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NEWTON's HOME PAGE
Privacy Policy
Rain Shadow Range
Name: Martha Status: educator Grade: 8 Location: MD Country: USA Date: Fall 2011
The "rain shadow" effect of mountains causes dry climates on the leeward side of mountains. About how far does that "rain shadow" extend? Less than 100 miles? Hundreds of miles? I am sure it depends on the size of the mountain range. How about the Rockies? The Himalayas?
The rain shadow extends until the air encounters a source of moisture. In North America, for instance, air that passes over the Rocky Mountains is quite dry; precipitation in the Midwest tends to come from moisture carried.from the Gulf of Mexico.
Richard E. Barrans Jr., Ph.D., M.Ed. Department of Physics and Astronomy University of Wyoming
An excellent example of an active rain shadows in the prevailing westerlies is the Coast Range followed by Sierra Nevada chain. The California Coast ranges create a rain shadow (hence the need to irrigate crops in the "Valley" and the existence of temperate rain forests) and the Sierras complete the job and create the Nevada desert.
This should spark a discussion on the effect of elevation on the drying effect, and prepare students to understand the wetter parts of the Colorado plateau and why the Western Slope is the source of water for Denver.
R. W. "Mr. A." Avakian
Click here to return to the Weather Archives
NEWTON is an electronic community for Science, Math, and Computer Science K-12 Educators, sponsored and operated by
Argonne National Laboratory
Educational Programs
, Andrew Skipor, Ph.D., Head of Educational Programs.
For assistance with NEWTON contact a
System Operator (firstname.lastname@example.com)
, or at Argonne's
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Educational Programs
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Update: June 2012


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HVAC ASHRAE 62.1 for iPhone
HVAC ASHRAE 62.1 Overview
ANSI/ASHRAE Standard 62.1-2010, Ventilation for Acceptable Indoor Air Quality, sets minimum ventilation rates and other requirements for commercial and institutional buildings. Standard 62.1 has served the building industry and the public as the most prominent standard on ventilation for indoor air quality.
The HVAC ASHRAE 62.1 iPhone, iPod touch, and iPad application allows you to perform comprehensive minimum ventilation calculations for a wide variety of commercial buildings based upon Standards 62.1-2007 and 2010. This app is based upon the "62MZCalc.xls" Excel spreadsheet that accompanies each copy of the 62.1 User's Manual. You can do pretty much everything in this app that you can do in the Excel spreadsheet, in addition to creating multi-system projects and emailing results so you can perform further analysis.
Other advantages over the spreadsheet include:
- Easily perform ventilation calcs (for either the 2007 or 2010 version of the Standard) in the field using your mobile device.
- By using slider-control inputs, you can Instantly see results update as input values are changed.
- Easily email inputs and results in an html-formatted email and also an Excel spreadsheet for further analysis back at the office.
The screenshot below describes the overall zone input and results information. You can select the space type, input the floor area, zone population, and design airflow. This application uses slider controls that allow you to quickly increment or decrement the input values and immediately observe the calculated results.
Below is a partial list of the available space types.
The system form automatically calculates totals for zone areas, occupancy, and air flows:
You can also email a comprehensive ASHRAE 62.1 report that can be imported into Excel for further analysis:
This application is available to display both english and metric units.
The HVAC ASHRAE 62.1 application was designed by Carmel Software Corporation exclusively for the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE).
Click here to go to Apple iTunes to download the HVAC ASHRAE 62.1 app.

subset: commoncrawl


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From Wikipedia, the free encyclopedia - View original article
William Scull (1739-1784) was an American cartographer and officer during the Revolutionary War. Scull was the grandson of Nicholas Scull, who was the colonial Surveyor General of Pennsylvania. In 1770, he published a map of Pennsylvania with Robert Sayer and John Bennett[disambiguation needed] and engraved by Henry Dawkins and James Nevil in Philadelphia. It was republished in many editions in France and England, although it is considered a compilation of the work of other cartographers.[1] He was commissioned an officer with the rank of Captain in the 11th Pennsylvania Regiment. He retired from that position on July 1, 1778, to take a position on the staff of Robert Erskine in the Geographer's Department of the Continental Army. William Scull was also a member of the American Philosophical Society from Reading, Pennsylvania.
This United States biographical article is a stub. You can help Wikipedia by expanding it. |


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Kroger Central Store 911
2140 Fort Harrison
Terre Haute, IN 47804
Map It!
Years Labeled (Rating):
2012 (91)
Facility Type:
Supermarket/Grocery Store
Total Floor Space:
Year Constructed:
Building Owner:
The Kroger Co
Property Manager:
The Kroger Co
For More Info:
Cornelius Anderson
Corporate Energy Engineer
Cincinnati, OH 45202
Please note: The building information in this profile was verified and submitted to EPA at the time of application. Building energy performance, operating
characteristics, and ownership/management may be subject to change over time.


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Our exceptional, friendly staff at Wenatchee Dental Arts is our greatest asset. Our dental assistants and hygienists are licensed professionals who pride themselves on staying on the cutting edge of dentistry and patient communication. We are excited about what we are doing, have high standards of quality and integrity, and are motivated to achieve the best results for our family of patients.
Hi, I am Dr. John Divis. I became interested in dentistry as a youngster. My childhood dentist was a WWll veteran who had fought on the beachheads in the pacific. Having treatment done was always scary and uncomfortable as a child. Fortunately, his son became a dentist as well. I say fortunately because he changed my perception of going to the dentist. He listened to me and respected any signs of discomfort. He got me numb enough to have pain free dental treatment for the first time. That is a major reason why I chose dentistry as a profession. It is also why I have taken a special interest in learning to treat people with deep anxieties towards dentistry. The biggest step I took occurred in 1999 when I attended an in hospital training program developed by the Society for the Advancement of Anesthesia in Dentistry, one of the oldest dental societies in the country. There I learned the science and art of sedation dentistry from experienced dentists and anesthesiologists. Through their training I became qualified to attain a permit to provide moderate levels of I.V. anesthesia. Since then I have performed sedation dentistry for hundreds of people. If you are looking for someone who take pride not only in providing high quality dentistry but also has a lot of experience providing sedation dentistry, you're in the right place.
We are dedicated and motivated with one primary goal—your utmost comfort! We feel it's important that you understand the treatment that you'll be receiving so that you can relax during the procedure. We are eager to answer any questions regarding your dental care. Please feel free to share with us your needs and concerns.
Call for a Wenatchee dental appointment and experience the difference today!
Meet our Staff!
Tiffany Otterstetter RDH was raised in Westport,WA. She received her dental hygiene degree from Yakima Valley Community college in 2001 and shortly after began working for Dr Divis at Wenatchee Dental Arts. She strives to live a healthy lifestyle and helps others improve their health as well starting with a healthy smile. Tiffany and her husband, Jason have two girls, Chloe and Bella. Tiffany enjoys camping with her family at Lake Chelan, riding her bike and boating.
Tammie Farley, Scheduling Coordinator…has moved back to this area after being away for 10 years to be closer to her family. Tammie started her dental career in 1995 here in Wenatchee. Tammie joined the team of Wenatchee Dental Arts in September of 2011. Tammie loves working in dentistry; she has compassion and loves to get to know our patients on a personal level. Tammie enjoys spending time with her son Michael and her family. In the spring and summer you will find her at the golf course or doing home improvement projects in her free time.


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By Publius Huldah Thursday, July 29, 2010
Does anyone read the U.S. Constitution these days? American lawyers don't read it. Federal Judge Susan R. Bolton apparently has never read it. Same goes for our illustrious Attorney General Eric Holder. But this lawyer has read it and she is going to show you something in Our Constitution which is as plain as the nose on your face.
Article III, Sec. 2, clause 2 says:
In all Cases affecting Ambassadors, other public Ministers and Consuls, and those in which a State shall be Party, the supreme Court shall have original Jurisdiction. In all the other Cases before mentioned, the supreme Court shall have appellate Jurisdiction…


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Indian girls nearly take down Garden
By BRETT MARSHALL
Special to The Hays Daily News
GARDEN CITY -- The Hays High School girls' basketball team knows all about winning the Western Athletic Conference basketball championship.
After all, they did it a year ago. So when they traveled on Friday to play Garden City, they wanted to do all they could to slow down the Buffs' march to this year's WAC title.
They almost pulled it off -- almost.
Despite shooting a better percentage from the field than Garden (41.4 percent to 29.5 percent for Garden City), and despite outrebounding the host team 36-27, the Indians came up on the short end of a 47-43 score against the Lady Buffs.
As a result, Garden City clinched what is believed to be its first girls' league title in program history.
While Indian coach Kirk Maska saw his team's season record dip to 8-10 overall and 2-4 in the WAC, Garden City stayed unbeaten in the league at 7-0 and improved to 16-3 overall.
"The biggest thing were the turnovers, that's what really cost us the game," Maska said. "We let them get the momentum back in the second half and when they did, it was pretty tough for us."
After an 8-8 first-quarter battle, the Indians moved ahead 22-16 at halftime thanks in part to red-hot shooting in the second period when they were 5 of 6 from the field and 3 of 3 at the free throw line.
"I thought we did a nice job of attacking their defense in the first half," Maska said.
