Articles Posted in Federal Preemption

by

U.S. District Court Judge Virginia M. Kendell denied a Chicago woman’s medical device liability claim that her left knee injuries were caused by her knee replacement device. The complaint was removed to the federal court from Chicago’s Cook County Circuit Court and contained claims of negligence, strict liability and breach of warranty based on Illinois law.

Judge Kendall granted summary judgment in favor of the the manufacturers, Zimmer Holdings, Inc., Zimmer U.S., Inc., and Zimmer, Inc., in a lawsuit brought by the plaintiff, Joyce Link.

After reviewing the case facts, Judge Kendell held that Ms. Link’s claim against Zimmer for their manufacturing of the Natural Knee II was preempted under the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act. Per Judge Kendall’s ruling this act “imposed detailed federal oversight onto the introduction of new medical devices onto the introduction of new medical devices onto the market”. Judge Kendall credited her interpretation of Riegel v. Medtronic, 128 S.Ct. 999 (2008), as partial basis for her opinion.

In addition, Judge Kendall cited 21 U.S.C. § 360(c), which states that as part of the oversight states and their subdivisions are barred from implementing their own requirements concerning medical devices, such as the Natural Knee II. The federal act specifically preempts any state requirement regarding a medical device “which is different from, or in addition to” a requirement imposed by the MDA.

In Judge Kendall’s opinion, the state requirement is not preempted unless it also “relates to the safety or effectiveness of the device or to any other matter” covered by the MDA. Kendall held that Ms. Link’s claim was just the kind that Congress intended to preempt under the MDA.

Continue reading

by

Since early 2006, drug and medical device companies have been on an unprecedented roll as pre-emption clauses become more and more prevalent. Despite recent controversies over prescription drugs like Vioxx and Celebrex, drug companies continue to successfully utilize Federal Drug Administration (FDA) policies to shield drug companies from civil lawsuits in the form of pre-emption clauses. This has far-reaching effects on pharmaceutical liability lawsuits in Illinois and the rest of the country.

And not just the FDA are upholding and propagating these preemption clauses- the U.S. Supreme Court has also supported pre-emption laws that prevent claimants from filing civil law suits against deep-pocketed drug and medical device companies in state courts.

The beginning of the preemption era can be traced back to January 2006, when the FDA issued a statement of its new labeling policy under the “Laws, Acts, and Rules > New Requirements for Prescribing Information.pdf.” This policy not only set out labeling requirements, but also deemed that if the FDA approved the labeling then this alone “pre-empts conflicting or contrary state law”.

The federal pre-emption clauses have little or no bearing on FDA drug recalls, which can be initiated by the FDA, by FDA statutory authority, or by the drug company itself. The FDA maintains a list of recent drug recalls.

Yet the seemingly simple pre-emption declaration had far-reaching effects within the legal community and reversed decades of policies enforcing state’s rights to civil enforcement of liability law. This was done without a public notice or hearing- instead it was quietly tacked on to the labeling policy.

Continue reading

by

A suit was filed against Phillip Morris claiming its practice of labeling cigarettes as “Light” qualified as consumer fraud. The Appellate Court denied Phillip Morris’s argument that it was immune from such lawsuits under federal law so the company is appealing to the U.S. Supreme Court.

The plaintiffs in Altria v, Good, 501 F. 3d 29 (1st Cir. 2007) alleged that Phillip Morris violated state laws prohibiting fraudulent misrepresentation in its false promotions and advertising for Marlboro and Cambridge Lights as “Light” with “Lowered Tar and Nicotine” when in fact the “Light” cigarettes would not deliver any less tar or nicotine to the smoker.

Phillip Morris responded to plaintiff by stating that the consumer fraud claims are preempted by the Federal Cigarette Labeling and Advertising Act, and preempted implicitly in the “efforts of Congress and Federal Trade Commission for 40 years to implement a national, uniform policy of informing the public about the health risks of smoking.”
The majority of the defendant’s argument rests on its assumption that the plaintiffs are bringing a claim for a failure to warn and not for fraud. Because a failure to warn would fall under the banner of warning label regulations, which is overseen by the federal government, any such claims would need to be brought under federal, and not state, law.

However, the US Court of Appeals for the First Circuit did not see plaintiffs’ claim as dealing with a failure to warn, but rather with Phillip Morris fraudulently representing its product. And because the federal law does not deal directly with fraud there is nothing to preempt the state law from taking precedent. Therefore, Phillip Morris is not immune from litigation dealing with plaintiffs’ claim because federal law does not negate consumer fraud claims related to the sale of light cigarettes.

To reach a final conclusion, the US Supreme Court has agreed to review Phillip Morris’s argument that federal law totally immunizes it from suits regarding consumer fraud claims as to “light” cigarette labeling. The case is set for oral argument in the fall of 2008.

Continue reading

by

Much has been said about the preemption of state actions for Illinois personal injury cases or Illinois wrongful death lawsuits. A recent federal district court decision ruled that a failure-to-warn lawsuit is not preempted by the federal statutes. The suit was brought by the parents of a teenager who committed suicide while taking the antidepressant Paxil.

The plaintiffs’ son was prescribed Paxil by his dermatologist, not for his acne, but to treat a psychiatric disorder in which the individual is overly concerned about real or imagined defects in their physical appearance. Shortly after the second prescription of Paxil was refilled, the plaintiff’s son committed suicide.

The parents alleged that the pharmaceutical company was liable for their son’s death because it failed to warn the physician about the risk of suicide that the drug posed to children and adolescents. The court rejected the argument raised by pharmaceutical giant, Glaxo-SmithKline (GSK), that preemption applied to this case.

Continue reading