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Los Angeles and San Francisco Daily Journal

 

A Dose of Skepticism: The Supreme Court's ruling in Wyeth is likely to unleash conflicting standards and a flood of litigation

March 19, 2009

By Paul Howard, James R. Copland

The facts of the case underlying the Supreme Court's March 4 Wyeth v. Levine decision are tragic. In 2000, professional guitarist Diana Levine had to have her arm amputated below the elbow after developing gangrene, caused by an arterial injection of Wyeth's anti-nausea drug Phenergan. The injection into Levine's artery was inadvertent: A physician's assistant at a Vermont clinic had attempted to administer the product into Levine's vein. The physician's assistant also injected double the dosage recommended on the drugs label, and he ignored his patient's complaints of severe pain while he administered the drug.

The injury Levine suffered should not have been a bolt from the blue: The risk of developing gangrene from an accidental arterial injection was warned against no fewer than six times on Phenergan's label. After suing the clinic and reaching a settlement, Levine sued Wyeth in state court, alleging a "failure to warn" on the label. Levine's lawyer argued that the company should have prohibited Phenergan's administration by "IV-push," notwithstanding that the Food and Drug Administration had long been aware of the risks of such intravenous injections and allowed the procedure. A Vermont court found Wyeth liable, and the Vermont and U.S. Supreme Courts upheld the judgment.

By holding Wyeth responsible for Levine's injury, despite its having been caused by obvious medical error, the Supreme Court denies drug manufacturers virtually any protection from state tort lawsuits based on a drug's FDA-approved label and accompanying warnings. In essence, the court held that a drug's label was merely a "floor" and that state courts could require manufacturers to issue "stronger" warnings without ever acknowledging the tsunami of conflicting standards that will surely emerge. As a construction of jurisprudence, this is a house with a floor but no ceiling. Instead of one national standard for drug safety, decided by the FDA, we will now have 50 potentially conflicting definitions of "safe" label warnings, varying from state to state.

How did the court justify this outcome? The majority, led by Justice John Paul Stevens, ruled that so long as a drug manufacturer could have conducted a different data analysis that might have led them to draft a stronger label regarding the injury in question, juries can find companies liable for fl awed label warnings. Faced with a badly injured plaintiff, juries in these cases will be sorely tempted by hindsight bias, assuming that the company could have issued a different warning or contraindication to prevent a devastating injury.

And they may be right. But juries are only considering one injured plaintiff—not the balance of risks and benefits that the FDA must address in its construction of an approved drug label. A new label warning or contraindication that prevents one injury could easily cause thousands of other patients to go without an important treatment or method of treatment—like the IV-push.

For companies, the law may be hopelessly murky, but the outcomes for patients are much more predictable. Drug prices will have to rise to offset increased litigation costs; companies will scramble to issue many more drug warnings and contraindications in the hopes of deflecting lawsuits, adding more confusion to medical practice; and some medicines will never be marketed at all because the risk of crippling lawsuits is just too great.

There is no doubt that drug litigation discourages new drug development; witness the fact that there is not a single morning-sickness drug on the U.S. market since Bendectin was sued out of existence in 1983 over charges that it caused birth defects—a charge later disproved. And we also know that litigation drives up drug prices: In the 1980s, prices for the diphtheria-pertussis-tetanus vaccine rose 40-fold—versus a "mere" doubling of vaccine prices overall—when a wave of lawsuits over the vaccine's side effects pummeled the vaccine's manufacturers.

The problem is that while state courts and juries are poorly equipped to rule on complex scientific issues and cannot even address the underlying risk-benefit tradeoffs with which the FDA must grapple, they are often the only recourse for plaintiffs who may be injured by unforeseen drug side effects.

Ideally, we should separate out the questions of regulating drug safety and compensating those injured by drugs, so that we maximize both societies' interest in promoting reasonably safe and effective drugs and in compensating claimants with serious but unforeseen drug injuries.

How to cut this Gordian knot? Congress's reaction to the vaccine crisis offers a road map for the proper legislative response to the Supreme Court's confused pre-emption jurisprudence concerning pharmaceuticals. In 1986, Congress passed the National Childhood Vaccine Injury Act, which pre-empted vaccine lawsuits and established a federal administrative compensation program to process claims from children injured by vaccine side effects.

Congress' program, while hardly perfect, has won plaudits for quickly meting out justice, with administrative costs only a fraction of those in the tort system, where the majority of payments go to lawyers. Furthermore, whereas juries often buy into dubious scientific claims, the congressional program has tended to reach the right answers. Just last month, the special master in charge of the vaccine program jettisoned the thousands of junk-science claims filed by plaintiffs' lawyers that had asserted a link between the vaccine preservative thimerosal and autism.

Once on the verge of bankruptcy, the vaccine industry is now thriving—with companies competing to produce safer vaccines and launch new treatments, including the first vaccines to prevent cervical cancer.

The existing vaccine system would have to be adjusted if applied to all drugs, but it could serve as a valuable template. We harbor no illusions that the current Congress will work to enact a program along the lines we prescribe, but policymakers should explore it as a better choice for patients and companies.

In the meantime, we will have to live with the shaky structure put in place by Wyeth v. Levine. We have a house with no roof—but at least we know how to fix it.

 

 
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