Prescription drugs sometimes cause serious side effects. A ruling by the U.S. Supreme Court expected this fall could radically alter consumers' ability to seek recourse from drug makers should they suffer harm. The case, called Wyeth vs. Levine, may lead to a new interpretation of federal law, which would shield pharmaceutical companies from the most common kind of lawsuit.
If you experience a serious reaction that you suspect may be linked to a medication you took, what can you do now, and how would a ruling in favor of the drug companies change that? We asked some consumer healthcare advocates.
The first hurdle is to determine whether the drug is very likely to be the cause. You should talk to your doctor about what's happening to you, and maybe stop taking the drug after consulting with him or her.
If the drug seems to be to blame, you can report it to the Food and Drug Administration on its MedWatch website ( www.fda.gov/med watch). The FDA encourages you to seek your doctor's help in filling out the form, but it's not required.
These actions will not be affected by the Supreme Court ruling, but your ability to seek damages will be.
Now, if a medication has caused you severe or irreparable harm, you can consult with a lawyer and consider suing those who gave you the drug (the healthcare provider that prescribed or administered it) or those who made the drug (usually a pharmaceutical company).
The case before the Supreme Court is based on an argument that is used in the vast majority of lawsuits involving prescription drugs: that the drug company failed to adequately warn about a known risk of its product.
All drugs approved by the FDA are extensively labeled with information on dosing and administration, side effects, precautions and warnings. That label, in addition to the medication itself, must be reviewed and approved by the FDA.
If the ruling this fall is made for the defendant -- the pharmaceutical company Wyeth -- it would tilt the playing field largely in favor of the pharmaceutical industry, by stating that such claims against drugs are preempted because experts at the FDA sanctioned the product and its label for safety. Because federal law supersedes state law, the ruling would affect lawsuits filed in all 50 states.
