As we roll out of bed on the day after Thanksgiving, we are often confronted with contradictory thoughts. For instance, “why did I have that third plate at dinner?” might be followed by “How can I eat some leftovers for breakfast?”  Leftovers are as much of an American tradition on this day as watching videos of altercations during frenzied early holiday shopping. Both celebrate wretched excess in their own way. Some leftovers, however, can be combined to create something tasty and worthwhile. Other leftover uses should not be attempted. We would put sandwiches of turkey, stuffing (dressing down South), and cranberry goop in the former category and Brussels sprouts omelets in the latter.

A while back, for a few years, we chronicled a real turkey of a case called Howard. The saga is recounted here, where the plaintiff’s expert was finally kicked for the unreliability of his defect opinion about the PMA device at issue in the case. Along the way, the case generated two notably foul (fowl?) opinions. Deciding on preemption in the context of a theoretical claim, the Sixth Circuit held that a negligence per se claim could be a parallel claim and avoid express preemption.  Years later, on a referred question, the Oklahoma Supreme Court okayed a negligence per se claim under Oklahoma law based on violations of the FDCA.  That gobbler took home the ribbon for third worst of 2013.  Our well-documented view that there can be no negligence per se claims based on violations of the FDCA notwithstanding, Oklahoma now has a claim that came from a case that was soon to be plucked and exposed as lacking merit.

A few years later, the plaintiffs in Cantwell v. De La Garza, No. CIV-18-272-D, 2018 WL 5929638 (W.D. Okla. Nov. 13, 2018), sued an implanting orthopedic surgeon, non-profit health care system, and medical device manufacturer for alleged injuries from the alleged off-label use of a PMA medical device in a spinal surgery. The manufacturer moved to dismiss. We do not have many details of the underlying facts or allegations, but we are focusing on the negligence per se claim—the leftover from the Howard turkey, in case you missed our less-than-subtle theme. A few weeks before the Oklahoma Supreme Court’s decision in Howard, the Western District of Oklahoma rejected the purported parallel claims in Caplinger. After a motion to reconsider was denied, the Tenth Circuit affirmed in Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015), one of our favorite preemption decisions and a 2015 winner.  In part because that decision was authored by future Justice Gorsuch, we have drilled down on Caplinger a few times and tracked its impact.

The Cantwell plaintiffs claimed that the manufacturer had promoted the device to be used off-label—it was approved for use in the thoracolumbar spine, but was used in the cervical spine—and that violated apparently unspecified provisions of the FDCA and its regulations. Under the Oklahoma Supreme Court’s decision in Howard, “To establish negligence per se, the plaintiff must demonstrate the claimed injury was caused by the violation [of a statute], and was of the type intended to be prevented by the statute . . . [and] the injured party [was] one of the class intended to be protected by the statute.” Pretty much the hornbook definition, along with the requirement that the plaintiff prove breach, causation, and damage. In the context of pleadings and the Howard decision, the court went back to basics. Plaintiffs did not plead a particular statute or regulation that had been allegedly violated, let alone that could be tied to the injuries attributed to the device at issue. Howard did not lower the pleadings bar: “The court said nothing to suggest, however, that a plaintiff wishing to bring such a claim could proceed without identifying the statute or regulation allegedly violated, and thus the duty allegedly breached by the defendant’s conduct.” Looking to Caplinger and the unaddressed but obvious issue of preemption, the court noted that “such identification is particularly important in the area of medical devices, where a state-law negligence claim must survive the FDCA’s provision of a federal preemption device.” So, no identified allegedly violated federal statute or regulation meant no properly pleaded claim for negligence per se. Citing to the FDCA in general or invoking the loaded term “off-label” was not enough to get past a motion to dismiss. Predictably, though, the dismissal was without prejudice, so we expect plaintiffs will try again. If they do, then we would not be surprised if Justice Gorsuch’s former colleagues on the Tenth Circuit get another chance to weigh in on express preemption with a re-heated version of Howard.

When it comes to medical device preemption, having Pre-Market Approval (“PMA”) is like being dealt pocket aces in Texas Hold’Em Poker.  It’s the strongest starting hand you can have; a 4:1 favorite over any other two card combo.  It means you’re starting in the power position.  Since the Supreme Court’s decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), manufacturers of PMA medical devices are in the power position in products liability litigation.  Very little slips by the double-edge sword of express and implied preemption in PMA cases.  The same can, and should be said for IDE cases as well.  And that’s what the Kentucky Court of Appeals said in Russell v. Johnson & Johnson, — S.W.2d –, 2018 WL 5851101 (Ky. Ct. App. Nov. 9, 2018).

Defendant manufactures medical catheters.  The catheter was approved by the FDA via the PMA process in 2004.  Id. at *1.  In 2015, the FDA approved use of the catheter under the Investigational Device Exemption (“IDE”) to the MDA which allowed the catheter to be used in a clinical trial to evaluate its safety in certain cardiac ablation procedures.  Plaintiff underwent a cardiac ablation procedure as part of the clinical trial in which defendant’s catheter was used.  Id.  After plaintiff’s procedure the catheter did receive full pre-market approval.  Id. at *4.

Plaintiff suffered complications during the procedure and subsequently filed suit alleging defendant was liable for strict liability, negligence, lack of informed consent, failure to warn, breach of warranties, fraud, and unjust enrichment.  Id. at *2.  Defendant moved to dismiss all claims on the grounds of preemption and the trial court, relying on Riegel, granted the motion.  Id.  Plaintiff later asked the court to set aside its ruling based on defendant’s voluntary recall of other catheters, but not the one used on plaintiff.  The court denied that motion.  Plaintiff appealed both rulings.

Not surprisingly, plaintiff’s primary argument was that the court should discount Riegel because at the time of plaintiff’s surgery, the device had not yet received pre-market approval.    Id. at *4.  But the court found the argument contradicted by numerous courts to have considered the issue.  Some courts find that timing of the grant of PMA to be immaterial.  Id.  While others find IDE approval to be synonymous with PMA.  Id.  This certainly follows the logic of Riegel.  Riegel adopted a two-step test for preemption and the first step is whether the FDA has established requirements applicable to the device.  Riegel concludes that a PMA does in fact establish such requirements.  Well, so does an IDE.

[b]ecause IDE devices are subject to a level of FDA oversight and control that is, for the purpose of a preemption analysis, identical to that governing PMA devices, the body of preemption law governing PMA devices applies equally to the IDE device at issue in this case.

Id. (citing Martin v. Telectronics Pacing Sys., Inc., 105 F.3d 1090 (6th Cir. 1997).

Thwarted by authorities from other jurisdictions on the issue, plaintiff next urged the court to rely on a Kentucky Supreme Court case decided before RiegelNiehoff v. Surgidev Corp., 950 S.W.2d 816 (Ky. 1997).  Id.  Niehoff rejected preemption in an IDE case relying on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  But as we all know, Lohr dealt with a device approved via the §510k “substantial equivalence” process.  As pointed out above, the IDE process is more analogous to the PMA process and therefore, in a post-Riegel world, Riegel is controlling.   In Niehoff, the manufacturer also stopped the clinical trial before the FDA considered its PMA application.  Id.  Whereas in Russell, the device was granted PMA just over one year after plaintiff’s procedure.  Id. at *5.

