Products Liability Prof Blog

GM Product Liability Plaintiffs Better Off Than Secured Creditors

General Motors Corporation has agreed to assume responsibility for all future liability claims filed after the automaker emerges from bankruptcy, regardless of when the vehicle was made.  GM had planned to include its product liability claims with its bad assets in the "old GM," grouping them with the company''s other unsecured creditors to fight over proceeds from the sale of GM's bad assets. The move would have relieved the "new GM" from any future liability for defective products made by the "old GM."  Although no one has explained why potential product liability plaintiffs should be treated differently than other unsecrued creditors injured by GM's bankruptcy, the company relented in the face of intense public pressure and effectively put these creditors at the head of the line of those with claims against the company.

JDP

Continuous Infusion Pain Pump Case Dismissed

Judge K. Michael Moore of the United States District Court for the Southern District of Florida granted summary judgment for the defendant in Kilpatrick v. Breg, Inc.:  Download Kilpatrick - Order for SJ, one of about 200 continuous infusion pain pump cases currently pending in various state and federal courts across the country.  The case was set to begin jury trial on July 6, 2009.  Like other plaintiffs in these cases, Kilpatrick alleged that the continuous infusion of local anesthetic into his shoulder joint by pain pump caused him to develop post-arthroscopic glenohumeral chondrolysis ("PAGCL"), a condition marked by the rapid deterioration of the cartilage of the shoulder.  Judge Moore granted summary judgment after ruling that Kilpatrick's causation evidence and testimony from his medical causation expert Gary Poehling, M.D., were inadmissible under Daubert v. Merrell Dow Pharm., because the cause of PAGCL continues to elude the scientific and medical communities.  Because Kilpatrick could not prove that the pain pump could or did cause his PAGCL, Judge Moore granted summary judgment and dismissed the case on its merits.  

 

JDP

Post-Sale Duties Update

An article in the most recent issue (74:3) of the Brooklyn Law Review by Ken Ross and J. David Prince provides an overview of the post-sale duty sections of the Restatement (Third) of Torts:  Products Liability.  The article discusses the relevant case law and the Restatement (Third)'s impact on the law's development since its adoption by the American Law Institute ten years ago.  The article, one of several in an entire issue devoted to the Restatement (Third), also provides a brief discussion of regulatory post-sale duties.  The issue is not yet in print but here is a PDF file of the Ross-Prince article:  Download BLS PrinceandRoss vol74 32009

JDP

The End of Preemption Preambles?

Yesterday, President Obama issued a memorandum calling for a rollback of Bush Administration regulations that included claims, often in the form of a preamble to a set of agency regulations, that the federal agency's regulations preempted state law.  Obama's memo says that federal agencies and departments should claim that state law is preempted only when there is a well-defined legal basis for such a claim.  The memo also orders federal agencies to review regulations from the past 10 years to see if a preemption claim has been asserted improperly.  See Alicia Mundy and Brett Kendall's story in the Wall Street Journal.

JDP

New York Court of Appeals and Delegation of Safety Choices to Employers

In Passante v. Agway Consumer Products, Inc., decided on May 5, the New York Court of Appeals considered a products liability case in which the plaintiff's employer, given a choice in product selection, selected a product  without a safety device that allegedly would have avoided the injury to the plaintiff.

Passante was injured while using a mechanical dock leveler at Agway, doing business as G & P Fresh Pac warehouse.  The dock leveler was manufactured by Rite-Hite Corporation and sold to G & P by Mullen Industrial Handling Corp. A dock leveler is a mechanical platform designed to provide a ramp between a loading dock and the bed of a truck or tractor trailer.

G & P was aware that it had the option of purchasing a safety option that would have avoided the risk that a truck would pull away from the loading platform, permitting the platform to drop and potentially cause injury.  G & P chose to buy a dock leveler without that safety option, which would also have included a warning system notifying the operator when it was safe to enter a trailer or the driver when the platform was in position.  The defendants moved for summary judgment.  Finding questions of fact on the design defect and warning claims, Supreme Court denied the motion and the Appellate Division reversed, dismissing the plaintiffs' complaint in its entirety.

