Consumers harmed by a generic drug manufacturer’s failure to warn have no recourse thanks to a U.S. Supreme Court ruling.

In 2004, Karen Bartlett took sulindac, a generic, prescription-only non-steroidal anti-inflammatory drug manufactured by Mutual Pharmaceutical, for her painful shoulder.  A few weeks after Bartlett took the drug, she developed an acute case of toxic epidermal necrolysis, which left her extremely disfigured, disabled, and almost blind.  Sulindac’s label did not warn about toxic epidermal necrolysis as a possible side effect because the brand name drug, Clinoril, did not warn about it.  Under federal law, generic manufacturers are prohibited from making unilateral changes to a drug’s composition and labeling, including warnings; a generic drug’s composition and labeling must be consistent with the brand name drug.  In 2005, however, FDA recommended changing all non-steroidal anti-inflammatory labeling to contain a more explicit toxic epidermal necrolysis warning.

Bartlett sued Mutual Pharmaceutical under a state law requiring manufacturers to ensure that their products are not unreasonably dangerous, and a jury awarded her $21 million for her design-defect claim.  The Fifth Circuit affirmed, but the U.S. Supreme Court reversed that decision.   In Mutual Pharmaceutical Co., Inc. v. Bartlett, the Court held that state law design-defect claims based upon the adequacy of a drug’s warnings are preempted by federal law.  The Court reasoned that it was impossible for Mutual Pharmaceutical to comply with state law requiring it to strengthen its warnings or change sulindac’s composition and federal law requiring it to not alter sulindac’s warnings and composition.  Thus, the Court concluded that the state law is “without effect.”

Despite the Court’s holding, it claimed that it was not unsympathetic to Bartlett’s situation.  The Court stated:

This case arises out of tragic circumstances. A combination of factors combined to produce the rare and devastating injuries that respondent suffered: the FDA’s decision to approve the sale of sulindac and the warnings that accompanied the drug at the time it was prescribed, the decision by respondent’s physician to prescribe sulindac despite its known risks, and Congress’ decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs’ compositions or their warnings. Respondent’s situation is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment below be reversed.

As it now stands, Bartlett and countless others injured because of generic manufacturers’ design defects have no remedy.  The availability of a remedy should not turn upon whether the drug at issue is brand name or generic.  Generic manufacturers must be held liable for their dangerous products, regardless of whether they are FDA approved, in order for consumers to be adequately protected.


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