In deciding the preemption question in the current case, the court started its analysis with the clear cut statement that “there is no presumption against preemption” in an express preemption case.  Id.  After checking that box, the court looked at the device at issue and concluded that “approval after being subject to both the IDE and PMA processes, satisfies the first prong of Riegel.”  Id. at *6.  So, to survive preemption, plaintiff cannot be alleging a claim that is different or additional to FDA’s requirements regarding safety and effectiveness.  Id.  That means, plaintiff in his complaint must allege three things: “violation of a federal requirement; violation of an identical state violation; and a link between the federal violation and [plaintiff’s] injury.”  Id.  Plaintiff went 0 for 3.

The court could find no allegations of federal violations, or even a cite to a federal regulation.  No factual support for any alleged violation.  No allegations that his injury was caused by a federal violation.  All plaintiff did was allege the device was defective – “in other words, the FDA should have imposed more stringent requirements – an attack precisely prohibited by the MDA.”  Id. at *7.

Failure to allege a parallel violation required dismissal of plaintiff’s strict liability, negligence, failure to warn, and fraud claims.  Id. at *7, *8.    Plaintiff’s informed consent claim failed because plaintiff signed a detailed consent form that was approved by the FDA.  Any claim that the consent was inadequate would impose a different or additional requirement on the defendant.  Id. at *7.  Claims that the device breached warranties regarding safety and effectiveness “directly contradict the FDA’s conclusion that the catheter was safe and effective.”  Id. at *8. As would an unjust enrichment claim premised on a claim that plaintiff did not receive safe and effective medical care.  Id.  Finally, plaintiff failed to allege a parallel federal statute to the Kentucky Consumer Protection Act.  Id.  So, all of the claims were properly dismissed as preempted.  The appellate court also upheld the trial’s court’s decision that any attempt at amendment would be futile.  “Additional time would not have transformed [plaintiff’s] claims into parallel state claims.”  Id.

As for the motion to set aside the dismissal based on the recall, the court again upheld the trial court’s decision.  A final judgement can be set aside based on newly discovered evidence which could not have been learned via due diligence in time for a new trial.  Id. at *9.  But new evidence is not events that occur after entry of a final judgment – such as the recall here.  Id.  Moreover, the new evidence needs to be relevant.  The recall was of different catheters, not the one used in plaintiff’s procedure.  Id.  Next, the voluntary recall “negated neither federal preemption nor FDA approval.”  Id.  The FDA was aware of adverse events and of the recall, but did not withdraw its approval of the device.  And, a recall is not a presumption that FDA regulations have been violated.  A recall doesn’t turn a “preempted claim into a parallel cause of action.”  Id.

             No doubt defendant had pocket aces going into this appeal, but Jim Murdica and Kara Kapke from Barnes & Thornburg and Lori Hammond from Frost Brown Todd deserve a shout out for knowing when to go all in!

Recently, the Enviably Youthful Drug and Device Law Mother has been pushing us to plan a mother/daughter vacation.   Her longtime companion no longer enjoys travel, and few of her friends share her sense of adventure. So we set about finding a suitable trip for next spring. Threshold categorical decisions proved troublesome. Our normal instinct, given the pace of our everyday life, is to sit still on vacation. We are fond of cruises, and we don’t care to where because we don’t get off of the boat.   The EYDDM prefers an eight-cities-in-seven-days pace. If we have to move, we prefer to rent a car and explore – we are not fond of printed itineraries. And we lean toward countries with national languages other than English. So, in the spirit of compromise, we booked eight days on a bus in Ireland over Memorial Day. Yeah, we know. But you should have seen the EYDDM’s smile. Sometimes, the answer is simple.

As it was in today’s case.   In Romer v. Corin Group, PLC, et al., 2018 WL 4281470 (M.D. Fla. Sept. 7, 2018), the plaintiff alleged that he was injured by when the defendant’s artificial hip implant released metallic contaminants into his body, causing pain and malfunction of the device and ultimately requiring another surgery. He sued in state court on the usual product liability theories, and the defendants removed the case on diversity grounds. After removal, the defendants moved to dismiss the negligence, negligence per se, and strict liability claims.

Listing seven alleged manufacturing defects in the hip implant, the negligence per se claim alleged that the defendants failed to comply with the manufacturing standards the FDA approved as “conditions of FDA’s approval [as well as] the general regulations applicable to Class III medical devices.” Romer, 2018 WL 4281470 at *3. A second negligence per se count alleged that the defendants’ simulator testing of the device was inadequate and violated federal regulations related to the compliance with Approved Design Standards. Id.   The defendants argued that both counts failed as a matter of law because Florida does not recognize a claim for negligence per se based on alleged violations of the federal FDCA or its implementing regulations. The court agreed, holding that, “[u]nder Florida law, the violation of a federal regulation does not create civil liability based upon a theory of negligence per se in the absence of a legislative intent to create a private cause of action.”   Id. at *4 (citations omitted). Because the FDCA and its implanting regulations do not “expressly create civil liability for non-compliance, strongly suggesting a legislative intent not to create a private cause of action,” id., the plaintiffs could not base negligence per se claims on the violations they alleged.

The defendants argued that the design defect claims sounding in both strict liability and negligence were preempted under Riegel because the hip implant device was a Class III medical device subject to pre-market approval (“PMA”) by the FDA. While the plaintiffs argued that the design defect claims escaped preemption because the claims were “based on defendants’ alleged failure to comply with federal laws after the FDA already approved the design of the device,” id. at *5, they made no allegation that the defendants had altered the design approved by the FDA during the PMA process.   The court concluded, “To the extent plaintiffs are asserting parallel claims, . . . . a valid parallel claim cannot challenge the rigorous PMA process itself or the requirements imposed by the FDA pursuant to that process. However, plaintiffs’ design defect claim does just that,” id at *6, and it was therefore expressly preempted.

Similarly, the defendants argued that the plaintiff’s negligence claims, based on the defendants’ alleged failure to warn of defects in the hip implant device or to report adverse events to the FDA, were expressly preempted because they sought “to second-guess the FDA’s determination that the warning language [was] adequate and [to] force [the defendant] to meet an additional standard beyond what the FDA requires.” Id. The defendants also argued that the reporting violations claims were impliedly preempted.

The court held that the warnings claims “imposed requirements that [were] different from, or in addition to, the federal requirements under the MDA,” and were thus expressly preempted. To the extent that the plaintiffs claimed that the defendants failed to comply with FDA reporting requirements, the claim was “simply an attempt to recast a claim for violation of the FDCA as a state law negligence claim.” Id. at *7. As such, it was “premised upon an FDA-reporting requirement that [was] not paralleled by a Florida law duty,” and was impliedly preempted under Buckman, which permits such claims to survive only to the extent that they “do not seek to privately enforce a duty owed to the FDA.” Id.

