United States: Another Slam Dunk Infuse Win – Preemption And More

Last Updated: September 29 2016
Article by Michelle Yeary

If you're even remotely interested in the topic of preemption in Pre-Market Approved (PMA) medical devices that were used in an off-label manner, simply search this blog for our Infuse cases. There are dozens and almost all are complete victories for the defense. What occasionally survives are fraud or misrepresentation claims, although they have a tough time meeting the heightened pleading standard of Rule 9(b), or failure to warn claims where a court recognizes failure to submit adverse events to the FDA as parallel to a state law duty to warn physicians. As you'll easily see from our prior writings, we don't understand that parallelism at all.

The most recent Infuse victory strikes a blow at each and every attempt by plaintiffs to circumvent, dodge, sidestep, and elude preemption and pleadings standards. And with each by-pass blocked, plaintiffs' claims had nowhere to go.

As a quick refresher, Infuse is a medical device used to stimulate bone growth in spinal fusion surgeries. It is a multi-component device that received FDA PMA approval for use in single-level, anterior, lumbar surgeries. Aaron v. Medtronic, Inc., — F. Supp.3d –, 2016 WL 5242957, *1-2 (W.D. Ohio Sep. 22, 2016). Aaron is actually a consolidation of the claims of several hundred plaintiffs who alleged they were injured by their surgeon's use of the Infuse device in an off-label manner. Specifically, they allege the device was either implanted without all of its component parts, implanted posteriorly, implanted at multiple levels, or implanted in their cervical or thoracic spines. Id. at *2. Plaintiffs' causes of action are fraud/misrepresentation, strict liability failure to warn, strict liability design defect, negligence, and breach of express and implied warranties. Id. Defendants moved to dismiss all claims on several grounds, including most predominantly preemption.

Before getting to the substantive analysis, the court had to consider what pleadings standard to apply. Wait. Isn't it TwIqbal? What's the issue? The answer is the Seventh Circuit decision in Bausch v. Stryker. The Aaron plaintiffs alleged that they did not need to plead the specific federal law or regulations that defendant allegedly violated because medical device products liability cases should have a "more permissive" review standard. Id. at *3. Plaintiffs got that idea from Bausch which held that particularity in pleading the specific FDA regulations violated was not necessary due to much of the "critical information" being kept confidential. Id. at *3-4. Many courts disagree with Bausch, including the Sixth Circuit which held in a non-medical device case that a "natural imbalance of information" does not warrant lowering Rule 8's pleading standards. Id. at *4. The discovery process cannot be used to find sufficient factual support for plaintiffs' pleadings after the fact. So, Aaron applies TwIqbal, not some watered down version (although the court does state that some of plaintiffs' claims might not have withstood application of that lesser standard).

The next question the court had to answer is whether any of plaintiffs' allegations about off-label use changed the Riegel test for PMA preemption – a two-step analysis that requires the court to determine first whether the FDA has established any specific requirements for the device (satisfied in PMA devices) and if so, whether plaintiffs' state law claim impose requirements that are different from or in addition to the federal requirements. Plaintiffs' argument is that because the device was used off-label the FDA has not established any PMA requirements for Infuse as it was used on plaintiffs. Incorrect said the court. "Premarket approval extends to all components of an approved device, even when a physician uses the components separately." Id. at *6. This is confirmed by the FDCA's definition of "device" to include "any component" of the device. Id. at *7. So, off-label allegations don't change the first part of the Riegel test – PMA devices are subject to specific federal requirements.

Moving to step two of Riegel, the court had to determine whether any of plaintiffs' state law claims were parallel claims. Traditional failure to warn is always easy – it's expressly preempted because the defendant cannot provide any warning other than that approved by the FDA. Id. But, plaintiffs have tried to morph their failure to warn claims into claims for failure to submit adverse event reports to the FDA. A claim unfortunately recognized by the Ninth and Fifth Circuits. We've never understood how an FDCA requirement that a device manufacturer submit adverse event reports to the FDA was the same as a state law duty to warn physicians and the Aaron court likewise did not see the connection. There is no Ohio state law duty to report adverse events to the FDA and the federal duty to do so "is not identical and thus not parallel, to the state-law duty to provide warnings to patients or their physicians." Id. at *8.   That seems readily apparent to us, but the court goes further in breaking it down. It starts with a simple concept that the Ninth and Fifth Circuits have overlooked: "Adverse-event reports are not warnings." Id. They are regulatory submissions. Adverse event reports are anecdotal accounts of incidents. More importantly, they are not "valid scientific evidence" upon which the FDA may base a labeling change. Id. In other words, if the theory accepted by courts who have recognized this cause of action is that by submitting adverse event reports to the FDA, the manufacturer is "warning" the FDA who will then in turn require manufacturers to warn doctors – that theory is just wrong. There is no federal requirement that manufacturers submit adverse event reports to physicians or the public. There is no state-law requirement that medical device manufacturers submit adverse event reports to the FDA. The requirements are not "genuinely equivalent." Id. There is no parallel claim.