The Indians still appeared to be in control of the game when they opened a 29-21 lead with 2:15 left in the third quarter. But Garden finally got its own offense moving, finishing the period with a 9-2 run, including a back-breaking 3-pointer from Jacksenie Tornero from just inside the halfcourt line right before the buzzer sounded to end the stanza.
"That one was the biggest momentum switch of the game," Maska said. "That really got them going at the start of the fourth and we never really had an answer for that."
After turning the ball over eight times in the first half, the Indians struggled against Garden City's fullcourt press, committing 15 miscues in the final half to finish with 23. Garden, meanwhile, had just 13.
Garden City finally got the lead at 38-37 midway through the fourth quarter and then hung on at the end, cashing in 9-of-10 free throws down the stretch.
Free throws, or lack thereof, proved to be a big difference in the game as the Indians were only 4 of 8 at the stripe compared to 18 of 27 for Garden City.
Katelyn Schumacher, who has been the big scoring spark for the Indians all season, led the way with 17 points and grabbed 10 rebounds to record a double-double.
Jaymie Bernbeck topped Garden's scoring with 11 points.
The Indians travel on Tuesday to Dodge City for a 6 p.m. tipoff.


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Dizzy Wright - Kill Em Wit Kindness
Kill Em Wit Kindness Dizzy Wright
Dizzy Wright not only drops off this new leak off his mixtape in audio-form, but also delivers the video for it. Produced by AF $upreme.
Stream Kill Em Wit Kindness, the newest drop from Dizzy Wright. The cut was released on Wednesday, April 3rd, 2013. Dizzy Wright continues to impress with each new leak, and Kill Em Wit Kindness is no exception. It's strengthens Dizzy Wright's already impressive body of work, which has seen positive change over the years. We're most definitely anticipating Dizzy Wright's next offering.
Check out Dizzy Wright on World Peace (Prod by Rikio). If you dig this, visit Dizzy Wright's profile for the latest info, news, songs, and mixtapes. Make sure to hit Dizzy Wright with a follow and/or like on Facebook and Twitter.
Are y'all feeling this one?
Quotable Lyrics
"Cautious with the image that I'm givin'
What used to be appealin' is the shit that I'm resentin'
Feel like I ain't livin', I'm dealin' with so much
On the low, I'm actin' tough, but I ain't been happy in a minute
And what's crazy is this is just the beginning
Ridin' 'round Vegas tryna build my foundation
That immediate happiness is awaitin'
But I feel it's overrated, I'm keepin' a clear conscience "


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Congratulations class of 2014! This page will contain information for graduates wishing to participate in the commencement ceremonies scheduled for Friday, May 16 in the Robert Collins Arena.
Commencement Information for graduates
How do I pick up my cap and gown?
Students planning to participate in the ceremony must purchase their cap and gown during Countdown to Graduation Week from Monday April 7 until Friday April 11 in the Scroll and Pen Bookstore. Cost for cap and gown is $30 and must be paid by cash or check. Click on the link provided for hours and further details. At the time of cap and gown pick up you will also receive your guests' tickets.
What are guest tickets?
With the number of graduates climbing we must limit the number of tickets to six per family. We will simulcast the Ceremony in the Warner Student Life Center but no-one without a ticket will be allowed in the Arena. This includes children. More information for your guests is available on another section of this web-page.
When and where is my ceremony?
In order to accommodate more guests Brookdale Community College holds two ceremonies on the same day, this year Friday May 16. The morning session for Associates in Arts (A.A.) degree candidates starts at 10 AM. The afternoon session for Associate in Science (A.S.), Associate in Fine Arts (A.F.A.), Associates in Applied Science (A.A.S.) and Certificate Program Candidates. Both ceremonies are held in the Robert Collins Arena on the Lincroft Campus.
When and where do I report to for the ceremony?
All graduates are asked to arrive one hour before each ceremony (9 AM for the morning & 2 PM for the afternoon) and report to the Brookdale Recreation & Events Center (B-REC) to line up. Our volunteers will assist you in getting in alphabetical order by last name so your families will know when to expect your name as you cross the stage.
What do I do to request an accommodation?
If you need an accommodation please contact the office of Student Life & Activities directly at 732-224-2788. You will need to give your name, contact information and the nature of your request. We work collaboratively with the office of Disability Services to make sure we are able to meet all reasonable accommodations. Please make sure we receive requests by Friday, May 2, 2014 so we have enough time to coordinate our assistance.
I'm interested in serving as Graduate Trustee, how do I run?
Each student who has applied for graduation in 2014 will receive a letter to your home address inviting you to consider running for the position of Graduate Trustee. The position is for one year, with a time commitment of at least two meeting per month. The Graduate Trustee serves as the student voice on the Brookdale Board of Trustees and has a vital impact on how the college is run. Students interested in running are asked to submit their completed application to the President's Office, located in the Brookdale Administrative Center (BAC), by Tuesday, April 15 at 5:00 PM.
How do I vote for Graduate Trustee?
The elections for the open board seat will be held on-line on the portal. To vote students must sign into the portal (red tab on homepage). The voting poll will show under the student page. All students may only vote once.
The voting poll will be open and available from 9 AM Tuesday, April 22nd, until 7 PM Thursday, April 24th. The election will be certified Thursday night, and the winner announced on Friday, April 25th.
I'm interested in giving the student speech at my ceremony, how do I enter consideration?
One graduate from both sessions is selected to give a speech at each of the 2014 Commencement Ceremonies as the student speaker. To be eligible to address the graduating class you must be participating in the ceremony. Speakers must also be available at some time on Thursday, May 15, to practice their speech in the Collins Arena.
For your speech to be considered it must be typed and submitted to the office of Student Live & Activities, located on the lower level of the Warner Student Life Center, room 101. The deadline for submission is Friday, April 18th. When you submit your speech you must also give your student ID number and contact information. Your speech should be a personal story about how Brookdale Community College positively impacted your life. Please limit your speech to three typed pages, double-spaced. The speakers selected will be contacted the week of April 21st.
Any other information I should be aware of?
Be on time: The lineup takes quite a while so you must be at the Brookdale Recreation & Events Center at the time designated. Anyone arriving late may be placed at the end of the line which will not follow the program listing.
Plan to stay: Commencement can run late since there are more than 500 graduates marching and two ceremonies. Once the ceremonies begin, no graduate will be permitted to leave. If you have plans following the graduation ceremony, please keep this in mind.
Enjoy yourself: This is a special moment and the entire Brookdale community is proud of your achievement.
If you still have questions please feel free to contact the Department of Student Life & Activities at 732-224-2788 or by e-mailing us at firstname.lastname@example.com.


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Posted: June 27, 2013
Nelson Mandela, the former South African president revered around the world, remains in a Pretoria hospital. His condition has improved slightly — though still critical, he is now "stable." His family is near, some of them angered by the army of reporters who have gathered near the hospital. President Obama, on a three country tour of Africa, arrives in South Africa on Friday.
Please follow our community discussion rules when composing your comments.


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By Kenneth S. Geller * and Alan E. Untereiner
May a defendant assert a preemption defense based on federal requirements it has not met? That question is being raised with increasing frequency in tort actions against the makers of medical devices and other products subject to preemptive federal regulation. Plaintiffs maintain that it disserves the overarching goal of enhancing safety to permit a defendant manufacturer who has not complied with federal safety standards to invoke the shield of preemption.
In Talbott v. C.R. Bard, Inc., 63 F.3d 25 (1995), the First Circuit recently refused to recognize a noncompliance exception to preemption under the Medical Device Amendments of 1976 (MDA) to the Food, Drug, and Cosmetic Act. In fact, the court of appeals rejected three variations of the "noncompliance" argument, including one advanced by the United States government in an amicus brief.
In this article, we examine the argument for a noncompliance exception to federal preemption. Endorsing the result in Talbott, we explain why the exception is not available under the MDA. We analyze the First Circuit's reasoning and identify additional reasons not mentioned by the court of appeals why a noncompliance exception is both inconsistent with the language of the MDA and unworkable in practice. Along the way, we offer suggestions to defendants seeking to defeat arguments for a noncompliance exception under other federal statutes.
Under the doctrine of federal preemption, Congress may nullify state laws, including common law tort duties, in order to ensure national regulatory uniformity or to achieve other federal objectives.
The doctrine is founded on the Supremacy Clause of the U.S. Constitution, which states that the laws of the United States "shall be the supreme Law of the Land; . . . any Thing in the Constitution or Laws of any state to the Contrary notwithstanding." Preemption defenses are routinely asserted in a wide array of tort lawsuits brought under state law.
Preemption can be either implied or express. Under the doctrine of implied preemption, state law may be preempted even without an explicit statement by Congress, as where state law conflicts with federal law. Preemption defenses, however, often rely on preemption clauses in federal statutes.
Among the many statutes in the United States Code with express preemption provisions are the National Traffic and Motor Vehicle Safety Act, 49 U.S.C. §30103(b) (formerly 15 U.S.C. §1392(d)); the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. §136v; the Federal Boat Safety Act, 46 U.S.C. §4306; and the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360k(a). In Talbott v. C.R. Bard, Inc., 63 F.3d 25 (1995), the First Circuit recently upheld the dismissal on preemption grounds of numerous state-law tort claims for damages brought against the manufacturer of a medical device and several of its corporate officers.