And so the court dismissed the plaintiffs’ design defect, failure to warn, and “failure to report” claims, leaving manufacturing defect claims pending. The dismissal was without prejudice, and the plaintiffs were given fourteen days to file an amended complaint. We’ll keep you posted

Permit us to recount a recent travel misadventure, though whatever eventual connection we draw to today’s case will be specious at best. Last Friday, we traveled from Philadelphia to Hartford, Connecticut for a deposition.  We were fresh off of a long flight home from Europe and were hesitant to take on a couple hundred miles of driving at each end of the day, so we investigated our options.  In the morning, direct flights from PHL to BDL abound.  But after 6 p.m., when our deposition was scheduled to end, there are no direct flights home. Nor are there Amtrak trains leaving Hartford after that hour.  So we threw up our hands and reserved a connecting flight home, reasoning that sleeping, reading, and eating Biscoff cookies would be more relaxing than driving.  This even though, to get from Hartford to Philadelphia, we had a totally illogical connection at Dulles, many miles out of the way.

Our originating flight landed at Dulles early.  And our 9:30 pm connection was showing “on time” on the board.  At 9:15 pm, the following announcement came over the loudspeaker: “We are very sorry, but your first officer is coming in on a flight that is delayed, so we need to delay your 9:30 pm flight until 11:30 pm.”  We were not pleased, but the new schedule would still get us home, crucial because we were leaving at noon on Saturday for an overnight trip.  At 11:20, the gate agent announced, “Your first officer’s flight has landed.  Give us a few minutes and we’ll get you boarded.”  At 11:30, we heard the following, dripping with contrition: “We are SO SORRY, but we are unable to put together a crew for your flight tonight, so we are delaying this flight until NOON TOMORROW.” [Emphasis added.]  Turns out that the long-awaited first officer had now exceeded his maximum hours for the day.

We did not react politely to this. We asked, “You mean to tell us that nothing in your computer could have told you this before we sat here for two hours and lost all other options??”  We did not receive a satisfactory response.  Ultimately, we took a 45-minute cab ride to Union Station (cavernous, pitch-black, and empty) and caught a 3:10 a.m. (!!) Amtrak train to Philadelphia.  When all was said and done, that was all that was left.

“Not much left” also describes (we warned you) today’s case, an excellent PMA and Buckman preemption decision out of the Northern District of Illinois.  In Gravitt v. Mentor Worldwide, 2018 WL 2933609 (N.D. Ill. June 12, 2008), the plaintiff alleged that she was injured by the defendant’s silicone breast implant.  Her complaint asserted claims under Illinois law, alleging design and manufacturing defects, failure to warn, and the defendant’s alleged failure to comply with the FDA’s pre-market approval (“PMA”) process for Class III medical devices, including numerous allegations of deficiencies in the defendant’s design and execution of post-PMA studies ordered by the FDA.

In earlier motion practice, the court dismissed most of the plaintiff’s claims without prejudice.  (We published a guest post on the first dismissals here.)  The plaintiff filed an amended complaint, which the court commented “strongly resemble[d] the original complaint.” Gravitt, 2018 WL 2933609 at *1.  The defendant again moved to dismiss, arguing that the plaintiff’s claims were expressly preempted under the Medical Device Amendments (“MDA”) to the FDCA or impliedly preempted under Buckman.

Express Preemption

The defendant argued that the plaintiff’s claims were expressly preempted to the extent that they were based on alleged methodological defects in the defendant’s post-PMA studies. The Court explained that under SCOTUS’s Lohr decision, as construed by the Seventh Circuit in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), as well as SCOTUS’s Riegel decision, state law tort claims related to Class III medical devices granted PMA are allowed to proceed if they: 1) allege violations of common-law duties that parallel federal requirements; or 2) claim violations of federal law.  Conversely, state law claims that “would impose on [the defendant] a requirement that is in addition to federal requirements” – in other words, claims that the defendant “violated state tort law notwithstanding compliance with the relevant federal requirements” – are preempted. Gravitt, 2018 WL 2933609 at *4 (internal punctuation and citations omitted).

The court held that, while the complaint alleged numerous deficiencies in the defendant’s post-PMA studies and alleged that each deficiency amounted to an “independent failure to comply with the FDA’s post-approval requirements” and thus a ground for withdrawal of PMA, the plaintiffs “simply assume[d], without legal or other support, that those deficiencies amount[ed] to violations of the FDA’s conditions for PMA.” Id. at *6 (citations omitted).   The court concluded that “such an assumption may not ground a viable claim,” id., and held that certain categories of the plaintiff’s allegations were expressly preempted.

Implied Preemption

But the court held that other categories of the plaintiff’s allegations were not expressly preempted. Specifically, the court held that “the complaint plausibly alleged that [the defendant] violated federal law” by failing to satisfy several categories of requirements related to, inter alia, follow-up of study participants, collecting and reporting of data at required intervals and related updates to labeling, warning of newly-discovered risks of the device, and failing to comply with requirements for manufacturing facilities.  Because the plaintiff “plausibly alleged” that these “shortcomings in [the defendant]’s post-PMA testing and manufacturing processes violated federal law,” section 360(a) of the MDA did not preempt those claims. Id. But the court emphasized, “Plaintiffs may proceed with those claims, however, only if they pass through a second legal filter” – the “filter” of implied Buckman preemption of “fraud on the FDA claims.” Id. at *7.

The court explained that, under Buckman, “federal law preempts claims to the extent they seek to deploy state law in the service of policing fraud against federal agencies based on statements that federal  law required the defendant to make to the agency, id. (internal punctuation and citation omitted), but doesn’t preempt traditional tort law claims involving breach of a duty to the plaintiff.  The court held:

Here, several of the claims that survive express preemption – for example, claims that the defendant reported results of the core study for fewer than the required number of years and recruited fewer than the required number of patients for a large post-approval study – are impliedly preempted under Buckman because those shortcomings breached no . . .  [tort duty to the plaintiff].  Rather, as in Buckman, those claims are unconnected to any traditional state tort duty, meaning that the existence of the relevant federal enactments is a critical element of those claims.

Id. (internal punctuation and citation omitted).  The court noted that the plaintiff attempted to tie the defendant’s alleged misconduct to her state tort claims, alleging that, if the defendant had more fully complied with the PMA process, its “disclosures would have led to much wider knowledge of the risks associated with its product.” Id. (internal punctuation and citations omitted).  But, it emphasized, “the Buckman analysis centers on the nature of the asserted claim and the source of the violation, not on the violation’s effects . . . . A claim arising entirely out of a violation of [the defendant’s] compliance with the FDA’s requirements in granting PMA is . . . . preempted under Buckman. Id.

