Commentary by Zebersky Payne Shaw Lewenz, LLP
On June 24 of this year, the Supreme Court overturned the earlier ruling of Mutual Pharmaceutical Co. v. Bartlett, in which a woman from New Hampshire was awarded $21 million dollars in damages, after suffering a rare reaction to the generic drug, sulindac. MPC (Mutual Pharmaceutical Co.) is a subsidiary of an Indian drug maker, and the original drug, Clinoril, an Nsaid, was approved by the FDA in 1979.
The victim, Karen Bartlett was originally prescribed the drug by her doctor to alleviate shoulder pain that she had been experiencing. Within two weeks, she began to suffer the horrific side effects of Toxic Epidermal Necrolysis, a severe form of Stevens-Johnson Syndrome. Two-thirds of her skin fell off, her lungs and esophagus were left permanently damaged, and she is legally blind. She spent two months in a burn unit, and then two in a medically induced coma. Her quality of life has been severely impaired.
Generic drugs account for 80% of all drugs prescribed in the U.S., and thanks to the shortfalls of the FDA and the latest Supreme Court ruling, consumers are now at the full mercy of generic drug companies. The most recent ruling only further limits the available channels for consumers to engage in litigation. In Pliva v. Mensing the Supreme Court ruled that generic drug companies could not have control over what their warning labels said, and therefore could not be sued for failing to warn consumers about the dangers of their drugs. The victim in the sulindac case wasn’t arguing this point. The lawsuit was based on the fact that it shouldn’t have even been on the market, given that the company was aware of its inherent dangers.
In 1978, when the FDA approved Merck Pharmaceutical’s Clinoril, it did not yet have all of the information regarding potential side effects. It wasn’t until 2005 that stronger warnings were issued, but this came too late for Karen Bartlett. It is evident justice was not served in her case.
So who is to blame here? Is it the Supreme Court for ruling in favor of a pharmaceutical giant? The FDA for pushing through drugs without fully understanding their dangers? Or the drug makers themselves for knowingly selling a product that could have adverse effects? As consumers, we need to take extra precautions, because clearly the powers that be do not have our best interests at hand.
If you have been the victim of the pharmaceutical company, contact us today to discuss your options.