The case is important because it illustrates the kinds of arguments that increasingly are being made — not only in MDA preemption cases but in other contexts as well — in support of exceptions to preemption based on a defendant's alleged failure to comply with otherwise-preemptive federal requirements.
The fact that the United States government filed an amicus brief urging adoption of one variation of the noncompliance argument, moreover, is significant because it may reflect either a high-level decision to press this theory in other preemption contexts or the government's dissatisfaction with the broad preemptive reading given by most courts to the MDA.
In any event, device manufacturers and other defendants who regularly invoke preemption as a defense can expect to encounter arguments based on the noncompliance theory in the future.
The 'Talbott' Case
Talbott arose out of a woman's death during angioplasty, a procedure in which a medical device known as a heart catheter is threaded up through an artery in the patient's leg to a coronary artery, where a balloon is temporarily inflated to reduce arterial blockage.
The woman died when a catheter manufactured by C.R. Bard failed to deflate. Her heirs' lawsuit included claims for negligence in the design, manufacturing and marketing of the device, willful and wanton conduct (punitive damages), breach of express and implied warranties, negligent infliction of emotional distress, fraudulent misrepresentation and concealment, battery, civil conspiracy, and unfair and deceptive trade practices.
The district court dismissed all of plaintiffs' claims as preempted under the MDA. 865 F. Supp. 37 (D. Mass. 1994). In affirming, the First Circuit relied principally on the language of the MDA's express preemption clause, which states:
Except as provided in subsection (b) of this section, 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 under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
21 U.S.C. §360k(a).
The First Circuit reasoned that all of plaintiffs' claims would impose "requirement[s]" that are "different from, or in addition to" those imposed by federal law on the Bard heart catheter.
As a so-called "Class III" medical device, the catheter was subject to extensive federal regulation and oversight, including premarketing approval (PMA) by the Food and Drug Administration (FDA) of the device's design, manufacture, and labeling. It was also subject to various post-approval reporting requirements.
The result reached by the First Circuit in Talbott is consistent with many other federal and state decisions that uphold preemption of claims relating to Class III devices under the broad reach of the MDA's preemption clause. See, e.g., Martello v. Ciba Vision Corp., 42 F.3d 1167, 1169 (8th Cir. 1994), cert. denied, 115 S. Ct. 2614 (1995); Gile v. Optical Radiation Corp., 22 F.3d 540, 542, 544, 546 (3d Cir.) cert. denied, 115 S. Ct. 429 (1994); Stamps v. Collagen Corp., 984 F.2d 1416, 1419-25 (5th Cir.), cert. denied, 114 S. Ct. 86 (1993). See also Martin v. Telectronics Pacing Systems, Inc., 70 F.3d 39 (6th Cir. 1995) (upholding broad preemption of claims relating to investigational medical devices).
Noncompliance Exception to Preemption
The issue of compliance with federal safety standards frequently arises in product liability and other tort litigation.
As a general matter, evidentiary rules in federal and in state courts permit the introduction of evidence of a defendant's violation of (or compliance with) federal safety requirements to prove (or disprove) non-preempted claims under state law.
Thus, a plaintiff might introduce evidence of a defendant's failure to comply with federal regulations mandating that a certain warning accompany a particular product in seeking to prove that the defendant negligently failed to provide an adequate warning. See Restatement (Second) of Torts §§288B(2), 288C (1965).
Similarly, the tort law of many states treats the violation of (state or federal) safety requirements as negligence "per se." Id. §288B(1). In these jurisdictions, a plaintiff may be able to establish negligence by proving that a defendant failed to comply with a federal statutory duty.
Analytically, however, these contexts are quite different from that of preemption. Preemption turns on Congress's intent and the relationship between federal and state law, not on the relevance of evidence to non-preempted causes of action or the manner in which a State chooses to define non-preempted duties under state law. As the American Law Institute recently explained:
When a court concludes that a defendant is not liable by reason of having complied with safety design or warnings statutes or regulations, it is deciding that the product in question is not defective as a matter of the law of that state. The safety statute or regulation may be a federal provision but the decision to give it determinative effect is a state law determination. In contrast, in federal preemption, the court decides as a matter of federal law that the relevant federal statute or regulation reflects, expressly or impliedly, the intent of Congress to displace state law, including state tort law, with the federal statute or regulation. The question of preemption is thus a question of federal law and a determination that there is preemption nullifies otherwise operational state law.
Restatement (Third) of Torts: Products Liability, §7 cmt. e (Tentative Draft No. 2, Mar. 13, 1995).
The Talbott case is an instructive example of noncompliance arguments in this unconventional context.
In its amicus brief in support of the plaintiffs, the United States urged the First Circuit to create an exception to MDA preemption where the FDA has made a determination that a defendant failed to comply with otherwise-preemptive federal requirements.
The plaintiffs advanced several variations of this argument. They contended that MDA preemption does not apply to a device whose approval by the FDA was fraudulently obtained. Plaintiffs also argued that the MDA does not preempt state-law tort duties that impose requirements that are identical to those imposed under the MDA. Although this last theory resembles a traditional preemption argument in that it turns on the relationship between state and federal law (rather than on the defendant's compliance with the latter), plaintiffs, in order to prevail on the merits of such a claim, would have to prove that the defendant failed to comply with standards embodied in federal law.
Criminal Prosecution
In making their arguments about noncompliance with federal standards, the plaintiffs and the United States both relied on the fact that Bard and six of its employees had been criminally prosecuted by the United States Attorney for Massachusetts.
Bard itself pleaded guilty to a 391-count information including counts of conspiracy, mail fraud, submission of false statements to the FDA, shipment of adulterated medical devices, and failure to submit required reports to the FDA. See United States v. C.R. Bard, Inc., 848 F. Supp. 287 (D. Mass. 1994).
According to the government's charging document in the criminal case, between 1987 and 1990 six Bard employees (including the two individuals named as defendants in the Talbott case) engaged in a course of illegal conduct in response to revelations that Bard heart catheters were malfunctioning.
The illegal conduct included failing to notify the FDA of reports of problems, distributing significantly redesigned catheters without first obtaining the requisite FDA approval and without disclosing the fact of redesign to physicians, and making false statements to the FDA concerning the location where catheters were being manufactured (in violation of the FDA's good manufacturing practices rules).
In pleading guilty, Bard agreed to implement various remedial measures and to pay a penalty of more than $61,000,000, consisting of $30,500,000 as part of a civil settlement, $30,500,000 in criminal fines, and $78,200 in special assessments. 848 F. Supp. at 289, 291-92.
Notwithstanding this unusual and extremely negative backdrop to plaintiffs' noncompliance arguments, the First Circuit declined to recognize any of the proposed exceptions to preemption under the MDA.
As we explain below, this result was correct—for reasons both stated by the First Circuit and unmentioned in the court's decision. The proposed exceptions for noncompliance are inconsistent with the language of the MDA and utterly unworkable in practice.
The Talbott case, moreover, illustrates well the kind of arguments that can be advanced by defense counsel to defeat claimed exceptions to preemption for noncompliance in other preemption contexts.
A Fraud-On-The-FDA Exception to MDA Preemption'
Relying on the fact of Bard's guilty plea, the plaintiffs in Talbott argued that the company was not entitled to the shield of preemption because it had defrauded the FDA in obtaining approval of the Bard catheter for marketing.
According to the plaintiffs, Bard had failed to disclose to the FDA all of the information required to be disclosed by federal law.
Allowing preemption in this circumstance, plaintiffs argued, "would conflict . . . with the MDA's basic purpose of protecting individuals from unreasonably dangerous and defective medical devices." Talbott, 63 F.3d at 28. Accord Evraets v. Intermedics Intraocular, Inc., 29 Cal. App. 4th 779, 790-91, 34 Cal. Rptr. 2d 852, 858 (2d Dist. 1994) ("It is fair to say that for a medical device manufacturer to claim the shield of preemption, the manufacturer must 'play by the rules.' If the manufacturer subverts the rules and obtains approval to market its product by misrepresenting [to the FDA] the risks involved, knowing that this disinformation will ultimately harm patients, the injured party should be entitled to sue.").
In rejecting this version of the noncompliance exception, the First Circuit relied primarily on the language of Section 360k(a), the MDA's preemption clause. Section 360k(a), the court explained, "preempts broadly any state tort law 'requirement' that is 'different from, or in addition to' the comprehensive and detailed requirements set forth by federal law." Talbott, 63 F.3d at 28-29 (emphases added). The statutory language, moreover,
make[s] no distinction based upon whether or not a manufacturer has in fact complied with the federal standard. We find nothing to indicate that preemption is conditional upon satisfactory compliance with the federal standard. Section 360k(a) does not mention compliance at all. As §360k(a) reads, the relevant inquiry is simply whether, in the abstract, the state tort law requirement is "different from, or in addition to" the federal requirement. If a device manufacturer fails to meet the federal requirements, it will be subject to federal penalties as set forth in the MDA. Nothing in §360k(a) suggests that the state requirements are somehow revived by this failure to comply with the federal standard.
Id. at 29.