The essential question in the case concerned the application of the New York Court of Appeals decision in Scarangella v. Thomas Built Buses, 717 N.E.2d 679, 683 (N.Y. 1999), in which the court held that a product that fails to incorporate safety equipment is not defective, as a matter of law:

where the evidence and reasonable inferences therefrom show that: (1) the buyer is thoroughly knowledgeable regarding the product and its use and is actually aware that the safety feature is available; (2) there exist normal circumstances of use in which the product is not unreasonably dangerous without the optional equipment; and (3) the buyer is in a position, given the range of uses of the product, to balance the benefits and the risks of not having the safety device in the specifically contemplated circumstances of the buyer's use of the product. In such a case, the buyer, not the manufacturer, is in the superior position to make the risk-utility assessment, and a well-considered decision by the buyer to dispense with the optional safety equipment will excuse the manufacturer from liability.

Finding that the first factor was satisfied, the court of appeals focused on the second, concluding that "[d]efendants have not shown that the dock leveler would normally be used in circumstances in which the product is not unreasonably dangerous without a trailer restraint system such as Dok-Lok."

The court of appeals also held that there was a fact question concerning the adequacy of the posted warnings concerning the dangers associated with the use of the dock leveler.  The plaintiff had experience with dock levelers, but not the specific leveler that he was using at Agway.

Judge Smith dissented on both points, concluding that

the more troubling of the two is the evisceration of Scarangella, which I fear will have real economic consequences. The predictability that was offered until today to manufacturers and distributors of equipment in this State is gone, and the result can only be an increase in cost-in the cost of liability insurance, and in the cost of safety features that buyers will no longer have the option to refuse. In much of this State, our economy struggles in the best of times, and these are not the best of times. Decisions like today's can only make things worse.

MKS

Attorneys Highlight Problems Created by the Consumer Product Safety Improvement Act

A National Law Journal article by Marcia Coyle focuses on the continuing debate over the Consumer Product Safety Improvement Act, focusing this time on the difficulties attorneys have in advising their business clients about the impact of the Act.  Ken Ross of this blog is quoted in the article.  He points out the lack of agreement of some members of Congress over how the Act is being interpreted by the Consumer Product Safety Commission and the difficulty of advising clients in light of that confusion.

MKS

State Food Inspections Vary Significantly

A New York Times article by Gardiner Harris points out the significant variances in state food inspection.  The article notes that while Congress and the Obama administration have noted the need for new food production rules and more inspections, less attention has been paid to fixing the existing fractured system of food inspection.   At this point, "uncovering which foods have been contaminated is left to a patchwork of more than 3,000 federal, state and local health departments that are, for the most part, poorly financed, poorly trained and disconnected," according to health officials.  Minnesota is singled out for the diligence of its health department's surveillance system.

MKS

Mega Brands America agrees to $1.1 Million Civil Penalty Arising from Dangers in Magnetic Building Sets

The Consumer Product Safety Commission announced in an April 14 releasethat Mega Brands America has agreed to pay a $1.1 million civil penalty, which the Commission has provisionally accepted, to settle allegations that Mega Brands America, formerly Rose Art Industries, Inc., failed to provide the government with timely information concerning dangers to children presented by Magnetix magnetic building sets.   The release notes that "[b]y the time Rose Art [the predecessor] agreed to the recall of Magnetix in March 2006, the firm had received more than 1,500 complaints of magnets falling out of plastic pieces in more than 65 different models of Magnetix," and that "[i]n April 2007, Mega Brands America expanded the recall of Magnetix sets for users of any age, after more than 25 children suffered intestinal injuries that required surgery to remove the magnets."

The release also notes that "[i]n agreeing to settle this matter, Mega Brands America and its parent, Mega Brands Inc., of Montreal, Canada contend that 1) Mega Brands Inc. did not know of the Magnetix defect at the time it acquired Rose Art and 2) Rose Art’s prior owners never advised Mega Brands Inc. of the problems of associated with Magnetix."

