Editorial from today's edition of The Washington Post:
Editorial Board Opinion
High court highlights a gap in drug safety regulation
GLADYS MENSING’S doctor prescribed the brand-name drug Reglan to treat a gastrointestinal problem. When the Minnesota resident went to fill the prescription, the pharmacist — as he was compelled to do in Ms. Mensing’s state — dispensed a cheaper, generic version of the drug.
Ms. Mensing now suffers from tardive dyskinesia, an irreversible neurological condition linked to the drug and characterized by “grotesque involuntary movements of the mouth, tongue, lips, and extremities, involuntary chewing movements, and a general sense of agitation.” Ms. Mensing sued the manufacturer under a state law for failing adequately to warn of this potentially severe side effect.
Last month a 5-4 majority of the Supreme Court threw out her case. The reason: She used the generic version of the drug. Had Ms. Mensing suffered the same harm after consuming the brand-name drug, her case would have been allowed to proceed.
The majority, led by Justice Clarence Thomas, had valid reasons for its decision, but even Justice Thomas admits the result “makes little sense.” We would go further: The result is a dangerous one that exempts some 75 percent of the drugs dispensed in this country from essential safeguards. This situation should be rectified — and quickly — through federal regulation.
Risks associated with long-term use of Reglan and its generic version were long known, but neither the brand-name nor the generic version carried a “black box” warning — the most serious kind — until years after Ms. Mensing began using the product. Ms. Mensing sued the generic’s manufacturer under a Minnesota law that dictates that “where the manufacturer . . . of a product has actual or constructive knowledge of danger to users, the . . . manufacturer has a duty to give warning of such dangers.” She argued that the generic drug’s maker should have changed its label to reflect heightened risks.
But federal law foreclosed this possibility. Brand-name producers are typically the first to be alerted to adverse affects of their products and are allowed to — and in some instances are obligated to — make unilateral changes to warning labels. Generics producers, on the other hand, do not enjoy such flexibility — or responsibility — and are tasked only with parroting the brand-name’s warning labels. The court concluded that federal law required dismissal of Ms. Mensing’s suit since it was “impossible” for the manufacturer to comply simultaneously with the state and federal rules.
Writing for the four dissenters, Justice Sonia Sotomayor correctly noted that “as a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug.”
This should not stand. The Food and Drug Administration should require manufacturers of generic drugs to track adverse effects and reach out to the FDA to initiate label changes to reflect new or heightened dangers. A fair right to sue is important, but even more so would be compelling full disclosure so that patients are not harmed in the first place.
