Sunday, March 22, 2009

Wyeth v. Levine

Case Recap:

In April 2000 Diana Levine went to be treated for a migraine. The staff at the Vermont hospital gave her an intramuscular injection of Demerol for her headache and Phenergan for her nausea. Not getting any relief she returned to the clinic and received a second injection of both drugs. The second time a physician-assistant administered the drug IV push (and the drug entered her artery, either because the needle entered the artery, or because it migrated from the tissue to the artery); ... this caused gangrene to set in and her right arm had to be amputated. After settling lawsuits with the clinic/hospital and staff for their error she sued the maker of the drug (Wyeth) claiming that the labeling was inadequate since although it warned against IV administration it did NOT prohibit it and warn doctors and nurses not to give promethazine IV push under any circumstances... Wyeth's defense was that the labeling of the drug conformed to what was approved by the FDA, and that it could not deviate. The judge instructed the jurors that they could consider Wyeth's compliance with FDA rules, but that this did not establish that the warning was adequate. The jury found that Wyeth was negligent, that Phenergan was a defective product due to inadequate warnings, and that the product defect was the direct cause of Levine's injury. They awarded Diana Levine USD 7.4 million. The judge reduced this since she had collected monies from her settlement with the clinician and clinic.

Wyeth appealed to the Vermont Supreme Court in 2006, but the court upheld the ruling of the lower court. In 2007 Wyeth filed a writ for certiorari, requesting that the SCOTUS review the case, and the court granted certiorari on January 18, 2008. The case was argued before the SCOTUS at the beginning of November.

Below is a scan of a promethazine package insert (warnings highlighted)...

March 2009 the SCOTUS decided 6-3 that federal law did not pre-empt Levine's state claims. They dismissed Wyeth's claims that it would not be possible to comply with state laws and federal labeling duties, given that the FDA has a procedure in place (CBE, or "changes being effected" provisions) by which a manufacturer may add or strengthen a drug safety warning. They rejected Wyeth's argument that the Food, Drug, and Cosmetic Act (FDCA) gave the FDA total labeling standards, ruling that a reading of Congressional intent showed that they did not intend the FDCA to pre-empt state laws.

OK, so the SCOTUS may have ruled completely correctly re the law and pre-emption. However, this blogger really can't agree with the initial judgment and finding of fact. He has a number of issues:
  • The physician assistant administered a dose greater than prescribed by the label, administered it improperly, and also continued to inject the drug even though Levine complained of pain. However, the jury rejected Wyeth's argument that these actions relieved it of liability.
  • The initial finding was that the product was defective as a result of inadequate warnings., and that the injury would not have occurred if Phenergan's label had included an adequate warning. However, the package insert already had no fewer than six warnings related to this issue, it's not sure what additional verbiage would have been useful given that all current warnings were ignored.
  • Levine argued that there should be a warning saying "Not for IV Push" The jury and the court did not accept this, thankfully. There are limited cases in which IV push is medically indicated, as in when immediate relief is needed, and we don't want manufacturers to make labels too tight. As it is, Wyeth might add this to the label to protect against further state tort actions, what would this do to the responsibility of medical personnel?
All in all, a dissatisfying set of circumstances. This blogger feels that a FDA-mandated label that pre-empts state law IS the way to go, and that this should be the law (since it is not currently). Otherwise, drug manufacturers are at the mercy of juries in every state!

Final note: Reading the reactions on-line to news accounts, and scanning blogs, it is disheartening that most folks don't seem to want to bother to read up on the facts of the case, but bring their pre-conceived biases to bear.

Preemption and Amputation: Diana fights Wyeth
Amputee awaits high court, wants musical glow back
Drug Label, Maimed Patient and Crucial Test for Justices
Preview: Wyeth v. Levine (recap of the case prior to the SCOTUS)
Wyeth v. Levine (links to all the documents) - SCOTUSWiki
Drug Ruling Puts Devices in Spotlight
Supreme Court Rules in Wyeth v. Levine

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