MKS

FDA Update on the Pistachio Recall

The FDA's "In the spotlight" focuses on the recent pistachio recall.  The FDA and California Department of Health are continuing their investigation of salmonella contamination in pistachios and pistachio products.  Setton Pistachio, Terra Bella, Calif., is voluntarily expanding its recall of roasted pistachios to include all lots of roasted in-shell pistachios and roasted shelled pistachios that were produced from nuts harvested in 2008.  Setton is also recalling raw shelled pistachios from the 2008 crop that are not subsequently roasted prior to retail sale. The pistachios may be contaminated with Salmonella.  Pistachios are used as ingredients in a variety of foods, so the expanded recall will affect many other products and will lead to other recalls. 

If you're not certain about which products are called, check the FDA's searchable database at http://www.fda.gov/pistachios/.  The FDA will continue to update the database.  It warns consumer to avoid eating pistachios or food products containing them (such as pistachio bakery goods and pistachio ice cream) until they can determine that the products do not contain pistachios recalled by Setton.

MKS

Consumer Product Safety Commission Announces $1,055,00 Civil Penalty

The U.S. Consumer Product Safety Commission (CPSC) announced in aTuesday release that 14 firms have agreed to pay a total of $1,055,000 in civil penalties to "settle allegations that the firms knowingly failed to report to the CPSC immediately, as required by federal law, that children’s hooded sweatshirts or jackets they sold had drawstrings at the hood and/or neck."  The drawstrings present a strangulation hazard that can cause death to children.  The companies recalled the garment as appropriate. The Commission  has provisionally accepted the settlements.  The firms are listed in the release.

MKS

NINTH CIRCUIT CERTIFIES STATUTE OF LIMITATIONS ISSUE TO CALIFORNIA SUPREME COURT

In Pooshs v. Phillip Morris USA, Inc., ___ F.3d ___ (9th Cir. April 1, 2009), Nikki Pooshs brought suit against the defendants based upon her terminal lung cancer, alleging a variety of theories, including "(1) negligence; (2) product liability; (3) misrepresentation; (4) fraud and deceit (intentional misrepresentation); (5) fraud and deceit (concealment); (6) fraud and deceit (false promise); (7) fraud and deceit (negligent misrepresentation); (8) concert of action (conspiracy); (9) pre-1969 failure to warn; and (10) off-label failure to warn." 

Pooshs was diagnosed with lung cancer on January 31, 2003.  She was diagnosed with chronic obstructive pulmonary disease in 1989 and periodontal disease in 1990.  She filed suit just under a year after she was diagnosed with lung cancer.  The issue was whether the statute of limitations started to run on all claims for tobacco-related physical injuries in 1989 and 1990, in which case her claim for lung cancer would be barred.   It is uncontested in the case that the etiology for lung cancer is distinct from the etiology for COPD and periodontal disease. 

In Grisham v. Philip Morris,151 P.3d 1151, 1161 (Cal. 2007), the California Supreme Court answered a series of certified questions from the Ninth Circuit concerning the application of California's statutes of limitations in tobacco-related cases.  The court did not answer the specific question at issue in Pooshs as to whether injury to separate physical interests might be considered to be an invasion of two primary rights for statute of limitations purposes.  The supreme court noted the split in authority in the California courts, but did not resolve the issue.  The Ninth Circuit in Pooshs certified the following issues to the California Supreme Court:

(1) Under California law, when may two separate physical injuries arising out of the same wrongdoing be conceived of as invading two different primary rights?

(2) Under California law, may two separate physical injuries-both caused by a plaintiff's use of tobacco-be considered “qualitatively different” for the purposes of determining when the applicable statute of limitations begins to run?

MKS

Fifth Circuit Applies Texas Learned Intermediary Law to Bar Recovery in Ebel v. Eli Lilly & Co.

