Supreme Court Rules State Drug Tort Claims Preempted by Federal Drug Regulations – PLIVA Inc. v. Mensing

By July 6, 2011 July 18th, 2019 Dangerous Drugs

As a dangerous drug attorney, I was saddened and disappointed by the Supreme Court’s late-June ruling in PLIVA Inc. et al. v. Mensing. This case consolidated two claims by people who took generic versions of Reglan (metoclopramide), and later developed a rare and permanent disability called tardive dyskinesia, which causes involuntary movements and tremors. They sued the drug makers under state-law claims for failure to warn them about the risk. In both cases, the drug makers responded that they had no duties under state law because state law was preempted by federal law and FDA rules. Those arguments were dismissed by the Fifth and Eighth U.S. Circuit Courts of Appeals, and when the manufacturers appealed to the Supreme Court, the cases were consolidated.
It is not disputed that metoclopramide can cause TD. Studies as far back as the 1990s showed the connection, and a 2004 study brought it to the FDA’s attention. However, the agency did not order a black box warning for Reglan and its generics until 2009, several years after the plaintiffs developed TD. The plaintiffs alleged that by the mid-1990s, generics manufacturers knew or should have known about the risk, which would have been adequate to press their claims under state product liability laws. However, federal law also applies, and among other things, federal law requires generics to carry the same labels as their brand-name equivalents. According to the Supreme Court’s five-justice majority, this creates a situation where it is impossible for drug makers to update their labeling independent of FDA action without violating federal law. Because federal law preempts, the court ruled against the plaintiffs.
In doing so, the majority distinguished this case from 2009’s decision in Wyeth v. Levine, which held that failure to warn lawsuits under state law were not preempted by federal regulations. In that case, the majority said, the drug was a name-brand drug, so it didn’t have the requirement that generics have to keep to the same labeling as the parent drug. Because different laws applied in Wyeth, the majority said, it was possible in that case for manufacturers to follow both sets of laws. The majority recognized that creating a split in duties between generic and name-brand manufacturers “makes little sense” — a phrase repeated by the four-justice minority in a heartfelt dissent — but felt that its job was not to overturn laws passed by Congress. The dissenters argued that generic manufacturers should be required to petition the FDA to make labeling changes, and protected from suits only when the FDA said no.
Because the majority of all prescriptions are for generic drugs, this decision worries me as a defective drug lawyer. This decision means all of those drug makers will be completely immune from litigation, even when a name-brand manufacturer who took the exact same actions would be liable. And even if every American understands the risks and wants to avoid them by requesting only brand-name drugs, it is not always financially possible to avoid generics. Not only are they less expensive than their name-brand counterparts, but some insurance plans outright refuse to cover name-brand drugs at all. Unless Congress passes legislation to fix what the Supreme Court majority sees as a gap in the law, this decision will seriously hurt people with a wide variety of injuries caused by generic drugs — and as a pharmaceutical liability attorney, I agree with the minority that Congress could not have intended that.


If you or someone in your family suffered a serious injury or illness after taking a drug you thought you could trust, you should call Carey, Danis & Lowe right away for a free, confidential case evaluation. To get in touch, call us toll-free at 1-877-678-3400 or send us a message through our website.
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