Two categories of claims remained. The court dismissed the plaintiff’s claims alleging that the defendant’s manufacturing facilities failed to comply with applicable law and regulations, holding that the complaint had not adequately alleged a true manufacturing defect claim.  In addition, the plaintiff had failed to respond to the defendant’s arguments against these claims.  The last claim alleged that the defendant learned, but did not disclose, that its device had a higher likelihood of rupture than had been reported.  The court acknowledged that these claims were not fully developed in the complaint, but held that Rule 9(b)’s particularity requirement did not apply to the claims.  Holding that the plaintiff’s pleading “cross[ed] the line from conceivable to plausible,” satisfying Twiqbal, the court allowed the claims to proceed.

But that was all that was left.  The claims that were preempted – expressly and impliedly – were dismissed with prejudice, in an infrequent and laudable turn of events.   We would wax on at greater length, but today’s flight is boarding in a few minutes.  At least that’s what the board says.  We’ll keep you posted.

This post is from the non-Reed Smith side of the blog.

You’re likely all familiar with the phrase, “don’t look a gift horse in the mouth.” Checking out a gift horse’s teeth is like looking for the price tag of the gift to see how much it’s worth. The expression is meant to convey that upon receiving a gift you should accept it gratefully. But what happens when you don’t accept the gift at all. In many instances, politely declining a gift is completely acceptable. When the gift actually comes in the form of help, passing it up may well be to your own detriment. Sure, it looks good to stand on your own two feet. To accomplish something on your own. But sometimes offers of help are extended because they are needed. A parent offers to help a child tie his shoe. A teacher offers to guide a student through a math lesson. A young man offers to cut the grass for an elderly neighbor. Or perhaps a judge offers plaintiff an opportunity to take discovery to save her case. And that plaintiff says: No thanks. I’ll stand “on the allegations contained in [my] original complaint.” That plaintiff shouldn’t be surprised that what wasn’t good enough the first time around, isn’t good enough the second.

The case is Benyak v. Medtronic, Inc., 2018 Ill. App. Unpub. LEXIS 998 (Ill. App. Jun. 14, 2018) and involves an implanted intrathecal pump that plaintiff alleges became inverted in her body causing her pain. Id. at *2. Plaintiff alleged only negligent design and manufacturing defect and negligent education of medical providers. Id. at *2-3. The medical device underwent pre-market approval by the FDA and so defendant moved to dismiss the claims as preempted. That motion was granted but the court granted plaintiff leave to serve written discovery on the manufacturer and then to file an amended complaint. Plaintiff opted to do neither and so the court dismissed her claims with prejudice. Id. at *2. Plaintiff then appealed that dismissal arguing that her original allegations should have survived defendant’s motion to dismiss.

The Illinois Appellate Court authored a nice accounting of PMA preemption, see id. at *5-15, which we won’t completely recount here because if you are even an infrequent reader of this blog, you’re likely well-versed in PMA preemption. And if not, check out this scorecard to start your PMA preemption education. We will point out the court’s proper conclusion that because of the MDA’s express preemption provision, there is no presumption against preemption. Id. at *10. Also that the court landed where most court’s do, finding that there is only “a small window in which a state-law claim may escape express or implied preemption.” Id. at *13. Finally, before turning to the case-specific details, the court notes that “the manner in which allegations are pled guides the analysis of whether a state-law claim involves requirements different from, or in addition to, the federal requirements.” Id. at *15.

Since it was undisputed that the device at issue was a PMA device, there was also no dispute that the FDA had established requirements applicable to it. Id. So the court moved on to the next part of the PMA-preemption analysis – did plaintiff’s state law claims involve requirements related to safety and effectiveness different from or in addition to federal requirements. Because safety was at the heart of plaintiff’s claims, the only real issue was the “different or in addition to” standard. In other words, did plaintiff’s claim parallel the federal requirements established by the FDA for this device.

As for design and manufacturing defect – plaintiff’s complaint was completely silent as to whether the device was designed or manufactured differently or out of compliance with the FDA’s approval and protocols. Id. at *16-17.

Absent such factual allegations, plaintiff, in essence, posits that the [device] should have been designed and manufactured differently than what the FDA approved during the premarket approval process, which necessarily would impose a requirement for the [device] that is different from, or in addition to, the requirements already imposed by the FDA.

Id. at *17.

On appeal, plaintiff argued that “the ability of the [device] to remain upright” was a premarket requirement that defendant failed to meet. However, the complaint “never specifically identified any specific requirement resulting from the premarket approval process.” Id. at *19. And this brings us back to that gift horse:

Understandably, at the time plaintiff filed her complaint, she might not have had enough facts to support her allegations, which is why the circuit court allowed her leave to serve written discovery on defendants and file an amended complaint. Had she taken the opportunity to conduct the discovery, she could have bolstered the allegations of her complaint and perhaps, her state-law claim would not have been expressly preempted by the MDA. But she chose not to conduct the discovery nor file an amended complaint, resulting in her design and manufacturing defect claim, as pled in her complaint, being expressly preempted.

Id. at *19-20. It jumped right up and bit her.

As for plaintiff’s other claim, negligent instruction, it is not a recognized claim under Illinois law. Id. Even if it were, plaintiff didn’t allege that the instructions defendant provided deviated from those approved by the FDA during the PMA process. Id. at *21. So, that’s two grounds to affirm the dismissal. Plaintiff attempted to turn the claim into a learned intermediary claim arguing it was really a failure to warn the doctor claim. But, that’s not what plaintiff alleged in the complaint. The complaint never mentions learned intermediary and the court was unwilling to construe it as such.

Finally, plaintiff asked for the case to be remanded with leave to amend her complaint. Wow. Once you refuse a gift it’s much less likely you’ll get offered it again. The appellate court found that because plaintiff had “intentionally” chose not to take discovery and amend her complaint when that opportunity was afforded to her, “she has waived any right to a remand with leave to amend.” Id. at *22.

We often talk about giving plaintiffs second bites at trying to plead their claims. But if you’re going to toss the apple away without so much as a nibble, don’t be surprised when the gift horse you decided to ignore gobbles it up and spits it out with nothing left for you to chomp on.

 

We have made it no secret that we think the Ninth Circuit wrongly decided Stengel v. Medtronic.  That is the case where the Ninth Circuit reversed express preemption of claims involving a pre-market approved medical device by divining a “parallel” state-law duty to report adverse events to the FDA.  As we have said here and here (and other places), we are not convinced that such a duty even exists.  That is why we liked the district court’s order from last year dismissing the Complaint in Ebrahimi v. Mentor Worldwide LLC, mainly because the district court emphasized another befuddling aspect of Stengel:  How on Earth can a plaintiff plead and prove that a purported failure to report adverse events to the FDA caused him or her any injury?

The plaintiff in Ebrahimi could not allege causation last year, and despite multiple opportunities to amend, she still can’t, resulting in another order granting another motion to dismiss.  The order is Ebrahimi v. Mentor Worldwide LLC, No. 16-cv-7316 (C.D. Cal. May 25, 2018) (you can view the order here), and the pleading at issue was the Second Amended Complaint.  The plaintiff again alleged injuries resulting from treatment with silicone-gel breast implants, and as in the initial Complaint, she alleged two failure-to-warn theories:  (1) The defendant allegedly failed to report “adverse events” to the FDA, and (2) the defendant allegedly failed adequately to warn patients and doctors. Id. at 3.

