Three days ago, on May 20, 2009, President Barack Obama, through the White House Office of the Press Secretary, released a “Memorandum for the Heads of Executive Departments and Agencies” regarding preemption. White House Preemption Memo (May 20, 2009)
On March 9, 2009, the United States Supreme Court granted petitions for writs of certiorari in two cases that were pending from the Third Circuit Court of Appeals: Colacicco v. Apotex, et al., 08-437, and Pa. Employees Benefit Trust Fund v. Zeneca, 07-822. The High Court ordered further review in each case in light of its decision last week in Wyeth v. Levine.
Yesterday, in a 6-3 decision handed down in Wyeth v. Levine, No. 06-1249, the United States Supreme Court struck a thunderous blow to Big Pharma’s most treasured defense tactic: conflict preemption.
On Monday, November 3, 2008, the United States Supreme Court heard oral argument in Wyeth v. Levine, and we have the full draft transcript available for you here: Wyeth v. Levine (Oral Argument Transcript)
A report released yesterday by the national consumer rights group Center for Justice and Democracy entitled “The Bitterest Pill – How Drugs Companies Fail to Protect Women and How Lawsuits Save Their Lives” revealed the devastating consequences that the regulatory failures and inadequacies of the FDA have had, specifically on women.
We would like to extend a special thank you to our friends at the American Association of Justice (formerly, the Association of Trial Lawyers of America), which yesterday published a comprehensive and thoroughly illuminating report examining the Bush Administration's preemption agenda during the last eight years. This is an excellent piece of work, and a must read for every plaintiff's lawyer. We won't belabor this blog spot with commentary (and there's not much we could add anyway), but instead let you get right to reading it ... AAJ Preemption Report.
On September 17, 2008, Wyeth filed its reply brief in Wyeth v. Levine, No. 06-1249, in which it continues to insist that it could not comply with both federal prescription drug regulations and any state-based common law duties to warn. Wyeth Reply Brief.
In yet another resounding victory for Plaintiffs in the battle against federal preemption, a federal district judge has rejected a drug manufacturer’s attempt to skirt liability by invoking the doctrine of implied conflict preemption. On August 29, 2008, in a 53-page memorandum opinion in Knipe v. SmithKline Beecham, d/b/a GlaxoSmithKline, 2:06-cv-03024 (RB) (E.D. Pa.), Senior Judge Ronald Buckwalter denied GlaxoSmithKlines’ (GSK’s) summary judgment motion based on preemption.
On July 24, 2008, the Eastern District Court of Missouri rejected yet another drug manufacturer’s attempt to jettison lawsuits based on preemption. In In re: Celexa and Lexapro Prod. Liab. Litig., 4:06-md-01736 (RWS), a Multidistrict Litigation with approximately 42 cases alleging suicidal injuries caused by either Celexa or Lexapro, the defendants, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. moved to dismiss 22 of the cases on conflict preemption grounds. The cases in question all involved plaintiffs or decedents who were over the age of 24 at the time of their suicidal event or their suicide.
No doubt the Plaintiff’s attorneys in Tucker v. SmithKline Beecham, d/b/a GlaxoSmithKline, 04-cv-01748 (DFH/WTL), S.D. Ind. (Indianapolis Division) are breathing a huge sigh of relief. On July 18, 2008, Chief Judge David Hamilton reopened the case by granting the Plaintiff’s motion for reconsideration, effectively reversing the court’s prior grant of summary judgment on preemption grounds. Perhaps even more remarkable than the 180-degree-turn of events is the depth of this particular jurist’s understanding of the preemption issue in the context of SSRI litigation – specifically, in the context of Paxil suicide cases – and the utter frankness of the opinion. Tucker v. GSK, Slip opinion (S.D. Ind. July 18, 2008) At last, someone gets it.
As plaintiffs’ attorneys and defense attorneys representing pharmaceutical manufacturers await the filing of the respondent-plaintiff’s merit brief in Wyeth v. Levine, No. 06-1249 it is useful to take note of one of the salient features of Wyeth’s brief, filed in May 2008.
Wyeth apparently appreciates the elephant in the room: that if the High Court applies the longstanding presumption against preemption, Wyeth faces a decidedly uphill battle to conjure an implied conflict to warrant preemption. And so Wyeth begins its brief by attacking the very applicability of the presumption. To make its point, Wyeth insists, inter alia, that while the presumption against preemption is applicable in “express” and “field” preemption cases, it has no similar applicability in a case where, as in Levine and in almost all prescription-drug, failure-to-warn cases, the only category of preemption urged by the defendant drug company is implied “conflict” preemption.
In the wake of Riegel, if you are a consumer advocate or a products liability lawyer you certainly wait with bated breath for the outcome in Wyeth v. Levine, No. 06-1249, the case currently pending on appeal to the High Court for review of whether or not a prescription drug failure-to-warn case is preempted by federal law. [NOTE: I use the term “federal law” as loosely as Pharma Counsel uses it the prescription drug context. You can pick your meaning – statute, regulation, notice-and-comment rule – because it is equally difficult to find preemptive force in any category you might search.]
The plaintiff, Diana Levine, developed gangrene and lost her arm to amputation following intravenous injection of Wyeth’s drug, Phenergen, which was administered to treat her nausea. She sued Wyeth alleging, inter alia, that the company failed to adequately warn her physician that Phenergen should not be administered intravenously. Following trial, she won a verdict of approximately $6.7 million, and the trial court denied Wyeth’s motions for summary judgment and judgment as a matter of law based upon preemption. The Vermont Supreme Court affirmed, and Wyeth petitioned the United States Supreme Court for certiorari.
With the United States Supreme Court’s recent decision in Riegel v. Medtronic, --- U.S. ---, 128 S. Ct. 999 (2008), the High Court certainly seems to have come one sizable step closer to abiding the Bush Administration’s backdoor tort reform agenda and eliminating consumer lawsuits for harmful products. Post-Riegel, a consumer injured by a product that happens to have been the subject of federal regulatory oversight or approval prior to its having reached the marketplace, will find it difficult to get out from the ever-growing shadow of preemption.
To be sure, the Court’s holding in Riegel is fairly narrow. Indeed, the Court passed on the viability of only a limited class of lawsuits: those involving injuries caused by medical devices that were subject of the FDA’s “pre-market approval” process under the Medical Device Act (“MDA”), which the High Court found to be a “rigorous” one. And, of course, the holding is limited in that it represents an interpretation of the MDA’s express preemption provision, and hence, will not be controlling on questions of preemption arising where there has been no express Congressional intent to preempt. Moreover, only State claims that do not “parallel” the MDA’s requirements are nullified by the federal statute’s express preemption clause.