Taking medication at your own risk of Medtronics, Wyeth and J&J

In this blog on February 21 I ranted about the Medtronic case and federal preemption, where FDA approval for a product essentially made the manufacturer immune from prosecution. A similar case involves whether an individual can recover under Vermont tort law for the consequences she suffered from another FDA approved product. In Wyeth v. Levine, Ms. Levine was treated for nausea from MIGRAINES with Phenergan. Initially injected into muscle, when the drug was ineffective, it was then injected into Ms. Levine's veins in a process described as IV push. The drug caused gangrene and Ms. Levine lost her arm.

In her lawsuit, the preemption rule was brought out by Wyeth which insisted that the FDA warning indicated that gangrene could result from the drug's contact with arteries.

The IV push method was not specifically mentioned on the label. Levine settled with her health services providers who do not have the protection of the government. In a separate suit, Levine was awarded $6.7 for Wyeth's failure to warn.

But the case after all is called Wyeth v. Levine. Wyeth appealed arguing that holding them to a standard greater than that required by the FDA was not legitimate. The Vermont Supreme Court upheld Ms. Levine's claim that additional warnings should have been included.

In another suit against Johnson and Johnson, a different issue is at stake. In the suit alleging that the Ortho Evra birth-control patch caused strokes, heart attacks, and blood clots, J & J settled several lawsuits though J&J claimed protection from federal preemption rules. The difference? Deception. Evidence that J&J did not accurately report numbers reflecting issues with its product including the actual dosage patients were receiving from the patch. The Ohio case is a lot easier because of the deception involved. But what of those FDA warnings?

The truth is that we are numbed to the implications of FDA warnings. The text provided for even the most common substances amounts to a disclaimer. When it comes to prescriptions, warnings seem to include everything in the range from no reaction to death. And when we are given something in the hospital? I'd say fewer than 10% of people ask about side effects. So, will additional warnings on medication be helpful? Only if medical services providers decide that the risks outweigh the benefits and that's because they will pay more attention to their wallets than we will to our lives. We're flooded with information on the warning labels of drugs and devices. Until an adverse reaction occurs, can we really be expected to explore every aspect of those warnings? This law says yes and basically amounts to take it at your own risk unless you were deceived by the label.

The consequence for consumers who already largely ignore the warning part of labels on their prescriptions is likely to be more text on the label. For medical services providers and your own protection, clearly indicate all your medications and make sure it's in your physician's record, your chart. And the FDA? Well, they're pretty much immune.