on July 6, 2005; and for the reasons set forth in the Opinion of today's date; and for good cause shown;
IT IS this 29th day of December, 2005 hereby ORDERED that Defendant Pfizer, Inc.'s motion for summary judgment [Docket Item No. 12-1] shall be, and it hereby is, DENIED WITHOUT PREJUDICE;
IT IS FURTHER ORDERED that Plaintiffs' motion for an extension of time to complete discovery pursuant to Fed. R. Civ. P. 56(f) [Docket Item No. 24-1] shall be, and it hereby is, GRANTED; and
IT IS FURTHER ORDERED that Plaintiffs may seek relevant discovery within the scope of this motion, to be concluded within the next 120 days, at which time Plaintiffs shall be required to serve a competent expert's report analyzing the data regarding suicidality and demonstrating prima facie why the Defendant's failure to supplement the FDA-approved label for Zoloft, as of January, 2003, is actionable in this case and how such conduct by Defendant resulted in an inadequate warning that was more likely than not a probable cause of Decedent's suicide.
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Cypher replied to TRiLeZ's topic in Site Updates@TRiLeZ Totally unrelated but could you please check your PM's from me about a credit purchasing issue. Sorry to post it on here but I fear my message will not be read otherwise!
Very strange was only aware my ISP offered IPV4, Ok no problems will wait and see what happens. Is there anyway I can buy credits in the mean time? If I purchase with a card instead of paypal will that yield the same issue?
@YoHoJo I just purchased credits using paypal (not had an issue before) to also buy VIP but after payment there was a database error. I've been charged $8 twice on my paypal but have no credits. Any idea?
Cypher replied to Cypher's topic in Scripting HelpBut what about when I need to interact with each item in the shop?
Cypher replied to Cypher's topic in Scripting HelpAs it won't seem to let me edit, i'll have to make a new post. I've had a little play around and this was the outcome. What do you think? public static RSItem[] getAllItems() { ArrayList<RSItem> items = new ArrayList<>(); RSInterfaceChild itemsChild = Interfaces.get(PARENT, ITEMS_CHILD); if(itemsChild != null) { RSInterfaceComponent[] components = itemsChild.getChildren(); for(RSInterfaceComponent component : components) { if(component.getComponentItem() == 6512) { break; } items.add(new RSItem(component.getComponentName(), component.getActions(), component.getIndex(), component.getComponentItem(), component.getComponentStack(), RSItem.TYPE.OTHER)); // Adds location of square to item. items.get(component.getIndex()).setArea(component.getAbsoluteBounds()); } return items.toArray(new RSItem[items.size()]); } return null; }
Cypher replied to Cypher's topic in Scripting HelpAwesome, thanks for this! However from this I'm not really sure how you would go about then clicking each item, preferably by name. As your not storing the bounds of the items or the name
Cypher posted a topic in Scripting HelpHi all, I'm developing a script that needs to interact with a shop. In my shopping API class I have the following: private static final int PARENT = 300; private static final int ITEMS_CHILD = 2; public static RSItem[] getAllItems() { RSInterfaceChild itemsChild = Interfaces.get(PARENT, ITEMS_CHILD); if(itemsChild != null) { return itemsChild.getItems(); } return null; } Then within another class I'm testing how it works. @Override public void execute() { RSItem[] items = Shopping.getAllItems(); if(items.length > 0) { for(RSItem item : items) { General.println(item.getStack()); } } } However, through debugging it never goes into the for loop as item.length is not more than 0. I am confident that my interface ID's are right as the interface explorer explicitly states that within interface 300, child 2 the components within contain information about each item in a shop. Can anyone possibly share an opinion as to why it may not be working? EDIT: From a brief conversation with @Starfox it appears that maybe interfaces have changed a bit since and I might have to loop through each component manually.
Cypher replied to Pwningcows's topic in Guides/TutorialsFair enough mate, do you have skype at all? It would be awesome to add you. Im not new to this game at all but would maybe good to bounce ideas off to develop newer techniques and tweaks for my own methods
Cypher replied to Pwningcows's topic in Guides/TutorialsNice guide What's your opinion on level 3's though? I've had both level 3's and accounts from level 40/50 but they get banned about the same rate
@TRiLeZ The same client approx. 6 hours later on
Damn it, its still on the creep
Trilez your a star! Did my thread help at all?