Practical Considerations
The First Circuit also relied on practical considerations in rejecting the fraud-on-the-FDA exception. "If state tort claims were allowed to go forward" on such a basis, the court explained,
a state court would initially have to determine whether the manufacturer had complied with the MDA. If, as in this case, the plaintiff claimed that the manufacturer had defrauded the FDA, the state court would need to determine whether the FDA had in fact been defrauded and whether the FDA would have approved the device absent the fraud. Under this scheme, a device manufacturer could potentially be subject to numerous inconsistent interpretations and applications of the MDA across different states, thus undermining the MDA's goal of uniformity. Moreover, if state courts erred in their application of the MDA, they would effectively be imposing requirements "different from, or in addition to" those imposed by federal law.
Talbott, 63 F.3d at 29.
"To avoid the possibility of disuniform treatment," the court explained, "Congress placed enforcement authority in the FDA." Ibid. If a manufacturer defrauds the FDA or otherwise violates federal requirements, the FDA may employ the "broad power[s]" granted to it by Congress — including ordering a recall of the device or rescinding its approval for marketing — to redress the violation. Ibid.
Resolution Of Conflicting Cases
The court of appeals' holding in Talbott resolves conflicting signals in prior First Circuit cases concerning the validity of the fraud-on-the-FDA exception to MDA preemption.
In King v. Collagen Corp., 983 F.2d 1130 (1st Cir.), cert. denied, 114 S. Ct. 84 (1993), two members of the panel, in a separate opinion oddly labeled a concurrence, concluded that a plaintiff's claim of "fraud on the FDA" (id. at 1140 n.8) was preempted because it would require a jury to decide, on the issue of causation, whether the FDA would have required a different labeling or approved a different use for the device if the manufacturer had provided the FDA with the information that it fraudulently withheld. Id. at 1140.
In a later MDA preemption case, however, a different panel of the First Circuit, without citing the King concurrence, purported to reserve the issue of "whether products liability claims are preempted only if the manufacturer complied with applicable FDA regulations." Mendes v. Medtronic, Inc., 18 F.3d 13, 19-20 (1st Cir. 1994).
Accord With Other Federal Appeals Courts *
The First Circuit's rejection of the fraud-on-the-FDA theory is consistent with the decisions of at least three other federal courts of appeals. See Mitchell v. Collagen Corp., 67 F. 3d 1268, 1283 (7th Cir. 1995); Michael v. Shiley, 46 F.3d 1316, 1328-29 (3d Cir.), cert. denied, 116 S. Ct. 67 (1995); Reeves v. AcroMed, 44 F.3d 300, 306 (5th Cir.), cert. denied, 115 S. Ct. 2251 (1995). See also Mears v. Marshall, 905 P.2d 1154, 1166-67 (Ore. Ct. App. 1995) (rejecting fraud-on-the-FDA theory) rehearing denied, 1996 Ore. App. LEXIS 5 (Jan. 3, 1996); Papas v. Upjohn, 985 F.2d 516, 518-19 (11th Cir.) (per curiam) (rejecting argument that pesticide manufacturer is not entitled to shield of preemption under FIFRA where it allegedly failed to disclose certain information to Environmental Protection Agency) ("[I]t is for the EPA Administrator, not a jury, to determine whether labelling and packaging information is incomplete and inaccurate, and if so what label changes, if any, should be made."), cert. denied, 114 S. Ct. 300 (1993). But see Reiter v. Zimmer, 830 F. Supp. 199, 204 (S.D.N.Y. 1993) (in case involving Class III device, holding that claim for negligent manufacture is not preempted where plaintiff alleges that manufacturer failed to comply with "the FDA's manufacturing specifications").
The analysis set forth in Talbott and the King concurrence is correct. If a plaintiff is permitted to sue for design defect or negligent design on the ground that the FDA would not have granted premarket approval of the device's design if the manufacturer had made full disclosure of the information required to be disclosed by federal law, some entity other than the expert agency that enforces the MDA and its implementing regulations — a state or federal court, or perhaps a jury — will have to answer the hypothetical question of what the FDA would have done had it received the withheld information.
Would the FDA have deemed the withheld information a violation of its disclosure requirements? Would it have approved the device anyway?
The same questions would arise with respect to failure-to-warn claims, where a manufacturer allegedly withholds information concerning the risks associated with a device in obtaining approval of the device's labeling. To allow state court judges or lay juries to decide how the FDA would have acted under counterfactual circumstances would necessarily threaten the very uniformity Congress intended to safeguard.
Incursion On Agency Authority
Indeed, the interference with federal prerogatives goes beyond the threat of disuniform results. It includes the incursion upon the expert federal agency's exclusive authority to enforce the commands of federal law.
Congress has vested in the federal government certain enforcement powers, including the authority to approve or disapprove Class III devices, to ban unsafe devices, and to order a device to be withdrawn from the market where subsequent information raises concerns over the device's safety and efficacy. See 21 U.S.C. §§360e(d), 360e(e)(1), 360f; 21 C.F.R. §814.46 (1995). The federal government is also empowered to issue orders requiring, for example, notification, repair, replacement, or refund. 21 U.S.C. §360h.
In Michael, the Third Circuit relied primarily on the potential for interference with the FDA's exclusive enforcement authority in rejecting a fraud-on-the-FDA exception to MDA preemption. The court of appeals explained:
[The plaintiff] seeks to use this general prohibition on deception [under Pennsylvania law] to encourage the district court to review the PMA application Shiley submitted to the FDA. This inquiry could ultimately require that a court determine whether the information Shiley submitted was truthful, whether it was complete, whether FDA procedures sufficed to avoid a material misrepresentation, and whether the FDA should have or would have approved the device despite the misrepresentations. In sum, this claim requires a court, applying state law, to perform the same functions initially entrusted to the FDA. Section 360k does not permit such a searching state inquiry into the inner workings of FDA procedures.
46 F.3d at 1329.
No Private Right Of Action
It is significant in this regard that Congress did not create a private right of action under the MDA. See Talbott, 63 F.3d at 30-31. As the district court in Talbott explained, Congress's failure to include any private right of action reflects a determination to vest in "the FDA and other agencies of the United States government" the exclusive authority to assert a claim "that the FDA has been defrauded" or federal regulations violated. 865 F. Supp. at 47.
It would severely frustrate Congress's goal of uniformity if the meaning of federal requirements under the MDA were routinely explicated in actions between private parties to which the FDA was not a party (such as the Talbott lawsuit).
The fraud-on-the-FDA theory is also flawed for another reason the First Circuit did not mention: if accepted, it would effectively deprive manufacturers in MDA cases of the right to obtain dismissal of preempted claims on the pleadings.
This would dilute much of the benefit to device manufacturers offered by the preemption defense. As the district court correctly explained, "[i]f a fraud on the FDA exception exists, it is foreseeable that it would often be alleged to apply in MDA cases. Initially, those allegations would have to be accepted as true. At a minimum, such cases would require extensive and expensive discovery." Talbott, 865 F. Supp. at 47. Elimination of manufacturers' rights to obtain dismissal of preempted claims at the threshold of a lawsuit would do much to nullify Congress's purpose of protecting manufacturers from undue litigation costs and thereby stimulating investment and innovation.
Affirmative Evidence Of Intent
Finally, it is worth noting that the MDA's preemption provision contains affirmative evidence that Congress did not intend to permit a fraud-on-the-FDA exception to preemption (or for that matter any exception based on noncompliance).
First, the preemption provision does recognize a different exception—and indicates by its plain language that the exception is exclusive. See 21 U.S.C. §360k(a) (mandating preemption of certain state law requirements "[e]xcept as provided in subsection (b) of this section"); id. §360k(b) (permitting states to apply to the federal government to exempt from preemption state requirements that are either (1) "more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection"; or (2) "required by compelling local conditions" and such that "compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter.").
The exception allowed by Congress, moreover, is one that ultimately remains under the control of the expert federal agency charged with enforcing federal law.
Second, the drafters of the MDA's preemption clause plainly contemplated the subject of the effect of violations of (and compliance with) state and federal requirements on the scope of preemption.
Thus, as just noted, Section 360k(b) authorizes the federal government to exempt state requirements that are "required by compelling local conditions" where "compliance with the [state] requirement would not cause the device to be in violation of any applicable requirement under this chapter." 21 U.S.C. §360k(b)(2)(B) (emphasis added).
In addition, Section 360h, which authorizes the federal government to issue orders requiring manufacturers (among other things) to make repairs, replace defective devices, or reimburse purchasers for the cost of a device, also states:
Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided him under such order shall be taken into account.
21 U.S.C. §360h(d). In view of these explicit references in the statute to the issue of compliance, the absence of any mention of a noncompliance exception in the MDA's preemption clause is all the more telling.
Effect Of FDA Determination Of Noncompliance
The United States' amicus brief in Talbott urged the First Circuit to recognize an exception to MDA preemption where the FDA has made a determination that a manufacturer failed to comply with federal requirements.
According to the United States, the fact of the FDA's determination eliminates any concern about nonuniformity in the enforcement of federal requirements. Relatedly, the Talbott plaintiffs argued that there was no preemption because their claims were founded on proven violations of federal law, as demonstrated by Bard's guilty plea.
The First Circuit rejected this exception as well, reasoning, again, that "neither the language of §360k(a) nor the legislative history give[s] any hint of congressional intent to create such a unique exception to the MDA's preemption clause." Talbott, 63 F.3d at 30.
