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). After Medtronic's motion to dismiss the amended complaint under Fed. R. Civ. P. 12(b)(6) was granted in part and denied in part, Medtronic moved for reconsideration [Doc. No. 32], asking the court to dismiss the remaining state law claims premised on an alleged failure to warn and grant the motion to dismiss in its entirety. For the following reasons, the court grants the motion.
Medtronic raised two issues on reconsideration, but based its motion on only one: whether the amended complaint sufficiently alleges causation. To state a plausible parallel claim for failure to warn and avoid preemption, Mr. McAfee must allege (and ultimately prove) that: (1) Medtronic violated a federal requirement applicable to the Sprint Fidelis lead; (2) state law imposes a "genuinely equivalent" requirement; and (3) the federal violation caused his injuries. See
Mr. McAfee's failure to warn claim is premised on these allegations:
[Doc. No. 19].
Medtronic argued in its original brief and on reconsideration that the fifteen adverse event reports on which Mr. McAfee relies to establish causation were filed before his lead was implanted and clearly didn't cause Mr. McAfee and his physician to consider or use an alternative product, so any delay in filing couldn't have caused his injury. Noting that Mr. McAfee hadn't presented any other facts which, if true, would establish a causal nexus between the alleged reporting violations and his injuries, Medtronic concluded that Mr. McAfee hadn't stated a plausible claim for relief based on a failure to warn.
Although Mr. McAfee didn't address the issue in his response to the motion to dismiss or move to amend his complaint, he now says that the fifteen violations alleged in paragraph 21 of the amended complaint weren't isolated events, but instead establish a "pattern of late reporting" and a "continuing wrong" that began before his lead was implanted on July 21, 2006 and continued thereafter. He cites in support the results of an internet search he conducted after the motion to reconsider was filed, which showed that the FDA received 166 adverse event reports of "inappropriate shock" between July 1, 2006 and March 1, 2007, one of which involved an event that occurred on July 2, 2006 (before his surgery), but wasn't reported until August 15, 2006 (44 days after Medtronic received notice of the event and 25 days after his surgery). [Doc. No. 38 (Exh. A and B)]. Mr. McAfee believes that there might be more.
Mr. McAfee can't amend his complaint by raising new claims in response to the motion to dismiss,
Accepting as true Mr. McAfee's assertion that the fifteen violations alleged in his complaint weren't the only reporting violations that occurred before his surgery, Mr. McAfee still hasn't suggested how any delay in filing a report (or reports) with the FDA caused or contributed to his injuries, i.e., that had Medtronic filed the report of the July 6, 2006 adverse event before his surgery, his physician would have received notice of that filing, and would have considered and used a different lead. Mr. McAfee simply alleges that the failure to file adverse reports with the FDA "proximately caused [his] injuries and damages." (Amd. Cmplt. ¶¶ 66(g) and 67). Conclusory allegations are insufficient. See
Although Medtronic didn't base its motion to reconsider on the argument raised in footnote 1 of its brief, it also contends that the court erred as a matter of law when it concluded that Mr. McAfee's failure to warn claims "would not impose state-law requirements `different from, or in addition to,' those imposed by the FDA during the premarket approval process," and assumed that Indiana law would recognize a failure-to-warn claim based on Medtronic's alleged failure to submit timely adverse event reports to the FDA.
The express preemption provision in the Medical Device Act precludes claims based on a state requirement "which is different from, or in addition to, any requirement applicable . . . to the device" under federal law, 21 U.S.C. § 360k(a);
To state a parallel claim and avoid preemption, Mr. McAfee must show that Indiana law imposes a requirement or duty that is "genuinely equivalent" to the federal reporting requirements that were allegedly violated. See
The court assumed for purposes of the motion to dismiss that Mr. McAfee had sufficiently alleged a parallel claim because the parties didn't address the issue of whether a warning to a third party, like the FDA, would satisfy a manufacturer's duty to warn the user or consumer of latent dangers associated with the lead under Indiana law, specifically IND. CODE §§ 34-20-2-2 and 34-20-4-2 (the state statutes on which Mr. McAfee based his claims).
For the foregoing reasons, Medtronic's motion for reconsideration [Doc. No. 32] is GRANTED, and the state law claims based on a failure to warn are DISMISSED, without prejudice. Pursuant to Fed. R. Civ. P. 15(a)(2), Mr. McAfee is afforded to and including May 26 to file an amended complaint, if appropriate.
SO ORDERED.