Does FDA approval guarantee safety? If the Supreme Court rules as expected, patients will have no legal recourse if they are harmed by an FDA-approved medicine.
The case that will soon be decided by the Supreme Court involves a musician who was treated for a migraine. The medicine that was injected to stop her nausea was administered incorrectly. This led to gangrene of her arm and eventual amputation just below the elbow.
The Vermont Supreme Court upheld a Superior Court finding that the drug company was negligent because it did not provide adequate warning about the injection process. The manufacturer maintains that the FDA approved the prescribing information that was used and therefore the drug company has no liability. In other words, FDA approval gets the pharmaceutical firm off the hook for any complications that might arise. Think of it as a Monopoly-style “get out of jail free” card.
This case could well set a precedent for all future pharmaceutical-related litigation. If FDA approval means that drug companies are not liable, then there will be no recourse if someone experiences a serious or even deadly adverse reaction.
Take Vioxx, for example. At last count tens of thousands of patients may have experienced heart attacks as a side effect of this arthritis medicine.
Questions about what the company knew about these potential problems and when it knew them have been raised. Many answers have been discovered only through the disclosure required in the process of lawsuits.
In recent years the FDA has approved many medicines that have later been shown to carry serious risks. In some cases the drugs have had to be removed from the market.
Rezulin was supposed to be a groundbreaking diabetes medicine. It was later discovered to cause liver damage that sometimes resulted in death. The FDA eventually asked the manufacturer to remove Rezulin from the market.
In another example, millions of patients took antidepressant medications before the FDA required a black box warning that these drugs might trigger suicidal thoughts or actions. No one knows how many deaths may have resulted during those decades.
A recent editorial in the Journal of the American Medical Association (Oct. 22/29, 2008) points out that FDA approval is often flawed: “The FDA is not infallible and the recently increased resources do not include a crystal ball. Therefore, unless and until the FDA drug approval process and the postmarketing surveillance system improve significantly, patients must have a means to seek recourse through tort litigation against product manufacturers. Anything less may well preempt the well-being and safety of the public.”
Postmarketing surveillance has long been a weak link at FDA. If the Supreme Court decides that drug companies are not legally vulnerable once the FDA grants approval, patients will need to be even more vigilant. Since all drugs have the potential to cause side effects, there will be no protection if things go seriously awry.