The court stressed the absence of a private right of action under the MDA. In declining to recognize the exception urged by the United States, however, the Talbott court stated that this exception "may be a workable arrangement" and "may or may not be . . . a desirable rule, from a policy standpoint." Ibid. These statements contrasted sharply with the court of appeals' characterization as "unwieldy" (id. at 29) of the claimed exception for state requirements that are identical to federal requirements (discussed below).
The First Circuit was correct to reject the variation of the noncompliance argument pressed by the government. The exception finds no support in the language of the MDA's preemption clause.
As explained above, the fact that the statute elsewhere mentions compliance shows that Congress thought about the issue but did not intend to create an exception to MDA preemption for noncompliance.
Indeed, this argument is even stronger with respect to the government's version of the noncompliance argument. The exception allowed by Congress under Section 360k(b), after all, empowers the federal government to grant exceptions to states under limited circumstances.
Thus, Congress obviously thought about and provided for a method by which the FDA, through its actions, could exempt state standards from MDA preemption. But Section 360k(b) does not authorize the FDA to create an exemption simply by finding that a particular defendant violated federal requirements applicable to the device.
Difficulties With Government Rule
Although the First Circuit reached the correct result, it appears to have seriously underestimated the practical difficulties that the government's rule would entail.
The government's suggestion that there need only be a "judgment" or "finding" by the FDA would, of course, invite plaintiffs to seize on any statement in FDA correspondence with manufacturers, inspection reports, or other informal agency communications or documents that might suggest that the manufacturer or the device has failed to comply with some federal requirement, in order to preserve their claims from preemption.
It would also invite a deluge of inquiries to the agency by plaintiffs concerning "judgments" the agency may have made but not disclosed.
The government in its brief did not explain what is meant by a "judgment" or what would happen if an FDA "judgment" leading to the initiation of a civil or criminal proceeding were subsequently rejected by a court or jury. Would the shield of preemption be applied retroactively?
Although at first glance the plaintiffs' argument based on Bard's plea agreement might appear to avoid these difficulties, in fact it does not.
A considerable portion of the parties' briefs in the First Circuit was devoted to discussing the significance of the Bard plea agreement and what violations of federal law had, in fact, been admitted.
Thus, although plaintiffs noted that Bard illegally redesigned its catheter and sold it to the public, the catheter used in the particular angioplasty operation at issue in Talbott was not one of the redesigned devices.
Defendants accordingly maintained that the violations of federal law to which Bard pleaded guilty were not relevant to the Talbott litigation.
In addition, the parties disputed the precise meaning and significance of Bard's plea agreement. Regardless of who was correct in these disputes, this disagreement demonstrates the kind of thorny problems that courts could face under plaintiffs' formulation of this exception.
Complex Inquiry
Finally, acceptance of the government's argument (or for that matter the fraud-on-the-FDA variation) would require courts applying the MDA preemption clause to engage in a time-consuming and complex inquiry into the precise relationship between the federal requirements that were violated and the defect or risk that forms the basis of the plaintiff's tort claim.
This is so because even if a plaintiff is suing to recover for an injury that was caused by a product that violated federal requirements, it makes no sense to remove the shield of preemption unless the federal violation somehow increased the risk that forms the basis of the plaintiff's claim.
For example, if a manufacturer violates the federal premarketing approval regulations by submitting an application for a Class III device that fails to include in "separate sections" data on nonclinical laboratory studies and on clinical studies (21 C.F.R. §814.20(b)(2)), the manufacturer could not through this de minimis infraction lose the shield of preemption for all claims of design defect, failure to warn, and so on.
Cf. Restatement (Third) of Torts: Products Liability, §7 cmt. c (Tentative Draft No. 2, Mar. 13, 1995) (in describing effect on liability of defendant's compliance or noncompliance with safety standards, noting that "the safety statute or regulation must be such that compliance reduces the risk that caused the harm in the actual case").
Such an inquiry into the relationship between risks that form the basis for the plaintiff's claims and requirements imposed by federal law would be cumbersome and difficult.
Where State And Federal Standards Are Identical
In Talbott, the plaintiffs also argued that the MDA does not preempt state-law claims that embody requirements that are identical to federal requirements.
Plaintiffs maintained that a state-law tort claim would not impose any requirement that is "different from, or in addition to" federal requirements within the meaning of Section 360k(a)'s preemption clause ":so long as the state judge instructs the jury that a manufacturer's obligations under state tort law were defined by the provisions of the MDA." Talbott, 63 F.3d at 29.
Notably, this last version of the noncompliance argument is somewhat different from the other two. It more closely resembles a traditional preemption argument. The argument, after all, seeks to win recognition not so much of an exception to preemption under Section 360k(a) as of a limitation on the scope of Section 360k(a) itself.
Nonetheless, to prevail on a tort claim spared from preemption under this theory, the plaintiff would be required to show that the defendant failed to comply with a federal requirement. Otherwise, the plaintiff's claims would fail — not for preemption, but for lack of proof.
The First Circuit in Talbott rejected this argument as well. In rejecting "[t]his theory of cooperative preemption," the court of appeals relied on dictum on a previous First Circuit case: "'We find nothing to support that Congress intended such a radical, unwieldy form of preemption . . . particularly where Congress did not intend to create a private right of action under the Federal Food, Drug, and Cosmetic Act.'" Talbott, 63 F.3d at 29 (quoting Mendes v. Medtronic, 18 F.3d at 19 n.4).
The First Circuit also relied on recent decisions from the Third and Eleventh Circuits rejecting this argument. See Lohr v. Medtronic Inc., 56 F.3d 1335, 1343 (11th Cir. 1995) ("[T]he MDA cannot be defeated by a common-law suit alleging a violation of the [federal] statutory standards"), petition for cert. filed, 64 U.S.L.W. 3360 (Nov. 13, 1995) (No. 95-754); Michael, 46 F.3d at 1329 (same).
FIFRA Case To The Contrary
This position has not met with universal acceptance, however. At least one other court of appeals has endorsed a contrary position in a case involving FIFRA, a statute that, like the MDA, preempts state labeling requirements that are "in addition to or different from" labeling requirements imposed by federal law.
See 7 U.S.C. §136v(b) (forbidding states to "impose or continue in effect any requirements for labeling or packaging" of federally registered pesticides that are "in addition to or different from" federal requirements).
In Worm v. American Cyanamid Co., 970 F.2d 1301 (1992), the Fourth Circuit held that "if the Maryland common law recognizes a tort based on breach of a federally imposed standard, the [plaintiffs] would be able to pursue that claim without conflicting with federal law." Id. at 1308.
The Fourth Circuit explained that states remain free to impose identical standards through their tort law "even if the state law provides compensation or other remedies for a violation." Id. at 1307.
See also Moss v. Parks, 985 F. 2d 736, 740 (4th Cir.) (reaching same result under the differently worded preemption clause of the Federal Hazardous Substances Act, 15 U.S.C. §1261), cert. denied, 113 S. Ct. 2999 (1993).
The Fourth Circuit would almost certainly apply this reasoning to a case involving the MDA. See Duvall v. Bristol-Myers-Squibb Corp., 65 F.3d 392, 400-01 & n. 8 (4th Cir. 1995) (declining in MDA case to distinguish subsequent opinion in Worm because the "in addition to or different from" language of FIFRA and MDA are "virtually identical"), petition for cert. filed, 64 U.S.L.W. 3439 (Dec. 22, 1995) (No. 95-1010).
Eighth Circuit Ruling
The Eighth Circuit, moreover, recently relied on Worm and Moss in an MDA preemption case involving a tampon, a Class II medical device subject to less extensive regulatory oversight than Class III devices. See National Bank of Commerce v. Kimberly-Clark Corp., 38 F.3d 988 (8th Cir. 1994).
The Eighth Circuit agreed that, "when a statute [such as the MDA] preempts state requirements that are different from and in addition to those imposed by federal law, plaintiffs may still recover under state tort law when defendants fail to comply with the federal requirements." Id. at 993. See also id. at 992 n.2 (explaining that "the FDA regulations simply serve as the standard by which to measure defendant's conduct").
At least one of the panel members, however, was of the view that this rule would not apply to a Class III device. See id. at 994 (Heaney, J.) (stating that if tampons were reclassified as Class III devices, this would "preempt any possible claim for failure to comply [with federal regulations] under state law").
The remaining two members of the panel went on to conclude that the plaintiff's claims for failure to warn and inadequate labeling were preempted because there had been no violation of federal law: the FDA had in fact approved Kimberly-Clark's labeling. Id. at 998-99 (Loken, J., joined by Fagg, J., concurring).
That disposition arguably rendered unnecessary the Eighth Circuit's discussion of whether preemption might apply to a claim based on a violation of a federal requirement.
Seventh Circuit Ruling
Even more important, the Seventh Circuit recently endorsed the analysis of National Bank of Commerce and expressly disagreed with the holding of Talbott and Lohr.
