This post is from the non-Reed Smith side of the blog.
It has been over 2 months since we lasted posted about an InFuse decision. What’s been happening (outside the DDL Blog world) since that last post. The Cuban flag was raised at its embassy in Washington DC officially restoring full diplomatic relations between the two countries for the first time since 1961. At almost the same time, the Confederate flag was removed from the South Carolina Capitol ending 54 years of it being on display. The Boy Scouts of America ended its ban on gay adult leaders and the first two women graduated from the Army Ranger School. And the last time Labor Day gas prices were this low, George W. Bush was in his first term as president (under $2 in New Jersey).
There is nothing quite so historical or monumental about the latest InFuse decision. It doesn’t break new ground or celebrate the demise of old prejudices. But it is a good, strong, solid opinion and another nail in the coffin for off-label promotion claims.
The case is Latimer v. Medtronic, Inc., No. 2014-CV-245871, slip op., (Ga. Sup. Ct. Sept. 4, 2015). The allegations are essentially the same as we’ve seen in other InFuse cases – because my doctor chose to use the device off-label, preemption should fly out the window. But as this court recognized, slip op. at 11-12, almost every court in the country that has considered that argument has found it significantly lacking. Time to add Georgia to the list. The decision includes a nice recitation of PMA preemption law, id. at 8-11, which serves as the court’s foundation for its ultimate conclusion that with the exception of affirmative fraud claims (which weren’t adequately pleaded), none of plaintiff’s other claims pass through the narrow gap between express and implied preemption. Id. at 11.
This plaintiff started like other InFuse plaintiffs by arguing that express preemption should not apply because his surgeon used the device off-label. Plaintiffs wield “off-label use” like vaudevillian magicians used “abracadabra.” Instead of pulling a rabbit out of a hat, plaintiffs try to make preemption disappear. But the courts have seen the smoke, the mirrors, and the strings – and they’re simply not buying it. Use doesn’t matter. PMA federal regulations are applicable to the device, not the use. Id. at 13. Plaintiffs’ parlor tricks don’t improve when they switch to “off-label promotion.” “[N]othing in §360k(a) suggests that the preemption analysis somehow depends on how the device is being promoted to be used.” Id. at 14 (citations omitted). So, regardless of off-label use and promotion, preemption still applies.
Failing to avoid preemption all together, plaintiff’s next argument was to claim that he was asserting a parallel claim for prohibited off-label promotion. The court by-passed the question of whether off-label promotion is in fact prohibited, ruling instead that even if it was – a claim based on it would be impliedly preempted. Id. at 15. There is no state law cause of action prohibiting off-label promotion. Off-label use is completely a “creature of the FDCA.” Therefore, “any claim based on off-label promotion would be in substance a claim for violating the FDCA.” Id. (citations omitted). That’s a Buckman no-no.
Having put aside any notion that off-label use/promotion somehow changes the equation, the court turned to applying the preemption analysis to plaintiff’s specific claims. First the court pooled together all of plaintiff’s failure to warn claims. Regardless of how they are “labeled” (negligence, strict liability, statutory fraud), “to the extent each claim rests on a contention that Medtronic failed to inform Plaintiff or his surgeon about risk allegedly associated with the use of the Infuse device, each is at bottom, a failure to warn claim.” Id. at 15. And since each is a claim that Medtronic should have provided warnings different from or in addition to those required by the FDA, each is preempted.
The court didn’t pull any punches. Even though the failure to warn claims were preempted, the court went on to find that they would also have failed as a matter of Georgia law. Having looked at the labeling and other medical information available from the FDA at the time of plaintiff’s surgery, the court concluded that “Medtronic had no duty to warn Plaintiff’s surgeon, because where a product is vended to a particular group or profession, the manufacturer is not required to warn against the risks generally known to such group or profession.” Id. at 22.
Plaintiff tried to save his failure to warn claims by alleging failure to report adverse events to the FDA. The argument is that since that is a federal requirement, a failure to warn claim based on it is a non-preempted parallel claim. First, plaintiff didn’t plead that claim in his complaint. But even if he had, “there is not duty under Georgia law to report adverse events to the FDA.” Id. at 17. For a state law claim to parallel a federal requirement, the state law claim must exist. This one does not. But the court didn’t stop there. It held that a failure to report claim would also be impliedly preempted as nothing more than a prohibited private right of action to enforce FDA reporting requirements. Id. at 18. Another Buckman no-no. And, the court found that the failure to report claim would fail because plaintiff did not allege a causal connection between the purported failure to report and his injuries. Id. at 18n.5. Express preemption, implied preemption, and no causation – a trifecta.
Moving next to design defect, it’s hard to argue that a claim that a product should have been designed in a manner different than that approved by the FDA is not expressly preempted. It is. Id. at 18-19. More importantly, applying Bartlett the court also found the claim impliedly preempted.
To the extent Plaintiff contends that Georgia law required Medtronic to change Infuse’s design or labeling without FDA approval, his claims are impliedly preempted, because federal law affirmatively prohibits manufacturers from changing the design or labeling of PMA-approved devices without obtaining prior or ultimate FDA approval. Any claim predicated on the contention that Medtronic was as a matter of state law required to adopt a different design or label fails, because under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted.
The court also ruled that plaintiff’s breach of express and implied warranty claims were preempted. Plaintiff’s claim was based on allegations that Medtronic had breached warranties that the device was safe. “To prevail on this claim, a jury would need to find that Infuse was not safe and effective as labeled” which would conflict with the FDA’s PMA determination that the device was safe and effective. Id. at 20. That conflict means that the state would be imposing different or additional requirements (express preemption) and that the claims “interfere with FDA’s regulation of Class III medical devices” (implied preemption). Id. at 20-21.
Finally, the court dismissed plaintiff’s claims under the Georgia Fair Business Practices Act and Uniform Deceptive Trade Practices Act. The claims survived preemption only to the extent they were predicated on “alleged affirmative misrepresentations rather than purported omissions.” Id. at 16. Fraud by omission requires a state law “disclosure requirement” that would be different from or additional to the requirements of federal law. Id. But these claims failed to clear several other obstacles — such as the fact that both statutes have safe harbors that exempt actions or conduct authorized or in compliance with federal law. Id. at 22. Since the FDA granted premarket approval and authorized the sale of the device – plaintiff is outside the scope of either act. Moreover, the Fair Business Practices Act applies only to consumer products, which a prescription medical device is not and the Uniform Deceptive Trade Practices Act only provides injunctive relief not damages. Id. at 22-23. To top it all off, these fraud claims were not pleaded with the requisite specificity. The complaint is missing the who, what and when for any alleged misrepresentation. And it might even be missing the misrepresentation. Plaintiff alleged that doctors were paid to promote off-label use. But “off-label marketing . . . is itself not inherently fraudulent.” Id. at 24. Off-label does not mean false.
This case might not be as newsworthy as say today’s trending news such as the NFL switching from Roman to Arabic numerals for Super Bowl 50, or that 5 NYPD police officers tackled and cuffed former tennis star James Blake after he was misidentified, or that Donald Trump has soared to 32% in the polls. Then again, if those are the headlines – we’ll stick with off-label use.