Medtronic to Settle Sprint Fidelis Defibrillator Suits - NYTimes.com

8,100 claims settled for $268 million - about $33,000 each - in the tort litigation against Medtronic, manufacturer of the defective Fidelis model electrical leads in their ICD's (Implanted cardiac defibrillators).  13 died, others have had their leads removed after failure - in a precarious operation as the leads are embedded in the arteries serving the heart.  Others have leads that may soon fail.


The settlement is at nuisance value because, following the United States Supreme Court's decision in Riegel v. Medtornic courts have concluded that all claims arising form the defective devices are preempted - and barred by federal law.  The FDA in reviewing new devices does not analyse whether an alternative safer design was practical and feasible.  Yet the the Supreme Court ruled 7-2 that the language of 21 USC 360k barred suits because it forbids states to impose requirements that are "different from or in addition to" those imposed by the FDA.  The only state suits that appear to survive Riegel are "parallel" to, not "in addition" to FDA "requirements".


The latest decision - by the 8th circuit in Bryant v. Medtronic dismissed all claims - even the manufacturing defect claims that seemed to have been spared in Riegel.  The 8th Circuit ruling was celebrated by the drug and medical device industry cheerleaders at Dechert's Drug & Device Law blog, where they have long practiced licking the hand that feeds them.


Fortunately for the plaintiffs they were able to salvage some value because Circuit Judge Melloy dissented.  the plaintiffs should have been given the opportunity - after a partial summary judgment grant - to amend their complaint to more specifically allege that there was a manufacturing defect - a departure from the Premarketing Approval requirements of the FDA.  The complaint lacked specificity about the defect the Circuit court held.  But specification was possible only if the plaintiffs obtained through discovery the FDA's otherwise unavailable manufacturing requirements.  The procedural specificity requirements of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) thus provided another obstacle in the already rocky road faced by plaintiffs.


Judge Melloy explained, in dissent:

[T]he parallel state claim that may escape preclusion under § 360k requires the plaintiffs to prove Medtronic failed to manufacture the Sprint Fidelis Leads in compliance with the requirements set forth in the confidential PMA and supplemental PMAs. To apply Twombly rigidly without permitting discovery as to these documents effectively creates an impossible-to-achieve specificity requirement.The combination of the rigid application of Twombly and the now-articulated parallel claim exception to § 360k preemption have, in these cases, led to the dismissal of over two hundred potentially meritorious lawsuits on a technicality.

The real villain is the Congress - and particularly the Republican minority thanks to the 60 vote cloture requirement.  They have blocked H.R. 1346, which would reverse Riegel.