But neither of those theories stated a parallel claim sufficient to avoid express preemption. The Medical Device Amendments expressly preempt any state-law requirement that is “different from or in addition to” any federal requirement related to safety or effectiveness. See 21 U.S.C. § 360k(a).  Under the much-misunderstood “parallel claim” exception, a plaintiff can sometimes plead a non-preempted state-law claim if the asserted state law duty “parallels” the federal requirement.  Theoretically, that claim would not be “different from or in addition to” federal requirements.

The alleged failure adequately to warn doctors and patient was clearly preempted. Imposing a state-law duty to warn that is different from what federal law requires runs headlong into the Medical Device Amendments’ express preemption provision.  That is Riegel v. Medtronic to a tee.

As for the alleged failure to report adverse events to the FDA, that was not an actionable “parallel claim.” As the district court observed, “To state a parallel claim under California law, Ebrahimi ‘will ultimately have to prove that if [the manufacturer] had properly reported the adverse event to the FDA as required under federal law, that information would have reached [her] doctors in time to prevent [her] injuries.’” Id. at 3 (quoting Stengel v. Medtronic, Inc., 704 F.3d 1224, 1234 (9th Cir. 2013)).

Of course, this gloss on a parallel claim assumes that a state-law claim for failure to report claim to the FDA actually exists, and we don’t think one does. But setting aside that fundamental disagreement, this district court has again correctly zeroed in on causation as essential to pleading a claim based on an alleged failure to report adverse events.  This plaintiff failed for two reasons.  First, the “adverse events” that she alleged were not “events” at all.  Plaintiff alleged “potential statistical issues” with six post-approval studies, but none of those “issues” was an “ailment or injury resulting from gel bleed.” Id. at 3-4.  Second, and we think more importantly, the plaintiff failed to allege a “causal nexus” between her injuries and the manufacturer’s alleged failure to report:

In particular, she does not allege any specific facts showing that had [the manufacturer] not “covered up” these purported adverse events, the FDA would have required [the manufacturer] to modify its labeling and marketing materials or otherwise warn patients and doctors that “significant gel bleed was a potential risk. . . .” Therefore, Ebrahimi’s failure-to-warn claim cannot escape express preemption because she has not shown that [the manufacturer’s] failure to report adverse events to the FDA resulted in her injury

Id. at 5. We have blogged on parallel claims on multiple occasions, but Ebrahimi is particularly strong on folding causation (or lack thereof) into defining which claims avoid express preemption and which do not.  This is more than TwIqbal.  This is a district court ruling that federal law preempts your claim unless you can allege specific facts showing that the violation of a “parallel” state-law duty actually caused you harm.  Other courts should do this, too.

This time around, the district court dismissed the failure-to-warn claims without leave to amend, which makes sense. The plaintiff filed a First Amended Complaint, and then a Second, and if she has not alleged a non-preempted claim by now, she never will.  The district court did grant leave to amend for the manufacturing defect claim, based on allegations that the implant suffered from “poor workmanship” and the like. Id. at 5-6.  So she gets another chance, but if all she is left with is a manufacturing defect claim in a medical device case, she does not have much.

Kudos to the attorneys at Tucker Ellis for achieving this result, and our thanks to Dustin Rawlin for sending the order our way.

This one comes from Alabama and it’s pretty straightforward – plaintiff’s claims are preempted and therefore dismissed with a little wiggle room left for an attempted amended complaint. But as we know, for Pre-Market Approved (PMA) devices, there is only a “narrow gap” between express and implied preemption through which a claim must fit to survive. And so far, plaintiff has been ping-ponging off the sides but hasn’t made it through the gap.

The case is Rice v. Allergan USA, Inc., 2018 WL 1618036 (N.D. Ala. Apr. 4, 2018). Plaintiff had LAP-BAND surgery to aid with weight loss. The LAP-BAND is a PMA device. After seven years, plaintiff started to experience difficulty swallowing and frequent vomiting and upon investigation it was discovered that the LAP-BAND had eroded into plaintiff’s stomach and had to be removed. Id. at *2. Plaintiff conceded several of her claims. Those that remained for ruling by the court were negligence, failure to warn, and negligent or fraudulent misrepresentation. Id. at *3. Plaintiff’s primary allegation in support of these claims was that while defendant’s label reported a 1% risk of erosion, studies revealed a higher complication rate. Id. at *2.

Because the LAP-BAND went through the PMA process, plaintiff’s claims are preempted unless they satisfy the “parallel claim doctrine.” That means plaintiff has to show that the state law duties she alleges defendant violated and for which she seeks damages are “genuinely equivalent” to the federal requirements imposed on the device. Id. at *5. Only when the state and federal duties are parallel will plaintiff’s claim not run afoul of the provision of the Medical Device Amendments (“MDA”) that a state not impose requirements that are “different from or in addition to” federal requirements. Id.

Plaintiff’s first negligence claim was for negligent design and manufacture. However, while she made several allegations about the device having significant risks, nowhere did plaintiff allege how the manufacturer’s duty of care under state law “parallels the federal requirement that the [device] be manufactured according to the approved specifications for the medical device.” Id. at *6. If the device was designed and manufactured according to its PMA specifications, then allowing a jury to find it was negligently designed or manufactured would be imposing a different or additional requirement on the manufacturer. Therefore, claim preempted.

Next up was plaintiff’s negligent failure to warn claim. The court actually broke the claim down into 5 theories on which failure to warn was premised: negligent marketing, negligent labeling, negligent failure to update labeling, negligent reporting, and negligent surveillance. Id. It’s worth noting here that the court applies all the same reasoning in concluding that plaintiff’s strict liability failure to warn claim is similarly preempted. Id. at *8.

Here plaintiff did cite federal regulations but still missed the mark. For instance, plaintiff cited 21 C.F.R. §99.101 which provides:

[a] manufacturer may disseminate written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling…provided that the manufacturer complies with all other relevant requirements under this part.

Plaintiff alleges that the defendant violated this federal regulation by failing to provide additional risk information about the device. But all this section does is provide a guideline should a manufacturer choose to disseminate additional information. Choosing not to do so doesn’t violate the provision. Id. at *6.

Plaintiff also cites to the Changes Being Effected (“CBE”) provisions arguing that the defendant violated those provisions by failing to implement a CBE warning. However, a CBE labeling-change is permission to change a label “while a manufacturer awaits a written FDA order approving the PMA supplement.” Id. at *7. But plaintiff did not allege that the defendant was awaiting an FDA order on a PMA supplement, so it is unknown if the provision even applies.

Plaintiff also tried to base her failure to warn claim on an alleged violation of defendant’s federal duties to report adverse events to the FDA and to conduct post-market surveillance. Id. But the court considered both of those claims impliedly preempted on the grounds that they were unlawful attempts to privately enforce the FDCA. The court said failure to report sounds like it could be failure to warn, but the requirement is to report to the FDA, not to plaintiff. And there simply is no state law cause of action for post-market surveillance. Id.

