United States District Court, N.D. Indiana, Fort Wayne Division
RONALD J. MCAFEE, Plaintiff
MEDTRONIC, INC., Defendant.
OPINION AND ORDER
ROBERT L. MILLER, Jr., District Judge.
Ronald McAfee sued Medtronic, Inc., a medical device manufacturer, under Indiana's Product Liability Act and common law alleging that he was injured by a defective Medtronic Sprint Fidelis Lead (Model 6949). Medtronic has moved to dismiss the amended complaint under Fed.R.Civ.P. 12(b)(6). For the following reasons, the court GRANTS the motion in part, and DENIES it in part.
The Medtronic Sprint Fidelis Lead is classified as a Class III device-one that "cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and is "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, " or "presents a potential unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(C)(ii); Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008). As such, it receives the most federal oversight. Id.
The Medtronic Sprint Fidelis Lead Model 6949 received Pre-Market Approval, known as a "PMA, " from the FDA in June 2004, subject to the conditions in the approval letter (Exh. C to the Amd. Cmplt.) and in the Conditions of Approval for Implantable Defibrillators and Programmers (Exh. B to the Amd. Cmplt.).
The Conditions of Approval for Implantable Defibrillators and Programmers required Medtronic to file "Post-Approval Reports" and adverse event reports. The former were due annually, the latter were to be submitted within 10 days after Medtronic "receive[d] or ha[d] knowledge of information concerning":
(1) A mixup of the device or its labeling with another article.
(2) Any adverse reaction, side effect, injury, toxicity, or sensitivity reaction that is attributable to the device and
(a) has not been addressed by the devices labeling or
(b) has been addressed by the devices labeling, but is occurring with unexpected severity or frequency.
(3) Any significant chemical, physical or other change or deterioration in the device or any failure of the device to meet the specification established in the approved PMA that could not cause or contribute to death or serious injury but are not correctable by adjustments or other maintenance procedures described in the approved labeling...
(Amd. Cmplt. ¶ 13).
On July 10, 2006, Medtronic submitted 15 adverse event reports to the FDA relating to the Sprint Fidelis lead and dating back to March 25, 2006. Eleven days after the reports were submitted, a Sprint Fidelis Lead was implanted in Mr. McAfee.
On March 21, 2007, Medtronic sent a letter to physicians notifying them of the occurrence of adverse events with the Sprint Fidelis Leads involving fracture of the lead wires and inappropriate shocks or loss of therapy; and on October 15, 2007, it initiated a recall of the leads (including the lead implanted in Mr. McAfee).
In November 2010, Mr. McAfee experienced inappropriate shocks in his chest, was hospitalized, and had the pacemaker-defibrillator and lead surgically removed and a new device implanted. He filed this suit two years later.
Mr. McAfee alleges that Medtronic received information about fifteen adverse events related to the Sprint Fidelis Lead causing inappropriate shocks between February 25, 2006 and May 22, 2006, but waited until July 10, 2006 to report those events to the FDA (Amd. Cmplt. at ¶ 21). He thus concludes that Medtronic violated the conditions of approval, thereby invalidating the PMA as of March 8, 2006 (ten days after Medtronic received the first adverse event notice) and rendering the product "adulterated" under 21 U.S.C. 351(f)(B), and "misbranded" under 21 U.S.C. 352(t).
Mr. McAfee alleges that:
28. [Medtronic] was or should have been aware no later than March of 2006 that the Medtronic Sprint Fidelis Model 6949 Lead was inordinately prone to develop fractures causing inappropriate shocks or loss of therapy after implementation in patients, yet failed to give effective notice to the physicians who had previoulsy implanted the product... of the danger of the product.
29. Such a warning, if given, would have caused such physicians, and subsequent patients to consider an alternative product prior to surgical implantation, and to avoid the serious injuries ...