Rejects Preemption of Class III Device Claims


The California Court of Appeals held iColeman v. Medtronic, that the plaintiff’s claims of negligence per se and strict liability failure to warn can move forward.  Appeal specialist  Martin Buchanan successfully argued the issue on behalf of Coleman, who will now proceed to the discovery phase, according to Gomez Trial Lawyers attorney John Fiske.  “The appellate court decided that Coleman’s failure to warn theory of liability, based on Medtronic’s failure to report adverse events to the FDA, is not preempted (following the Ninth Circuit’s Stengel v. Medtronic decision), but that failure to warn based on off-label promotion was preempted,” Fiske told HB.  “Under a negligence/negligence per se theory, Coleman’s case is not preempted for failure to report adverse events to the FDA and is not preempted for off-label promotion.  And finally, the court decided it was premature to decide preemption issues regarding Coleman’s manufacturing defect theory until discovery reveals more information.”

The Deepening Divide

In a post on their site, Faegre Baker Daniels attorneys Andrew L. Campbell and M. Joseph Winbrenner said Coleman is just “the latest contribution to the deepening judicial divide over preemption of state law tort claims in cases implicating Class III medical devices.”

“If courts continue to validate these tactics,” Campbell and Winbrenner wrote, “the medical device industry could feasibly see a surge in the number of claims implicating Class III medical devices, as well as the number of such claims surviving preemption challenges at the pleadings stage. While some cases will continue to be dismissed on preemption grounds, others will survive, requiring a greater investment in discovery and motion practice. Although, later on, such cases likely will be vulnerable to summary judgment challenges on causation grounds, as the Coleman court observed, an influx of claims of this type will no doubt raise the industry’s overall costs of defense and, in turn, potentially increase costs to patients.”

In her post on the Drug & Device Law Blog, Michelle Yeary, a Dechert attorney, asked:  “So, how did Coleman get it so wrong?”  Here is some of  how she answered that question:  

“Here comes the misplaced reliance on Farm Raised Salmon’s “it’s not federal, it’s state law” rationale.  Coleman, slip op. at 22.  Farm Raised Salmon was a food case and as such, the California Supreme Court based its decision on a food-specific amendment to §337(a).  That section, part of the 1990 Nutrition Labeling Act, provides that “no State. . .may directly or indirectly establish under any authority or continue in effect as to any food. . .any requirement for the labeling of food. . .that is not identical to the [federal] requirement.” 21 U.S.C. §343-1(a).  As we discussed at considerable length, the ruling against preemption in Farm Raised Salmon is entirely and exclusively based on the “negative implication” of §343-1(a) – that states may enforce “identical” requirements” with respect to “food” pursuant to the Nutrition Act amendments to the FDCA.  Indeed, when we first commented on Farm Raised Salmon, we noted that the court’s extensive reliance upon §343-1(a) was a silver-lining for prescription drug and device cases.  To this day Congress has not enacted anything that detracts from or contradicts its original decision to prohibit private enforcement with respect to drugs and devices.  But Coleman ignores this critical difference.”


HB will present the Mass Tort Med School for Plaintiff Attorneys on May 7-9, 2014 at the Boca Raton Waldorf Astoria, where Infuse and several other products will be discussed by physicians and trial lawyers.  Click for more details.