The 5-4 ruling shields manufacturers from liability for the low-cost versions of brand-name prescription medicines.
The Supreme Court on Monday eliminated the last major avenue for consumers to seek damages for faulty generic drugs, giving manufacturers a broad shield from liability for the low-cost versions of brand-name prescription medicines.
In a 5-4 decision, the court tossed out a $21-million jury verdict won by Karen Bartlett, a New Hampshire woman who suffered horrible skin burns over most of her body and was nearly blinded after taking a pill to relieve shoulder pain.
The court majority conceded that the woman’s plight was tragic. But the justices said the Food and Drug Administration had approved the drug sulindac for sale and that federal approval trumped a state’s consumer-protection laws, under which she had sued.
“You go to the pharmacy, and in most states they substitute a generic drug for the name-brand drug because it’s cheaper. And when they do that, they wipe out your rights,” said Arthur Bryant, executive director of public interest law firm Public Justice.
The ruling creates an oddity in the law. People who are hurt by a brand-name drug can sue the maker for damages, the Supreme Court said in 2009.
But, with Monday’s ruling, the same is not true for those who take generic drugs, which account for about 80% of prescriptions written in the country.
Generic drug maker Mutual Pharmaceutical Co. Inc. argued successfully that the FDA had approved Clinoril, the brand-name drug, as safe and effective and that the company simply was selling a version of the same drug with the same formulation.
With the decision, the court now has handed down two rulings that have largely closed the door to lawsuits from people injured by generic drugs.
Monday’s decision, which applied to the design of a drug, followed a 2011 decision that shielded generic manufacturers from lawsuits for improper labeling.
Taken together, the rulings mean there now are “very few claims left that can be brought against generic drug manufacturers,” said James M. Beck, a lawyer with the Reed Smith law firm in Philadelphia who has represented drug makers.
The exception would be for a company that had a flaw in its manufacturing process, which is extremely rare, he said.
Allison Zieve, director of the litigation group at Public Citizen, another public-interest organization, said the court has gone down “a troubling path” on generic drugs.
“The decision expands the range of claims from which generic drug manufacturers are immune from liability, and in doing that, they go further along this road of creating an industry that has no accountability to consumers and responsibility for its products,” she said.
Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) and five other lawmakers wrote to FDA Commissioner Margaret Hamburg on Monday asking 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.
In a brief filed in January on the Bartlett case, the Justice Department said that the FDA was “considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances.”
FDA spokeswoman Sandy Walsh said Monday that the agency was reviewing the court decision and that while discussions were underway “it is premature to cite what changes in the regulations might be.”
But the FDA’s authority in the area is in question because federal law mandates that generic manufacturers use the same labeling and drug design as the brand name product, Beck said.
“The FDA can try, but they’d have an uphill battle, I think, given the language in the statute,” he said.
The generic drug industry painted the court’s decision as a win for most consumers because it will keep the price of generic drugs low.
Although the decision could be considered “a blow to individuals who may have been injured, the incidence of that is actually very low,” said Victoria Davis Lockard of the law firm Greenberg Traurig.
“If the case came out the other way, it would have been far more detrimental to average citizens,” she said.
Generic drugs rely on the research and testing of brand-name drugs, she said. If generic manufacturers were suddenly not allowed to piggyback on the work of the brand-name manufacturers, they would have to do years of their own research and testing.
“You just wouldn’t have generics,” Lockard said.
A spokesman for Mutual Pharmaceutical, now a subsidiary of Indian firm Sun Pharmaceutical Industries, could not be reached for comment.
Ralph G. Neas, president of the Generic Pharmaceutical Assn., an industry trade group, said the Supreme Court left decisions about drug safety with the FDA, not state courts.
“Millions of patients rely on drugs like sulindac, which has been on the market for more than 30 years,” he said. “Decisions with this much at stake belong in the hands of the scientific, public health and regulatory experts at the FDA.”
Bartlett took the non-steroidal anti-inflammatory drug at the direction of her doctor, and she had a rare, but severe, reaction. The skin on nearly two-thirds of her body burned away. She spent more than two months in the burn unit of a Boston hospital, and she was left with permanent injuries.
Bartlett sued Mutual Pharmaceuticals in state court. Her lawyers argued that sulindac was more likely than other similar pain relievers to cause the severe reaction that she suffered, known as toxic epidermal necrolysis.
A jury decided the pain pill was unreasonably dangerous. The company appealed, arguing that the verdict conflicted with federal law.
Bartlett’s situation was “tragic and evokes deep sympathy, but a straightforward application of preemption law requires that the judgment [in her favor] be reversed,” Justice Samuel A. Alito Jr. wrote for the court majority. Chief Justice John G. Roberts Jr. and Justices Antonin Scalia, Anthony M. Kennedy and Clarence Thomas agreed.
Dissenting, Justice Sonia Sotomayor said that “the court has left a seriously injured consumer without any remedy despite Congress’ explicit efforts to preserve state common-law liability.”
By David G. Savage, Jim Puzzanghera and Melanie Mason, Los Angeles Times June 25, 2013
