The Supreme Court highlights a hidden cost of generic drugs

At least three times this week, the Supreme Court has punched a hole in the protections that Americans have come to expect from the government or the courts. In at least one of those cases, though -- the one involving a generic drug that maimed a patient in New Hampshire -- the court appears to be taking a policy Congress adopted to its logical conclusion.

The justices periodically interpret a statute or constitutional provision in an unexpected way, leaving Americans seemingly without legal remedies. A good example is the 2007 decision in the lawsuit that Lilly Ledbetter brought against Goodyear Tire and Rubber Co. after years of receiving less pay than male employees who held similar jobs in the company. The ruling barred workers from bringing such lawsuits more than six months after their employer began paying discriminatory wages, even if it took them that long or more to find out that they were being victimized.

Congress responded in 2009 by amending the pay discrimination statute to restore the ability of workers like Ledbetter to win back pay.

And two of this week’s decisions -- nullifying a portion of the Voting Rights Act and immunizing employers from liability for the harassment done by some supervisors -- are sure to prompt lawmakers to try to plug the gaps the court created. (Although, truth be told, the chance of them succeeding seems slim in this Congress.)

The ruling that threw out Karen Bartlett’s legal victory over Mutual Pharmaceutical Co. would seem to fall into the same category. To treat Bartlett’s shoulder pain, her doctor prescribed the anti-inflammatory medication Clinoril. Her pharmacist substituted the generic version of the drug (sulindac), which was made by Mutual. After taking the drug, however, Bartlett experienced what Justice Samuel A. Alito Jr. described as “horrific” injuries.

“Sixty to sixty-five percent of the surface of [Bartlett’s] body deteriorated, was burned off, or turned into an open wound,” Alito wrote in the majority opinion. “She spent months in a medically induced coma, underwent 12 eye surgeries, and was tube-fed for a year. She is now severely disfigured, has a number of physical disabilities, and is nearly blind.”

Bartlett sued, claiming that Mutual violated New Hampshire law by selling an unreasonably unsafe product. A jury awarded her more than $21 million, and after Mutual appealed, the U.S. 1st Circuit Court of Appeals affirmed the verdict.

Split 5 to 4, the justices held that the federal law governing generic drugs pre-empted state laws like New Hampshire’s. To avoid being held liable for a drug found to be unreasonably dangerous, Alito wrote, Mutual would have to change the drug’s chemistry or the warnings on its label -- either of which would violate federal law, which requires generic-drug makers to duplicate the design and warnings of their brand-name counterparts in order to obtain speedier approval.

“Federal law prohibited Mutual from taking the remedial action required to avoid liability under New Hampshire law,” Alito declared. “Because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law, New Hampshire’s warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce.”

That’s the choice Congress made, not the courts. One of the main reasons generic drugs are so much more affordable than brand-name equivalents is that their manufacturers don’t have to conduct extensive safety and effectiveness tests to win the Food and Drug Administration’s approval. Instead, they make drugs with identical active ingredients, dosage levels and warnings as their brand-name predecessors, and piggyback on the tests that the brand-name drug maker conducted.

Such tests may not expose all the serious harms that a drug can cause, so manufacturers are required to report new problems as they discover them. And if a brand-name drug is eventually found to have inadequate warning, the manufacturer of that drug can be held liable under state law, the Supreme Court ruled in Wyeth vs. Levine in 2009. Had Bartlett been taking Clinoril and suffered the same injuries, her right to sue would have been clear.

(According to Alito, the warning label for sulindac cautioned users about the possibility of “severe skin reactions” and “fatalities” at the time it was prescribed to Bartlett. And the package insert specifically warned about the chance of experiencing the two gruesome adverse reactions that she suffered, Stevens-Johnson Syndrome and toxic epidermal necrolysis. But after the FDA completed a review a few years later, it called on makers of sulindac and all other non-steroidal anti-inflammatory drugs to warn more explicitly about the risk of toxic epidermal necrolysis.)

The appeals court held that Mutual’s duty was to pull sulindac from the shelves when it proved to be unreasonably dangerous. But that’s going too far, Alito wrote. “Our pre-emption cases presume that an actor seeking to satisfy both his federal and state law obligations is not required to cease acting altogether in order to avoid liability,” he wrote.

In a stinging dissent, Justice Sonia Sotomayor wrote that the majority was abandoning the principle that federal and state laws operate “in tandem to promote consumer safety.” Congress gave consumers no power under federal law to sue drug manufacturers, Sotomayor wrote, because lawmakers believed state law would do so.

“Tort suits can help fill the gaps in federal regulation by ‘serv[ing] as a catalyst’ to identify previously unknown drug dangers,” the justice wrote. “Perhaps most significant, state common law provides injured consumers like Karen Bartlett with an opportunity to seek redress that is not available under federal law.... While the court has not always been consistent on this issue, it has repeatedly cautioned against reading federal statutes to ‘remove all means of judicial recourse for those injured’ when Congress did not provide a federal remedy.”

That’s apparently what the court is doing with the Bartlett decision. And yet Congress charted this path when it gave drug makers a shortcut onto the market for generic drugs. If that’s not where lawmakers meant to go, they’ll need to come up with a new approach to generic-drug approval and regulation that allows injured parties to challenge medicines they believe to be unreasonably unsafe without putting manufacturers in a Catch-22.

Otherwise, with generics making up about 80% of the drug sales in the United States, we’re likely to see more Karen Bartletts -- people grievously injured by an unsafe product but unable to hold anyone responsible. And if that’s the way we’re headed, lawmakers should consider creating a fund to compensate victims like her.

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