In Ebel v. Eli Lilly & Co., ___ F.3d ___ (5th Cir. March 30, 2009), the Fifth Circuit in a per curiam opinion applied the learned intermediary defense to bar recovery in a wrongful death action arising out of Philip Ebel's suicide, allegedly caused by Eli Lilly's drug Zyprexa, an atypical antipsychotic drug, which Mr. Ebel's physician, who was board certified in pain management, prescribed off label to treat Mr. Ebel's severe and chronic headaches.  The district court granted Eli Lilly's motion for summary  judgment on the basis that the drug warning was adequate as a matter of law and that it was not the producing cause of Mr. Ebel's death.  The Fifth Circuit affirmed on the second ground.  The court applied Texas learned intermediary law in reaching its conclusion.  Texas law requires a showing that the warning is inadequate and that the failure to warn was the producing cause of the injury.  While Eli Lilly argued that the warning was inadequate, the Fifth Circuit did not reach that issue, deciding instead that there was no producing cause, given the prescribing physician's familiarity with the side effects, including the suicide risk, associated with Zyprexa, and the lack of evidence showing that an alternative warning would have altered the physician's decision to prescribe the drug.

Supreme Court Dismisses Writ of Certiorari in Philip Morris USA, Inc. v. Williams

On March 31 the Supreme Cout of the United States dismissed the writ of certiorari as impovidently granted in Philip Morris USA Inc. v. Williams.  The dismissal means that the $79.5 million punitive damages award affirmed by the Oregon Supreme Court in Williams v. Philip Morris Inc. , see 176 P.3d 1255 (Or. 2008) on remand, stands. 

MKS

Nothing Related to Products Liability

But Professor Anthony Varnoa at American University asked nicely, so here is the announcement of their conference and call for papers:

LatCrit XIV: Fourteenth Annual LatCrit Conference

CALL FOR PAPERS & PANELS
OUTSIDERS INSIDE:  CRITICAL OUTSIDER THEORY AND PRAXIS
IN THE POLICYMAKING OF THE NEW AMERICAN REGIME

American University - Washington College of Law
Washington, D.C.

October 1 - 4, 2009

Please join us at LatCrit XIV, the Fourteenth Annual LatCrit (Latina and Latino Critical Legal Theory, Inc.) Conference, which will take place in Washington, D.C., from Thursday, October 1 through Sunday, October 4, 2009.

LatCrit/SALT Junior Faculty Development Workshop

The Seventh Annual Junior Faculty Development Workshop, sponsored jointly with the Society of American Law Teachers (SALT), will begin at 9:00 am, Thursday, October 1st and continue through Friday morning.

LATCRIT XIV THEME

OUTSIDERS INSIDE:  CRITICAL OUTSIDER THEORY AND PRAXIS IN THE POLICYMAKING OF THE NEW AMERICAN REGIME

In October 2009, LatCrit will meet inside the Beltway for the first time in its history amidst a tectonic shift in American government.  With the January inauguration of President Barack H. Obama, the nation’s first “outsider” president, we also saw the ascendance of a new progressive governance philosophy in Washington.  As a biracial former law professor with working class and immigrant roots and an international and multicultural upbringing, Mr. Obama ran a progressive campaign that echoed many core LatCritical values, including internationalism and global-mindedness, the valorization of human rights and multidimensional diversity, the centrality of antidiscrimination work, a commitment to rigorous interrogation of longstanding dominant assumptions and norms, and a preference for discourse and dialogue over militarism.  Notably, President Obama’s Yes We Can! campaign slogan has its roots in the ¡Si Se Puede! rallying cry coined by Dolores Huerta of the United Farm Workers movement and invoked in more recent progressive and mostly Latino/a political actions.

The new Presidential administration and enlarged bicameral Democratic majority in Congress account only for part of the historic paradigmatic transition in American national government.  The ongoing deterioration of the American and world economies also has catalyzed an aggressive reassessment by moderate and even some conservative thinkers of the wisdom of the Reagan Revolution’s uber alles dependency on the private marketplace for the realization of the public good – an antiregulatory disposition that dominated federal government through the last seven presidential administrations.  In the United States, the failure of the government’s dominant antiregulatory disposition to prevent the ensuing economic meltdown has catalyzed a new, aggressive Federal response in the form of much more statist economic interventions, including the de facto nationalization of key economic components. To add irony, it was the administration of President George W. Bush – the loudest in exalting the power of unbridled private marketplaces to regulate themselves – that laid the foundation for the national takeover of large sectors of the financial services and banking industries.

