When guitarist Diana Levine visited a clinic in April, 2000 complaining of nausea, she received an intramuscular injection of Phenergan, an antiemetic made by Wyeth Pharmaceuticals.
The shot didn’t work, so a provider gave Ms. Levine a second dose, this time directly into a vein in her arm. Or so he thought.
The FDA-approved label for Phenergan warns that giving Phenergan “IV push” can be dangerous because if the drug is injected into an artery rather than a vein by mistake, it can cause gangrene and necessitate amputation. The label describes how to avoid such a mishap.
But the worst happened. Ms. Levine lost her arm and her livelihood.
Ms. Levine sued the clinic and the parties quickly settled. Then she sued Wyeth in state court, arguing that the company should have strengthened the warning on its label to prevent the mishap, even though the FDA had signed off on the label as it was. The jury agreed with Ms. Levine, and she pocketed $6.7 million.
Earlier this week, the US Supreme court began hearing Wyeth’s appeal. Central to the Court’s deliberations will be whether a jury that is forced to deal with a disastrous but exceptional case like Ms. Levine’s is positioned correctly to establish precedents governing the function of entire medical care systems where benefits, costs and risks play out every day and bad things sometimes happen despite everyone’s best efforts.
This notoriously pro-business Supreme Court will be inclined to limit an individual’s right to sue and reaffirm the pre-emptive powers of federal regulatory agencies in the process. But it can’t overlook the fact that regulatory agencies like the FDA can get things wrong.
Recent settlements against Eli Lilly (Zyprexa), Merck (Vioxx), and Wyeth itself (fen-phen) show in fact that a patient’s right to sue—in a state court if need be—can be the best way to assure consumer safety and punish corporate fraudsters.
It’s a conundrum, so the Court will probably try to interpret the case narrowly. I suspect the case will turn on what the FDA knew and what it didn’t know about the risks of Phenergan “IV push” when it approved the label. This translates to what Wyeth told and what it didn’t tell the FDA about these risks.
If a properly informed FDA approved the label, Wyeth wins its appeal (in my view). If the FDA wasn’t properly informed, Levine prevails. This way, the Court supports the role of federal regulatory agencies while preserving a patient’s rights to sue.
Congress would then be left to figure out how to make the FDA work better. Good luck on that.