Cypher replied to Aropupu's topic in AgilityThanks Aro, i've noticed another issue though. When seers is disabled on auto-levelling it will still choose it as a viable course.
Cypher replied to Aropupu's topic in AgilityAwesome pal, cheers!
Cypher replied to iprocheat's topic in General ProgrammingAye, the good old days! Was anyone here a member of rs-resources with the release of ARGA? Was admined by Taios, Zappacky and Iamadam


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Sutured Ghoul
Judgment — Rare
Creature — Zombie
Sutured Ghoul is legal in the following formats:
French Commander
Modern Duel Commander
Recently viewed cards:
Judgment — Rare
Creature — Zombie
Sutured Ghoul is legal in the following formats:
French Commander
Modern Duel Commander
TCGPlayer avg. price:
Creature — Human Artificer (1/3)
Fabricate 3 (When this creature enters the battlefield, put three +1/+1 counters on it or create three 1/1 colorless Servo artifact creature tokens.)
Whenever an artifact you control is put into a graveyard from the battlefield, target opponent loses life equal to Marionette Master's power.
Creature — Nightmare Horse (0/0)
Flying (This creature can't be blocked except by creatures with flying or reach.)
Nightmare's power and toughness are each equal to the number of Swamps you control.
Creature — Crocodile (4/6)
When Dukhara Scavenger enters the battlefield, you may put target artifact or creature card from your graveyard on top of your library.
Creature — Zombie Beast (4/5)
When Baloth Null enters the battlefield, return up to two target creature cards from your graveyard to your hand.
Creature — Demon (5/5)
When Demon of Dark Schemes enters the battlefield, all other creatures get -2/-2 until end of turn.
Whenever another creature dies, you get (an energy counter).
, Pay : Put target creature card from a graveyard onto the battlefield under your control tapped.
Creature — Zombie (0/0)
Noosegraf Mob enters the battlefield with five +1/+1 counters on it.
Whenever a player casts a spell, remove a +1/+1 counter from Noosegraf Mob. If you do, put a 2/2 black Zombie creature token onto the battlefield.
Creature — Dragon (5/6)
When Deathbringer Regent enters the battlefield, if you cast it from your hand and there are five or more other creatures on the battlefield, destroy all other creatures.
Legendary Creature — Demon (6/6)
Whenever a permanent owned by another player is put into a graveyard from the battlefield, you draw a card and you lose 1 life.
Artifact Creature — Construct (5/4)
When Noxious Gearhulk enters the battlefield, you may destroy another target creature. If a creature is destroyed this way, you gain life equal to its toughness.
Creature — Eldrazi (6/8)
Devoid (This card has no color.)
, Exile a creature card from your graveyard: Target opponent loses life equal to the exiled card's power. ( represents colorless mana.)
Creature — Vampire (3/4)
Landfall — Whenever a land enters the battlefield under your control, other creatures you control get +1/+0 until end of turn. If that land is a Swamp, those creatures get +2/+0 until end of turn instead.
Creature — Spirit (0/0)
Revenant's power and toughness are each equal to the number of creature cards in your graveyard.
Creature — Eldrazi Processor (5/5)
As Ulamog's Despoiler enters the battlefield, you may put two cards your opponents own from exile into their owners' graveyards. If you do, Ulamog's Despoiler enters the battlefield with four +1/+1 counters on it.
Creature — Vampire (4/5)
Delirium — Dusk Feaster costs less to cast if there are four or more card types among cards in your graveyard.
Creature — Slug Horror (7/7)
Menace (This creature can't be blocked except by two or more creatures.)
Whenever Morkrut Necropod attacks or blocks, sacrifice another creature or land.
Creature — Horror (3/1)
Despoiler of Souls can't block.
, Exile two other creature cards from your graveyard: Return Despoiler of Souls from your graveyard to the battlefield.
Creature — Zombie Giant (6/9)
As an additional cost to cast Skaab Goliath, exile two creature cards from your graveyard.
Trample (This creature can deal excess combat damage to defending player or planeswalker while attacking.)
Creature — Vampire (4/5)
Whenever you gain life, target opponent loses that much life.