In Mitchell v. Collagen Corp., 67 F.3d 1268 (7th Cir. 1995), the court of appeals had this to say about the First Circuit's reasoning in Talbott:
When the claim is that a particular product is adulterated because it does not comply with standards explicitly established by the FDA or that a particular label does not comply with standards explicitly established by the FDA, the correctness of this approach is not self-evident. In such circumstances, the existence of the FDA-approved paradigm appears to ensure that state law cannot impose requirements "different from or in addition to" federal law. The Eighth Circuit has stated that, "when a statute only preempts state requirements that are different from and in addition to those imposed by federal law, plaintiffs may still recover under state tort law when defendants fail to comply with the federal requirements." . . . In the absence of more explicit legislative or regulatory direction, we hesitate to say, therefore, that an adulteration claim based on a product's failure to meet PMA standards—standards that have been explicitly set forth by the FDA — does not survive MDA preemption. Such a claim seeks merely to enforce the federal standard, not to add requirements "different from, or in addition to" it.
Id. at 1281-1282. (footnote omitted). The court went on, however, to uphold summary judgment in the defendant's favor on these claims. Id. at 1282-83.
Other State And Federal Courts
Other state and federal courts have reached the same conclusion with respect to the validity of this third variant of the noncompliance argument.
At least one district court recently cited National Bank of Commerce with approval in a case involving a Class II device (a tampon) and held that "plaintiffs may maintain a claim for inadequate warnings so long as such claim is premised on the warning[] requirements established by the FDA." Forrester v. Playtex Family Products Corp., 1995 U.S. Dist. LEXIS 13371, at *14 (N.D. Ill. Sept. 12, 1995).
In addition, a California intermediate appellate court has held that "[s]tate actions which echo or attempt to enforce federal standards" under the MDA "are not preempted" and that such violations of federal requirements qualify as negligence "per se" under California law. Evraets v. Intermedics Intraocular, Inc., 29 Cal. App. 4th 779, 792, 34 Cal. Rptr. 2d 852, 859 (2d Dist. 1994). But see Scott v. Ciba Vision Corp., 38 Cal. App. 4th 307, 324, 44 Cal. Rptr. 2d 902, 911-12 (6th Dist. 1995) (disagreeing with Evraets on this point).
FDA Interpretation
The FDA itself has interpreted Section 360k as not preempting "State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act." 21 C.F.R. §808.1(d)(2) (1995).
Notably, the vast majority of the courts that have considered the third version of the noncompliance argument have overlooked this FDA interpretation. But see Mitchell, 67 F.3d at 1282 n. 9; Evraets, 29 Cal. App. 4th at 792, 34 Cal. Rptr. 2d at 859.
Assuming that a court should defer under Chevron to an agency's interpretation of an express preemption clause (see note 8, supra), this aspect of the FDA's interpretation of Section 360k (like some others, see note 3, supra) would not warrant deference because it departs from the plain language of the MDA's preemption provision.
There is simply no way, for example, to reconcile with the statutory language the FDA's statement that a state requirement can survive preemption if it is substantially identical to a federal requirement applicable to a medical device.
A "substantially" identical requirement would be "different from" the federal requirement and thus preempted under Section 360k.
Equally untenable is the FDA's view that a state requirement that is "equal to" a federal requirement is spared from preemption under Section 360k. For several reasons, that interpretation of the preemption clause — and the conclusions of the courts in National Bank of Commerce, Mitchell, Worm, and Moss — are open to serious doubt.
Most importantly, the FDA's interpretation is inconsistent with the plain language of the statute. Section 360k(a) preempts "any [state] requirement — (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." 21 U.S.C. §360k(a) (emphasis added).
But a state law that embodies a standard identical to a federal standard clearly imposes a requirement "in addition to" the federal requirement (just as, for example, a second coat of paint of the same color as the first would be "in addition to" the first coat).
The manufacturer's obligation or duty to comply is completely independent of any federal-law obligation.
A contrary interpretation, moreover, would read the phrase "in addition to" out of Section 360k(a), since the companion phrase "different from" already accomplishes the preemption of all qualifying state requirements that are not identical to the federal requirements. See generally United States Department of Treasury v. Fabe, 113 S. Ct. 2202, 2210 n.6 (1993) (each word of a statute must be given meaning).
Alternative Basis for Rejecting Argument
There is another textual basis in the statute for rejecting this variation of the noncompliance argument. As noted previously, the MDA preemption clause permits states to apply to the FDA for an exemption from preemption. 21 U.S.C. §360k(b).
The statute recognizes two possible grounds for such an exemption. The first is where the state requirement "is more stringent than a requirement under this chapter which would be applicable if an exemption were not in effect under this subsection." Id. §360k(b)(1).
The second basis on which an exemption may be obtained is for a state requirement that is both (1) "required by compelling local conditions" and (2) such that "compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter." Id. at §360k(b)(2).
But whenever a state requirement is "identical" to a federal requirement, the latter condition will be satisfied.
If identical state requirements are exempt from preemption, it is difficult to see why Congress would have required states to take the trouble of seeking an exemption and of making the further showing that the identical state requirement is "required by compelling local conditions."
Preserving State-Law Claims
Congress, moreover, clearly knows how to preserve from preemption state-law claims that impose requirements identical to those in federal law.
See, e.g., Radiation Control for Health and Safety Act, 21 U.S.C. §360ss ("Whenever any [federal] standard prescribed . . . with respect to an aspect of performance of an electronic product is in effect, no State or political subdivision of a State shall have any authority either to establish, or to continue in effect, any standard which is applicable to the same aspect of performance of such product and which is not identical to the Federal Standard.") (emphasis added); National Traffic and Motor Vehicle Safety Act, 49 U.S.C. §30103(b) (formerly 15 U.S.C. §1392(d)) ("When a motor vehicle safety standard is in effect under this chapter, a State or a political subdivision of State may prescribe or continue in effect a standard applicable to the same aspect of performance . . . only if the standard is identical to the standard prescribed under this chapter.") (emphasis added); Federal Boat Safety Act, 46 U.S.C. §4306 ("Unless permitted by the Secretary . . ., a State or political subdivision of a State may not establish, continue in force, or enforce a law or regulation establishing a recreational vessel or associated equipment performance or other safety standard . . . that is not identical to a regulation prescribed under section 4302 of this title.") (emphasis added); see also 15 U.S.C. §§1476(a), §2075(a), 2617(a)(2)(B); 21 U.S.C. §343-1(a)(1).
But see Moss, 985 F.2d at 740 & n. 3 (stating that these two formulations are coextensive); Duvall, 65 F.3d at 400.
Congress did not include similar language in the preemption clause of the MDA (or FIFRA). Indeed, an earlier version of the MDA's preemption clause (contained in a bill that Congress did not enact) did spare from preemption state requirements that were "identical to the Federal requirements."
See S. 510, §704, 94th Cong., 1st Sess. (passed Senate Apr. 17, 1975). Congress's rejection of this language in favor of the broader language contained in the MDA militates strongly against the plaintiffs' argument.
Damages As 'Requirements'
In addition, even if a state tort duty imposes a standard that is absolutely identical to that embodied in a federal safety requirement, a private lawsuit seeking to force a defendant to pay damages plainly imposes a requirement that is "different from, or in addition to" requirements imposed by federal law.
Given the absence of a private right of action under the MDA, federal law imposes no requirement similar to the obligation to pay damages.
Thus, a private tort action cannot, by its terms, impose requirements that are identical to those imposed by the FDA's regulations. But see Worm, 970 F.2d at 1307 (holding that states remain free under FIFRA to impose identical standards through their tort law "even if the state law provides compensation or other remedies for a violation").
As the First Circuit in Talbott recognized, moreover, the fact that Congress declined to recognize a private right of action under the MDA undermines as well the argument that Congress meant to exempt from preemption state requirements that are identical to federal requirements.
Congress's failure to include any private right of action reflects a determination to vest in "the FDA and other agencies of the United States government" the exclusive authority to assert a claim that federal standards have been violated. Talbott, 865 F. Supp. at 47.
It is most unlikely that Congress intended to foreclose private enforcement of federal norms but to allow states to permit such private enforcement of identical norms under state law.
In any event, there is no guarantee that a lay jury or state judge resolving ambiguities concerning the precise scope or applicability of an identical state norm would reach the same conclusions as would the FDA concerning the identical federal requirement.
Practical Difficulties
Finally, interpreting Section 360k as exempting "identical" state requirements would give rise to far greater practical difficulties than does a similar exemption under statutes (such as FIFRA) that preempt only labeling and packaging requirements (or for that matter under statutes that allow states to enforce identical performance and safety standards).
In the latter situations, it is relatively easy to identify a label or warning or design feature mandated by federal law and to permit state failure-to-warn or design defect claims based on the manufacturer's noncompliance with the federal requirement.
See also Mitchell, 1995 U.S. App. LEXIS 27709, at *32 (using as examples of kinds of claim where problems of administrability do not arise (1) state-law defective warning claims that are based on warnings identical to those required by federal law, and (2) design defect cases based on federal safety standards).
The Talbott case is significant because it illustrates the kinds of arguments that are increasingly being made in preemption cases for exceptions based on a defendant's noncompliance with otherwise-preemptive federal requirements.
The case is also an important doctrinal advance because it establishes in the First Circuit that these arguments are lacking in merit. But as the foregoing discussion makes clear, the courts are in disagreement over the validity of the various "noncompliance" exceptions to preemption under the MDA.
