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Drug / Device Law BlogLegal updates, news, and commentary from the attorneys of Baker Sterchi Cowden & Rice LLC

Federal Judge Clobbers Claims in a Class III Medical Device Case

May 22, 2017

Talk about a one-two punch. First, federal question jurisdiction kept a medical device case in federal court.  And then came the knock-out blow: a federal judge in North Carolina ruled that federal preemption barred all of the state law claims against the medical device companies.  In Burrell v. Bayer Corp., U.S Dist. LEXIS 38769 (W.D. N.C. March 17, 2017) (Burrell I), Judge Max O. Cogburn, Jr. retained jurisdiction over the medical device related lawsuit based on federal question jurisdiction.  In a subsequent order, Judge Cogburn granted Bayer’s motion to dismiss plaintiff’s claims because federal law preempts those claims.  Burrell v. Bayer Corp., U.S Dist. LEXIS 71374 (W.D. N.C. May 10, 2017) (Burrell II). 

The plaintiff in Burrell alleged she was injured as a result of her use of an Essure birth control device.  The Essure device is a Class III medical device approved by the FDA through the pre-market approval process.  Plaintiff sued various Bayer entities, as well as local doctors for malpractice to defeat diversity jurisdiction.  Bayer removed the case to federal court arguing it belonged there because of federal question jurisdiction.  As evidenced by the inclusion of local defendants in her Complaint, plaintiff did not want the case in federal court and, thus, filed a motion to remand.

But the plaintiff’s Complaint was “replete with references to the FDA” and included numerous allegations “that the defendants violated the federal requirements of the Federal Food, Drug & Cosmetic Act (FDCA).”  Burrell I, at *4-5.  Because plaintiff’s Complaint “necessarily raise[d] federal issues,” Judge Cogburn concluded it was “properly a case that ‘arises from’ federal law, as the MDA was passed by Congress to govern the safety and effectiveness of Class III medical devices.”  Id. at *11.  He therefore retained jurisdiction over the case and denied plaintiff’s motion to remand.  Id.

Just under two months later, Judge Cogburn delivered the knockout punch by granting Bayer’s motion to dismiss.  Before delivering the decisive blow, though, Judge Cogburn had to block plaintiff’s counter punch – a motion to reconsider the remand denial order.  In Burrell II, plaintiff tried again to convince Judge Cogburn that he should remand the case to state court.  Judge Cogburn had no trouble crushing plaintiff’s reconsideration attack.  For her reconsideration argument, the plaintiff relied on a 2005 Fourth Circuit case for the proposition that:

“[A] preemption defense that raises a federal question is inadequate to confer federal jurisdiction. Again, a case may not be removed to federal court on the basis of a federal defense, including the defense of preemption," even if the complaint begs the assertion of the defense, and even if the defense is the only question truly at issue in the case.

Burrell II, at *8-9 quoting Pinney v. Nokia, Inc., 402 F.3d 430, 446 (4th Cir. 2005).

But Judge Cogburn easily rebuffed the reconsideration wrangle by distinguishing Burrell from Pinney. While federal law “was ‘lurking’ as a question in the background” in Pinney, in Burrell II, “[b]y plaintiff’s own admission,” she alleged violations of the FDCA as part of her state law claims and thus her Complaint met the requirements for federal jurisdiction.  Motion for reconsideration denied.

After successfully deflecting plaintiff’s reconsideration left hook, Judge Cogburn led with a little jab about preemption.  Usually, when a judge begins a preemption discussion by noting that “Federal law generally recognizes a presumption against preemption,” the defendant can expect a body blow at the end of the discussion.  Thankfully, that was not what happened in Burrell II.  Instead, Judge Cogburn followed the jab with the express and implied preemption combination by noting that “the task of avoiding express and implied preemption is a difficult one.”  Burrell II.  He then thoroughly analyzed plaintiff’s claims and concluded federal law preempted all of the claims against the Bayer defendants.

Negligent Failure to Warn Claims

Plaintiff alleged the Bayer defendants were negligent by failing to warn of adverse events relating to Essure and that they “were under a continuing duty to comply with requirements” in the FDA’s pre-market approval of Essure.  On this point, the court agreed with the plaintiff. Burrell II at *12. But that agreement also meant federal law preempted plaintiff’s negligence claims because “plaintiff’s cause of action is being brought because the Bayer defendants allegedly failed to meet those reporting requirements.”  Id. at *12-13.

