Bad Law Leads To a Bizarre SCOTUS Outcome
In 2008, the Supreme Court ruled that a Vermont woman who had her hand and forearm amputated because of gangrene after being injected with a brand name antinausea drug could sue the manufacturer for inadequate warning of the risks; she won $6.8 million from Wyeth.
In 2011, the court ruled that similar failure-to-warn suits could not be brought against makers of generic drugs. As a result, an Indiana woman who was also forced to have her hand amputated because of gangrene after being injected with a generic version of the same antinausea drug had her case dismissed.
Same drug. Same devastating health consequences. Opposite results.
Full editorial in the New York Times.
Although I’m not a fan of malpractice litigation that rewards patients for every adverse outcome, I find it somewhat strange that the makers of generic drugs cannot communicate information to patients about the generic drug. In this case, the maker of the generic version was not allowed to warn the patient unless the brand manufacturer also had warning label.
This is strange.
There are other possible remedies than those discussed in the Times, which is typically outraged at the the injustice of not being able to sue: The woman injured by the generic drug (assuming she should have been able to sue over this issue at all) could have sued the brand name drug manufacturer for not changing the label the generic drug manufacturer HAS TO USE.
Is this all due to flawed rule making at the FDA? Sounds like it.
The different outcomes are only strange because we have a heavily regulated third party payer system for drugs and health care and patients are not part of the contractual purchase negotiations. The individual harmed did not get to choose generic versus branded. Generics are cheaper and the usual assumption is that is due only to R&D, patent and manufacturing costs, but legal rights are also part of the price. Additionally, normal commercial transaction legal rules about warranties, etc., do not apply to most of health care.
For example, using a non-medical situation of construction, a homeowner can hire an insured or uninsured contractor; demand that the contractor increase the amount of his liability insurance; demand the contractor purchase a performance and completion bond; demand that everyone on the job be experienced and licensed and so forth. The above-mentioned items will increase the cost of the job, but will allow a homeowner to sue successfully for damages. It is the homeowner’s choice whether to pay more and get a contractor that can pay damages in a lawsuit or not. Many homeowners choose to pay less and forego the additional insurance benefit. Large companies and governments tend to pay more to have the additional insurance benefits.
Our regulated third party health care system removes the price versus benefit discussion from the patient and focuses only on cost without consideration of the lost social benefits to the consumer, such as the right to sue and many other intangible benefits.
Pure insanity.
When I saw that Henry Waxman of CA had co-authored the law, I understood perfectly.
Neither the editorial nor the article it cites get the story quite right. The issue in Wyeth vs. Levine was whether Vermont’s product-liability law was pre-empted by the FDA label. Wyeth and the Bush Administration argued that it did. SCOTUS said no.
This was important because the harm suffered by Ms. Levine was a clearly described risk on the label. Although the Vermont jury found against Wyeth, this was a runaway jury. The facility and the clinician who injected the drug were liable, as they should have been, but Wyeth really should not have been.
So, while there should be the same legal treatment for the generic and brand-name drugmaker, it is not that the jackpot should be expanded to include the generic drugmakers, but the other way around.