Government Issues

The author wishes to thank Porter Durham for his assistance in preparing this post.  Porter is currently a Summer Associate with the firm.   

On June 24, the United States Supreme Court announced its decision in Mutual Pharmaceutical Co., Inc. v. Bartlett that state law design-defect claims focusing on labeling of generic drugs are preempted by federal law. In many ways, the Bartlett decision can be seen as a major victory for generic drug manufacturers, which now enjoy far more protection from state law product liability suits. However, the Court did leave open some questions about tort liability for generic drug manufacturers.

In its holding, the Court analyzed the clash between New Hampshire tort law, which the Court concluded imposes a duty on manufacturers to ensure that their products are not “unreasonably dangerous,” and the federal Hatch-Waxman Act, which requires that the generic version of a name-brand pharmaceutical be chemically identical and bioequivalent to the name-brand version and that it carry the same labeling as that approved for the name-brand version. The Court reasoned that it would be impossible for a generic drug manufacturer to abide by both the state law (requiring it to alter the formula or labeling of a product to prevent “unreasonable danger”) and the federal law (forbidding the same). Accordingly, the Court held that because under the Supremacy Clause federal law pre-empts state law where they conflict, the New Hampshire standard could not be enforced.

The Court also dismissed the “stop-selling theory.” Recalling its decision in PLIVA, Inc. v. Mensing, the Bartlett Court acknowledged that a generic manufacturer could abide by both federal and state law by not selling its product within states where state law clashes with federal law or by not manufacturing its product at all. However, the Court argued that this sweeping solution is no solution at all, asserting that pre-emption cases have never required that an actor stop acting “to satisfy both his federal- and state-law obligations.” Moreover, the Court argued that impossibility pre-emption would be virtually meaningless if a claim of impossibility could be defeated by “the option of ceasing to act.”

Bartlett follows closely the Court’s holding in PLIVA (that federal drug law pre-empts state law and bars claims for inadequate warning) and extends that holding to claims brought for design defects. In doing so, Bartlett effectively bars product liability suits against generic drug manufacturers for anything other than manufacturing defects. While this bar has profoundly negative implications for potential plaintiffs, it largely benefits consumers on the whole. Because the Court’s decision reinforces the limitations on alterations to formula and packaging placed on generic drug manufacturers by the Hatch-Waxman Act, it further facilitates access to affordable generic drugs. Moreover, the reduced likelihood of being called to defend costly product liability suits also likely lowers the overall cost of doing business for generic drug manufactures, which again means greater access to affordable prescription drugs for consumers.

Are you still trying to understand the changes made in the HIPAA Omnibus Rule?

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Harvey Tettlebaum, a Husch Blackwell attorney specializing in healthcare law with an emphasis in post-acute care, contributed an article to the June 2013 issue of the Journal of Health & Life Sciences Law titled “Quality Measurements, Payment, and the Law: Disincentives to Physician-Patient Discussions of End-of-Life Care.”  Here is the abstract of the article.

With …

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On April 16, in a win for Purdue Pharma, the maker of OxyContin, the FDA issued a decision approving updated labeling for Purdue’s reformulated, abuse-resistant OxyContin tablets. The decision places drug makers on notice that the FDA will not accept or approve any abbreviated new drug applications (generics) that rely upon the agency’s December 1995 approval of Purdue’s original OxyContin formulation.

The FDA’s decision was issued just as Purdue was set to lose its patent on the original formulation of OxyContin. Loss of this patent would have opened the opioid-painkiller market to competition from generic drug makers. But now, going forward, new applications for generic “copycat” forms of the drug must meet Purdue’s approved, abuse-resistant standard, without infringing upon Purdue’s patent for reformulated OxyContin, which lasts until 2025.

Concern over abuse of the well-known painkiller was central to the FDA’s decision. The agency explained, in a press release accompanying its decision: Purdue’s “labeling indicates that the [reformulated] product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).” The press release further stated that: The original formulation of OxyContin “was abused, often following manipulation intended to defeat its extended-release properties. Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death.”

According to the New York Times, the FDA’s decision was pushed by some state attorneys general, as well as pain treatment experts, who argued that the release of generic versions of OxyContin would feed street demand for the narcotic. Critics, however, have argued that the decision will result in higher prices for OxyContin, as the reformulated drug will not face generic competition.

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