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Indiana Judge Relies on Bausch to Bounce Preemption Motion

May 15, 2017 | Jeffery Kruse

The old adage “location, location, location” applies as much for medical device preemption as it does for real estate. Despite acknowledging that the plaintiff’s Amended Complaint “would likely not survive a motion to dismiss if this case was pending in a court in the Eighth Circuit (or perhaps the Eastern District of New York),” an Indiana federal judge recently denied Medtronic’s motion to dismiss the Amended Complaint in Cavender v. Medtronic, Inc. (Cavender II), 2017 U.S. Dist. LEXIS 57376 (N.D. Ind. Apr. 14, 2017). 

As frequently happens in cases involving pre-market approved medical devices, the court dismissed the initial complaint.  He dismissed the initial Complaint because it was “nothing more than the sort of “unadorned, the-defendant-unlawfully-harmed-me accusation” and was “still in the ‘assembly required’ stage.” Cavender v. Medtronic, Inc. (Cavender I), 2016 U.S. Dist. LEXIS 154540 *20-21 (N.D. Ind. Nov. 8, 2016).  But, just as many other courts do, the judge in this case, Judge William C. Lee, granted the motion to dismiss without prejudice and gave the plaintiff another chance to try to plead a valid claim.

In Cavender I, the plaintiff alleged that her implantable cardioverter defibrillator malfunctioned and injured her.  She filed her initial complaint “apparently asserting product liability, breach of warranty and negligence claims against Medtronic.”  Cavender I, at *2.  Judge Lee’s first task in Cavender I was to determine whether the Indiana Product Liability Act (IPLA) preempted and subsumed plaintiff’s attempted product liability claims.  Judge Lee concluded that the IPLA subsumed the negligence and product defect claims. 

However, plaintiff’s complaint lacked specifics and was “nothing more than the sort of ‘unadorned, the-defendant-unlawfully-harmed-me accusation’” which was “chock-full of keywords that imply” that the plaintiff was “attempting to assert various product liability claims.” Id. at *20.  Because the plaintiff’s complaint “need[ed] work” and was “still in the ‘assembly required’ stage,” Judge Lee gave plaintiff another chance to plead valid claims.  Id. at *21-22 and 37. 

In his order in Cavender I, Judge Lee offered guidance for what plaintiff needed to do to plead valid claims.  For example, in response to Medtronic’s argument that federal law preempts plaintiff’s claims, Judge Lee noted that the Complaint “is completely devoid of any facts whatsoever that would even imply that she is alleging a violation of federal law.”  Id. at *28.  Judge Lee advised the plaintiff that the “amended complaint will clarify this issue also.”  Id. at 29.

Rather than directly clarifying the issue as instructed by Judge Lee, in the Amended Complaint, the plaintiff switched which device she was claiming caused her injury.  In the initial Complaint, she vaguely alleged that a defibrillator malfunctioned and injured her.  Id. at *2.  In the Amended Complaint, she copied allegations from the Master Consolidated Complaint in the Sprint Fidelis Leads Prods. Liab. Litig. MDL and alleged a separate device, a Sprint Fidelis lead, caused her injuries.  

Plaintiff copied the allegations from the Sprint Fidelis Leads Prods. Liab. Litig. MDL even though the MDL judge dismissed those claims with prejudice at the pleading stage. See In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F.Supp.2 1147 (D. Minn. 2009) (dismissing the Master Complaint because federal law preempted the negligence and strict liability claims) aff’d Bryant v. Medtronic, Inc. (In re: Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig, 623 F.3d 1200 (8th Cir. 2010). 

By copying the preexisting and previously dismissed complaint, the plaintiff added more detail than in her initial complaint.  Judge Lee noted that:

[W]hile the claims contained in her original Complaint were barely discernible, they now jump vividly off the page in full regalia, all because they are clothed in language taken—largely verbatim—from another complaintfiled against Medtronic that was summarily dismissed by another district court eight years ago. Id. at *8-9.

Despite the product switcheroo and the blatant copying of a previously dismissed complaint, in Cavender II, Judge Lee concluded that the Seventh Circuit’s decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), “precludes dismissal of Cavender’s IPLA claim at this point and the motion to dismiss must be denied as to the issue of federal preemption of that claim.”  Cavender at *33. 

Judge Lee noted that the Seventh Circuit in Bausch agreed with the dissent in the Eighth’s Circuit’s decision affirming the dismissal of the Master Complaint in the Sprint Fidelis Leads Prods. Liab. Litig. MDL. In short, “the Seventh Circuit took a decidedly different approach to the issue of MDA preemption as it applies to state law claims.”  Cavender II at *26-27.  Thus, according to Judge Lee, “the Bausch decision mandates that [plaintiff] be permitted, at this juncture, to proceed with that claim notwithstanding the preemption clause in the MDA.” Id. at *38.

One other aspect of Judge Lee’s order is noteworthy.  The plaintiff argued that because preemption is an affirmative defense, that she should not have to "defend" against an affirmative defense at this stage, thus the Court should not consider the defense as a basis for dismissal.”  Id. at n.5 *21.  Medtronic did not take issue with “that statement of the law” and Judge Lee declared that plaintiff was “correct, of course.”  Id. Rather than take issue with the statement of law, Medtronic argued that because the plaintiff copied and pasted the very detailed, dismissed MDL complaint relating to this Lead[,]" she has, "[u]nder Seventh Circuit law . . . pled enough facts for the Court to consider the affirmative defense of preemption."  Id. Because Judge Lee concluded that the Bausch decision precluded preemption at the pleading stage in this case, he determined that the issue was “rendered irrelevant.”  Id. 

Judge Lee’s order is yet another example of how the Bausch decision continues to cause problems for medical device makers at the motion to dismiss phase in cases in the Seventh Circuit.  The plaintiff in Cavender II simply copied allegations the Eighth Circuit had already dismissed as preempted.  But because of the overly permissive language of Bausch, those same claims survive the motion to dismiss in the Seventh Circuit.  Medtronic’s preemption argument may very well prevail at the summary judgment stage, but only after spending on unnecessary litigation expenses.

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The BSCR Drug / Device Law Blog examines topics and legal developments of interest to the drug and device industry. Learn more about the editor, Angela Higgins, and our Drug and Device practice.

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