The Pre-Emption Defense - Joseph Hetrick of Dechert LLP on "Levine" and More

Federal pre-emption could be the ultimate defense in pharmaceutical litigation.  Joseph Hetrick, a partner at Dechert LLP in its Philadelphia office, explains why, and if pre-emption will be blessed by the U.S. Supreme Court in its review of the tragic Diana Levine case this Fall.

Hetrick represents a number of pharmaceutical companies and was directly involved in the diet drug, statin, and anti-depressant individual and class-action litigation.  He lectures globally on pre-emption and has been a commentator on this blog as well as Pointoflaw.com on subjects ranging from managing risks in biotechnology to Central Europe as the new Silicone Valley.

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JOSEPH HETRICK, exclusive interview on pre-emption:

JG: Should the Diana Levine case, to be reviewed in November by the U.S. Supreme Court, get all the attention it has been getting in both the legal and business media?

JH:  Absolutely, all that attention and more.  The "Levine" decision could significantly weaken or strengthen the most powerful defense the pharmaceutical industry currently has available.  Depending on the specifics of the decision, other industries, such as securities, banking, transportation, construction and communications could be significantly affected. 

Regarding the latter - communications - In "Farina v. Nokia," on September 2, 2008, the U.S. District Court in Pennsylvania granted the motion to dismiss. The rational was that a class action alleging that cell phones are unsafe and defective if not used with headsets is pre-empted by federal law.  The decision reads, "Congress, by creating the FCC and giving that agency plenary jurisdiction over technical standards for radio communications, has impliedly pre-empted contrary state laws regarding radio frequency emissions. Moreover, the telecommunications industry has been subject to prevasive federal regulation since its inception."  Will the ruling in "Levine" reverse this decision?  Time will tell.

So, both attorneys and their corporate clients are watching "Levine" very very closely.  Also, there are key issues of public policy to be decided, such as the injured parties right to a jury trial in state court, who is best equipped to answer complex scientific questions, and whether the current federal regulatory scheme for pharmaceuticals can be relied on to properly govern the industry.

JG:  What is "pre-emption?"

JH: In essence, "pre-emption" in our legal system means that federal law can and often does override any and all state law that is inconsistent or conflicting with the federal scheme.  The power behind this, of course, is the United States Constitution.  The Supremacy Clause [Article VI, Section 2] of the Constitution specifies that the Laws of the United States are the supreme Law of the land.  Any conflicting laws are invalid (i.e. pre-empted).

More specifically, there are two main types of pre-emption. Express pre-emption is found where Congress has make explicit in a statue that the federal law trumps state and local law - for example, the statue governing medical devices.  The other type of pre-emption is implied pre-emption and that gets a bit more tricky.  Attorneys have to battle it out over what Congress intended, in the absence of express language, and what policy reasons might support pre-emption in the particular factual setting at issue.

JG: When did pre-emption become so important in pharmaceutical litigation?

JH: Relatively recently.  As of 10 years ago, the Federal Food and Drug Administration took the position that its role in pharmaceutical labeling was to set a "floor" for drug labeling.  The label, which would be negotiated with the sponsoring drug company, to produce the final product label, was viewed by the agency (and the courts) as a minimum requirement.  In short, the door was left open for states to augment the federal labeling through their common law tort system.  It was a two-way street, so to speak.

More recently, under the Bush Administration, the FDA took a much stronger position. In 2006, the FDA published its "Final Rule" in which it held itself out as a floor, but also a ceiling and that it wold be a great mistake to allow lay people on a state jury to decide 50 potentially different criteria for the adequacy of a particular drug label.  The FDA believed that its mandate was to serve as "The Expert" on drug labeling, and that states could not alter or augment the final approved label.

But there is more than that to it, Jane.  The FDA approved label was often non-negotiable.  For example, there were situations, as with the anti-depressant drugs, where the drug companies stepped forward, after usage revealed additional adverse event data, and asked the FDA to review and possibly amend the drug label to add a new warning.  In the case of the anti-depressant drugs, the FDA did review the data, but would not allow the requested additional warning.  Indeed, the FDA went so far as to tell the companies that if they made the requested changes over the objection of the FDA, that the bureau would view the drug as "misbranded" and possibly subject to seizure.