Even if not persuaded on express preemption, a failure to submit adverse event reports to the FDA fits squarely within Buckman implied preemption. As noted above, there is no state law for failure to submit reports to the FDA. The duty to submit doesn't exist absent the FDCA, so plaintiffs' claim is "an impermissible attempt to enforce exclusively federal requirements with no counterpart in state law." Id. at *12.

Design defect seems like an easy preemption question in a PMA case as well. The FDA has approved a specific design. Any design defect claim asks a jury to find that the device should have been designed in a manner different than that approved by the FDA. Express preemption. Once again plaintiffs tried a little sidestep maneuver. In their response to the motion to dismiss, they cite to some FDA manufacturing regulations and argue that their design defect claim should survive based on allegations not asserted in the complaint that defendant failed to adhere to FDA manufacturing standards. Id. at *10. But the complaint didn't allege a manufacturing defect claim, only design defect. As to the latter,

allowing a design defect claim to proceed would be tantamount to holding that a medical device design that has been approved by the FDA can nonetheless by legally deficient – an encroachment on federal regulatory authority that 21 U.S.C. §360(k) was specifically designed to prevent.


The next expressly preempted claim was breach of express warranty.   Because plaintiffs alleged breach of warranty as to effectiveness and safety, a jury would have to find the device not safe and effective – which would directly conflict with the FDA's PMA conclusion that the device was safe and effective. Id.

The last preempted claim was for "off-label promotion." Another concept for which no state-law duty exists. The "very concept" of off-label promotion doesn't exist outside the MDA and its requirement that the FDA approve medical devices and their labels. Id. at *12. There is nothing in Ohio state law that prohibits manufacturers from promoting their devices for off-label uses. Any allegation that off-label promotion is unlawful is actually a claim for violating the FDCA. Therefore, it is impliedly preempted as an attempt to privately enforce the FDCA, something that has been left exclusively to the FDA.   Id. at *13.

Although all plaintiffs' product liability claims were dismissed as preempted, the court still reviewed other state law arguments for dismissal, including one based on comment k of the Restatement. Comment k provides an exemption from strict liability for unavoidably unsafe products, such as prescription drugs and medical devices. Plaintiffs argued that whether any particular medical device is unavoidably unsafe is a case-by-case determination that could not be made at the pleadings stage. The court thought defendant had the better argument: "Infuse's classification by the FDA as a Class III medical device inherently means that it is unavoidably unsafe." Id. at *15. The court was satisfied that Infuse was an unavoidably unsafe product based on the FDA's determination that it needed to be a restricted device due to its "potential for harmful effect," and that Class II regulatory controls weren't sufficient to ensure safety and effectiveness. Id.

The court was also unpersuaded by plaintiffs' arguments that it was too early in the proceedings to determine whether there was a less risky alternative design because "there is no alternative design for Infuse that could lawfully be marketed." Id. Manufacturers are prohibited from changing the design of a PMA device without FDA permission. No need to belabor the issue in discovery.

That brings us to plaintiffs' fraud claims which are subject to the heightened pleadings requirements of Rule 9. The court focused on one of the ways in which plaintiffs' fraud allegations failed to meet that standard. Plaintiffs alleged both that their surgeon, acting as defendant's agent, knew about the risks of using the Infuse device in an off-label manner and concealed those risks from plaintiffs, and that defendant did not adequately inform plaintiff's surgeon of the risks and that he was justified in relying on defendant's concealments and misrepresentations. Id. at *17. While you can plead alternative causes of action, you can't plead inconsistent versions of the facts in support of a single claim. Id. Plaintiffs can't have it both ways. Either the surgeon had or did not have knowledge of the risks. The contradictory allegations defeated plaintiffs' fraud-based claims.

With that several hundred Infuse claims were dismissed in their entirety. Another great victory for Medtronic and a really strong opinion rejecting some of our least favorite decisions. Win-win.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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