Articles Posted in Federal Preemption

Mary Ann Nichols of Chicago has filed a federal lawsuit against the dietary supplement company NaturMed Inc., which is also known as Institute for Vibrant Living. Her suit alleges that the company violated federal and state advertising laws.

A federal judge decided against dismissing the class-action lawsuit against this company.

In the lawsuit, she accused the company of breaches of warranty and deceptive practices in the advertising of a drink supplement the company manufactures, All Day Energy Greens, after she found it did not achieve statements on the label that claimed it would increase energy and improve digestion.

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Peggy LeGrande, who worked as a flight attendant for Southwest Airlines, was injured when the plane she working in encountered severe turbulence. She brought a lawsuit against the United States under the Federal Tort Claims Act (FTCA), 28 U.S.C. §2674, claiming that the air traffic controllers employed by the Federal Aviation Administration (FAA) were negligent when they chose not to warn the flight’s captain that turbulence had been forecasted for the plane’s flight path.

At the federal district court level, the judge ruled that FAA employees did not breach any duty owed to Ms. LeGrande and granted summary judgment to the United States. On appeal to the Seventh Circuit Court of Appeals, the plaintiff sought reversal of the district court’s judgment.

On appeal and for the first time, Ms. LeGrande raised the issue that her injuries came from the negligence of a National Weather Service (NWS) meteorologist. Because the FAA breached no duty owed to Ms. LeGrande and because she failed to give NWS the written notice that the FTCA statute requires, the Court of Appeals affirmed the judgment of the district court.

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Federal preemption has long been a hot button issue in pharmaceutical drug cases, with consumer advocates arguing that drug companies should be held to the sometimes higher state standards. However, the U.S. Supreme Court appears to have reversed the federal preemption stance it took in Wyeth v. Levine. In Wyeth, the Court held that the negligence claim against the pharmaceutical company was not preempted by federal regulations and that the drug company was liable for its failure to provide adequate warning of its drug’s dangers.

However, in Pliva v. Mensing, No. 09-993, the Supreme Court ruled that a pharmaceutical manufacturer could not be sued under state law for failing to warn consumers about its drug’s risks. This decision seems to go against the Court’s ruling in Wyeth just two years ago; both lawsuits deal with federal preemption issues and involve states setting higher safety regulations than the Food and Drug Administration (FDA). Yet in Wyeth, the Court held the drug company responsible, while in Pliva, the Court ruled the pharmaceutical lawsuit was barred under federal preemption.

Yet on closer inspection, there appear to be some key differences between the facts surrounding the drug warning labels in Wyeth and Pliva. The main issue in both the Wyeth and the Pliva pharmaceutical cases involved an FDA regulation referred to as “changes being effected” (CBE). Under the CBE regulation, a drug manufacturer may modify its warning label without prior FDA approval if the modifications will improve the drug’s safety. Under CBE regulations, the FDA approval comes after the warning changes, not before; however, the assumption is that the warning changes in such matters are so important to consumer safety that the FDA will eventually approve those changes.

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The United States Supreme Court has ruled that a family is allowed to pursue its lawsuit in California against Mazda Motors of American, Inc. in the case of The Estate of Thanh Williamson v. Mazda, 08-1314. The product liability lawsuit deals with claims that the auto company’s 1993 Mazda MPV minivan were unsafe because the middle seat of the vehicle’s second row was only equipped with lap seat belts.

The wrongful death lawsuit was filed after Thanh Williamson, a Utah mother, died in a 2002 auto crash. Mrs. Williamson was seatbelted into the back middle seat of the family’s Mazda minivan at the time of the car crash. According to eyewitnesses of the car accident, the impact of the car crash caused Mrs. Williamsons’s body to jackknife around the lap seat belt, which resulted in her fatal internal injuries.

Again, central to the estate’s product liability claim was that the seatbelt the late Mrs. Williamson was using was not equipped with a harness or shoulder belt. However, this option is not required by federal regulations. While federal law does require that a vehicle’s front and rear outer seats come equipped with both lap and shoulder belts, car manufacturers may decide whether or not to also provide this option in their middle or aisle seats.

