Generic Drug Immunity Redux

Karen suffered “hell on earth” because of a generic drug, according to her burn surgeon.  Is the maker immune from responsibility?    

Last week the Supreme Court agreed to hear a case that could have an impact on those who are injured after taking a generic drug.

The new case involves the heartbreaking story of Karen Bartlett, a young active woman who in 2005 developed Stevens-Johnson Syndrome and related injuries that caused over 65% of her skin to burn off.  A drug called sulindac, the generic form of the pain medicine Clinoril, caused Karen’s suffering.  A doctor had prescribed it to help Karen with some minor shoulder pain. 
 
Karen is now living with its terrible effects.  Today she is legally blind, cannot read or drive, and is severely disfigured in her face and body.  She is lucky to be alive after spending more than 100 days in five hospitals including 70 days in a burn unit, more than a month of which she was placed in a hospital-induced coma.  After that she had to be tube fed for a year.


In March, Karen’s case will go before the Supreme Court where it will decide if Mutual Pharmaceutical, the maker of Karen’s drug, can be held responsible for her life-altering injuries.  Lower courts affirmed the jury’s verdict that sulindac’s  risks outweighed its benefits, calling it “unreasonably dangerous.”  But the generic drug maker appealed and now it’s in the hands of a Supreme Court that has already given immunity to the generic industry on cases where they failed to warn patients of a drug’s side effects. 
 
Eighty percent of all consumers take generic drugs, either by choice or because of insurance requirements.  The problem is what happens when a drug causes an unfortunate injury like Karen’s?  Who is responsible for that and the resulting medical bills? 
 
We only need to look at Kira to see thousands of people that have lost their right to justice after being injured by a generic drug when the U.S. Supreme Court ruled against Gladys Mensing in a case called Pliva v. Mensing.  The Court held that because a generic maker follows the brand drug’s label, the generic company cannot be held responsible when the generic drug fails to warn about an injury.

We will be watching the case of Karen Bartlett closely as it progresses.  There is a lot at stake for consumers.