Court case could undermine drug approval process

Article Highlights

  • Crucial legal and medical principles hang in the balance in the Mutual Pharmaceutical Co. v. Bartlett case

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  • Tuesday, SCOTUS will weigh a novel legal theory being advanced by the trial bar that could become the torts’ next payday against drugmakers

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  • The theory that plaintiffs may sue manufacturers over a “design defect” could send lawyers into state courts to second-guess any new drug

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On Tuesday, the Supreme Court will weigh a novel legal theory being advanced by the trial bar that, if upheld, could become the torts’ next big payday against drugmakers. The case could also undermine the basic tenets of the Food and Drug Administration’s process for approving new medicines.

For this latter reason, the trial bar finds itself on the other side of the Obama administration, which has filed an amicus brief in the case.

Mutual Pharmaceutical Co. v. Bartlett involves a generic version of the old, and once widely used anti-inflammatory drug sulindac. The plaintiff, Bartlett, suffered a rare but known side effect called Stevens-Johnson syndrome with use of the drug. She claims the medicine was “defectively designed” because it harbored that risk. The FDA is well aware that sulindac could, in unusual situations, cause the condition (as do similar drugs in the same class).

A New Hampshire jury nevertheless awarded Bartlett more than $20 million based on her “design-defect” claim that benefits of sulindac didn’t justify its risks. In essence, she is arguing that the drug’s “design” was flawed from the very beginning. The FDA, she argues, should never have approved the original medicine for sale. The 1st Circuit Court of Appeals upheld the decision.

Previously, most tort claims aimed at drugmakers have turned on claims that a drugmaker failed to quickly or adequately warn patients (or the FDA) of the risks that manufacturers uncovered with their medicines. But the theory that plaintiffs may sue manufacturers over a “design defect” could send tort lawyers into every state court to second-guess just about any new drug and the FDA’s decision to approve it.

As the Obama administration explains in its brief, the plaintiffs “design-defect claim rests on the premise that the active ingredient of a drug that the FDA approved as safe and effective for its labeled conditions” could nonetheless be judged as “unreasonably dangerous,” despite adequate warnings on its approved labeling.

In this case, the medicine at question was generic. But the same tort theory could apply to any drug — old or new. Lest branded drugmakers rest too easy, Obama’s solicitor general provided in his brief a subtle road map for the trial bar, on how tort lawyers could successfully mend their future pleadings. It leaves wide open the possibility that a “design defect” claim could still apply to a branded drugmaker.

At stake is the chilling effect that such a legal precedent could have on any drug development. The theory would allow state juries to relitigate the risk-benefit analysis that is at the very core of the FDA’s authority to approve prescription drugs. It could undermine the carefully constructed standards that exist for how new drugs need to be researched and developed. These are not trivial matters. They reflect years of contentious debate, reams of guidance documents issued by the FDA, and thousands of past precedents that have all coalesced to form general principles. These standards guide FDA decisions as well as the clinical practice of medicine.

The case involving Mutual Pharmaceutical also challenges prior legal precedent; in particular a 2011 decision in Pliva Inc. v. Mensing, in which the high court ruled 5-4 that certain state tort claims against generic drugmakers are pre-empted by federal law. Because the FDA requires generics to use the same ingredients and labeling as the branded drugs they’re copied from, the court said that the makers of generic drugs couldn’t be held liable as a matter of state tort law for “failing to warn” consumers of risks.

That prior ruling is what set the trial bar searching for new ways to bring tort cases against generic drugmakers. The “design defect” theory is the latest step in that effort. In hearing the original appeal of the current case, the appellate court openly said that it was challenging, if not refusing to follow the high court’s prior ruling.

The administration decision to side — albeit cautiously — against the trial bar is significant. The entire case could well decide whether “design defect” claims will become the next product liability bonanza. While the Supreme Court, in deciding whether to affirm the 1st Circuit decision, will only influence whether these “design defect” claims can be made against generic drugs, the high court could issue dicta that would help makers of branded drugs forced to face similar suits.

It’s one reason why those branded drugmakers have filed their own brief in the case, alongside the administration. The case has made for strange bedfellows, underscoring the crucial legal and medical principles that hang in the balance.

Scott Gottlieb, a physician and resident fellow at the American Enterprise Institute, was FDA deputy commissioner from 2005 to 2007.


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About the Author


  • Scott Gottlieb, M.D., a practicing physician, has served in various capacities at the Food and Drug Administration, including senior adviser for medical technology; director of medical policy development; and, most recently, deputy commissioner for medical and scientific affairs. Dr. Gottlieb has also served as a senior policy adviser at the Centers for Medicare & Medicaid Services. 

    Click here to read Scott’s Medical Innovation blog.

    Follow Scott Gottlieb on Twitter.

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