This month, the US Supreme Court will hear arguments in the case of a woman who suffered the gruesome skin reaction toxic epidermal necrosis (TEN) after taking a generic form of sulindac, a mild non-steroidal anti-inflammatory drug (NSAID). The case, Bartlett v. Mutual Pharmaceutical Company, Inc, follows up on 2010’s Pliva v. Mensing decision, which protected generic drug manufacturers from failure-to-warn lawsuits. The Supreme Court has the opportunity to either clarify the circumstances under which a generic drug manufacturer may be sued for pharmaceutical injuries or extend a blanket protection against lawsuits.
By no means should the Supreme Court give additional protections to generic drug manufacturers. They should allow defective product lawsuits against manufacturers of generic drugs.
Court Should Not Make a General Generic Preemption Rule
In the circuit court decision under review, the judges noted that disallowing defective design claims would essentially grant full protection to generic drug manufacturers under the cover of federal preemption. After all, if lawsuits cannot be brought on the basis of a failure to warn claim or on the basis of a defective design, on what basis could they be brought?
Making a general preemption rule would contradict the findings of Wyeth v. Levine (2009), in which the Supreme Court decided that the Food, Drug, and Cosmetics Act (FDCA) and its amendments were never intended to completely prevent state-based tort claims. The Supreme Court said these lawsuits play an important role in helping to ensure the safety of drugs on the market. Since generic drugs make up to 80% of all prescriptions filled in the US, preempting lawsuits against their manufacturers would dramatically undermine the function of these claims.
Manufacturers Have a Responsibility to Ensure Safety of Product
For at least a century of product liability lawsuits, the Court has asserted that manufacturers have the ultimate responsibility to ensure the safety of the products they make and sell. If the Hatch-Waxman amendments to the FDCA limit the discretion a generic drug manufacturer has in the composition of the drug or its label, there is still nothing in them that says a manufacturer has to manufacture a particular drug. A manufacturer considering marketing a generic drug has to consider, among other things, whether the safety risks associated with a drug make it one they should manufacture and market.
Mutual Pharmaceutical Company claims that because it did not design the drug, it cannot be held responsible for defects in its design. However, how is this different from a car manufacturer who does not design—or even manufacture—all of the components that go into its vehicle, but still has a responsibility to evaluate the safety of those components to ensure the safety of the final product? (See, for example, Macpherson v. Buick (1916).)
Allowing Claims Ensures Effectiveness of Lawsuits
In a market-based medical system like ours, lawsuits play an important role in evaluating the overall usefulness of drugs. They allow us to weigh the value of a drug to patients that take it, measured by the total value of prescriptions sold by the manufacturers, against the harm a drug does to individuals, measured by the verdicts and settlements in pharmaceutical injury cases. If a drug provides more good than harm, the drug will remain profitable for both name-brand and generic manufacturers. If a drug is more harmful than good, it will cease to be profitable and will leave the market without the need for the FDA to act.
Protecting generic drug manufacturers from lawsuits will keep dangerous drugs on the market long after we have become aware of the dangers they pose. Often, as in the case of sulinac, safer alternatives exist, and by culling the dangerous ones, we will be left with a better selection of treatments.
Allowing Claims Protects Name-Brand Manufacturers
Protecting generic drug manufacturers from design defect claims will encourage courts to decide name-brand manufacturers should pay for injuries caused by generic drugs. After all, who wrote the label that carried inadequate warnings? The name-brand manufacturer. And who designed the drug that was deemed to be defective? The name-brand manufacturer.
We need name-brand manufacturers to continue spending money on research and development of new drugs, and protecting generic drug manufacturers could end that. After all, who would spend the money to develop a new drug if they will not only lose patent protection on it and be forced to compete with generic alternatives—they will have to pay court losses for those generic alternatives?
A name-brand manufacturer would not even be able to protect itself by ceasing production on a drug—it is still at risk as long as generic manufacturers decide to keep making a drug that they designed and labeled.
For all these reasons, the Supreme Court should affirm the well-considered and excellently written decision of the United States District Court of New Hampshire.