In 2004, when Bartlett was prescribed sulindac for shoulder pain, the drug's label did not specifically warn of the risk of “toxic epidermal necrolysis,” the clinical name for the group of devastating symptoms she experienced. In 2005, the FDA finished a review of the drug and recommended adding necrolysis to the packaging, but Bartlett had already begun experiencing the dangerous symptoms.
After a two-week trial, a jury found that Mutual violated New Hampshire's law against failure to warn consumers of drug defects. But two years ago, the Supreme Court ruled in PLIVA v. Mensing, that drugmakers cannot alter their warnings unless told to do so by the FDA, absolving the companies of liability for failing to disclose health risks. On Monday, the court ruled that is still true, even when state law would require a safety disclosure.
The situation with sulindac, it turns out, is not novel. A report by not-for-profit advocacy group Public Citizen this week finds that at least 53 drugs have had so-called “black box” warnings regarding serious health or safety side effects after a generic version was approved for sale by the FDA.
But while manufacturers of brand-name drugs can update their warnings and precautions when new potential risks are discovered, manufacturers of generic drugs must either petition the FDA to make a change or wait for the maker of the branded version to do so, since generic labels must directly mirror the branded equivalent drugs' warnings.
“Today a majority of prescriptions are filled with generics, and they are an important source of medicine for consumers. And it is a unique and unfortunate circumstances that the court, with the FDA's encouragement, has held that the generic industry is not held accountable for the labeling of their products,” said Allison Zieve, director of litigation group at Public Citizen.
The situation is especially worrisome, Public Citizen said, for the 434 drugs for which there are no branded versions on the market. The only way those drugs can have their labels amended is through the lengthy FDA label-change process, Zieve said.
On Monday, the court's left-leaning justices published two separate dissents in Bartlett v. Mutual. Justice Sonia Sotomayor wrote that Mutual could have chosen to withdraw its product from the New Hampshire market rather than face a situation where it could not follow state and federal law at the same time.
“From a manufacturer's perspective, that may be an unwelcome choice. But it is a choice that a sovereign state may impose to protect its citizens from dangerous drugs or at least ensure that seriously injured consumers receive compensation,” Sotomayor wrote.
But the court's majority found such reasoning unpersuasive, concluding that it contradicts a line of past Supreme Court decisions that say the Constitution's Supremacy Clause allows federal law to pre-empt state laws in such conflicts.
The trial-lawyers association American Association for Justice released a statement after Monday's opinion blasting the high court for letting the drugmaker “off the hook” for product safety.
“Today the U.S. Supreme Court issued another handout to the generic drug industry, shielding it from lawsuits for the design of their drugs at the cost of consumer safety,” the group said. “Despite lower court rulings in favor of Karen Bartlett that the drug she took is an unreasonably unsafe drug, SCOTUS sided with Mutual and decided that they cannot be held responsible for the design of their drugs.”
Officials with Mutual, which is owned by India-based Sun Pharmaceutical Industries, did not immediately return a call for comment Monday on the ruling.
Follow Joe Carlson on Twitter: @MHJCarlson