The Supreme Court heard oral arguments on Tuesday, March 19 in Mutual Pharmaceutical Co. v. Bartlett, one of a series of cases this term the outcome of which could have a significant impact on public health.The case, closely watched by pharmaceutical companies, regulators and lawyers, could determine the extent to which individuals can hold generic drug manufacturers liable for injuries allegedly caused by their copycat products. During a one-hour oral argument justices questioned whether federal law, in this case the requirement that generics have same design as the name-brand version, prevents plaintiffs from making such claims under state law. Some justices signaled concern about juries making sweeping judgments about the effectiveness of drugs while others questioned how to differentiate the case from another case involving generics decided in 2011.
Ms. Bartlett, who lives in Plaistow, N.H., developed a rare but severe reaction to the anti-inflammatory drug sulindac after a doctor prescribed it to treat shoulder pain in 2004. Within weeks of taking the drug, her skin began to slough off until nearly two-thirds of it was gone.
Karen’s legal team argued sulindac was unreasonably dangerous compared to similar drugs. Lower courts concurred, awarding Karen $21 million in damages for her injuries. Mutual argued it is only making a copy of the brand drug, and therefore it has no legal responsibility for its design or safety.
Justice.org:Patient Safety at Risk with Mutual v. Bartlett
Karen’s condition resulted in her spending months in a burn unit in a medically induced coma, covered in gauze because her skin would stick to any fabric it touched, resulting in over 60 percent of her skin peeling off. She had 13 eye surgeries, numerous cornea implants, and now has trouble walking as far as out to her own mailbox. She cannot drive, read, or eat as she once did. She is lucky to be alive.
Under federal law, generic companies are not allowed to deviate from the brand-name drug they are copying. Sulindac is the scientific name for Clinoril, a drug similar to ibuprofen that was approved by the Food and Drug Administration in 1978 and is sold by Merck. Like ibuprofen, sulindac is in a class of drugs known as nonsteroidal anti-inflammatory drugs or Nsaids, which are in widespread use.
Mutual appealed a decision by the United States Court of Appeals for the First Circuit, in Boston, that upheld the jury verdict and argued that even if Mutual could not have changed the drug’s design, it had no obligation to continue selling a defective product and could have taken the drug off the market. Mutual is a subsidiary of Sun Pharmaceutical of India.
Interest groups on both sides say any decision could have serious consequences. If the court agrees with Mutual and rules that generic companies cannot be sued for defective products, patients will be left with very few options if they are injured by a generic drug.
But manufacturers of generic drugs and other business groups have said that if the court sides with Ms. Bartlett, the decisions of individual juries could trump the authority of federal agencies like the Food and Drug Administration and potentially lead drug makers to remove valuable medicines from the market. The federal government has sided with with the generic drug makers in this case even though it opposed the industry in the Mensing case.
A decision from the Court is expected this summer.