As we previously reported, Mutual Pharmaceutical Company appealed a $21 million judgment against it to the United States Supreme Court. By a 5-4 vote, the Supreme Court has now reversed and rendered judgment in favor of the drug company. Mutual Pharmaceutical Co., Inc. v. Bartlett, No. 12–142 (U.S. June 24, 2013).
The case concerned Karen Bartlett who was prescribed Sulindac, a generic anti-inflammatory medication, to help treat her shoulder pain. She began suffering from a severe reaction called Stevens-Johnson syndrome which deteriorated over 60 percent of her skin to the point of causing open wounds. She spent nearly two months in a medically induced coma in a burn unit. She endured more than a dozen eye surgeries and is now legally blind.
A jury found that Sulindac was unreasonably dangerous to consumers and therefore was defectively designed. On appeal, the drug company argued that federal law governs generic drug manufacturers’ conduct and therefore Bartlett cannot pursue a design defect claim based on New Hampshire state law.
The case involved a generic drug and thus the FDA rules regarding generic drugs. Under FDA rules, generic drugs must be chemically equivalent to the approved brand-name drug: it must have the same “active ingredient” or “active ingredients,” “route of administration,” “dosage form,” and “strength” as its brand-name counterpart. Second, a proposed generic must be “bioequivalent” to an approved brand-name drug which means it must have the same “rate and extent of absorption” as the brand-name drug. Third, the generic drug manufacturer must show that “the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug.”
New Hampshire requires manufacturers to ensure that the products they design, manufacture and sell are not “unreasonably dangerous.” The New Hampshire Supreme Court has recognized that this duty can be satisfied either by changing a drug’s design or by changing its labeling.
However, generic manufacturers are prohibited from making any unilateral changes to a drug’s label. Rather, generic drugs must use the same label as the approved brand-name drug. In PLIVA, Inc. v. Mensing, 564 U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), the Supreme Court had held that state law claims arguing a generic drug company failed to provide proper warnings were thus preempted by federal law.
Instead of directly challenging the drug’s labeling, Bartlett argued that the generic drug was defectively designed and that a claim based on defective design should not be preempted by federal drug law. Ultimately, the Supreme Court found that to be a distinction without a difference under the facts of the case. The court ruled that a generic drug maker typically can no more change the drug’s design than the label:
In the drug context, either increasing the “usefulness” of a product or reducing its “risk of danger” would require redesigning the drug: A drug’s usefulness and its risk of danger are both direct results of its chemical design and, most saliently, its active ingredients. […] In the present case, however, redesign [of the drug] was not possible for two reasons. First, the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based. ….] “Mutual cannot legally make sulindac in another composition.”[…] Indeed, were Mutual to change the composition of its sulindac, the altered chemical would be a new drug that would require its own NDA to be marketed in interstate commerce. […]Second, because of sulindac’s simple composition, the drug is chemically incapable of being redesigned. […] “Mutual cannot legally make sulindac in another composition (nor it is apparent how it could alter a one-molecule drug anyway).”
Mutual Pharmaceutical Co., Inc. v. Bartlett, No. 12–142.
Given the impossibility of redesigning sulindac, the Supreme Court determined that the only way for Mutual to ameliorate the drug’s “risk-utility” profile—and thus to escape liability—was to strengthen “the presence and efficacy of [sulindac’s] warning” in such a way that the warning “avoid[ed] an unreasonable risk of harm from hidden dangers or from foreseeable uses.” However, under the holding in PLIVA, Inc. v. Mensing, all such failure-to-warn claims against generic manufacturers are pre-empted by the FDCA’s prohibition on changes to generic drug labels.
Thus, because federal law prevented Mutual from changing sulindac’s label, Bartlett could not sue the company for failing to change the label. The judgment in Bartlett’s favor was reversed.
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Case results depend upon a variety of factors unique to each case. Results of other cases do not guarantee or predict a similar result in any future case.