To insure the negligent failure to warn claims remained knocked out, as an added bonus, Judge Cogburn also ruled that “plaintiff cannot support a finding of causation” for those warnings claims.  Id. at * 13.  Judge Cogburn explained that by the time the plaintiff in Burrell received her device, “the FDA had the related information regarding the adverse event reports mentioned by plaintiff.”  Id. Thus, in addition to being a preempted claim, Judge Cogburn found that plaintiff “failed to show that the failure-to-warn caused her injuries.”  Id.

Negligent Failure to Train Claims

In addition to her negligent failure-to-warn claims, plaintiff also asserted claims that the Bayer Defendants failed to train the implanting physician about how “to implant the device, deal with potential complications, and remove the device.” Id. at *14.  Judge Cogburn quickly dispensed with plaintiff’s failure-to-train combination.  Federal law preempted plaintiff’s negligent training claim because plaintiff’s claim “imposes a duty that is beyond the confines of the MDA.” Id.  But on the downside, Judge Cogburn noted that such a claim could survive a preemption attack “to the extent that the manufacturer failed to provide the training required by the MDA.”  Id.  However, plaintiff’s Complaint did “not provide information as to how the training violated the FDA’s requirements or how her physician was trained.”  Id. at *14-15.  Due to lack of information on that point, federal law preempted the claim.

As with the negligent warning claims, Judge Cogburn also found plaintiff failed to provide sufficient facts to establish that any training failure caused her injuries.  Thus, in addition to being preempted, the negligent training claims failed for lack of causation.

Manufacturing Defect Claims

Judge Cogburn also knocked aside plaintiff’s weak attempt at throwing a manufacturing defect punch.  Although the plaintiff alleged her Essure was “manufactured improperly,” she did not link “any manufacturing deficiency to the device that [she] received and how it caused the alleged injuries.”  Id. at *16.  Thus, her manufacturing defect claim failed.

Design Defect Claim

Judge Cogburn parried plaintiff’s product liability claim as well. To the extent plaintiff argued that Essure suffered from a design defect, federal law expressly preempted those claims.  In brushing aside the design defect claim, Judge Cogburn simply noted that “The FDA made its determination [about the] safety and effectiveness” of the Essure and therefore “these design defect claims are preempted.”  Id. at 17.

Breach of Warranty Claims

Judge Cogburn blasted the breach of warranty claims.  The plaintiff alleged the Bayer defendants “expressly warranted Essure to be safe for use by the general public, including Plaintiff” and that the “warranties and representations ‘were untrue in that Essure was unsafe and unsuited for the use for which it was intended.’” Id. at *18.  In short, Judge Cogburn noted that “Congress provided the FDA with the authority to regulate the safety and effectiveness of Class III medical devices.”  So, he dismissed the breach of warranty claims.

Fraud and Unfair Trade Practices Claims

Finally, with all other claims against Bayer flat on the mat, Judge Cogburn crushed plaintiff’s unfair and deceptive trade practices claims.  Judge Cogburn noted that the “allegations largely repackage the allegations” he already dismissed and that “several of the alleged misrepresentations are indistinguishable from FDA-approved labeling statements.”  Id. at *19-20.  Plaintiff’s allegations of “deviations from the FDA-approved language” were insufficient to “support a claim based on fraudulent behavior or unfair trade practices.”  Id. at *20.  Federal law preempted those claims.

Medical Malpractice Claims

After knocking out all of the plaintiff’s claims against the Bayer defendants, Judge Cogburn came full circle and turned his attention to the medical malpractice claims against the local defendants.  Plaintiff eventually got her wish – the case will not remain in federal court.  Judge Cogburn declined to exercise supplemental jurisdiction over the medical malpractice claims and dismissed those claims pursuant to 28 U.S.C. § 1367(c)(3) so plaintiff could reassert those claims in state court.

Post Bout Summary

Under Riegel v. Medtronic, Inc., 552 U.S. 313, 128 S. Ct. 999 (2008), plaintiffs in Class III medical device cases have a “narrow window” through which they must plead when attempting to state “parallel claims.”  Judge Cogburn’s orders in this case provide great training roadmaps for knocking out claims in Class III medical device cases when plaintiffs allege violations of the FDCA or FDA regulations.  Bayer used a great combination of federal question jurisdiction and preemption arguments to flatten plaintiff’s claims in this Class III medical device case.  Bayer made the arguments, and Judge Cogburn delivered the epic knockout.

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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 Clark, and our Drug and Device practice.


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