This post is from the non-Reed Smith side of the blog only.
The InFuse litigation has certainly given us quite a lot to talk about – and almost all of it positive. It has been a treasure trove for defendants on off-label marketing and promotion claims. We’ve collected this bounty of riches here. While each case has its own nuances, they are all really slight variations on a theme – the almost unanimous rejection of plaintiffs’ attempts to use off-label marketing to thread the preemption needle. While the reasoning varies from court to court, the over-arching message is the same – off-label marketing does not change the preemption analysis. The InFuse device, regardless of how it was used by a particular surgeon in a particular surgery, is a PMA-approved, Class III device and therefore covered by both Riegel express preemption and Buckman implied preemption. Very little slips through the small space between the two.
If you want a more complete history of the InFuse litigation, we point you to our collection referenced above. For even casual readers of our blog, we think you’ve probably seen some of our writings on the topic and so we aren’t going to wade back through the details. Today’s post is more of an update. Here are the latest four InFuse victories.
Truthful v. Untruthful Promotion
First up is Byrnes v. John Small, 2015 U.S. Dist. LEXIS 33555 (M.D. Fla. Mar. 18, 2015). This case is fairly typical for InFuse. Failure to warn and design defect claims are preempted, id. at *13-14, *17-19. We will point out that this is another court that understands that the FDA approves devices, not “specific uses” of devices. Id. at *18. More importantly, Byrnes is also another outright rejection of our least favorite InFuse case, Ramirez, and points out the poor logic of that ruling. Id. at *18-19.
That leaves fraud and misrepresentation based claims which most courts, present company included, hold are not preempted. The reasoning however is very important to understanding why allegations of off-label promotion in and of themselves don’t trigger a shift in the preemption analysis:
The Court emphasizes that is ruling applies only to untruthful off-label promotion. . . To the extent that Plaintiffs are suggesting that a claim premised on truthful off-label promotion is not preempted, the Court disagrees. Such a claim would be impliedly preempted because, even if off-label promotion were prohibited under the FDCA, Plaintiffs have failed to identify a state law duty to refrain from off-label promotion.
Id. at *15-16, n.2 (emphasis in original). This court places the focus on the right thing – not whether the promotion by the defendant was on-label or off-label, but rather whether it was truthful or untruthful. The FDCA prohibits false and misleading promotion and it is in this context that there is the possibility for a state law claim to run parallel to (not conflict with) a federal requirement. We stress “possibility” because outside of preemption, the reason most of the InFuse claims fail is because plaintiffs can’t meet the heightened pleading standards for fraud. For instance, in Byrnes, plaintiff’s fraud claim was dismissed because plaintiff “only allege[s] in a vague and conclusory manner that Medtronic ‘fraudulently concealed and misrepresented’ the dangers of the off-label use.” Id. at *16. Plaintiff’s misrepresentation and express warranty claims suffered the same fate. Id. at *21, *24-25.
No Causation; No Plaintiff-Created FDCA Requirements
In Jones v. Medtronic, 2015 U.S. Dist. LEXIS 29827 (D. Ariz. Mar. 6, 2015) we focus on two primary takeaways – well, three if you include yet another complete rejection of Ramirez, which we certainly do. Id. at *29. Our first takeaway was the dismissal of plaintiff’s claim that Medtronic should have provided additional safety information, beyond that required by the FDCA, specific to the off-label use. The court correctly interpreted this as an attempt by plaintiff to “write in a new provision and add to the requirements provided by the FDA.” That’s definitely a conflict with federal requirements and so no question it was preempted. Id. at *27.
Second, like we mentioned above, often fraud claims get by preemption, but fail just as quickly on other grounds. Here that ground was causation: “Missing from [plaintiff’s] allegation is that Defendant fraudulently induced her doctor to use Medtronic products in her surgeries.” Id. at *22 (emphasis in original). Usually, courts give plaintiffs an opportunity to fix this type of deficient pleading, but here plaintiff’s causation problems were too large to surmount. In her complaint, plaintiff actually alleged “she has no idea of what specifically caused her injuries” and that it may be impossible to establish which of the specific devices used in her surgery caused her injuries. Id. at *23-24. Sounds to us like this could have been the start, middle, and end of the decision on all counts, but we won’t argue that point since the court ultimately came to the right conclusion and dismissed this case in its entirety.
Round 2 Goes to Medtronic
The new Scovil can be found at 2015 U.S. Dist. LEXIS 25708 (D. Nev. Mar. 2, 2015). The prior decision was entered when the case was jointly filed by the two Scovil brothers (Leigh and Brett) and was pending in Arizona. The Arizona court dismissed certain of plaintiffs’ claims as preempted but as to those that remained, it severed Brett Scovil’s claims and transferred them to Nevada. After an amended complaint was filed in Nevada, Medtronic again moved to dismiss. Id. at *2-3. To the extent plaintiff re-pleaded claims that were previously dismissed by the Arizona decision – the result was no different, the claims were dismissed. What that boils down to is that plaintiff is left with a Stengel failure to advise the FDA of adverse events claim, a fraud and misrepresentation claim, and possibly an express warranty claim. On that last one, plaintiff has to amend his complaint with allegations of the specific affirmations made by defendant to him or his surgeon and how those affirmations became part of the basis of the bargain. Id. at *32.
And the new Schouest opinion can be found at 2015 U.S. Dist. LEXIS 34673 (S.D. Tex. Mar. 20, 2015). It is exactly what we hope for when a court gives a plaintiff a do-over – a complete dismissal.
The first decision left open three claims that could possibly survive preemption. On negligence, plaintiff couldn’t demonstrate a state law duty to report adverse events to the FDA and didn’t point to any reporting regulation allegedly violated. Id. at *4. No Stengel claim. On express warranty, plaintiff had to identify the specific warranties made to plaintiff or her physician. Plaintiff made all her same general allegations but added: “Medtronic made express warranties regarding the safety and efficacy of the Infuse Bone Graft in off-label uses.” Id. at *5. Finding this new allegation even broader and less-specific, the court dismissed the warranty claim. Finally, plaintiff was given a chance to keep her Texas Consumer Protection Law claim if she pleaded which specific statutory duties defendant allegedly violated. She didn’t do so yet again, so that claim failed too.
On fraud and misrepresentation, the court applied the heightened pleading standard and found all plaintiff’s claims lacking. As to her general fraud claim, the Fifth Circuit requires plaintiff to identify the speaker of the allegedly fraudulent statements as well as when and where the statements were made. Id. at *12. Plaintiff failed to satisfy those requirements by not identifying the Medtronic employee who spoke to plaintiff’s physician and/or not identifying a single piece of literature that contained a false statement. Id. On constructive fraud, plaintiff failed to allege how Medtronic violated a legal or equitable duty to plaintiff. Again, plaintiff alleged misstatements of material facts, but “never specifies what those material facts are or how they misrepresented the truth.” Id. at *15. And plaintiff’s misrepresentation claim suffered the same fate – no specific misrepresentations. As to off-label allegations, the court found plaintiff’s allegations that defendant misrepresented the safety of off-label to be “conclusory and general.”
Bottom line — Scovil and Schouest stumbled into Round 2. Scovil is on the ropes but still standing. Schouest is down for the count.