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An Illinois prescription drug case that originally had been dismissed due to issues of federal preemption, has been reinstated by the 7th Circuit Court of Appeals in Chicago. This case, Mason v. SmithKline Beecham Corp. d/b/a Glaxo SmithKline, No. 08-2265,___F.3d___, 2010 WL 605922 (7th Cir. Feb. 23, 2010) may be the first decision that addresses preemption with respect to prescription drugs.

The original Illinois prescription drug lawsuit was brought by the parents of 23 year-old Tricia Mason after she committed suicide just two days after being started on the prescription drug Paxil. The Illinois prescription drug lawsuit alleged that Paxil increases the risk in suicide in children and young adult, which the manufacturer should have known and therefore had a duty to warn its users.

The lawsuit alleged that GSK violated Illinois law by choosing not to warn Tricia Mason on its label that Paxil increases the risk of suicide for children and young adults. Two years after the decedent’s suicide, Paxil added a label warning of an increased risk of suicide among children taking the drug.

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The Moot Court Team of the John Marshall Law School of Chicago headed by Mary Nagel, their faculty sponsor, argued their moot court competition at Chicago’s Kreisman Law Offices before Civil Justice Attorney Robert Kreisman.

Moot Court is an activity where law students participate in simulated appellate court proceedings. However, moot court is actually more challenging than real appellate proceedings because students have to argue both sides of the critical issues in the case. The John Marshall Law School law students will be arguing both the appellant’s position and the appellee’s position in the national competition to be held in Cincinnati.

The issues of the fictional case involved pharmaceutical preemption by federal law, similar to those at issue in Riegel v. Medtronic, Inc and Wyeth v. Levine. The federal preemption issue revolves around whether or not warning language as to medical devices or pharmaceuticals approved by the Food & Drug Administration (FDA) are open to medical device liability lawsuits or product liability lawsuits under state law if those medical devices or drugs had been approved by the FDA. The law students also argued issues of punitive damages and constitutional law. The underlying case was on appeal to the supreme court from appellate level after a jury verdict of $900,000 was entered against the defendant pharmaceutical company. The appellate court denied a reversal of the compensatory damages, but remittur was allowed on the punitive portion of the verdict.

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In its recent ruling the U.S. Supreme Court ruled that premarket approval from the Food & Drug Administration (FDA) does not preempt pharmaceutical companies from being held liable when their drug fails to meet state standards. In Wyeth v. Levine the court held that drug manufacturers can be sued in state courts even when they follow the rules and standards set out by the FDA.

Wyeth v. Levine involves a female, Vermont musician who lost part of her right arm after Wyeth’s drug Phenergan was injected into one of her arteries. The drug’s FDA-approved warning label warned against administering the drug this way, but did not prohibit it.

Wyeth argued that they were not required to change their labels to comply with Vermont regulations and that meeting the federal standards was enough. Levine argued that she was able to bring a liability claim under Vermont law even though Wyeth complied with federal standards.

The key issue of the case was whether or not Levine’s claim was preempted since Wyeth met the federal standards. The Supreme Court ruled that the case was not preempted and that Levine is able to bring a claim under Vermont law.

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Federal scientists associated with the Federal Food and Drug Administration (FDA), have written to the Obama transition team of widespread managerial misconduct within the medical device review department. The letter alleged that “the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers.”
The letter came from the FDA’s Center for Devices and Radiological Health, which is responsible from reviewing medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The letter alleges that the agency managers employed intimidation to thwart scientific debate, the result being that some medical devices were approved despite questions as to their effectiveness. Furthermore, the letter states that scientists were forced to “accept clinical and technical data that [was] not scientifically valid.”
The authors of the letter expressed concern with the lowered standards and the effects that an ineffective review process would have on consumers. Approval by the FDA carries a certain level of integrity and instills a certain level of trust in medical professionals and their patients. However, if that process has been corrupted or compromised then that trust is unwarranted.

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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.

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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.

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