Finally, the court had to dismiss plaintiff’s misrepresentation claim based on plaintiff’s vague pleadings. If what plaintiff was alleging is that defendant should have disclosed additional information and such a disclosure requirement exceeded FDA’s requirements, the claim would be preempted as not parallel. If, on the other hand, plaintiff was alleging that the defendant “held its product out as meeting a higher standard than that required by the FDA,” such a claim would not be preempted. Id. Since the former is more likely, it appears that a properly pleaded claim is likely preempted.

Yesterday happened to be the deadline for plaintiff to file an amended complaint, which she did. A quick skim of the amended complaint leads us to believe it contains most of the same allegations and therefore deficiencies the court has already addressed. And, plaintiff re-pleaded the claims she conceded as insufficiently pleaded the first time around. We suspect another round of preemption briefing in this case’s future.

 

This is not new. PMA devices should have broad preemption against product liability claims. Not just from the express preemption provisions of the MDA, but from attempts to get around express preemption by basing claims on violations of the FDCA and running smack into implied preemption under Buckman. We have talked about the narrow gap a claim needs to squeeze through to not be subject to either version of preemption. We have, when we were feeling mythological, likened this to traversing the Strait of Messina between Scylla and Charybdis. Without overdoing the analogy, each state law claim must neither 1) impose a requirement that is “different from or in addition to” the PMA approval requirements, nor 2) have federal requirements as a “critical element,” or it will be smashed or swallowed into preemption oblivion. A good analysis of these issues starts with looking at what plaintiffs have alleged and how that fits within the cognizable causes of action under applicable state law.

In In re Smith & Nephew BHR & R3 Hip Implant Prods. Liab. Litig., No. CCB-172775, 2018 U.S. Dist. LEXIS 49021 (D. Md. Mar. 26, 2018), more than two hundred plaintiffs purported to assert fairly standard state law product liability causes of action against the manufacturer of a PMA hip implant. The actual allegations of what the manufacturer did wrong and what was bad about the device were not so standard. They were very heavy on alleged non-compliance with a range of FDA requirements. The defendant moved to dismiss under express and implied preemption and TwIqbal. We will focus on the preemption part and will resist griping about how the TwIqbal analysis should have come before the preemption analysis. We cannot, however, avoid commenting on the decision to address whether state law claims—under the law of forty-two states—are preempted without looking at state law. While the defendant may have liked the court’s willingness to address preemption on a motion to dismiss—something the plaintiffs resisted—the limited analysis helped to predict the result. The court said that “there is little need to analyze the elements of underlying state laws” and that it was “merely deciding which claims, and which arguments within those claims, would run afoul of state requirements that differ from and add to federal regulations,” but states do not impose requirements unless there is some statutory or common law claim that fits what plaintiff is complaining about in the case. Id. at **61-62.

The court started its preemption analysis by citing some cases we like, such as Mensing and the Bexis favorite Puerto Rico v. Franklin California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016), on no presumption against preemption. It then cited some cases we do not like, such as Mink and Bausch on parallel claims. Id. at *66. When it said this, we knew where things were headed:

So, if a plaintiff may succeed on her state law claim by proving conduct that violates federal requirements, then that claim parallels federal requirements. The state law reliance on a federal regulation need not be explicit. Rather the elements of traditional state laws need only be satisfied by conduct leading to a violation of a federal regulation.

Id. Not only is that bit of bad logic eerily reminiscent of another case following Bausch that we lambasted, but you might want to look at the “elements of traditional state laws” before you declare them parallel to federal requirements. And there is that whole Scylla/Buckman part of the preemption analysis that cannot be defined away. With this background, the court’s analysis actually started out pretty well with strict liability design defect claims getting sucked down into the sea. “[P]remarket approval is FDA recognition of a particular medial device’s fitness for the market. Having received that approval, the BHR system cannot be labeled unreasonably dangerous by state law without imposing requirements on medical devices different from or in addition to federal regulations.” Id. at **67-68 (citing Reigel). Not bad.

The rest was. Claims for undifferentiated negligence, negligence per se—with no separate analysis—failure to warn, negligent misrepresentation, express warranty, and manufacturing defect were all considered parallel claims because they were based on the manufacturer’s “alleged failure to comply with duties already required by the FDA.” Id. at **69-70. Even if were not for Buckman, this is not what makes a state law claim parallel to a federal requirement. There needs to be a state law requirement that exists independent of FDA requirements and then it has to be parallel to the federal requirements. If state law required truthful communications about the risks and benefits of all products sold in the state and FDA required specific formats for communications about an approved device, but generally that communications about its risks and benefits be truthful, then that could be parallel. Those state law requirements probably apply equally to mushrooms as they do to implanted prescription medical devices.

By contrast, the purported state law requirement to train surgeons would be different than and in addition to federal requirements, because there is neither a federal requirement that surgeons be trained—states regulate the practice of medicine—nor a state law requirement that a manufacturer train surgeons before they can use its products. The court is correct that this claim is not impliedly preempted—it is not based on a federal requirement—but there needs to be a cognizable state law duty requiring training in the first place. Id. at *69 n.11. Similarly, the court held that a “failure to warn” claim based on reporting adverse events to FDA would not be expressly preempted, without considering whether state law imposes any duty to report—it does not. Id. at * 71. A claim for failure to warn “the general public or the medical community is, however, expressly preempted because there is no such parallel federal requirement”—but there is similarly no actual state law duty. Id. For negligent misrepresentation and express warranty, there are state law duties independent of any federal obligations and, here, we are not critical of the analysis. False marketing claims that a product is safer than it is or safer than a competing device can give rise to liability regardless of FDA requirements. So, we are fine with the court’s statement that “any state law claim that imposes liability for making false statements regarding the device’s relative safety parallels federal requirements,” even if we do not think the cases cited for that proposition are all good law. Id. at **72-73. We also agree that misrepresentation and warranty claims cannot be based on the alleged falsity of FDA-required statements about the device. Id. at *73. On manufacturing defect, the court reverted to an incomplete analysis, assuming that deviations from “the FDA’s approved design of the BHR device” could give rise to non-preempted state law claims, ignoring state law claims require manufacturing defects to render a product dangerous. Id. at *73.

Having found all these claims based on purported violations of FDA requirements to escape express preemption, without considering whether any state law authorized them, the court gave short shrift to implied preemption

All of the plaintiffs’ claims in the MACC fall within the states’ traditional power to regulate matters of health and safety. Not one cause of action tries to enforce a legal right held by a federal agency or relies on the statutory scheme for its existence—they all long predated modern medical devices.

