Proposed Changes at FDA and Proposed Legislation Threaten Both Pharmaceutical and Medical Device Companies

March 2009Alerts Life Sciences Practice Alert

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The Wyeth V. Levine Ruling and the Medical Device Safety Act

The Supreme Court issued its opinion in the intensely watched case of Wyeth v. Levine on March 4, 2009. Many in the pharmaceutical industry held their breath, hoping that the rigorous process of obtaining approval from the Food and Drug Administration (FDA) for drug labels would protect them from state court tort liability in the same manner as the Court had done in the widely publicized case of Riegel v. Medtronic, which held in favor of medical device companies on the preemption issue in an 8-1 decision.

In a 6-3 decision, the Supreme Court ruled in Wyeth that state tort claims over the warning labels of pharmaceutical companies were not preempted by federal law simply because the FDA had approved the warning labels. Specifically, in this failure-to-warn on a drug label case, the Court rejected Wyeth's claim that (1) Wyeth could not possibly comply with both state-law duties and federal labeling duties, and (2) if Wyeth had been required to comply with state-law duties to have stronger labeling, such duties would have been preempted by Congress' intent to entrust the FDA with drug labeling powers; otherwise, the law would allow for the substitution of a jury's decision in place of the expertise of the FDA.

Even more distressing is the fact that in light of the Wyeth ruling, 18 U.S. Senators are aggressively seeking the passage of a bill entitled, "The Medical Device Safety Act." This bill would overturn Riegel v. Medtronic, which held that the express preemption provision of Section 360k(a) of the Medical Device Amendment to the Food, Drug and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received pre-market approval from the FDA. While the Senators previously sought to implement this law unsuccessfully, Wyeth has built their momentum. This is especially noteworthy, since the preemptive effect of Riegel only applied to medical device manufacturers that filed an application for pre-market approval of a new medical device, rather than filing an application under Section 510(k) of the Act, which seeks FDA approval by showing that the device in question is "substantially equivalent" to a device previously approved by the FDA. Many in the medical device community were puzzled by the Court's ruling in Riegel, since a device deemed to be substantially equivalent to a device that has already been approved as safe and effective by the FDA was not granted Riegel preemption protection.

In the wake of this decision and the possible passage of the Medical Device Safety Act, pharmaceutical companies and medical device manufacturers should review any existing labels (including, but not limited to, package inserts, instructions for use, etc.) and establish systems that ensure regular evaluation and updating of product labels. Fox attorneys strongly urge all pharmaceutical and medical device companies to consider specific disclaimers for issues such as off-label use and other matters that typically are the basis of many products liability claims.


In Wyeth v. Levine, the Supreme Court awarded Vermont musician Diana Levine $6.7 million after her forearm was amputated in 2000 due to gangrene. The gangrene developed after a physician-assistant administered the anti-nausea drug Phenergen to the Plaintiff via an "IV Push" method. The "IV Push" method resulted in the drug leaking into the Plaintiff 's artery causing gangrene. As a result, after settling with her health care provider, Ms. Levine brought a common law negligence claim against Wyeth in Vermont state court for failure to provide adequate labeling that prohibited the use of the "IV Push" method. Although the drug's label warned against the use of the "IV Push" method, it did not prohibit it. Wyeth defended its drug and claimed that since it had complied with the FDA's rigorous labeling requirements, it should be immunized from such state failure-to-warn lawsuits.

Under federal law, the FDA is responsible for regulating the warning labels for drugs as part of its mandate to assure that drugs are both safe and effective as part of the pre-market application process. However, as a result of this ruling, the Supreme Court has allowed a lay jury to replace the expertise of the FDA in deciding whether a pharmaceutical label adequately warns of potential dangers based on the information and analysis available at the time.


Wyeth was labeled as one of the most significant business cases to go before the Court and came as a surprise to the pharmaceutical industry because of the Supreme Court's ruling in Riegel. The Court's holding in Riegel would be specifically overturned by the Medical Device Safety Act. Many medical device attorneys are concerned that by the time the bill gets to the floor of Congress, amendments to the bill might actually expand the exposure of pharmaceutical and medical device companies beyond that which existed before Riegel and Wyeth.

Significantly, influential legislators plan to introduce a bill consistent with Wyeth, giving injured people the same right to sue pharmaceutical and medical device companies in state court.


  • The Wyeth decision has stripped the pharmaceutical companies of any protection previously provided by the FDA label, and the Medical Device Safety Act threatens to strip even more protection from medical device companies. Plaintiffs' lawyers have already stated in various publications that Wyeth and the above-referenced legislation present a "golden opportunity" to continue to sue pharmaceutical and medical device companies for allegedly defective products.
  • Pharmaceutical companies and medical device companies must take more responsibility by updating labels on an active basis. This means reviewing company records and updating warning labels based on old and new information. While the impact of this ruling on medical device companies will be dependent on whether Congress responds by overriding the Riegel device decision, the time to act is now. Plaintiffs' lawyers are eagerly waiting for the passage of such legislation and claim that it is necessary because the FDA has repeatedly approved the sale of faulty medical devices.
  • The Wyeth decision and the Medical Device Safety Act, if passed, will place a greater burden on pharmaceutical and medical device companies to be responsible for the labeling of their drugs and devices.
  • We urge all pharmaceutical and medical device companies to consult counsel to assure compliance with regulations and to have adequately updated labels, as the consequences of not doing so could result in significant liability.

For more information about this Alert, contact Alfred J.Monte, Jr., chair of the Life Sciences Practice, at 610.397.6514 or [email protected] ; Lilian Nikolaevsky at 610.397.7972 or [email protected] ; or Dean Wang at 609.844.3036 or [email protected].