The fact that the United States government filed an amicus brief in Talbott in support of one version of the noncompliance argument is significant because it may reflect either a decision to press this theory in other preemption contexts or a disagreement with the broad preemptive reading given by most courts to the MDA.
In any event, it suggests that the validity of noncompliance exceptions will continue to be litigated in the state and federal courts.
Kenneth Geller is the managing partner of the Washington, D.C. office of Mayer, Brown & Platt. In Talbott v. C.R. Bard, Inc., 63 F.3d 25, 23 PSLR 880 (1st Cir. 1995), the authors submitted a brief on behalf of the Product Liability Advisory Council, Inc. as amicus curiae in support of the prevailing device manufacturer. Back to Article
[Copyright © 1999 Mayer, Brown & Platt. This Mayer, Brown & Platt article provides information and comments on legal issues and developments of interest to our clients and friends. The foregoing is not a comprehensive treatment of the subject matter covered and is not intended to provide legal advice. Readers should seek specific legal advice before taking any action with respect to the matters discussed herein.]


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Western Conference - Playoff Update - 05.17.09
4. Chicago Blackhawks
2. Detroit Red Wings
Game 1: @ Detroit, Sun. 5/17, 3:00 p.m. ET
Game 2: @ Detroit, Tue. 5/19, 7:30 p.m. ET
Game 3: @ Chicago, Fri. 5/22, 8:00 p.m. ET
Game 4: @ Chicago, Sun. 5/24, 3:00 p.m. ET
*Game 5: @ Detroit, Wed. 5/27, 7:30 p.m. ET
*Game 6: @ Chicago, Sat. 5/30, 8:00 p.m. ET
*Game 7: @ Detroit, Mon. 6/1, 7:30 p.m. ET
* If necessary
The histories of the Chicago Blackhawks and the Detroit Red Wings are legendary. Names like Gordie Howe, Bobby Hull, Ted Lindsay, Stan Mikita, Denis Savard, and Steve Yzerman are names that echo the greats scorers and leaders of their time.
Old time hockey returns as rivalry is renewed between the 'Hawks and the Wings.
The Red Wings come into the matchup as the favorite; they are the defending Stanley Cup champions, captained by Nicklas Lidstrom and powered by Henrik Zetterberg, Pavel Datsyuk, Tomas Holmstrom, and elite right winger Marian Hossa, who joined the team in the off season after being defeated by Detroit as a Pittsburgh Penguin.
On the flip side, the youthful movement has brought a hockey renaissance to Chicago. Donning the captain's "C†on his sweater is 21-year-old Jonathan Toews, who is joined by 20-year old RW Patrick Kane, 25-year-old defenseman Dunkan Keith, and 23-year-old LW Kris Versteeg as some of the most exciting young players in the game today. Leading the team in scoring this post season is veteran speedy winger Martin Havlat, who has 13 points (5 G – 8A), one more than Kane and 3 more than both Toews and Versteeg (both of whom have 10 points).
One of the biggest issues the Blackhawks will have to overcome will be their "lack of drive†early in a game. In their semi-final matchup against the Vancouver Canucks, the Blackhawks appeared to come out flat and would end up being down one or two goals before really turning things on. While they were able to rally from behind, this method will definitely not cut it against the defending champions, who love to shut things down with their aggressive style of defensive play. Falling down by one or two goals early in each game could easily be a death sentence for the Blackhawks season.
Detroit faced the Blackhawks six times in the regular season, winning four of the contests. The highest profile contest between the two clubs was the 2009 Winter Classic, held outdoors at the hallowed Wrigley Field in Chicago, IL. Detroit won that meeting, which was broadcast nationally on NBC, 6-4.
Chicago netminder Nikolai Kabibulin will need to be a brick wall in net to help keep the dream of bringing a Stanley Cup back to Chicago alive. Khabibulin, often times referred to as the "Bulin Wallâ€, has posted a 8-4 record this post season, with a 2.76 goals-against average with a .896 save percentage. Detroit was getting over 35 shots per game on net against the Anaheim Ducks' Jonas Hiller. Will the "Bulin Wall†be able to weather such a storm?
8. Anaheim Mighty Ducks 3
2. Detroit Red Wings 4
Detroit wins series 4-3
It was a rough and tumble series, but the Detroit Red Wings found a way to defeat the Anaheim Ducks, who put on a great show as the "dark horse†8 seed in the Western Conference.
With the defeat of the Anaheim Ducks, the defending Stanley Cup champions find themselves once again close to their goal. They will face off against the Chicago Blackhawks, long time "Original Six†rival, for the Western Conference championship.
Defeating the Anaheim Ducks was no easy task. The 8th and final seed in the West fought valiantly throughout the playoffs. They defeated the number one seed in the West, and best team points wise in the league, the San Jose Sharks to even advance to face the Red Wings, who handedly defeated the Columbus Blue Jackets.
Game seven scoring began with a power play goal at 15:43 of the first period, scored by Detroit Red Wing Jiri Hudler as Anaheim's Ryan Getzlaf sat in the box feeling shame. A mere 1:17 into the second period, Detroit struck again, this time at even strength, by Darren Helm. This gave the Red Wings a 2-0 lead.
Helm told reporters, "I think I got a pretty good jump on the puck there. I just wanted to get away from both 'D' as quick as I could. I didn't put any added pressure on myself. I knew I was going to respond, and the team was going to as well."
The "Finnish Flash†Teemu Selanne put the puck past Detroit netminder Chris Osgood at 14:50 of the second period to cut the deficit in half. Only a minute and thirty seconds later, Detroit's Mikael Samuelsson scored his third goal of the post season to return the Red Wing lead to two goals.
With 16:46 left in the second period, Jiri Hudler was called for goaltender interference on Anaheim netminder Jonas Hiller. On the ensuing power play, Corey Perry notched his 8th post season goal at 17:12.
With twenty minutes remaining in regulation, the Ducks needed to show some urgency, crash the net, and somehow find a way to tie things up. Bobby Ryan answered the call by scoring his 5th of the post season at 7:37 of the third regulation period.
The Detroit Red Wings, however, would not stop their onslaught. They peppered Jonas Hiller with 17 shots in the first twenty minutes. They had a lull in the second period, getting only 7 shots on goal. But in the third period, they turned things back on, shooting another 15 shots towards the young Anaheim netminder. In all, Jonas Hiller faced 40 shots. One of those shots ended up costing Anaheim their chance to advance in the post season.
With a loose puck in front of Hiller, off of the stick of Henrik Zetterberg, Dan Cleary found a way to get a shot off that trickled through the Anaheim goalie, putting Detroit up 4-3 with 3 minutes remaining in regulation.
"Z made the play really … he put it on net, and I just happened deflect it," Cleary said to the media post game scrum. "I stayed with it. It's the biggest goal I've ever scored, considering the situation and the time."
And so, the stage is set. The two teams that met in the 2009 Winter Classic, outdoors at Wrigley Field in Chicago will once again renew hostilities, reviving a decades old rivalry. This Western Conference Final will be one to remember.
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Terry starts this workshop simply, with demos of a wide variety of trees, painted in every season. He then paints a charming tree-lined lane in both summer and winter, focusing on perspective, light and shadow to make your trees realistic. Terry concludes the workshop with a colorful autumn scene where he uses stippling, double-loaded brushes, line work and more for beautiful fall foliage. See Materials List
Runtime | Producer: 00:50:35 - Teaching Art


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Hyaluronic Complex created and manufactured by Source Naturals is a joint supplement said to increase elasticity and lubrication of joints that might prevent inflammation and joint pain. The supplement acts as a dual formula with ingredients that aid resilience and lubrication of joints, improves functioning and strength of sensitive joints. It's suggested the supplement might also offer joint health improvement by taking preventative measures against several arthritis forms. Source Naturals does have an official website which showcases lots of their products in various categories of health. The website is simple to navigate and does not contain lots of information but there is a contact section and several other beneficial sections. All products are shown with full labels and dosage instructions. The company also appears to sell only to retailers not consumers but does offer assistance in locating retailers carrying its brands.
Ingredients in Hyaluronic Complex are a proprietary complex which contains type 2 Collagen, Glucosamine, MSM, BioCell Collagen 2, Hyaluronic Acid and Chondroitin Sulfate.
There is a possibility that Hyaluronic Complex does work. A 2006 clinical trial which was funded through the National Institutes of Health showed both Chondroitin and Glucosamine had abilities to lessen pain caused by moderate and severe Osteoarthritis, a bone degenerating type of disease. Individuals who used both regularly were also able to retain a greater amount of cartilage in comparison to those suffering from OA that didn't use them, that was according to another study which occurred in 2008. The sulfuric compound MSM was proven to offer joint pain reduction within several clinical trials but researchers have claimed they were preliminary studies while not suggesting them to be either effective or ineffective in relieving joint pain.
Glucosamine does have the ability of lowering blood glucose and that could present danger to diabetics, but the overall supplement has only few other side effects. It might also increase or decrease efficacy of a few diabetic drugs. A doctors consultation is recommended for those pregnant and breast-feeding before use especially for diabetics who might consider avoiding this supplement altogether. Recommended dosage is two tablets daily.