That very issue was decided in my home state of Pennsylvania, in a case "Collacicco v. Apotex" which may well be reviewed by the United States Supreme Court this spring. In "Collacicco," the company explored with the FDA a warning about the possibility of adult suicide.  The FDA reviewed the existing data and said "no." 

During hearings on defendant's motion to dismiss the case, based on federal pre-emption, and at the Court's request, the FDA filed an amicus brief indicating that in October 2003 (when plaintiff's wife was taking the drug) "there was no reasonable evidence available at the time of an association between adult use of the drug and suicide."  The FDA contended that given this lack of evidence, altering the label would have rendered it false and misleading. Based on the FDA's position, the trial court held plaintiff's "failure to warn," claim to be pre-empted by the bureau's decision and dismissed the case.  The dismissal was affirmed by the United States Court of Appeals for the Third Circuit, and is currently pending before our Supreme Court.

Where we currently stand, however, is in a state of confusion. There are conflicting decisions based on different factual scenarios involving different drug's different labels and different risks. Some of the recent rulings by the U.S. Supreme Court, including the "Riegel" ruling, are so narrow, or the Court is so badly split, that the question of pre-emption and prescription drugs is largely undecided as to its scope and significance.

JG:  Will the ruling in "Levine" clear up the confusion?

JH:  That depends on the ruling.  The case itself is quite complex.  It arises out of a tragic factual situation - the plaintiff, Mrs. Levine, was a professional musician who lost her arm because a nausea medication was administered incorrectly.  Before this medical event, the drug manufacturer had approached the FDA with information about the risks associated with the drug when it was administered, as it was to Mrs. Levine, through an "IV push." The company made the FDA aware of the potential risks of this application, but the FDA did not see any necessity for a label change and allowed the "IV push" mode of treatment.  The manufacturer now claims that given the FDA's labeling decision, it should be immune from plaintiff's state law claim.

Obviously, not only the company, but also the FDA will come under close scrutiny, both in the U.S. Supreme Court, and quite possibly afterwards in Congress.  It is fair to say, Jane, that everyone is watching this case.  Whatever the Court decides may be subject to legislative amendment following its attempted implementation.

The Court could decide that times have changed - that is, there are more new drug applications filed each year; there is now direct to consumer drug advertising; and much more scientific knowledge exists than did even a few years ago.  Therefore, the Court may see the "Levine" case as the perfect vehicle for redefining the authority of the FDA in the "modern world." 

Alternatively, the Court could say pre-emption is justified, assuming the regulatory system is working as it was intended to work - that all information is presented to the agency, and the agency reached a reasoned decision based on that information.  Many argue, however, that the current system is, in fact, not working.  Their allegation is that the FDA lacks the proper manpower, lacks the proper funding, and may not be "The Expert" in the sense it believes itself to be.  These are competing interests that the U.S. Supreme Court will need to analyze.

Under the most extreme result, the Court could come down on the side of total immunity.  That is, the FDA is the legislatively appointed expert, and its decision is final.  End of story.  It would be interesting to see what, if any, Congressional response would follow such a holding.  There are already bills drafted and "waiting in the wings" to challenge any such result.

Alternatively, the Court could rule somewhere in the middle, allowing FDA decisions to be final in specific factual scenarios (such as those where the very risks in question were presented to and rejected by the bureau) but not give the FDA unbridled and final discretion on all labeling issues. 

I anticipate that it will take a year or two to "flesh out" whatever holding comes down in "Levine."

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Joseph Hetrick was selected among THE BEST LAWYERS IN AMERICA for product liability litigation last year.  As a partner at Dechert LLP, the Philadelphia Office, he is a member of the mass torts and product liability group.  He can be contacted at Joseph.Hetrick@dechert.com.

 

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