Generic Drug Sulindac Causes Toxic Epidermal Necrolysis

Sulindac | RxRecall | the maher law firm | frank eidsonSulindac is the generic name for Clinoril, a drug similar to ibuprofen.  Like ibuprofen, Sulindac is in a class of drugs known as Nsaids (Nonsteroidal Anti-inflammatory) drugs.

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 defective.

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.

Bookmark and Share

Comments are closed.