These quantum changes in the leadership and driving philosophies of American government present unique and in some cases unprecedented opportunities for scholars engaged in critical outsider scholarship to influence and inform national policy and legislation. The new executive and legislative branch incumbents have telegraphed early receptivity to the instantiation of LatCritical and other progressive theories and principles in the tangible products of Federal government (i.e., legislation, regulation, presidential directives, and, of course, caselaw). As President Obama’s aspirational campaign continues to transition into the nouveau regime at the helm of the most powerful government on Earth, millions of Americans expect the vague Yes We Can promise to become the Yes We Are reality.

But with these openings come potential pitfalls.  Although the ascendance of a putatively progressive president and likeminded Congressional majority indeed may open up new opportunities to bridge the theory/praxis chasm, it also may pose serious challenges to the independence and even legitimacy of progressive critical theory movements. Should the cooption or even distortion of conservative theory by militaristic, extremist partisan politicos serve as a cautionary tale in the formation of new relationships between the progressive government and outsider critical theorists? More specifically, what if the first year in office of the Yes We Can presidential candidate unfolds into more of a No We Won’t disappointment?  What if the exigencies of governing to and from the middle – which many pundits insist is the sine qua non for reelection viability – result in the sacrificing of Obama’s progressive promise?  What roles should outsider critical legal scholars and their scholarship assume then? More generally, what should the incarnation of progressive theory in the new American regime look like? And what prevents that theory from being co-opted and corrupted by the corroding influences of insider power?

The LatCrit XIV Host Committee invites the submission of proposals for panels and papers related to this open-textured theme and encompassing the fullest array of theoretical and doctrinal topics and approaches.  Because we will be in Washington, DC, we encourage the submission of paper and panel proposals propounding prescriptive critiques of discrete areas of law, policy and regulation of specific relevance to outsider communities, including (but by no means limited to) economic justice, international and comparative law, criminal law and the death penalty, civil rights and constitutional law (including gender and LGBT equality, reproductive and disability rights), feminist legal theory, immigration, political and electoral (dis)enfranchisement, communications policy and intellectual property, healthcare, education, employment, tax policy, and the environment.  We also, of course, welcome proposals for more theoretical panels and papers, particularly (but not exclusively) in areas linked to the challenges posed by progressive governance and the ascendance of outsiders to positions of ultimate authority.

Please submit your panel and paper proposals through the online process at the LatCrit website (www.law.du.edu/latcrit/index.htm) no later than MONDAY, APRIL 27, 2009.  Please note that although paper proposals for work-in-progress sessions may be submitted now, we will continue to accept those proposals through mid-July (please refer to LatCrit website for forthcoming additional details).   

Standing LatCrit Themes

LatCrit conferences seek to feature and balance four basic perspectives in organizing each annual conference’s substantive program. These four perspectives are listed as themes below. They have, thus far, served as useful lenses of LatCritical inquiry, enabling LatCrit scholars to develop an impressive body of work that increasingly links issues of identity to the substantive analysis of law, policy and process. This effort to link identity issues to substantive analyses has been particularly fruitful in revealing the way race and ethnicity are implicated precisely in those areas of law and policy that are ordinarily thought not to be about race and ethnicity: for example, in the operations and assumptions of international law and legal process, foreign affairs, liberal democracy, religion and sexuality, to name just a few areas of recent LatCrit attention.

To build on these accomplishments, everyone is encouraged to develop their proposals with a view to: (1) expanding our understanding of the impact of race and ethnicity in substantive areas of law and policy ordinarily thought to be about "something other than race" (e.g. issues of sovereignty, labor rights, globalization, intellectual property, antitrust law); and (2) deepening our analysis of the various ways in which identity issues intersect, conflate and conflict in our self-understandings and coalitional efforts. The following four themes are offered, therefore, as possible points of reference for thinking in new ways about familiar issues (like affirmative action and bilingual education), as well as for encouraging critical forays into new substantive areas (like communications or antitrust laws):

1) Papers or panels that focus on the multidimensionality of Latina/o identity and its relationship to current legal, political and cultural regimes or practices. The ideal is to explicate aspects of the Latina/o experience in legal discourse, both domestically and internationally. Nonetheless, you are free to address identity issues that do not specifically touch upon Latina/o identity or the law.

