Mutual Pharmaceutical v. Bartlett Lawsuit

Mutual Pharmaceutical v. Bartlett Lawsuit
This week, in a far-reaching decision, the U.S. Supreme Court demonstrated once again that pro-business decisions are defining the Roberts court.
In a case involving Philadelphia’s Mutual Pharmaceutical Co., the court split 5-4 along the traditional conservative-liberal line to award a victory for the drug industry and, indirectly, the U.S. Food and Drug Administration. The court ruled that federal law related to pharmaceutical regulations preempts a person’s ability to sue in state courts and allege that a generic drug is designed badly.
The generic drug industry, which accounts for almost 80 percent of the U.S. market, now has a blanket exemption from liability. The ruling means that consumers who take name-brand drugs can sue for damages, but consumers who take a generic version of the same drug can’t sue
This ruling came from the case of Mutual Pharmaceutical Company v. Bartlett. Karen Bartlett suffered a rare, severe skin reaction three weeks after starting therapy with a generic version of the pain reliever Clinoril. She is now legally blind. She claimed not only that Mutual didn’t adequately warn of its drug’s dangers, but also that the product was defective and shouldn’t have been sold. A jury awarded her $21 million for her injuries. Mutual Pharmaceuticals argued that the product and its label were FDA-approved and that those approvals preempt Bartlett’s state-court claims.
The conservative majority wrote that Bartlett’s situation was “tragic and evokes deep sympathy,” but said the law requires that the judgment of the lower court be reversed.
Business decisions by the Supreme Court are almost always overshadowed by cases on controversial social issues. But the business docket reflects something truly distinctive about the court led by Justice John G. Roberts Jr. Studies have shown the current court over all is only slightly more conservative than the courts led by Justices Warren E. Burger and William Rehnquist. Business decisions have been far friendlier to business than any court since at least World War II.
Since the Bartlett decision, Senate Judiciary Committee Chairman Pat Chairman Patrick Leahy (D-Vt.) and five other lawmakers wrote to FDA Commissioner Margaret Hamburg and asked her to rewrite regulations so people can sue generic drug manufacturers for injuries.
“A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug,” Leahy said.
While the FDA has indicated they will review the court decision, given the language of the federal statute, it is unlikely they will be able to change the regulations. Past rulings by the agency have been unusually favorable to generic drug manufacturers.
But what remains most troubling in the Bartlett ruling is that the court has stripped consumers of their 7th Amendment rights to access the court and allowed a multi-billion dollar industry to operate without impunity over the consumers they serve.