Thornton Law Firm LLP on Jul 29, 2013 7:23:00 AM
In a 5-4 decision, last month, the Supreme Court of the United States ruled that generic drug manufacturers are shielded from lawsuits arising from adverse side effects caused by their drugs. From now on, only ‘branded’ drugs manufacturers can be held liable for failure to appropriately warn against potentially harmful side effects.
By so ruling, the Court ruled in favor of the defendant, nullifying a $21M award to a woman who had developed Stevens-Johnson syndrome and suffered grave burns after taking a generic anti-inflammatory drug.
This decision, Mutual Pharmaceutical v. Bartlett, reaffirming the Court’s 2011 Pliva v. Mensing decision that held that only pharmaceutical laboratories might be sued for failure to appropriately warn against potentially harmful side effects of their branded drugs, not the manufacturers of cheaper generic drugs.
Writing for the majority, Justice Samuel Alito indicated that it was a difficult decision, mentioning the “tragic”circumstances of the patient, who was “permanently disfigured, physically handicapped and legally blind”. But Justice Alito estimated that it was impossible for Mutual or other manufacturers to conform at the same time to State law (in New Hampshire), and to Federal law, which simply requires that a generics manufacturer copy the branded drugs’ label warnings.
The impact of this decision is substantial, as over 80% of prescribed drugs are generics. This is a decision that leaves very little legal recourse for people harmed by drugs. Moreover, long-term (and potentially harmful) side effects of drugs are not necessarily known when a drug is first approved for the market. There is mounting evidence that generic drugs are not exact copies, but approximations of the original, branded drug, and are often manufactured overseas, where inspections to ensure that the manufacturer follows proper manufacturing regulations are harder to conduct.
The plaintiff in this case is Karen Bartlett, who developed a rare but extremely severe reaction after taking a prescribed generic version of the non-steroidal anti-inflammatory drug sulindac for pain in her right shoulder. She suffered horrific burns to over 60% of her body, causing her body to become an open wound, spent months in medically-induced coma, and has been left nearly blind and with permanent damage to her lungs and esophagus. She will require care for the rest of her life. A lower New Hampshire Appellate Court had ruled that Mutual Pharmaceutical should have abstained from producing the drug, and had awarded Bartlett damages totaling $21M.