Id. at **75-76. This is neither an accurate recap of what Buckman means, nor consistent with how the court had characterized plaintiffs’ causes of action as not seeking to impose liability based on violating requirements that were different from or in addition to FDA requirements. Rather than belabor the problems with this court’s analysis, we will end with pretty obvious gaffe. In returning to the purported state law claim for “failure to warn” by failing to report adverse events to FDA, the court concluded that “plaintiff’s failure to warn claims do not attempt to enforce the FDA’s right to be warned of information concerning the safety of approved medical devices” because plaintiffs claimed failing to report adverse events to FDA “violated a legal right owed to them.” Id. at *77. Presumably, that would be a right that the law of a state—or, rather, the law of 42 separate states—bestowed on private citizens based solely on federal law. To put it mildly, this is the kind of mess than can happen when preemption analyses skip steps and make unwarranted assumptions.

 

This post is from the non-Reed Smith side of the blog.

We’ve posted on two other occasions about the Shuker v. Smith & Nephew case as the Eastern District of Pennsylvania systematically dismantled the case on the grounds of preemption and pleading deficiencies. You can find those posts here and here. Unfortunately, the recent Third Circuit opinion deciding plaintiff’s appeal isn’t the full affirmance we had been hoping for. But before you get the wrong idea, the Third Circuit got the most important issue right – when you have a multi-component medical device, PMA preemption is to be addressed on a component-by-component basis. After that, however, the appellate decision does some unraveling of the district’s dismissal of the claims that survived preemption and so the case is going back to the Eastern District.

Briefly, the facts are that plaintiff underwent a hip replacement surgery in which his surgeon opted to use a Smith & Nephew device that consisted of several component parts, one of which was the R3 metal liner. Shuker v. Smith & Nephew, PLC, 2018 U.S. App. LEXIS 5160, *11 (3d Cir. Mar. 1, 2018). Unlike the other components of the device, the liner had undergone FDA Pre-Market approval. Id. And, the parties are in agreement that the surgeon’s decision to use the R3 metal liner with this particular device was an off-label use. Id. at *12. Plaintiff suffered complications that required additional revision surgeries.

In its first decision, the district court tossed out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. When plaintiff filed an amended complaint attempting to correct the pleading deficiencies for the non-preempted claims, he again missed the mark and his remaining claims were dismissed with prejudice. The district court also entered a decision finding that it lacked personal jurisdiction over Smith & Nephew, PLC – a foreign parent company. Those three rulings are what the Third Circuit addressed in last week’s decision.

The question of how to apply PMA-preemption to a multi-component device was one of first impression in the Courts of Appeal. Id. at *2. And it is an important question because surgeons engaging in off-label use do mix and match parts with different regulatory backgrounds. The Third Circuit did a precise analysis that landed at the proper conclusion. However, the analysis does start up with a bit of a hiccup. Since we are talking about PMA-preemption, we are dealing with express preemption. Yet, in a footnote the court refused to follow the Supreme Court’s recent abolition of the presumption against preemption in the express preemption context set forth in Puerto Rico v. Franklin Cal. Tax-Free Tr., 136 S.Ct. 1938 (2016), because that decision wasn’t a products liability case and therefore did not directly concern the “historic police powers of the States.” Shuker, at *16n.9. We respectfully disagree with this conclusion for all the reasons we mention in our post discussing Franklin and simply point out that other courts have reached the opposite conclusion. Accord Watson v. Air Methods Corp., 870 F.3d 812, 817 (8th Cir. 2017) (following Franklin and rejecting presumption against preemption in express preemption case); EagleMed LLC v. Cox, 868 F.3d 893, 903, (10th Cir. 2017) (same); Atay v. Cty. of Maui, 842 F.3d 688, 699 (9th Cir. 2016) (same); Conklin v. Medtronic, Inc., ___ P.3d ___, 2017 WL 4682107, at *2 (Ariz. App. Oct. 19, 2017) (under Franklin courts may not invoke a presumption against preemption in PMA preemption cases); Olmstead v. Bayer Corp., 2017 WL 3498696, at *3 n.2 (N.D.N.Y. Aug. 15, 2017) (plaintiff’s assertion of presumption against preemption in PMA preemption case held “frivolous” after Franklin).

Fortunately, that did not derail the Third Circuit from ultimately concluding that plaintiff’s negligence, strict liability, and breach of implied warranty claims were all preempted under Riegel. To do that, the court had to determine to what device it was applying the preemption analysis. Plaintiff argued that you have to look at the device that was implanted as a whole. Whereas defendant, bolstered by an amicus brief filed by the FDA at the court’s request, maintained that the proper focus is on the component of the device with which plaintiff takes issue. Shuker, at *18. Agreeing with the defense position, the court anchored its decision on three findings. First, the FDCA defines “device” to include “components, parts, and accessories.” Id. at *19. Second, the FDCA’s off-label provisions specifically acknowledge that a physician can and will use components separately from the system for which the FDA approved use. Id. at *20. And despite the use to which the component is put, the FDA’s PMA-regulations for the component follow with it. In other words, “premarket approval requirements apply equally to the components, as manufacturers generally may not deviate from the requirements imposed through premarket approval regardless of how [a component] is used.” Id. (citation and quotation marks omitted). Third, the FDA’s position is that the device is not limited to the device as a whole but includes components. Further, the FDA is charged with assuring the safety and effectiveness of components as well as finished devices. Id. at *21-22.

Therefore,

[t]aken together, the statutory definition of “device,” the treatment of off-label uses, and the guidance of the FDA all counsel in favor of scrutinizing hybrid systems at the component-level. . . .. And the Riegel test is properly framed at Step One as “whether the Federal Government has established requirements applicable” to a component of the hybrid system.

Id. at *22-23. Because the part of the device plaintiff attacked was the R3 metal liner which was premarket-approved, any state tort claim that seeks to impose requirements that are different from or in addition to the FDA’s requirements for that component are preempted. That includes plaintiff’s negligence, strict liability, and implied warranty claims.

The appellate court next reviewed the dismissal of plaintiff’s claims that survived preemption – negligence and fraud claims based on alleged off-label promotion in violation of federal law – and found the negligence claim was adequately pleaded but that plaintiff failed again to satisfy Rule 9’s heightened standard for pleading fraud. As to negligence, the court found TwIqbal satisfied as to duty, breach, causation where plaintiff alleged:

  • the R3 metal liner was approved only for use with a different system and therefore under federal law defendant had a duty to refrain from false or misleading advertising;
  • in a press release, defendant misleadingly marketed the R3 metal liner as an option for the system used by plaintiff’s surgeon (one other than the one it was approved for); and
  • plaintiff’s surgeon “either read” or “was aware” of the press release.

Id. at *28-29. Like the district court, the Third Circuit considered and relied upon the press release cited in plaintiff’s complaint. Unlike the district court, the Third Circuit appears to only focus on the portions of the press release upon which plaintiff relied (see prior post for more details) and concludes that’s enough to get plaintiff to the discovery stage. Id. at *29n.18. Although we wonder if the court’s calling plaintiff’s allegations enough to “nudge” the claim over the threshold is a veiled acknowledgement of just how narrowly the complaint squeaked by. See id. at *30.

