Over two years ago, amidst the DOMA and Voting Rights cases, the Supreme Court of the United States (SCOTUS) quietly ruled in favor of pharmaceutical companies indicating that generic drug makers have no legal obligation to update labeling and warn patients of nasty side-effects should those reactions occur post FDA approval. The case, Mutual Pharmaceutical Co. v Bartlett is a decision that will affect medication safety, healthcare responsibility and states rights for years to come, but few in the media bothered to cover the ruling.
Background of the Case: Mutual Pharmaceutical Co. v Bartlett
In 2004 Karen Bartlett was prescribed a topical NSAID pain-reliever called Sulindac for her shoulder pain. Sulindac is generic version of Merck’s Clinoril that is manufactured by Mutual Pharmaceutical. Shortly thereafter she developed toxic epidermal necrolysis (TEN) – a severe, life threatening and debilitating adverse reaction to the drug. Sulindac caused her skin to peel away from her body, a gruesome, flesh-eating reaction that spread over most of her body.
According to documents discovered later, the drug makers, Merck originally and Mutual for the generic version, knew about the potential for TEN but failed to label it. (Merck has since changed their labeling). Ms. Bartlett sued Mutual under New Hampshire’s design-defect law and was awarded $21 million. Mutual appealed under the auspices that they were not responsible for labeling because that rested with the federal government and the FDA. Since the FDA had not, in its original approval of the drug included the warning, the generic company could not change the labeling without violating federal law. Moreover, even though not labeling the drug violated New Hampshire state law, under which the case was originally brought, state law was in conflict with federal law.
Ms. Bartlett’s case before SCOTUS rested on the fact that Mutual knew about the ‘defect’ and failed to warn consumers. In state court she won. But in the appeal, Mutual contended that even though they knew about the dangers of the drug, as a maker of generic drugs, which are essentially copies of the name-brand drugs, they were not only not responsible for the labeling, Merck and FDA were, Mutual could not change the labeling under federal law. The state’s remedy, and upon which much of the SCOTUS case rested, was to not permit the sale of the ‘defective’ product – the drug – in New Hampshire. In other words, to abide by state law, Mutual should not have sold and not be allowed to sell the product in New Hampshire. SCOTUS again disagreed, effectively forcing the sale of ‘defective’ products’ in states.
There was no question that the drug was responsible for Ms. Bartlett’s injuries, but the since the case rested on the eminence of federal versus state law and the work-around proposed by the state, there was ample precedence for SCOTUS to overturn the lower court’s ruling and they did so, 5-4, mostly along party lines.
We must decide whether federal law pre-empts the New Hampshire design-defect claim under which respondent Karen Bartlett recovered damages from petitioner Mutual Pharmaceutical, the manufacturer of sulindac, a generic nonsteroidal anti-inflammatory drug (NSAID). New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe, and a drug’s safety is evaluated by reference to both its chemical properties and the adequacy of its warnings. Because Mutual was unable to change sulindac’s composition as a matter of both federal law and basic chemistry, New Hampshire’s design-defect cause of action effectively required Mutual to change sulindac’s labeling to provide stronger warnings. But, as this Court recognized just two Terms ago in PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), federal law prohibits generic drug manufacturers from independently changing their drugs’ labels.
In an opinion written by Justice Alito:
Accordingly, state law imposed a duty on Mutual not to comply with federal law. Under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are “without effect.” Maryland v. Louisiana, 451 U. S. 725, 746 (1981) .
The Court of Appeals’ solution—that Mutual should simply have pulled sulindac from the market in order to comply with both state and federal law—is no solution. Rather, adopting the Court of Appeals’ stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court’s pre-emption case law.
Accordingly, we hold that state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under PLIVA. We thus reverse the decision of the Court of Appeals below.
Why This Matters
SCOTUS ruled that manufacturers of generic drugs have no safety or labeling obligations beyond what was expressly given by the brand name company and the FDA approval. If the FDA approved a particular label and adverse events appear later, even when associated with the generic drug, the manufacturer of the generic drug is not liable. The makers of the brand name drug are still liable, but only for their brand name drugs. When an individual is given the generic version rather than the brand name version, even if those two compounds are exactly the same, the individual cannot sue the generic manufacturer per this new ruling, nor can he/she sue the brand name manufacturer, because the adverse event occurred with the generic and the brand name company is not responsible for the generic.
Since the majority of all prescriptions are for generic medications, this ruling effectively absolves drug manufacturers of responsibility for adverse events, once FDA approved. What’s more, where states could have stepped in and prevented the sale of defective products within their boundaries, this ruling preempts that protection as well. If the federal agencies say it is safe, the states can do nothing. For a conservative court, this is a pretty big usurping of states rights.
Can we sue the FDA for failing to protect consumers?
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This article was published previously on Hormones Matter in July 2013.