Sulindac is the generic name for Clinoril, a drug similar to ibuprofen.
Like ibuprofen, Sulindac is in a class of drugs known as Nsaids (Nonsteroidal
In 2004, Ms. Karen Bartlett was prescribed Sulindac by her doctor to treat
shoulder pain. In less than two weeks, Ms. Bartlett’s skin began
to slough off. After spending two months in a burn unit and months more
in a medically induced coma, she awoke to permanent lung damage, permanent
esophagus damage and is now legally blind.
“I wouldn’t want anybody to go through what I went through.
It was horrible, and the medication that I took, Sulindac, I don’t
think it should be prescribed.” said Ms. Bartlett
In 2010, Ms. Bartlett sued Mutual Pharmaceutical Company, the manufacturer
of the generic drug Sulindac and was awarded $21 million U.S. dollars
by jury. This month, the Supreme court, will hear arguments on whether
Mutual Pharmaceutical Co. can be held responsible for Ms. Bartlett’s injuries.
A Supreme Court decision last year said that companies did not have control
over what their labels said, therefore, could not be sued for failing
to alert patients about the risks of taking their drugs. However, Ms.
Bartlett’s case is different, she is not arguing that the drug’s
warning label was inadequate, she is claiming that the drug itself was
Mutual Pharmaceutical Co. is contending that the rationale is the same
since, like the label, it has no control over the drug’s design.
Under federal law, generic drug companies can not deviate from the brand-name
drug they are copying. Mutual Pharmaceutical Co. is also appealing the
decision by the U.S. Court of Appeals that upheld the jury verdict.
It would appear that if the court finds that generic companies cannot be
sued for defective products, agreeing with Mutual Pharmaceutical Co.,
it would leave patients with few options if they are injured by a generic
drug. In spite of that, manufacturers of generic drugs have said that
if the court sides with Ms. Bartlett, it could potentially lead drug manufacturers
to remove valuable medicines from the market.
To Ms. Bartlett, it does not make a difference which drug manufacturer
made the drug, “I think the generic companies, as well as brand-name
companies, should be held accountable for the medicines that they put
out there.” she said.