The Alabama Supreme Court ruled Friday that brand-name drug makers can be held liable for warnings on a generic version of the company’s medication made by another company. The case, which was originally filed in federal court by Danny and Vick Weeks, alleged that Mr. Weeks suffered injuries from use of the prescription drug metoclopramide, which is the generic form of the brand-name drug Reglan. Reglan is used to treat nausea, vomiting, loss of appetite, heartburn, and early satiety (feeling of fullness).
The Weeks claimed that the warning labels on the generic drug failed to sufficiently inform the prescribing physicians of potentially hazardous side effects, such as tardive dyskinesia (involuntary muscle movements and tics). Under the Erie doctrine, the federal court would have applied Alabama products liability law.
The federal judge hearing the Weeks’ case asked the Alabama Supreme Court to clarify Alabama state law on the question of whether the brand-name manufacturers could be held responsible for fraud or misrepresentation. In 2013, the Alabama Supreme Court said the couple could sue brand-name makers. The Court reasoned that “an omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product.”
The Court faced much criticism from business interests, particularly Wyeth, which made Reglan, and the Business Council of Alabama. The defendant companies asked the court to reconsider. When the all-Republican court agreed to reconsider, many anticipated that it would reverse its 2013 decision. However, the justices issued a second opinion last week withdrawing the 2013 decision but nonetheless reaching the same result.
In an opinion written by Associate Justice Michael Bolin, the court said that it is not unfair to hold the maker of a brand-name drug liable for warnings on a generic medication if the maker of the generic drug only copied warnings first issued by the brand-name manufacturer, a practice permitted by the U.S. Food and Drug Administration. The justices emphasized that the products liability ruling applied only to a specific set of facts involving a product subject to heavy regulation by the federal government.
While I beleive that this decision is flawed, it represents the only path to justice for patients like Mr. Weeks. In 2011, the United States Supreme Court ruled in Pliva v. Mensing that a generic drug manufacturer could not be held liable for providing defective side effect warnings because such generic manufacturers were required by federal regulation to match the brand name drug’s label. After this decision, consumers who were forced by their health insurers to use generic drugs (which is over 80% of consumers), had no remedies for injuries or death caused by the defective drugs. Indeed, many women who suffered femur fractures as a result of generic Fosamax are currently facing dismissal of their cases.
I believe that the Mensing decision has resulted in bad law. Manufacturers should be personally responsible for their products, not a competitor’s product. When the patent for drugs like Reglan or Fosamax expires, generic pharmaceutical companies take all of the benefits of the brand-name drug manufacturer’s work and simply sell the drug under a new name. If the generic drug company is not going to study the safety and efficacy of its own product, then it should be liable for any defects in that product. The problem is that the U.S. Supreme Court has granted generic manufacturers legal immunity from liability, which allows them to reap all of the profits from another company’s drugs without taking any of the risks if the product is defective.
In a truly free market, Wyeth would be liable for injuries caused by the used of brand-name Reglan, and the manufacturer of metoclopramide (generic Reglan) would be responsible for injuries caused by the use of metoclopramide. Wyeth does not profit from the sale of metoclopramide. The seller of metoclopramide is Wyeth’s competitor. Congress should legislatively reverse Mensing to introduce rationality into the drug market. Manufacturers of generic drugs should stop getting a free ride.