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When generic drugs harm patients, can’t count on FDA; lawsuits play role

When generic drugs harm patients, can’t count on FDA; lawsuits play role

By Claire Prestel, Staff Attorney

On Tuesday the U.S. Supreme Court will hear argument in a case called Mutual Pharmaceutical Co. v. Bartlett, which will decide whether generic drug makers can be held responsible for the harm their products cause. Public Justice joined an amicus brief filed by the American Association for Justice because this case presents a critical access to justice issue for millions of American patients: the Supreme Court will decide whether patients injured by generic drugs can recover from the profitable drug companies that caused them harm, or whether the drug makers can force patients to bear all the costs of their drug-caused injuries.

The facts in the Bartlett case are tragic and help show why the issues are so important and the drug makers’ arguments so troubling. The plaintiff is a former secretary named Karen Bartlett. Ms. Bartlett visited her pillbottlesdoctor in 2004 to seek treatment for shoulder pain, and her doctor prescribed a drug known generically as sulindac and manufactured by Mutual. 

Sulindac caused Ms. Bartlett to develop a terrifying condition called Stevens-Johnson Syndrome/toxic epidermal necrolysis (SJS/TEN). Sixty to sixty-five percent of the surface of Ms. Bartlett’s body deteriorated, burned off, or turned into an open wound. She survived but is severely disfigured, has a number of physical disabilities, and is nearly blind. 

Ms. Bartlett sued Mutual for some of her damages, and after hearing evidence that sulindac is more likely to cause SJS/TEN than any other pain medication in its category, and that sulindac is no more effective than similar drugs, a New Hampshire jury found Mutual liable. The jury decided that sulindac is “unreasonably dangerous” because its risks outweigh its benefits.    

Like the jury (and me), you may think this sounds like a pretty straightforward case. But on Tuesday, Mutual will argue to the Supreme Court that Ms. Bartlett should recover nothing, and should never even have been allowed to get to a jury, because federal law gives the company complete immunity. Mutual’s theory is that the jury held it liable under New Hampshire law for failing to change sulindac’s “design” and that Mutual can’t change the design because federal law requires it to make sulindac just like its brand-name counterpart. 

Mutual’s arguments are wrong, illogical, and deeply troubling as a matter of public policy. The drug company’s arguments are wrong for all the reasons given in Ms. Bartlett’s brief, but most obviously because the jury held Mutual liable for selling an unreasonably dangerous drug, not for failing to change the drug’s design. 

Mutual’s arguments also seem illogical: Under the drug company’s theory, you would think New Hampshire could impose a stricter rule — requiring every drug company to pay every patient who experiences a side effect. That rule wouldn’t even arguably have to do with drug design, so it couldn’t run afoul of the federal law Mutual cites. And if federal law allows absolute liability, how can it logically preempt New Hampshire’s narrower, unreasonably dangerous rule? 

The policy implications of Mutual’s immunity argument are also deeply troubling. For one thing, if Mutual is immune from liability, then even though it sold the drug that caused Ms. Bartlett’s injuries and (presumably) profits from the drug’s sale, it won’t have to contribute a dime toward Ms. Bartlett’s costs. For another, if drug companies like Mutual are immune from liability, then they won’t have the same incentive to examine their drugs’ dangers and take those dangers seriously. As the New York Times stated in its editorial about the case, we need lawsuits “as deterrents to negligence or wrongdoing.” 

In case you’re wondering why the Food and Drug Administration can’t take care of safety, sulindac’s story provides some good answers.

FDA reviewed data related to sulindac back in 1978, when it approved the drug’s branded version. The studies available then indicated that the drug’s side effects were “relatively mild.” Data about the SJS/TEN risk accumulated only after FDA approval, and it took years for the under-resourced FDA to realize what was happening. The agency didn’t recommend a stronger warning until 2005, after Ms. Bartlett was injured and more than 25 years after the drug was first approved. 

The reality is that FDA can’t do all the work of surfacing drug risks alone. Lawsuits play an important role. They help bring risks to FDA’s attention and force drug companies to internalize some of the related costs so that they take the risks seriously. 

We need lawsuits and a strengthened FDA. Let’s hope the Supreme Court sees it the same way.