This post is from the non-Reed Smith side of the blog only.
Having to report on a negative InFuse decision happens about as often as meteorologists correctly predict snowstorms. Boy did they get it wrong for New Jersey and Pennsylvania this week. Talk about deflated snowfall expectations. Speaking personally for a minute, this non-skiing, non-snowboarding, warm-weather-loving blogger was not disappointed at this turn of events. And, we actually feel a little sorry for weather forecasters whose sole job it is to predict the often unpredictable, but who are held to exacting standards. Next time a blizzard is predicted, people will mock the forecast, go to work, get stuck in ten inches of snow, slip and slide the whole way home, and then complain that the warning wasn’t strong enough. Meteorologists really can’t win.
Defendants in the InFuse litigation, however, usually do. But like meteorologists who occasionally hit it right on, sometimes an InFuse judge gets it wrong. When that judge is confined by having to apply Bausch v. Stryker Corp., 630 F.3d 546, 552 (7th Cir. 2010), the result isn’t completely shocking. Disappointing, but not shocking.
The basic allegations in Garross v. Medtronic, Inc., 2015 U.S. Dist LEXIS 6675 (E.D. Wis. Jan. 21, 2015) are like those in all of the other InFuse cases. The InFuse bone fusion system is a Class III, pre-market approved medical device. As such, plaintiff’s claims should only survive if they can squeeze through the “narrow gap” left after application of express and implied preemption. Notably, the Garross court called it only “a gap,” id.at *7, suggesting a more spacious opening then we believe is supported by the case law.
To try to wedge their claims into that narrow gap, the InFuse plaintiffs focus almost exclusively on allegations of off-label promotion which they allege should get them around express preemption. Most courts, however, have ruled that the majority of plaintiff’s InFuse claims don’t fit that tight space and that allegations of off-label promotion don’t change the equation. See prior InFuse posts.
So, where does this decision differ from the majority? First, the court places an over-emphasis on product use. For instance, in describing the PMA process, the court focuses on the fact that manufacturers have to specify the “intended use” of the product. Id. at *2. The court goes on to say that the “FDA has never approved use of the combination device in other parts of the body or in any other type of procedure.” Id. at *3. But this completely misses that the FDA approves products, not uses. Nor can the FDA prohibit surgeons from using a device anyway they see fit, including for an off-label use. And, as other InFuse courts have found, products liability isn’t about uses either, it’s about products. So how a plaintiff’s surgeon chose to use a device doesn’t alter the preemption analysis.
Next, the court found that each of plaintiff’s state law claims is premised on an “alleged underlying violation of federal law.” Id. at *8. The court ruled that plaintiff’s fraudulent misrepresentation and fraud in the inducement claims are based on off-label promotion which is prohibited by the FDCA. Id. Putting aside whether that is an overly broad interpretation of what is permissible under the FDCA, the court doesn’t distinguish between truthful and false off-label promotion. An untrue statement or misrepresentation could support a fraud claim while also not running afoul of FDCA prohibitions on untruthful off-label promotion, hence escaping express preemption. A claim for fraud premised more generally on off-label promotion regardless of veracity, should be impliedly preempted. A state law fraud claim requires a misstatement, a falsehood. Without that, plaintiff’s claim is actually one to enforce FDCA off-label promotion regulations. That’s not allowed.
The court then found plaintiff’s negligence, negligent misrepresentation, strict liability failure to warn, fraud and constructive fraud claims weren’t preempted because they were premised on “failure to report adverse events to the FDA and to submit a supplemental application seeking approval of the off-label use it was promoting.” Id. at *10. We know that for now at least we are stuck with the “failure to report adverse events” in the circuits that have allowed it. We find it a little discomforting that it could be used to support all of these state law claims, but the court seems to think they are all essentially failure to warn claims. Id. What we haven’t seen before is a claim for failure to submit a supplemental application which this court allowed without much separate discussion. Our guess is that the discussion wouldn’t look much different than the one that supports failure to report claims, but some recognition that it was adopting a new claim would have been nice.
Finally, the court upheld plaintiff’s design defect claim as premised on off-label promotion, failure to report, and failure to seek supplemental approval. Id. at *10-11. This is probably the court’s longest stretch to avoid preemption and it is where the court’s incorrect focus on use comes into play. Plaintiff’s argument is that the InFuse device was defectively designed “for the use Medtronic promoted.” Id. at *11. But the FDA has conducted a safety analysis (risk/benefit analysis) of the InFuse device and determined that it was appropriately designed. Any decision by a jury to the contrary would be in direct conflict with the FDA’s determination and therefore the claim is expressly preempted. Allegations of off-label use and promotion have no bearing on design.
Medtronic argued various other reasons why plaintiff’s claims should also be dismissed, including failure to plead the fraud claims with particularity. The court found that plaintiff had satisfied the requirement of pleading “the who, what when, where, and how” of fraud with general allegations that Medtronic paid “opinion leaders” to promote off-label uses at sometime prior to plaintiff’s surgery in various places. Id. at *15. If that satisfies “particularity,” then I guess I owe my 10-year an apology for not being satisfied with a description of his day as “we did stuff, with people, it was good, we came home.”