Creature — Avatar (0/0)
As Living Lore enters the battlefield, exile an instant or sorcery card from your graveyard.
Living Lore's power and toughness are each equal to the exiled card's converted mana cost.
Whenever Living Lore deals combat damage, you may sacrifice it. If you do, you may cast the exiled card without paying its mana cost.
Creature — Human Rogue (2/2)
, Exile Ghoulcaller's Accomplice from your graveyard: Put a 2/2 black Zombie creature token onto the battlefield. Activate this ability only any time you could cast a sorcery.
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10 Reviews
Great choice for my skin issues!
Posted 3/14/2016 by Nicole
I love Desert Mist! I've been using it daily for 4+ years and it's my go-to for hydration/toning. I have sensitive/dry/irritated skin around my nose and this product helps keep the redness/flakes away. It's especially helpful during the harsh winter months when my skin has a greater tendency to get upset. I highly recommend Desert Mist from Arcona.
Love it!
Posted 1/5/2016 by fabienne
I have been using Arcona products for over 20 years. I've tried other products, but I always come back. The products are natural and effective.
Posted 11/28/2015 by Yvonne
I use this product to seal in other Arcona serums. It gives a dewy and youthful glow to skin.
Posted 11/26/2015 by A
You think you know moisturizing in the morning until you add desert mist to lock it in and add beautiful dewy glow. Has transformed my skin. I cannot go a day without it - 5 days without right now and my skin is seriously sad, once my desert mist arrives I will feel complete again!
Posted 8/12/2015 by Chloe
Same with some of the reviewer, I don't particularly enjoy the scent of this product, but I don't dislike it either. It does a good job keeping my skin bright for the rest of the day!
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Desert Mist gives my skin extra hydration and because it's job is to seal skin against environmental damage. mMy skin feels dewy all day. That is pretty good for a 65 year old skin. It also works great as a primer.
Magic In a Bottle
Posted 3/5/2015 by Jennifer
Desert Mist is a must every day! My skin looks and feels amazing, healthy and fresh. Adding this product changed my very dry skin into dewy glowing skin.
Love it
Posted 1/10/2015 by Dee
This a must! It helps clear my skin! And doesn't smell bad either!
Posted 11/26/2014 by Molly
This makes you glow!
Get Your Glow Back
Posted 7/13/2014 by Sue
I was not sure about this product when I first started to use it. As time went on I noticed that my skin was looking healthier and dewier. I was getting a youthful glow again. If I stop using it I notice a difference within a few days. It has a light gold color with a soft herbal scent. It is very liquid and just a few drops smoothed on in the AM does it for me. Instead of faking a dewy glow I have it for real now! A wonderful, gentle product that is always on my vanity.


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Pakistan's top spinner Saeed Ajmal has been banned for Bowling by ICC after his action was declared 'illegal'.
Saeed Ajmal is one of the best spinners in Pakistani cricket team. He has been Pakistan's top bowler and leading spinner in all formats of cricket, was reported after the first Test Match against Srilanka in Galle last month.
The news of Saeed Ajmal Banned for Bowling has shocked his million of fans. His fans and cricket lovers called it "conspiracy" against the star bowler Saeed Ajmal.
Pakistanis are also deeply hurt on this news and expressing their views on social media accounts.
Saeed Ajmal Banned For Bowling
Saeed Ajmal Banned For Bowling
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Homemade Foot Scrub For Dry and Cracked Heels-Get Baby Soft Smooth Skin


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Odoo Help
This community is for beginners and experts willing to share their Odoo knowledge. It's not a forum to discuss ideas, but a knowledge base of questions and their answers.
view on invoice line
hi everyone, i have to add some fields on invoice line and by checking or unchecking a checkbox, these fields appear or desappear. I have tested this solution:
<field name="name" attrs="{'invisible': [('is_room','=', True)],'required': [('is_room','=', False)]}"/>, but it didn't work.
can you help me.
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TV on the Radio and Marty Party due at 2012 Snowball Festival. Advance tix on sale Weds.
Update (11/30/11): Bassnectar, making a return engagement at Snowball, and Elephant Revival were both announced this morning.