Grade D has been given for Hyaluronic Complex which is seemingly a beneficial joint supplement for relieving joint pain occurring through joint-degenerating types of diseases like Osteoarthritis. It's also good for reduction of cartilage loss that could occur due to the diseases, but possibly harmful for diabetics.


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MLB: Josh Hamilton ALLEGEDLY had a relapse. But here's the thing - I was under the impression that stuff like this was supposed to be...Read More
Its baseball time is finally here. Welcome to Opening Weekend 2012. Ok last week it was opening day as the As and the Mariners played in Japan then of course they had to play exhibition games. Afterward but they get Easter Sunday off...
I love the opening of Baseball season last night we were treated to a nice opening night pitching performance by the Cardinals Kyle Loshe throwing a 2 hitter to open Marlins Stadium. Did they really have to change the name from Florida to Miami? Then again did the Angels really need to hyphenate their name (But that was a blog for a few years ago).
Speaking of the Angels if your Angel fan you have to be excited about Albert Pujols being in town. The guy play and I think the Angels will be in the mix all year. They will be a playoff team Im not sure of they are going to be in the play-in game. Or win the Division but I think they will give the Rangers a run for their money.
The play in game, I liken this little gem right up there with the Winter Classic. The NHL has done it right keeping the Winter Classic once a year. It works its fun it gets a lot of Hype but Once year works well. This play-in game in a few years will be a 3 game series, than few more years it will be 3 out 5 as the other teams sit coldly. Then it will be 4 out 7. Because thats what baseball does. The concept of one game is fine. The idea is that sort division or last playoff sport one game playoff to see who gets in when two teams tie. We all get giddy over those games. They are fun they are intense. This in my opinion is baseball capitalizing on that rare event that only happens every few years that kind of makes that one game playoff special.
Its not a baseball show without predictions instead of boring you Ill go straight to the punch with just the winners. Philadelphia in the NL East, Cincinnati in the Central, The west is a mess but I like the D-Backs. St. Louis and Atlanta (who almost collapsed as bad as the Red Sox in September will play for the Wild Card. ( if this anything like my bracket Im so wrong).. Reds and The Phillies battle it out, .with the Phillies coming in on top.
In the AL Tigers win the Central Rays win the East (Pitching , Pitching and More Pitching) Angels in the West. The Play-in The Yankees vs Rangers, The Tigers and the Angels battle it ourt and the Tigers win it all beating the Phillies in the World Series.
A Boston Guy cant end a baseball blog without talking about the Red Sox. I know your sick of them but They are my team. I think they battle it out for 3rd with the Blue Jays who have gotten better. I like the Sox lineup on the fireld they are solid for the most part but the corner outfield positions worry me Ryan Sweeney in right sharing time with Cody Ross. And Darnell Macdonald in left filling in for Carl Crawford. All three guys are serviceable but not making go Yippee but than again neither did JD Drew. The Sox have no closer with Bailey out until sometime in July so that leaves Aceeves with the job until he screws it up. Then we will see Mark Malacon or they will have to make a move. Im not thrilled with Mike Avilles at Shortstop good bat ok glove. I think the Red Sox are strong enough to put up some runs .
I think there pitching is questionable after John Lester. I would say after Lester and Beckett but who knows were Becketts head is Blue Jays Manager John Farrell was the best thing to ever happen to Josh Beckett when he was the Red Sox pitching coach. He left last year and Beckett was awesome right up to the point it counted and he just sort of gave up. Clay Bucholz has good stuff but is fragile. They are giving Felix Dubront a chance this kid has paid his dues and I like the fact that he gets a shot but I also think he wont go deep into games he is that 5 inning type starter. That leaves Daniel bard, I wont this kid to do well and I think he will but I think he will also suffer growing pains. The Red Sox need to come out of the gate hot because their schedule in the first month will make them or break them.
Finally, Im not loving the bullpen Franklin Morales is ok . Matt Albers scares me,as does Scott Atchison . At least with Atchison he can be good.. the rest will be ok Mike Bowdoin maybe a nice surprise I just not loving this Pitching staff. Who knows what Bobby Valentine pulls out of his hat dont forget these guys sat down on Terry Francona who always had their backs especially when it came to the media. I think Bobby Valentine puts up with no crap and throws them under the bus before they sit down on him.
Finally the Lil Lanz's will be playing on these teams this year
Littlest Lanz
The Tucson Sidewinders ok they are now the Tucson Padres of the PCL. He has two good coaches here ok I'm coaching this team. 14 kids and a good practice today.
The Other Lil Lanz of those lil Lanzs playing Baseball this year. Will be on the Major League.The key is having good coaches and he has three great ones.
Enjoy the Season
Hello, Hello, Hello Happy Thursday but an even Happier Baseball Season. My players are ready to perform with a huge amount of stats. Oh wait thats fantasy baseball... Lets get it right. The freshness of green grass and the smells of hot dogs at 9 bucks a pop they turn into real wieners. I mean the smell of hot dogs and peanuts $47.50. I mean lets try this again the smell of hot dogs and peanuts in the air. The juice from the ball and the cork of the bat. Wait thats not right lets try again. I mean the crisp sound of a round ball striking a round bat. And the deafening crack that goes with it.
Just having some fun its baseball season once again and the fun begins. Who will be the VCU and Butler this year. Are the Red Sox the Jets of MLB already to head to the World Series. Are the Phillies going to be their foe. Both look great on paper but thats on paper.
Could the Phillies be challenged by the Braves very easily with a Tomahawk Chop. Or will the Marlins prove they are big fish in the pond. The Mets may have to go and ask
For a bailout because their debt is bigger than the National debt. The Nationals spent lots of cash typical of Washington and they may also get nothing in return which also maybe typical of Washington
How about the trendy pick of last year in the Central the Brewers(explain to me why they are in the NL). Not if the Reds have their say about anything as the new big red machine emerges.. Will the Cardinals bounce back or will they simply whistle sweet tune.. Will the Cubs grow into Bears or will the remain in habernation. The Astros will they gravitate to the top or just float harmlessly in space. and will the Pirates simply remain shipwrecked without Jack Sparrow. Its a Pirates life for me unless your in Pittsburgh.
In the West will the World Champs repeat or will the Padres find some heavenly guidance. Will the Diamondbacks find the Cobra from the San Diego Zoo and spoy some venom bringing the Giants down like Jack cutting the beanstalk. Or will some Sun simply shine down on them in the dessert. Will the Rockies head down a Rocky path one wrong step they could easily turn into an avalanche. Or will the make it to the summit.
In the American League, Hamilton has replaced Walker as the Texas Ranger and will they make it back to get some Justice (Not Dave who is long retired). Will the Angels get some divine intervention and face the padres in a heavenly match in October or will the evil spirits of all hollows eve have other ideas like the Yankees. Maybe the athleticism of the As turn into track meet because they always say its a Marathon and not a sprint. The Mariners seem lost at sea will they find their way. Or will they drift and float.
In The Central Will it be a couple of brothers from the St Paul area our will the Tigers take a bigger bite than they did out of Penn and Teller.. Perhaps the White Sox plan to get in the mix and get a little dirty however not as dirty as the Black Sox because if they were to get that dirty there would need a Bonds to get them out of that bind. We all know there is nothing clean about the Bonds which I refer. The Indians maybe sending smoke signals from help but that wont come from the Royals because the only ring they will see are the ones that Willie and Kate exchange
That brings us back to keeping our Sox on thats Red Sox but if the Yankees have anything to do with it that Red will be blood. The Blue Jays may swoop in as well as the Orioles who may make a pigeon proud by doing nothing else but pooping on the Red Sox parade. The Rays may also be in this thing because they wont swim peacefully like Manetas.
No mater your team best of like its baseball season and all seem fresh and bright unless youre dealing with the local little league.
Other Stuff
Had a great lunch with Sully and Moe, even Mrs. Lanz showed up . You know her as Scout 318 from her TSN Days.
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Home Styles Bedford Executive Desk
Item # WX2-143081
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Home StylesTM Bedford Executive Home Office Pieces set your office apart in rich hardwood style... PRICED RIGHT !
Not a scrap of particle board in sight! If you're tired of living with disposable furniture these Home Styles Bedford Executive Home Office pieces are just the ticket.
Each of the three pieces is made from real hardwoods and veneers with a rich multi-step oak finish for real beauty that's built to last. Plus you get 2 sets of hardware brushed steel and black wood. Finally furniture you'll be proud to have in your home office.
Executive Desk features:- 3 easy glide drawers... center drawer front is hinged to fit a keyboard
- Only assembly required is attaching the legs
- Approx 54 x 28 x 30", 105 lb.
- 2 Drawers
- Open storage areas
- Wire management opening
- Comes fully assembled
- Approx 54 x 11 x 9 3 / 4 ", 40 lb.
- 2 easy glide drawers: Utility drawer and lateral file drawer
- 4 casters for easy mobility
- Approx 25 1 / 2 x 21 x 24 3 / 4 ", 60 lb.
Hardwood class that's priced to own. Order ONLINE Today!
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text: The Banyan Beach reminds me of an old time motor court, which it is -sort of. Price is very reasonable and we had a room with a stove, fridge and even flatware and cutlery. Nice view of the lake although the internal furnishings are somewhat dated. Bathroom fixtures are old although the shower had great pressure and spray. We were... More