Generic Drug Side Effects Lawsuit News

Two years ago the Supreme Court unknowingly created a two-tiered system for the liability faced by drug makers. In Pliva v. Mensing, the court severely limited the conditions under which consumers of generic drugs could sue the manufacturers.
The court ruled that since makers of generic drugs did not have control over the content of warning labels, they could not be held liable for failing to alert patients to the risks of taking their drugs.
Now, the Supreme Court is set to decide a number of cases that challenge that earlier ruling.
At issue is a group of three consolidated cases brought by women who took the generic equivalent of Reglan for stomach ailments and developed a serious neurological disorder. Appeals courts ruled against the drug makers, saying that the federal regulatory regime did not block claims under state law.
If the makers of generics can’t be held liable, who can? The position of the generics is one in which they would be immune from liability for selling a product with inadequate warnings — even though the name-brand company selling the same drug with the same warnings would be liable.
That position would leave the women who were harmed by the generic version of Reglan with no recourse.
In another similar case heard by the court recently, Bartlett v. Mutual Pharmaceutical Company, defendant Karen Bartlett developed a rare but severe reaction to the anti-inflammatory drug Sulindac after a doctor prescribed it to treat shoulder pain in 2004.
Sulindac, similar to Ibuprofen, is in a class of drugs known as nonsteroidal anti-inflammatory drugs — or Nsaids — which are in widespread use and was approved by the FDA in 1978. Within weeks of taking the generic version of Sulindac, Bartlett developed toxic epidermal necrolysis, a severe form of a related condition called Stevens-Johnson Syndrome. The reaction permanently damaged her lungs and esophagus and rendered her legally blind.
Bartlett sued Mutual Pharmaceutical Company, which made the generic drug she took, arguing that the drug’s design was dangerous and defective. A jury in the Federal District Court in Concord, N.H., awarded her $21 million. An appeals court upheld the verdict.
Now Mutual Pharmaceutical Company has appealed the case to the U.S. Supreme Court, maintaining it can’t be held liable since it had no control over the drug’s warning label or design.
If the court agrees with Mutual and rules that generic companies cannot be sued for defective products, what recourse will patients have who were injured by a generic drug? Then the question becomes can a generic manufacturer be held liable for anything?
It is worth noting that currently 70 percent of prescriptions in the U.S. are being filled with generic drugs and of that number, a third of generics have no brand-name competitors.
If the Supreme Court rules in favor of the makers of generic drug in these cases, who will remain liable if the drugs harm patients?
Karen Bartlett is desperate to know the answer to that question.