Supreme Court Expands Immunity for Big Pharma
Generic Drug Manufacturer Escapes Liability for Safety of its Drug
Washington, DC—The U.S. Supreme Court gave pharmaceutical companies another gift today, 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.
“I know of no other industry where the maker of a product has such limited responsibility for the safety of the product they make,” said American Association for Justice President Mary Alice McLarty. “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. She 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. Today the Supreme Court expanded that immunity. It is time for the FDA to address the huge disparity between generic and brand drug makers’ responsibility,” added McLarty.
Members of Congress (Senator Leahy and Senator Landrieu) have sent letters to the Food and Drug Administration, calling on the agency to address generic drug accountability. Public Citizen also filed a citizen petition asking the FDA to address the Mensing decision. AAJ filed comments in support of the petition.
Hundreds of cases have been dismissed because of the Supreme Court’s Pliva v. Mensing decision. Public Citizen issueda new report today highlighting how many potential hazards are not discovered until years after drugs have been on the market and the risk this poses to patients. Here you can see examples of real people that have been denied access to justice just because they took a generic drug.