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Bush, Obama and why Wyeth v. Levine is so important

Doug Kendall, founder and President of the Constitutional Accountability Center, puts the Wyeth v. Kendall case currently before the Supreme Court into a broader context, and analyzes how presidential politics has contributed to – and may ultimately change – the way product liability litigation against pharmaceutical companies are decided.

Kendall notes that this case is an illustration of both “the importance of Supreme Court rulings to ordinary Americans and the aggressive efforts of the outgoing Administration to use the Court and its own regulatory authority to protect corporations from being held accountable for the harms caused by their products.”

As he goes on to explain, the Federal Food, Drug & Cosmetic Act (FDCA), the federal statute governing drug approval, labeling and safety regulations, is the relevant statute in this case. But when it was originally enacted by Congress back in 1938, all remedies available to consumers under state law were consistent with the FDCA, unlike today where there are numerous conflicts between federal law and the law in each state (as is the case in Vermont).

In the past seventy years, Congress has amended the statute numerous times, and yet has managed to avoid addressing the critical issue of whether the FDCA expressly preempted state law claims against pharmaceutical companies such as Wyeth in this case. Kendall does point out, however, that it did choose to include an “express preemption clause regarding medical devices” (as per Riegel v. Medtronic).

This revision of long-standing FDA policy on preemption in the drug labeling context was made over the objection of career agency officials, including the highest official in the drug review process, who warned that “much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”  [. . .]

According to a report released today by the House Committee on Oversight and Government Reform, “the White House played a significant role in the preemption provisions and pressured the agency to reject the concerns of career experts.”

This attempt to achieve “preemption by preamble” not only places Americans’ health and safety at risk, but it also circumvents Congress and the Constitution–the Supremacy Clause, after all, states that the laws of the United States are supreme, not federal agency preambles.

But here is where it gets really interesting: Could the Bush Administration’s policy of “preemption by preamble” be reversed next year, regardless of the high court’s ruling? Kendall argues that: 

“A top priority of the new administration should be to review the preemption decisions by the Bush Administration and reverse them unless Congress has declared clearly in federal law its intent to displace state law. And Congress can overturn any holding by the Court in Wyeth, as well as a long-list of other bad preemption decisions by the courts in recent years, by amending the laws in question and clarifying that the states should not be inappropriately displaced by federal law.”

The Court needs to do its job and rule for Diana Levine in Wyeth. But the results of the election held the day after the Wyeth argument should have an equally great impact on the ability of states to serve as laboratories of democracy and the availability of remedies for individuals who are harmed by corporate wrongdoing.

It has been reported that the court is not expected to rule on the case until next June, and that the justices are “torn” over how they will make their decision, and yet the most important question to ask is actually whether the incoming Obama administration and new Congress will decide to take Kendall’s advice and push forward legislation that will effectively reverse a potential ruling in favor of the defendant.


Supreme Court to rule in Wyeth v. Levine

The Supreme Court has now finished hearing oral arguments from the defense and plaintiff in Wyeth v. Levine, a case with profound implications for product liability litigation – specifically in the pharmaceutical industry. The decision will also set an important precedent for constitutional law, specifically in the way lower courts will interpret the doctrine of implied preemption in the future.

Derived from the Supremacy Clause of the Constitution, the doctrine of Preemption bars individuals injured by a product from filing a civil action in state court if the product complied with federal safety standards. Attorneys practicing in the field of product liability law, especially those who represent individuals injured by dangerous drugs should be closely following this development.

First, some background on the facts and procedural history of the case. The plaintiff, musician Diana Levine, began suffering from migrane headaches and turned to a local health clinic for treatment in April 2000. There, she was prescribed pain medicine as well as Phenergan, a drug manufactured by Wyeth for treating nausea. However, the physician’s assistant who administered the latter drug injected it into one of her arteries, rather than a vein — despite warnings on the drug’s label that doing so could lead to irreversible gangrene.

Tragically, as a result of receiving this negligent care, Levine ended up with gangrene and needed to have one of her arms amputated below the elbow. She filed a civil suit against the clinic and the PA for malpractice and received an undisclosed settlement out of court.

Then, in 2004, a jury in her home state of Vermont found that Phenergan’s label offered insufficient warning about the danger of that injection method compared with two other, safer ways to administer the drug and awarded her $6.7 million from Wyeth. The Vermont Supreme Court upheld the jury’s verdict in 2006.

This is where Levine’s lawsuit becomes enmeshed in the complexities of constitutional law, and why the Supreme Court agreed to hear the case. All of this will be fleshed out in a series of posts over the next few days. Stay tuned.

Here is some online reading for further background:

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