The U.S. Supreme Court gave pharmaceutical companies another huge gift on June 25th, largely shielding the generic industry from lawsuits for the design of their drugs. This is the second Supreme Court decision giving the generic drug industry immunity. In 2011, the Court decided generic makers cannot be held responsible for failing to warn about a drug’s side-effects, saying the generic maker is only making a “copy” of the brand drug and must follow the brand drug’s label. American Association for Justice President Mary Alice McLarty had this to say:
I know of no other industry where the maker of a product has such limited responsibility for the safety of the product they make. Over eighty percent of drugs dispensed are generic; the manufacturers must be held responsible for their drugs’ harmful effects.
The case (Mutual Pharmaceutical v. Bartlett) is about Karen Bartlett, a woman who permanently suffers from Stevens-Johnson syndrome after taking the generic drug sulindac for shoulder pain. The disease left Karen nearly blind and caused over 60% of her skin to burn off. She spent months in a coma and a year being tube fed. Karen is permanently disfigured and will need care for the rest of her life.
Two lower courts in New Hampshire ruled sulindac is unreasonably dangerous and awarded Karen $21 million. The Supreme Court’s decision nullifies those rulings. It has been two years since the Supreme Court granted generic drug companies immunity for their drugs’ warning labels in Pliva v. Mensing. The Supreme Court has now expanded that immunity.
It’s essential for the Food and Drug Administration to address the huge disparity between generic and brand drug makers’ responsibility. Senators Patrick Leahy and Mary Landrieu have sent letters to the FDA, calling on the agency to address generic drug accountability. Public Citizen had previously filed a citizen petition, asking the FDA to address the Mensing decision and the group will join in with the current request.
Hundreds of cases have been dismissed because of the Supreme Court’s Mensing decision. Public Citizen has issued a new report highlighting how many potential hazards are not discovered until years after drugs have been on the market and the risk this poses to patients. People who have been injured and damaged have been denied access to justice just because they took a generic drug. Does anybody believe that the public’s health and safety will benefit from what the Supreme Court has done? The drug industry has to be still celebrating with this undeserved win. Hopefully, the public outrage over what the court has done may be enough to make this a short-lived victory.
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