So if you missed it yesterday, Snowball Festival, the cold weather, mountain-based event, which is now entering into its second year, announced its first two headliners, Rusko and Unknown Mortal Orchestra. Organizers are slated to announce the rest of the headliners every day for the rest of the week, including word that came down just moments ago that TV on the Radio and Marty Party have been confirmed on this year's bill.
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Manufacturing defects
By Dr MES-MN
from Undisclosed
Comments about Eldorado High Back Chair with Knee-Tilt:
I have looked at this chair in the showrooms for two years and found it to be the most comfortable chair I could find for a tall and big person chair. I loved the infinite lock tension control to tilt it back 1"-5" and lock it in place. The beautiful leather and wood are very nice looking. However, when I ordered it (great quick shipping!) I assembled it and within 2 weeks the Gas Lift Piston had stretched the metal ring in the wooden base and the piston slid all the way to floor to the point where I was pivoting on the piston and the wheels were not touching on all five wheels. It was impossible to wheel across the floor.I followed the video to remove the piston with a gentle tap but with the full 2" wide part of the piston now in the 1-1/2" hole it was impossible for the piston to be removed. A local office design store even tried their piston press and it was impossible to remove it.The people at Officechairs were super gracious and sent a new chair and we even attached a non-intrusive screw clamp above the metal ring to keep the piston in place, but within 10 days the piston has already slid down the hole by nearly 1" and now only 1" left until it hits the floor. This was not a store problem but DEFINITELY a manufacturing defect in using inferior metal on the metal rind that holds the Gas Lift Piston. In addition, this second chair had wooden legs over the metal leg bars but the wood was so dried out that in 7 days, two of the five legs had wood crack and splinter.Yes, the office chairs staff and I even checked and the two chairs were from different lot numbers and made on different dates, Thus a manufacturing defect. I advise you to look elsewhere on the website and spend a $100 more for a better base and chair.The company stands behind their guarantee!
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Dried and cracked wood
Piston hits floor
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Cantu Cantu Shea Butter Rinse-Out Conditioner Reviews
- Other Hair Conditioners:
- Average: 4.3
- High: 5.0
- Brand:
- Cantu
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Comments about Cantu Cantu Shea Butter Rinse-Out Conditioner:
My daughter is biracial, so her hair is curly but it's doesn't have tight curls like most biracial kids. It's long but since she's biracial, it needs to be kept moisturized or it will get too dry. She sleeps on her back, so her hair also gets tangled at the back. I started looking for a moisturizing shampoo that would take out her tangles without drying it out like baby shampoos did to her hair. If anything, Johnson's dried it out more as well as tangled it. With Cantu, it has a rich lather, it takes out the tangles without a fight. It smells great like shea butter and it's a thicker shampoo but even after a day or two without wash, her hair is never weighed down, heavy or oily. It produces the perfect amount of moisture and control. Wish I would've known about this sooner!
Comments about Cantu Cantu Shea Butter Rinse-Out Conditioner:
Though this product is intended for African hair, I notice I get much better results when I try shampoos and conditioners with this fact in mind. I dye my hair frequently and flatiron it almost daily, so I need hair products that basically save me from myself.
Cantu's shea butter conditioner smells and feels wonderful. It rinses very cleanly and doesn't leave your hair with any extra weight. I normally condition only my ends because most conditioners leave my roots too heavy from the oils in them; this conditioner doesn't! My ironed, dry ends drink up this conditioner, and I notice that my hair responds really well to styling products when I use it. I can condition my scalp with this conditioner, and it won't be an Exxon Valdez-type mess by the end of the day.
You don't need to use a lot to get the job done, even if your hair is long. The conditioner isn't very thick, but it is just the right density so you won't feel as though you're not using enough. A little will go a long way with this conditioner. If you do a lot of processing on your hair (I have the triple threat of color/bleach/flatiron), you'll enjoy the results you get from Cantu.
The price is very reasonable, and it's easy to find at either Wal-Mart or Target. They make a nice line of hair and body products, all of which smell delicious. This conditioner is better than a few salon brands I've used, and I completely plan to try some of their other products soon.