2) Papers or panels especially salient to this region (the East Coast). Regional emphasis ensures that the Conference's geographic rotation will illuminate local issues, helping us understand how local particularities produce (inter)national patterns of privilege and subordination.

3) Papers or panels that elucidate cross-group histories or experiences with law and power, such as those based on the intersections of class, gender, race, sexuality and religion. In this way, each Conference aims to both elucidate intra-Latina/o diversities and contextualize Latina/o experience within inter-group frameworks and Euro-Heteropatriarchy. Accordingly, we constantly ask how we can create progressive movements, communities and coalitions that meaningfully recognize difference.

4) Papers or panels that connect or contrast LatCrit theory to other genres of scholarship, both within and beyond law and legal theory, including but not limited to the various strands of critical outsider jurisprudence (critical race theory, feminist legal theory, queer legal theory) that critique class, gender, race, sexuality and other categories of social-legal identities and relations.

The Sponsoring Institution – American University Washington College of Law

Founded in 1898, the American University Washington College of Law is the first law school in the world founded by women, Ellen Spencer Mussey and Emma Gillett, who did so in part to combat the de facto exclusion of women from legal education and practice.  WCL also was the first law school to have a woman dean and the first to graduate an all female law school class.  The law school later expanded its mission to provide more generally opportunities for those historically outside the mainstream of the legal profession.

Today WCL is one of the most diverse law schools in the country, with 1,216 full-time JD students (40% identifying as minorities and 55% women), 160 students in two LLM degree programs and 25 SJD candidates.  WCL’s student body includes native speakers of 92 languages and dialects, with almost all nations of the world represented.  Its main building at 4801 Massachusetts Avenue, NW, occupies nearly 180,000 square feet over six stories, including the 54,000-square foot Pence Law Library.

WCL’s faculty consists of 61 tenured and tenure-track and over 100 active visiting and adjunct professors engaged in teaching, scholarship and service benefiting a myriad of professional and community institutions and social justice causes.  Dr. Claudio Grossman, WCL dean and Raymond I. Geraldson Scholar for International and Humanitarian Law, is the longest serving Latino law school dean in the nation and an active practitioner of international and human rights law, currently serving as the unanimously elected chair of the United Nations Committee against Torture (UNCAT).

The Conference Sites

The LatCrit/SALT Junior Faculty Development Workshop (On Thursday, October 1) and the first full day of the LatCrit Conference (Friday, October 2) will take place in the Conference Center at the Hyatt Regency Bethesda Hotel in Bethesda, Maryland, which also will serve as the primary lodging site for conference attendees.   A very accessible and comfortable hotel, the 390-room Hyatt Regency Bethesda offers two full-service restaurants, fully equipped fitness center, in-room broadband Internet access, and spacious conference facilities.  The hotel is located at the heart of Downtown Bethesda, a diverse and lively urban center two miles northwest of the Washington, DC, border and three miles from American University.  Over 200 restaurants, three live theaters, two cinemas, and several bookstores are within a short walk of the hotel, which sits directly above the Bethesda station on the Metro Red Line, offering rapid, low-cost and high-frequency rail service to Dupont Circle (15 minutes); the National Mall, White House, and Capitol Hill (20 minutes); and Reagan National Airport (30 minutes).

The LatCrit XIV planning committee selected the Hyatt Regency Bethesda in June 2008 after a lengthy and exacting search, and was able to lock in a significantly discounted guestroom rate for LatCrit attendees, comparable to previous LatCrit conference rates, in what is one of the most expensive hotel markets in the nation.  Hotel reservation information will be made available, together with conference registration information, in early summer.

Most of the conference events on Saturday, October 3, including several rounds of panels, all work-in-progress workshops, and a community lunch, will take place at the American University Washington College of Law.  Free shuttle bus transportation will be available between the hotel and the law school.

