A new wave of product liability against drug makers? Tomorrow the Supreme Court decides

Article Highlights

  • Mutual Pharmaceutical Co. v. Bartlett turns on a novel tort concept that’s being advanced by the trial bar called “design defect” claims

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  • The “design defect” legal theory puts state juries in the position of second-guessing FDA’s judgment in approving new drugs

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  • Because the legal theory undermines the heart of FDA’s mission, the Obama Administration has filed a brief siding against the plaintiffs

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On the Op Ed page of today’s Politico.com, I comment on a case that’s being heard before the Supreme Court tomorrow. It concerns drug makers and the issue of federal pre-emption of state tort claims. And it has big implications for the industry.

The case, Mutual Pharmaceutical Co. v. Bartlett, turns on novel tort concept that’s being advanced by the trial bar called “design defect” claims.

In a nutshell, the allegation in a “design defect” claim is that a drug product was flawed from the very beginning – in other words, the drug’s risks always outweighed its benefits. In short, the plaintiffs in these cases are arguing that the drug should never have been marketed in a particular state. Not to mention, approved by the Food and Drug Administration in the first place.

If it sounds like the “design defect” legal theory puts state juries in the position of second-guessing FDA’s judgment in approving new drugs, that’s precisely the point.

Although this particular case involves a generic drug maker, the same claims are going to be filed against branded drug makers. If the trial bar is successful in the current case, this could be the next big area of product liability against drug makers.

Because the legal theory undermines the very heart of FDA’s mission and its mandate to weigh the risk and benefits of medical products, the Obama Administration has filed a brief in the case siding against the plaintiffs. This has put the Obama Administration on the record opposing an area of product liability and supporting the drug maker’s argument of federal preemption from these suits.

But the company involved in the current case is a generic drug firm. And before the branded drug makers think that brief puts the Administration on their side, too, they should read that brief closely. It goes to great lengths to provide a roadmap on how trial attorneys could mend future pleadings to satisfy the Administration’s concerns while advancing their novel tort theory against the branded drug industry.

 

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About the Author

 

Scott
Gottlieb
  • 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.


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