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GA from $89
VIP from $129
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3 Bedrooms Semi Detached House for sale
BRIERLEY HILL, Quarry Bank, Bickon Drive
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Let's be Heard
By (author) Bob Grant
Format: Paperback
Normal Price: $37.21
Your Price: $33.49 AUD, inc. GST
Shipping: $7.95 per order
You Save: $3.72! (10% off normal price)
Plus...earn $1.67 in Boomerang Bucks
Availability: Available, ships in 8-11 days
Let's be Heard by Bob Grant
Book DescriptionThis "New York Times" bestseller proved that before there was Rush Limbaugh, G. Gordon Liddy or Howard Stern, there was Bob Grant, the undisputed king of conservative talk radio. In "Let's Be Heard", Grant expounds on topics from "Slick Willie" Clinton to feminist "emasculators" and welfare swindlers.
Buy Let's be Heard book by Bob Grant from Australia's Online Bookstore, Boomerang Books.
Book DetailsISBN: 9780671537210
(216mm x 140mm x 14mm)
Pages: 256
Imprint: Pocket Books
Publisher: Simon & Schuster
Publish Date: 1-Mar-1997
Country of Publication: United States
Other Editions...
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MALVERN, Pa. -- Acme Markets here, a division of Boise, Idaho-based Albertson's, has become the latest retailer in the industry to use on-pack labels that emphasize for customers the proper handling and cooking of ground beef. The initiative, called the Acme Food Safety Information Campaign, was launched last month with the purpose of teaching consumers to cook ground beef to 160 degrees Fahrenheit in order to kill any bacteria that may be present in the meat. According to Walt Rubel, ...
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text: 21 photos $486,750 295 acres 0 Click Wells Road, Baker Hill, AL 36027 - Barbour County Wilson Branch Recreational Investment Just Reduced! This sporting tract is East of the East Fork Choctawhatchee River and is located on Click Wells Road in Baker Hill, AL 26 minutes from Eufaula, 51 minutes from Dothan, 53 minutes from Union Springs, and about an hour and 8 minutes from Enterprise. This is a nice recreational and investment property with heavy deer and turkey activity. The acreage is rolling to sloped topography with bottomland. There is a 4 acre lake on the property that is approximately 30 feet deep and a large creek named Wilson Branch runs through the land providing for the area's wildlife. Additional features of this tract consists of 200 +/- acres of pines with the remainder in hardwoods and cut-over, established greenfields, abundant county road frontag Jody Doles National Land Realty


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Retailers' holiday ad spending falls
Retailers shift their ad spending from TV, radio and print ads to digital ads.
Retailers' holiday ad spending falls
Retailers shift their ad spending from TV, radio and print ads to digital ads.
Retailers rack up big holiday gains on online marketplaces
Sellers say they are faring particularly well on the marketplaces of Amazon and Wal-Mart so far this holiday season.
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EMusic.com has launched a recommendations engine that creates music profiles tailored for subscribers based on past behaviors and other data gathered from the Internet. The recommendation engine and a redesigned home page went live this month.
Posted 12/24/2008Don DavisPost a comment
First Time an Online Music Service Delivers True, 1:1 Personalization; Broader Deployment Based on ChoiceStream`s Proven ROI CAMBRIDGE, Mass.--Sept. 12, 2005--ChoiceStream, Inc., the leading provider of personalization solutions for online consumer services, mobile and media operators, announced today that eMusic, the world`s No. 2 digital download service, is launching two new ChoiceStream features: Your New Arrivals and Personalized Playlists....
Posted 09/16/2005
80% of consumers said they are interested in receiving personalized content -- but 63% of them expressed concern that their personal data might not be secure with personalization, according to a survey commissioned by ChoiceStream.
Posted 08/18/2005Mary WagnerPost a comment
Following the successful launch of its free Internet service, Kmart Corp.'s BlueLight.com is offering a Spanish version. Just a few weeks after signing up the 4 millionth registered user to its popular English-language service, BlueLight.com is distributing millions of the free Spanish-language ISP CD-ROMs for its Totally Free Internet Service through 1,600 Kmart retail locations nationwide. BlueLight.com PC-based CD-ROMs are also available at no...
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The Dinette Set by Julie Larson
- October 03, 2013
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The village idiots are at it again
Good Morning All
Um, sitting!
Right…. they may not be sitting still (right this second, anyway) ….
but they are still still sitting.
And of course, when they've got their butts parked in front of the TV, they're not just sitting there, they're busy watching.
