Is Supreme Court Wyeth Ruling On Labeling a Victory for Consumers?by sterling1 on Mar 5, 2009 • 7:05 pm No Comments
Yesterday the U.S. Supreme Court, in a 6 to 3 decision, upheld a judgement of $6.7 million in damages awarded to a Vermont woman in a case against the pharmaceutical company Wyeth. You can find hundreds of stories online about this decision. Here’s one I found on Scientific American’s 60-Second Science blog. It also includes a link to an interview with an expert in product liability at the Charleston Law School.
In summary, the case was about a lot of issues but boils down to this: since, by federal law, a drug company is required to get FDA approval of its products and packaging, does that federal approval shield drug makers from state court jurisdictions finding against the manufacturer for labeling deficiencies. In this specific instance, Wyeth’s label apparently did include a warning about one method of administering its anti-nausea drug Phenergan but state court decisions ruled it hadn’t been worded strongly enough.
Almost universally, the media has declared this outcome as a victory for consumers. I disagree completely. I think everyone loses, and here’s why.
First, as a consumer, I can no longer have any confidence that the labels on prescription drugs, as ordered and approved by the FDA, are worth much. If you want even more evidence of this in a related case, examine this interview with Dr. David Graham, Associate Director for Science, Office of Drug Safety in the U.S. Food and Drug Administration. He’s the FDA insider whose complaints about Vioxx labeling went unheeded inside the FDA for years.
Secondly, I expect labeling now to become so voluminous that practically no one will take the time to read any of it, including my doctor. Labeling costs will increase; effectiveness and safety will decline.
But does any of this mean I think the Vermont woman isn’t entitled to an award for her personal injury? Not at all. And, it seems to me the drug manufacturer bears some of the liability if it soft-pedaled an important potential side effect from a drug administering procedure. But — and this will get me shot — I think the FDA is responsible, too.
Going forward, an FDA that doesn’t share the liability for product labeling due diligence just isn’t a consumer-friendly organization. It is an FDA that in effect is saying we can only rely upon what product manufacturers tell us. Frankly, I don’t think that’s good news for consumers or manufacturers.