Notwithstanding the activity in the Supreme Court, the lower courts continue to address and decide preemption questions based on existing law.

Since our last update in March 2007, federal district courts in West Virginia, Missouri, Indiana, and Kentucky all have considered whether the express preemption clause for medical devices resulted in the preemption of tort lawsuits. Each held that the premarket approval granted for a Class III medical device created device-specific federal requirements that preempted different or additional state requirements generated through state tort lawsuits. Cottengim v. Mentor Corp., No. 05-161-DLB, 2007 WL 2782885 (E.D. Ky. Sept. 24, 2007); Rattay v. Medtronic, 482 F. Supp. 2d 746 (N.D.W. Va. 2007); Madsen v. Am. Home Products Corp., 477 F. Supp. 2d 1025 (E.D. Mo. 2007); Thornburg v. Stryker Corp., No. 05-CV-1378, 2007 WL 1742172 (Mag. S.D. Ind. June 12, 2007), adopted, 2007 WL 1959117 (S.D. Ind. July 3, 2007); Alfred v. Mentor Corp., No. 05-483-C, 2007 WL 708631 (W. D. Ky. March 5, 2007). In a similar vein, the Utah District Court in Tuttle v. CIBA Vision Corp., No. 05-CV-340, 2007 WL 677134 (D. Utah March 1, 2007), held that an FDA Guidance Document gave rise to preemption. The Guidance Document governed hydrogen-peroxide-based solutions like the defendant’s product, and the court concluded it constituted a federal labeling requirement. Id. at *2. As a result, the plaintiff’s state tort claims that asserted liability based on the alleged defectiveness of the Guidance Document-specified warnings were preempted. Id.

As for state courts, in a case of first impression in Wisconsin, the Wisconsin Court of Appeals upheld express preemption in a PMA medical device case as well. See Blunt v. Medtronic, Inc., 738 N.W.2d 143 (Wis. Ct. App. 2007) (holding that the PMA approval process created federal requirements that preempted state law tort claims), petition for review filed, No. 2006AP001506 (Wis. Aug. 30, 2007). Reed Smith’s Michael Brown and Lisa Baird represent Medtronic in Blunt.

Even though the overwhelming majority of cases favor preemption in Class III, PMA-approved medical devices, several notable adverse cases have been handed down in the past six months as well. Frequently in such adverse cases, the court believes the manufacturer’s compliance with the applicable federal requirements is in question. See, e.g., Brown v. DePuy Spine Inc., 22 Mass. L. Rptr. 425, 2007 WL 1089337 (Mass. Super. Apr. 9, 2007).

Thus, in In re Guidant Corp. Implantable Defibrillators Products Liability Litigation (Duron), No. 05-1708, 2007 WL 1725289 (D. Minn. June 12, 2007), the court accepted for purposes of a summary judgment motion

1011, 2007 Phila. Ct. Com. Pl. LEXIS 64 (Phila. Ct. Com. February 28, 2007), the court examined the plaintiffs’ claim that an over-the-counter homeopathic drug, Cold-Eeze, was falsely advertised for the treatment and prevention of the common cold and allergies. Id. at *5. The court held that the plaintiff’s tort claims were preempted, stating:

If the Court were to permit Plaintiffs’ claims to proceed and Plaintiffs were successful, Defendant would be required to include different information in its label than that reviewed, approved and required by the FDA. Id.