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.
Consumer advocates say this tilt would be unfair, because consumers should have a remedy against a drug company that sold them a defective drug or didn't fully disclose its side effects. "This is as sweeping a legal decision as the Supreme Court has ever made for prescription drug users," says Jamie Court, president of Consumer Watchdog, a consumer rights organization based in Santa Monica. "This preemption is exactly what the drug companies have sought for the last 20 years from Congress."
Congressional leaders are already drafting legislation that would restore liability if the Supreme Court rules for Wyeth, Court says.
Wyeth's position is that the adequacy of warnings on its FDA-approved drug label is an issue for experts at the FDA to decide, not juries.
Two types of cases
Currently, two main arguments are used by plaintiffs in pharmaceutical product liability cases: "failure to warn," meaning that the drug company failed to adequately warn consumers about possible side effects of the drug, and "design defect," that the drug is defective.
Failure to warn typically involves labeling issues, as in the case currently before the Supreme Court. The Wyeth drug Phenergan, used to relieve nausea, was labeled with a warning about risks if the drug were injected in a certain way -- and that risk became reality for plaintiff Diana Levine when she lost an arm to gangrene. Levine's argument is that the risk was high enough and serious enough that the label should have told users not to inject the drug that way.
No patient should be subject to such a serious risk, even if its likelihood is rare, for a condition that, although uncomfortable and distressing, is so nonthreatening to life and physical health, says Brian Wolfman, director of litigation at Public Citizen, a consumer advocacy group in Washington, D.C., and legal team member for Levine.
"The risks and benefits are out of whack," he says. On the one hand, "the patient was sick to her stomach." But on the other, "it's a serious, serious risk -- you lose your arm."
The "design defect" argument refers to adverse effects of a drug that were unknown at the time of a drug's approval and labeling. Rare reactions, the type that might affect 1 in 10,000 or 1 in a million, can become apparent only after a drug that was clinically tested in thousands of patients gets prescribed to millions of patients.
Most likely, advocates say, only one of these two arguments would be affected if Wyeth wins the Supreme Court ruling. An individual could still file a suit against the drug's maker for defects in manufacturing or design. But it couldn't do so for "failure to warn."