It's the kind of tragedy that leads to difficult legal decisions. A woman took a generic drug, prescribed by her doctor for an on-label use approved by the FDA. She developed a rare, but known, side-effect, and suffered serious permanent damage. Who's at fault?
The story in today's New York Times concerns Karen Bartlett of Plaistow, NH, who took sulindac. It's a pain killer in the NSAID category. The brand-name form, Clinoril, is made by Merck and was approved by the FDA in 1978. The generic sulindac was made by Mutual Pharmaceutical. Ms. Bartlett got Stevens-Johnson Syndrome. Her skin began to fall off. She was comatose for months and ended up legally blind, disfigured, barely able to walk, unable to work. Her life is basically ruined.
But there was nothing "wrong" with the drug; it was made correctly. The label warns of possible side effects. But the Supreme Court ruled a couple of years ago that generic drug makers cannot be sued for harm caused by drugs when the warning label was inadequate. Generic makers don't print their own labels -- the brand-name maker does that, and the generics have to copy it. But the brand-name drug didn't harm the patient. So in that case, the patient lost. In the Bartlett case, the label had a warning; the question is whether the generic maker gets the same protection in this case when the rare side effect occurs. Had she taken brand-name Clinoril, she would have won damages from Merck.
There are only two bad outcomes possible within the American legal and medical system as it exists. So the Times article, and the Court, are ignoring the elephant in the room.
If Ms. Bartlett wins the case, then generic drug makers will be held liable for labels that they do not control. This may discourage companies from making generic drugs, which are generally chemically identical to brand-name drugs but a lot cheaper. Generics are one of the few things that lower the cost of medical care. At least in some states, pharmacists are required to substitute generics for brand-name drugs unless the doctor specifically says otherwise, and insurance companies much prefer generics. (They aren't always quite identical, which is why substitution isn't always possible.) Drug shortages might even occur -- they are already happening in some generics. This would be a very bad outcome.
If Ms. Bartlett loses the case, then she and other patients who are harmed by drugs will be without recourse. This would often leave them damaged without the ability to support themselves, and with no one to sue for the damages, no one to pay their ongoing medical bills. This would be a very bad outcome.
Those are the two Sophie's choices, essentially whom do you kill? It is the sort of philosophical problem that serious journalists like to raise, and that lawyers like to discuss. It is also bullshit.
The two choices before the court are created by our medical system, which is designed to make profits for providers and insurers alike; it treats medical care as a discretionary product, like TV sets and vacation travel. And it's created by our legal system, which has to find fault with someone in order to recover for damages. The cost of the medical system is driven up by "defensive medicine", extra tests and procedures performed in order to avoid malpractice suits, but there are also bad doctors who need to be policed by the malpractice system that Republicans want to do away with. If the patient has medical insurance, then her insurance company has every incentive to sue the drug company, lest its costs be raised.
This case wouldn't happen in mos of Europe. Bad things happen there too. But a true universal health care system, one run for the public's benefit rather than for private profit, would simply cover the patient's medical needs for the rest of her life if necessary. Social insurance would cover her living expenses since she was disabled. If the drug company was truly at fault, they could be sanctioned. But if it's just bad luck -- one out of some huge number of patients has the bad reaction, but most patients are helped -- then drug regulators decide on whether or not a drug is worth the risk. It would be a balance, not a battle. The courts probably wouldn't even get involved.
That's why the two choices before our courts are so bad. We are all about profits and lawyers. Everything is about money. Nothing is about people. The business of America really is business, and to hell with the human collateral damage. Until we rethink our medical care system holistically, and not just patches to the private system, we'll still be stuck with these bad choices.