- New Jersey Appellate Court Weighs in on Federal Preemption of Pharmaceuticals
- October 3, 2008
- Law Firm: Wilson Elser Moskowitz Edelman & Dicker LLP - Newark Office
By way of background, Vioxx® was approved by the FDA on May 20, 1999. The initial labeling required by the FDA did not contain any warnings or precautions regarding cardiovascular risks. After significant research and other studies, including ongoing interaction with the FDA, a revised label was approved on April 11, 2002. The new label contained a "precaution", not a "warning" that limited the use of Vioxx among patients with a medical history of ischemic heart disease or patients whose already-diagnosed coronary artery disease was symptomatic. Prior to the label revision, plaintiffs John McDarby and Thomas Cona took Vioxx to treat osteoarthritic pain. McDarby took Vioxx on a daily basis from March 2000 to treat osteoarthritis in the hands and knee, until his heart attack in April 2004. Cona took Vioxx for over two years and suffered a heart attack in 2003.
In John and Irma McDarby v. Merck & Co., Inc., A-0076-07T1; and Thomas and Joyce Cona v. Merck & Co., Inc., A-0077-07T1, plaintiffs brought claims under the New Jersey Product Liability Act, N.J.S.A. 2A:58C-1 et seq.(PLA) and the New Jersey Consumer Fraud Act, N.J.S.A. 56:8-1 et. seq. (CFA) alleging inter alia, inadequate warnings and consumer fraud in connection with Merck's sale of the prescription drug Vioxx. After a consolidated trial, the jury found that Merck committed consumer fraud by failing to disclose the cardiovascular risks that Vioxx presented and intentionally concealed and omitted information regarding these risks. A $15.7 million judgment, comprising compensatory and punitive damages, attorneys' fees and costs, was awarded to plaintiffs, John and Irma McDarby; and a $2.27 million judgment awarding damages of $135 and attorneys' fees and costs was awarded to Thomas and Joyce Cona.
Merck asserted on appeal that the trial judge failed to give proper effect to the PLA's presumption of adequacy for prescription drug warnings approved by the FDA and that the Federal Food Drug and Cosmetic Act (FDCA), 21 U.S.C.A. §§ 301 to 399, preempts McDarby's claims challenging the adequacy of the FDA-approved Vioxx labels. The Appellate Court determined that the principles of preemption did not require dismissal of McDarby's action under the PLA. In distinguishing the U.S. Supreme Court case of Riegel v. Medtronic Inc., 552 U.S. ___, 128 S.Ct. 999, 169 L.Ed. 2d 892 (2008) the court found that Riegel concerned the proper interpretation of an express preemption provision contained in the Medical Device Amendments of 1976 to the FDCA, which is inapplicable to prescription drugs. Additionally, the Court distinguished Riegel on the grounds that McDarby's claims are consistent with and relied upon the FDCA regulations whereas in Riegel, the plaintiff's claim as to the safety and effectiveness of the device at issue conflicted with premarket approval requirements under federal law. In sum, the Court found that Merck's duty in this case, as found by the trial judge, and its violation, as found by the jury, are premised upon a federal obligation, mirrored by state tort law, and are not simply state-law constructs.
With respect to the issue of regulatory preemption, the Court was satisfied that the McDarbys' inadequate warnings action, asserted under the New Jersey PLA, was not preempted by statements contained in "D. Comments on Product Liability Implications" found in the Preamble to a final rule governing "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," 71 Fed. Reg. 3922, 3933-36 (Jan. 24, 2006) effective June 30, 2006, ("Preamble") as the labeling changes sought by plaintiffs at trial did not conflict with federal requirements, but were in fact consonant with them. The Court went on to note that the Preamble does not constitute a regulation duly adopted after notice and comment, but is merely an expression of opinion, reflective of current Administration views, on the part of the FDA. See, e.g., Vioxx Prods. Liab. Litig., 501 F. Supp. 2d 776, 786-87 (E.D.La. 2007)(declining to grant deference to preamble, which "actually conflict[s] with statements made in the original notice of proposed rulemaking out of which the 2006 Final Rule grew," and determining that "[a]t best, the preamble merely offers an opinion on the viability of the plaintiffs' state-law claims given the existence of the federal regulatory scheme as a whole").
It is not known at this time whether Merck will petition the New Jersey Supreme Court for certiorari. New Jersey, like other states, will now look with renewed interest to the Vermont case of Levine v. Wyeth [citations omitted] which has been heard by the United States Supreme Court for oral argument in October 2008. The Levine case has been viewed as the definitive case on the issue of federal preemption of pharmaceuticals. Levine involves a plaintiff who received two injections of Wyeth's drug Phenergan and after a jury trial, Wyeth appealed on grounds of federal preemption. Since, pharmaceutical products are not given express preemption under the FDCA, the primary arguments for preemption of pharmaceuticals are found in implied preemption. These coming months will set the stage to see if the United States Supreme Court will decide the issue, or if Congress will act to state definitively whether or not FDA approval of these products precludes state common law actions.