JDP

Supreme Court Finds No Preemption in Wyeth v. Levine

In a much-anticipated decision released today, the U.S. Supreme Court ruled that state common law product liability claims against prescription drug manufacturers are not preempted by the federal Food & Drug Administration's approval for marketing of the drug and its label.  Diana Levine was injured when she was injected with Wyeth's anti-nausea drug, Phenergan.  The drug was adminstered by the "IV-push" method in which the drug is injected directly into the patient's vein.  But the drug entered an artery instead.  Levine developed gangrene as a result, a risk known to Wyeth, and had to have her arm partially amputated.  A Vermont jury found that Wyeth failed to warn adequately about the risks of administering the drug by this method.  The trial court rejected Wyeth's argument that this claim was preempted because the drug's label had been approved by the FDA and the state's supreme court upheld that ruling.

Writing for a 6 - 3 majority, Justice Stevens said that there was no direct conflict between federal and state law that would make it impossible for Wyeth to both comply with the FDA's labeling requirements and to make the Phenergan warnings stronger.  The FDA had not specifically considered and rejected a stronger warning and, under the agency's regulations, Wyeth could have unilaterally strenghthened the warnings regarding the risks of IV-push administration.  Nor, said Stevens, would compliance with state law create an obstacle to achieving an important federal purpose.  No weight should be given to the FDA's 2006 "preemption preamble" asserting that state law represents such an obstacle.  That agency interpretation of the law is inherently suspect in light of the FDA's failure to offer interested parties notice or opportunity for comment on the preemption question; it is at odds with the available evidence of Congress' purposes; and it reverses the FDA's own longstanding position that state law is a complementary form of drug regulation without providing a reasoned explanation, said the court.

JDP

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Florida Jury Awards $8,000,000 against Philip Morris USA

A Miami Herald article today by Patrick Danner notes that a Florida jury in the Hess case, part of a long-running series of product liability claims in that state against cigarette manufacturers, and noted on February 13 on this blog, awarded $8,000,000 to the widow and son of Stuart Hess, who died of lung cancer as a result of his smoking addition.  The jury reached its verdict after about nine hours of deliberations over a two day period.  The award includes $5,000,000 in punitive damages.  Philip Morris USA will appeal.

MKS

Wisconsin Supreme Court Rules Product Liability Claim Against Device Manufacturer Preempted

The Wisconsin Supreme Court ruled yesterday that state law tort claims against the manufacturer of an FDA-approved medical device are preempted.  In Blunt v. Medtronic, 2009 WL 367768 (Wis., 2-17-09), the Wisconsin court concluded that the U.S. Supreme Court's ruling last year in Riegel v. Medtronic, 128 S.Ct. 999 (2008) governed in this case as well.  Joseph Blunt had a Medtronic pacemaker implanted in 2004 to keep his heart from failing.  Based on its own laboratory testing, Medtronic warned the following year that the devices' batteries might fail in one out of 10,000 patients.  Blunt then chose to have the device removed.  Medtronic became aware of the problem two years before it issued the warning.  The manufacturer submitted to the FDA a supplemental application reflecting design changes aimed at eliminating the battery problem.  The FDA approved these changes but did not order the device with its original design recalled nor did it withdraw its 2002 approval of the original design.  During all of this time, Medtronic continued to market and sell the device with its original design. 

Riegel says that a device-specific pre-market approval of a Class III device by the Food & Drug Administration constitutes a federal requirement that preempts any different or additional state law requirements.  The Wisconsin court concluded that the specific device implanted in Mr. Blunt, manufactured according to its original design, had been determined to be safe and effective after a rigourous pre-market review by the FDA.  It is in precisely that situation that the federal agency's approval preempts state law, including common law, claims.

Two Justices concurred but criticized both Riegel and the FDA's process for assuring the safety of medical devices.

JDP

Florida Jury: Smoker Was Addicted

In the latest chapter in the long-running Engle tobacco litigation saga that began in 1994, a Florida jury has found that Stuart Hess, a 40-year chain smoker who died in 1997, was helplessly addicted to nicotine as a result of deceptive practices by Philip Morris that hid the dangers of smoking, including the danger of addiction.  In Engle v. R.J. Reynolds Tobacco Co., a Miami jury found way back in 1999 that smoking caused 20 diseases and that five cigarette manufacturers, individually and in conspiracy with each other and two trade groups that they had established, committed a variety of torts including fraud and fraudulent concealment.  This finding followed the trial court's class certification on behalf of all Florida smokers and their families.  A $145 billion punitive damages award followed in 2000.  In July 2006, the Florida Supreme Court ordered that the punitive damages award be vacated and the class de-certified but that members of the de-certified class members could file individual claims within one year of the de-certification.  The court also ruled that several important findings from the first phase of litigation were entitled to "res judicata" effect, including the addiction, smoking-causes-cancer, and fraudulent concealment findings.