And at the kitchen table, with its ever-present boxes of snack cakes…
they're not sitting still…. they're busy eating.
Nope… sitting still just isn't their style… they've always got something to do….
even if it's something you can't tell by watching them, like, say … thinking heavy thoughts.
Good morning, Leaky….
and all the rest of you Crustwoodians who just can't sit there doing nothing….
so you read the comics.
El Guapo, I posted to you on yesterday's strip about finding "Oat" and about the GoComics A to Z listings….
There are links in my post…
So Dave H… you might want to see it too.
And there were birthday greetings for RiverHawk… hope you stop by some time.
Can't sit still, eh? 'Course not! They're so fat that if they sit in one position for too long their bums get sore, so they HAVE to fidget about.
Cleaning the grill? remind me not to eat anything cooked on it. No telling what kind of toxic cleaner they are using..
I see they have their "snacks" with them.
Are those the seats that have to be pulled off when they stand up?
BURL… Not a good idea to do this on your deck…. Take the grill out into the yard and hit it with your power washer… And while you are at it…. hose JOY down….. ! ! !
Sitting whilst scrubbing the grill. With a snack nearby in case they get a little light-headed from the exertion.
Why are they cleaning their grill? Isn't that out of character? Are they trying to sell it? Did Burl seal, er, "rescue" a newer one from the U-Stor-It?
Don't accuse them of being lazy. They just won't stand for it.
Cleaning the grill. Don't they know that it takes years to get the proper grease build up on those things? I bet their hamburgers taste like some kind of 'diet food'.
Burn and brush.
Burl and Joy, are all about activity, lot of hand to mouth lifting exercises.
Merci, Mlle Sunshine.
and it would actually be harder to clean sitting then standing over it
Burl likes to sit in the living room and be alone with his thoughts.
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The price for this vehicle as equipped does not include charges such as: License, Title, Registration Fees, State or Local Taxes, Finance Charges, Credit Investigation, Optional Credit Insurance, Physical Damage or Liability Insurance, Delivery Fees, or a negotiable $150 Documentary Fee. Any and all differences must be addressed prior to the sale of this vehicle.
Cruise Control
Rear Defrost
Rear bucket seats w/center armrest, trunk pass through
Infotainment centralized control system
Steering wheel mounted gear shift paddles
GPS Navigation
HomeLink Universal Garage Door Opener
AM/FM stereo system-inc: 6-disc CD changer located in glove box, (8) speakers, 300-watt amp, RDS, diversity antenna, Sirius satellite radio
Front & rear seat cigar lighters (2007)
Single color 4-spoke leather-wrapped steering wheel w/audio & cruise controls
Leather & chrome gear shift knob
Front & rear parking distance sensors (2007)
Power Trunk Operation
Voice Activation System
Front & rear reading lights (2007)
Stainless steel foot pedals & driver foot rest
Leather & wood rear center console-inc: storage compartment
Keyless Entry & Ignition
Rear seat ventilation ducts
Front seatback storage pockets (2007)
Power Windows
Auto-Dimming Rear-View Mirror
Dual illuminated vanity mirrors (2007)
Instrumentation-inc: tachometer, trip computer, low fuel level, external temp display, clock (2007)
Heated Power-Adjustable Front Seats
Automatic Dual-Zone Climate Control
Burl Walnut Trim
Power Door Locks
Tire Pressure Monitoring System
Power Tilt/Telescoping Steering Wheel
Twin stainless steel oval tail pipes
P275/40ZR19 tires (2007)
4-wheel antilock braking system
Electronic stability program (ESP) (2007)
Vehicle speed-sensitive pwr steering
All-Wheel Drive
Electronic park brake
Ventilated Brake Rotors
Electronic Brake Force Distribution
Traction control system (2007)
19" x 9" 5-spoke painted alloy wheels
Twin-turbocharged 6.0L W12 Engine
Space saver spare tire
6-Speed Automatic Transmission
Air Suspension
Front & rear 3-point seat belts w/pre-tensioners
Front / Rear Head Curtain Airbags
Driver & front passenger frontal multistage airbags w/occupant sensors
4-wheel antilock braking system (ABS)
Traction Control
Front / Rear Side-Impact Airbags
Electronic brake force distribution
Rain-Sensing Wipers
Bi-Xenon Head Lamps
Body color front & rear bumpers
Bright Finish Chrome Matrix Grille
Power Soft Top
Color-keyed pwr folding heated electrochromic pwr mirrors w/memory
Rear Spoiler
Side & rear tinted glass (2007)


text:
Course Objectives:
At the end of the
course, the participant will be able to:
1. Define ethical distress, dilemma and locus of
2. Discuss confounding factors that impact ethics
of care.
