A recent Virginia federal court decision demonstrates the powerful effect of the Riegel v. Medtronic precedent in product liability cases where PMA-devices are subject to claims-sounding in negligence or breach of duty related to the design, manufacturing, and labeling of the device. According to this court, however, the preemption defense of Riegel reaches only those allegations based on the safety and efficacy of the device itself, not on the alleged conduct of a company representative in the operating room during use of the device.

In Adkins v. Cytyc Corp, No. 4:07CV00053, 2008 WL 2680474 (W.D. Va. July 3, 2008), plaintiff brought suit against the manufacturer of a device called the NovaSure, used during a surgical procedure called endometrial ablation that was performed on plaintiff. In addition to the usual product liability claims, plaintiff pleaded a cause of action implicating direct actions of defendant’s representative (presumably a sales representative; the opinion describes the person simply as a “corporate representative”) during the surgery in mistakenly instructing the operating physician. Id. at 1. Because of an error in measuring the size her uterine wall, plaintiff suffered injuries during the ensuing ablation procedure.

Defendant moved to dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure, based upon the Supreme Court’s decision in Riegel v. Medtronic, 128 S. Ct. 999 (2008). Because the NovaSure device is a Class III medical device that received pre-market approval by FDA, the court dismissed with little fanfare all of plaintiff’s causes of action “that sound in negligence or breach of duty related to the design, manufacturing, and labeling of the NovaSure device.” Id. at 2. To allow plaintiff to proceed with her action “would impose requirements that differ from by the FDA on [the manufacturer].” Id.

But the preemption issue was not the end of the court’s analysis. Plaintiff also pleaded that “defendant’s corporate representative” had “a duty to ensure that the NovaSure device was operating correctly and that [the surgeon] followed the proper procedures when using the NovaSure device.” Id. (internal citation omitted).

The court found that FDA did not regulate plaintiff’s agency theory of liability, and that preemption did not reach this claim. Describing such “localized situations,” id. at 3, as traditional matters for the common law, not FDA’s regulatory approval process, the court held that the agency claim “does not challenge the design, manufacture, and labeling of the NovaSure device so as to implicate Riegel preemption, but rather challenges negligence by a corporate agent acting as a de facto physician’s assistant during a surgical procedure.” Id.

However, plaintiff’s complaint failed to adequately plead, under Bell Atlantic Corp. V. Twombley, 127 S.Ct. 1955 (2007), facts to explain what defendant’s representative did or failed to do as part of his alleged duty. Further, the complaint did not specify whether plaintiff’s alleged injuries were caused by a failure of the NovaSure device or by a treatment error induced by instructions from the corporate representative. Therefore, under Twombley, the complaint fell short and, as a result, the court dismissed the complaint without prejudice and granted plaintiff leave to re-plead only on her agency theory of recovery. Id. (Query whether plaintiff will in fact state an actionable claim if she re-pleads, as some courts have rejected attempts to impose liability on non-physicians for failing to control a physician’s delivery of medical services for policy reasons. See, e.g., Kernke v. The Menninger Clinic, 173 F. Supp. 2d 1117 (D. Kan. 2001) (physician running clinical trial, not clinical trial sponsor, owed study participants duty to provide adequate medical care and duty to obtain informed consent); McKee v. American Home Prods. Corp., 113 Wash. 2d 701, 716 (1989) (non-physician without patient’s medical history not qualified to determine propriety of treatment, as that would require non-physician to improperly interfere with physician-patient relationship, where physician might have sound medical reasons for what appears to be a non-standard treatment); Cottam v. CVS Pharmacy, 436 Mass. 316, 321 (2002)(same)).

That the majority of this decision is devoted to the issue of whether plaintiff stated a claim against defendant’s corporate representative demonstrates the strength of the Riegeldecision in cases involving PMA-approved devices – as does the court’s willingness to grant a preemption dismissal on a Rule 12(b)(6) motion. Also of significance is the court’s application of Twombley to product liability claims, which all product liability defendants should consider when analyzing whether a plaintiff’s complaint uses mere labels, conclusions, or simply a formulaic recitation of the elements of a cause of action.

Use the following links to read the court's Memorandum Opinion, the original Order, and its Amended Order.