Hess's suit is the first of about 8000 pending cases to go to trial since those 2006 developments.  The case was delayed once due to flooding last year at the Broward County courthouse and then again last December when a mistrial was declared after a witness used a racial epithet.  But the trial finally got underway on February 4th, the addiction determination is now complete, and the fault and compensatory damages phase, in which Hess's lawyers will presumably ask for millions of dollars, has begun.  A third, punitive damages, phase of the trial could follow.

JDP

CPSIA Activity for this week - it went from bad to worse

This was an active week regarding CPSIA implementation (or non-implementation).  Last Friday, as my last blog summarized, the CPSC approved a stay of certain testing and certification requirements.  Then on Tuesday, they issued a ballot for another stay, this time for the effective date of limits on lead content in accessible parts and components in children’s products.  This was the stay requested by NAM in their January 28th letter to the CPSC (NAM-1-28-09.pdf).   The CPSC didn't even bother to draft a stay, they just attached the letter. 

Today, a federal judge in overturned a CPSC advisory opinion.  On November 17, 2008, the CPSC issued an advisory opinion letter stating that products violative of Sections 108(a) and 108(b)(1) [phthalate ban] may continue to be sold and distributed in commerce after February 10, 2009, as long as these products were manufactured prior to February 10, 2009.  This interpretation was challenged in a lawsuit by the Naturall Resources Defense Council and Public Citizen. (nrdc_complaint)

The judge issued a ruling today setting aside the advisory opinion. (phthalate_order) The judge said that the phthalate prohibitions unambiguously apply to existing inventory. Therefore, if this decision stands, affected products that violate the phthalate requirements cannot be sold or distributed after February 10, 2009.  California already has banned products with phthalates and their ban was effective January 1, 2009.  (CA_phthalate_letter)

In addition, Congresssmen Waxman and Rush and Senators Rockefeller and Pryor sent a letter to President Obama demanding that he ask CPSC Acting Commissioner Nancy Nord to step down.  (waxman_to_obama)
And, Senator DeMint has drafted a bill to take care of all of the problems.  (DeMintBill)

Stay tuned.  Who knows what will happen next. 

Kenneth Ross

Criminalizing Products Liability

Professor Frank J. Vandall of Emory University School of Law has published an article entitled "The Criminalization of Products Liability: An Invitation to Political Abuse, Preemption, and Non-Enforcement," in 59 Cath. U.L. Rev. 341 (2008).  The SSRN abstract reads as follows:

Senator Arlen Specter called a hearing in March 2006, on a proposal that urges the criminalization of products liability for the manufacture of intentionally lethal goods. The hearing before the Senate Judiciary Committee provided an opportunity to comment on the numerous issues raised in the far-reaching proposal. Responding to these issues requires revisiting the foundational question of whether the manufacture and sale of a defective product should be addressed by civil litigation or criminal prosecution. Understanding the issues will assist state legislatures and federal agencies in considering such a proposal. To plumb the issues raised by Senator Specter history, economics, and the system of product design and manufacture must be examined. Because Senator Specter argues for a federal act and federal enforcement, his proposal demands consideration of the concepts of preemption, political abuse, and nonenforcement. Fundamental concepts of cause-in-fact and proximate cause must also be considered. After examining these concepts, it should be clear that the criminalization of products liability is neither necessary, nor desirable.

Vandall, Frank J.,The Criminalization of Products Liability: An Invitation to Political Abuse, Preemption, and Non-Enforcement(January, 14 2009). Catholic University Law Review, Vol. 57, No. 1, 2008. Available at SSRN: http://ssrn.com/abstract=1327761

MKS