3. Recognize conflict between legal and ethical
4. Review the Texas Practice Act and Rules and
regulations as they apply to physical therapy.
5. Apply the steps of the ethical decision-making
process to case studies.
6. Review the APTA Code of Ethics in conjunction
with case studies.
11/5/2015OPTIM Orthopaedic Manual Physical Therapy Fellowship Granted Accreditation
11/4/2015APTA Neuro Section Needs Your Feedback
10/27/2015Congratulations Newly Elected TPTA Leaders!
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text:
Saint-Gobain Weber Co., Ltd.
Saint-Gobain Weber belongs to Saint-Gobain Group, a big international group.
Our Headquarter Office is located in France. Saint-Gobain Weber is present in more than 40 countries employing more than 10,000 people. In Thailand, we are the leader in the tile adhesive and grout market.
Our business is growing rapidly and we are looking for dynamic, hands-on and proactive candidates for the following positions:
Cost Accountant
jobsDB Ref. JTH300003001245715
The Cost Accountant is responsible for inventory ledger and cost analysis and executes tasks assigned by the Finance Analysis Manager.
- To review and reconcile costs of various sections (ie. materials / production costs / costs of sales / product development / overhead, etc);
- To analyse actual production costs and month-end close;
- To analyse and monitor RM inventory / in charge of physical stock;
- To create new inventory items (code of products), new RM, new packaging, new spare parts, new XP ,price setting, etc in the system and review the controls needed for data and reporting system;
- To ensure that BOM are properly created and ready to use in production line. Review and activate of BOM revised in system
- To prepare / check reports: reports comparing budgeted costs to actual production costs, reports on work center costs, on product margin, sales reports, etc.
- Physical stock checking to ensure the all items and transactions are moved accuracy
- Bachelor in Accounting
- ERP systems experience ,preferably with AS400 and Movex M3
- At least 2 years of experience in accounting, finance and cost control in manufacturing environment
- Background experience working with inventory / cost accounting systems and financial analysis
How to apply Click APPLY NOW to submit your application
Saint-Gobain Weber Co., Ltd.
Gypsum Metropolitan Tower 14th Floor 539/2 Si-Ayutthaya Road,
Thanonphyathai, Ratchthewi Bangkok 10400
ATTN: HR Department
Khun แหม่ม (089 939 7401 / 02 245 8777 # 134)
Khun โจ๊ก (095 423 5651 / 02 245 8777 # 138)
Keywords: Cost Accountant accounting บัญชี


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Copyright (c) 2016 CouponMount.com. All rights reserved.


text:
The FSA has finally come out with a best practices guide for financial advisers on assessing client-risk suitability.
In a report published today morning, the FSA issued guidelines on investment fund selection for clients and said many firms are unable to asses client risks properly because they fail to collect client data in the desired fashion.
Its research showed that firms assign improper weightings to answers and often provide poor answer options to their questionnaires, thus wrongly evaluating the client's capacity to absorb losses.
It cautioned against the prevalent practice of too much reliance on asset-allocation and risk profiling tools and said firms should be aware of the flaws in risk-profile calculating tools.
"These tools often have limitations which mean there are circumstances in which they produced flawed results. Where firms rely on tools they need to ensure they are actively mitigating any limitations", the report said.
In January, the FSA warned that 9 out of 11 tools can give 'flawed outputs' because of their inherent weaknesses.
"We expect all firms to consider whether they need to improve the way they assess and check the risk a customer is willing to take. As we apply our intrusive and intensive supervisory approach, we will be looking to see how firms have acted on this report", the current report says.
The current risk-profiling tools are found to be 'vague' on many occasions and do not differentiate risk levels adequately, the report found.
"Even where the risk profile of the customer is correctly assessed, the product or portfolio (and underlying asset-allocation) does not always match this profile", the report said.
The report also expresses concern over the high level unsuitable investment solutions for customers as half of the files it evaluated between March 2008 and September 2010, showed the solutions offered misjudged the amount of risk the client is willing or able to take.


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4 Channel Passive Cat5 Utp Video Balun Cctv Balun
Posted at: Offers to Sell and Export | Posted on: Wed 27 Jan, 2010 10:36 am | Targeted Countries: American Samoa | UK | Australia
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4 Channel Passive Cat5 Utp Video Balun (CCTV balun).
Shenzhen Baifuda Electronic is
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text:
CAMPIA MODA Men's Tropical Palm Tree Short-Sleeve Woven Shirt
Style# 1388825
$24.99 $12.99
This Value Deal Product cannot be used in conjunction with any coupon or bonus offer.
Style# 1388825
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FREE SHIPPING when you spend $29 or more.
This Value Deal Product cannot be used in conjunction with any coupon or bonus offer.
Additional Information
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Relaxation, a vacation in the islands, and time enjoying the warm, balmy weather are all on your mind – and this shirt shows it. A detailed palm tree print covers the front, while colors fade from white to turquoise to black in the background.
- Made out of 100% rayon
- Button-up front with a relaxed collar
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- Imported
Print this tab
Miscellaneous Attributes
- Country of Origin: Imported
- Gender: Men's
- Clothing Type: Button Front
Tech Specs
- Sleeve Length: Short sleeve


text: I have a 2g 8gb iPod Touch running firmware 3.0. I recently installed Winterboard and tried installing some themes and everything works except the springboard wallpaper. I've tried several different themes that use both Wallpaper.html and Wallpaper.png images but none of them show. The rest of the theme, including lockscreen wallpaper works fine. I've searched around and tried the methods suggested, like the removing the lockbackground.jpg method but it's still not working. Does anyone know how to solve this problem?


text:
Lakers vs Golden State Warriors Preseason Preview: Part Deux
The Los Angeles Lakers fell to the Golden State Warriors in their first preseason meeting in Las Vegas, but the team will get another crack at the champs Wednesday night in San Diego
Despite only losing by five points to the Warriors on Saturday, 107-112, the final score didn't really tell the story for the Lakers.
The new look Dubs jumped out to a quick lead in the first half prompting Steve Kerr to rest his big guns for the majority of the second, though he likely would've done so regardless of the score.
Ironically, having been compared to Kevin Durant incessantly since coming onto the scene, rookie Brandon Ingram had his best game scoring 12 points on 3-of-6 shooting, including 2-of-2 from behind the arc. It's not certain who Kerr plans on resting Wednesday — he gave Draymond Green and Andre Iguodala last game off — but should Ingram get another chance against his muse, he's likely to embrace the challenge.
More from Lake Show Life
- Lakers: Jordan Clarkson Deserves a Spot In the Starting Lineup1 d ago
- Lakers: 3 Takeaways From Preseason Loss to the Golden State Warriors2d ago
- Lakers: D'Angelo Russell's Preseason Shot Chart Is Absolutely Insane3d ago
- Lakers vs Golden State Warriors Preseason Preview: Where and When to Watch3d ago
- Lakers: 3 Takeaways From the Preseason Loss vs Sacramento Kings4d ago
It is no secret that Luke Walton is attempting to recreate the magic he had up in San Francisco down here in Los Angeles and Draymond Green even recently came out and said that his Lakers' counterpart, Julius Randle has the potential to be better than him.
Of the the team's young core members, Randle is often the lowest on the totem pole, so to hear praise like this is encouraging for him and the fan base alike. In his comments, Green made a good point, Randle already has the "God-given gifts" and more importantly, he's still only 21 years of age.
This often gets forgotten in the hustle and bustle of things, how truly young the Lakers' core is, so it's good to be reminded of that every once in a while.
Golden State Warriors at Los Angeles Lakers
Date: Wednesday, October 19
Start Time: 7:00 p.m. PT
Location: San Diego, California
Arena: Valley View Casino Center
TV Info: Spectrum Sportsnet, ESPN
Be sure to tune in Wednesday night as Los Angeles looks to get revenge on the defending champs in San Diego and follow @TheLakeShowLife and @ericdyee on Twitter for live updates as always!
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