Meanwhile, plaintiff’s fraud claim needed more than a nudge and it didn’t get even that. The court focused on plaintiff’s failure to plead justifiable reliance on the alleged misrepresentation. The “read” or “was aware” of allegation that sufficed for negligence lacked the requisite details regarding how the press release “induced or influenced” plaintiff’s surgeon for a fraud claim. Id. at *33-34. Plaintiff has to allege the “circumstances of the alleged [influence on Mr. Shuker’s surgeon] with sufficient particularity to place [defendant] on notice of the precise misconduct with which it is charged.” Id. at *34. Despite this having been plaintiff’s second failed attempt at meeting the pleading standard on fraud, the Third Circuit decided to give plaintiff another chance and found the claim should only be dismissed without prejudice.

Finally, there was a separate finding by the district court that it did not have personal jurisdiction over Smith & Nephew, PLC, a foreign parent company. The Third Circuit agreed with the district court that specific personal jurisdiction was not conferred on a stream-of-commerce theory. Id. at *36-37. We’ve talked about this before and more recently in light of BMS v. Superior Court, and like the Third Circuit “we have no cause to revisit” the precedent on the issue (but you should feel free to). But the court did think plaintiff alleged enough in his complaint to allow some limited jurisdictional discovery on possible alter ego based personal jurisdiction. Id. at *38-40. Emphasis on the limited part. See id. at *40n.20 (“District Court should take care to circumscribe the scope of discovery . . . to only the factual questions necessary to determine its jurisdiction;” further referencing proportionality amendment to Rule 26(b)(1)).

So, on the third pass plaintiff got a little life breathed back into this case which is unfortunate, but as the first appellate decision on component preemption – we’ll put it in the win column.

This post is from the non-Reed Smith side of the blog.

In our post earlier this week “No Causation, No ‘Parallel Claim’” we examined the enormous causation hurdle plaintiffs face in trying to prove a Stengel or Hughes type failure to warn claim in those jurisdictions where such a claim has been found not to be preempted. In that post, we commented that we “would have preferred an order finding the failure-to-warn claims preempted.” Well today, we bring you two that do just that. The first a complete preemption win, the other only a partial, but we’ll start with the good news.

Both Golden v. Brown, Case # 17CV30568, slip op. (Colo. Dist. Ct. Sep. 24, 2017) and Norabuena v. Medtronic, Inc., 2017 Ill. App. LEXIS 593 (Ill. App. Sep. 20, 2017) refused to recognize a failure to warn claim premised on a failure to report adverse events to the FDA – a Stengel claim if you’re in the Ninth Circuit and a Hughes claim if you’re in the Fifth. Now neither Colorado nor Illinois is in those circuits, but we’d like to think that regardless these state courts would have reached the same conclusion they did – neither Colorado nor Illinois law recognizes a claim for failure to warn the FDA. So, plaintiff can allege defendant violated a federal regulation by failing provide information to the FDA – but it isn’t “parallel” to any state law claim because there is no such state law claim. The Illinois appellate court summed it up nicely:

[A]lthough plaintiffs have identified a federal requirement that their complaint alleges Medtronic violated, there is no Illinois requirement that parallels it. Plaintiffs asserted claims for failure to warn. Although Illinois recognizes that a manufacturer may satisfy its duty to warn by conveying information to third-party learned intermediaries, this is not synonymous with an affirmative duty to warn a federal regulatory body. The learned intermediary doctrine states that a manufacturer has a duty to warn prescribing physicians of a drug’s known dangerous propensities” under the understanding that those physicians will use their expert knowledge in adequately warning the patient. We cannot find that this duty is parallel to the federal requirement.

Norabuena, 2017 Ill. App. LEXIS 593 at **14. The Colorado court not only found that allegations of failure to report adverse events to the FDA don’t state a parallel claim, but also concluded that Stengel and Hughes “cannot be reconciled with 21 U.S.C. §360k(a) as interpreted in Riegel or 21 U.S.C. §337(a) as interpreted in Buckman.” Golden, slip op. at 3. In other words, failure to warn a learned intermediary is different from and in addition to federal requirements regarding reporting of adverse events and a claim for failure to provide information to the FDA is an improper attempt at private enforcement of the FDCA. Just what we’ve been saying since these two awful decisions came down.

Both decisions have a little more to discuss.

In Golden, plaintiff also attempted to base a parallel claim on alleged violations of Current Good Manufacturing Processes (“CGMPs”). Noting that it was joining the majority of courts to have considered the issue, the court ruled that the CGMPs are too “vague” and “open-ended” to serve as a basis for a parallel claim. Id. at 2. The court also found plaintiff’s breach of implied warranty of merchantability claim preempted as essentially an allegation that the device was not safe and effective which would directly contradict the FDA’s PMA decision that “there is a reasonable assurance of . . . safety and effectiveness” and therefore expressly preempted. Id. at 3. And finally, the court found plaintiff’s claims impliedly preempted because plaintiff failed to explain “how Defendant’s conduct violated state law duties absent the FDCA.” Id. Simply stating that her claims were premised on Colorado common law was insufficient – “true merely in title, not substance.” Id. Instead, plaintiff’s claim exist solely under the FDCA which is not allowed.

The Golden case also suffered from some pleadings defects, such as failure to allege facts to support either a defect or causation. Id. at 2. But even if those pleading deficiencies could be cured, none of plaintiff’s claims survived preemption, so the case was dismissed in its entirety.

Switching gears to Illinois – unfortunately the court ruled that one of the bases for plaintiff’s failure to warn claim was not preempted. The FDCA contains regulations against device misbranding, which includes advertising that is false and misleading. Norabuena, 2017 Ill. App. LEXIS 593 at **15. Plaintiff alleged that defendant’s advertising was false and misleading in that it concealed known risks of using the device in an off-label manner. Id. at **16. In reaching its conclusion, the court distinguished plaintiff’s claim as not an attack on the device’s label which would be preempted as having been specifically approved by the FDA during the PMA process. But rather, plaintiff was challenging allegedly deceptive marketing practices post pre-market approval. Id. at **17. But that is a distinction without a difference where plaintiff’s allegation is that in its advertising defendant should have included a warning different from or in addition to the warning the FDA approved. The FDA-approved warning is what must accompany product advertising. Think about what the court is saying – if the warning is in the product label it must adhere to the FDA-approved language. If the warning accompanies an advertisement for the product it does not. We do not believe that is something the FDA would allow. While we can understand how a court can find that a false statement made in product promotion may be both a violation of state law and FDCA misbranding regulations, where that falsity is alleged to be a failure to include a warning not approved by the FDA, we respectfully disagree.

But, all is not lost in Norabuena. The appellate court found that plaintiff’s claims were properly dismissed on another ground – failure to plead causation. The complaint apparently was replete with allegations of “omitted” risks, “[h]owever, there are no specific factual allegations in the complaint asserting that [plaintiff’s] surgeon encountered or relied on any of the asserted promotional marketing.” Id. at **21. If a tree falls in the woods. . . . It’s not enough to plead the act or omission, the complaint was also allege facts supporting proximate cause. This pleading deficiency wasn’t enough for a dismissal with prejudice, so the case is heading back to the trial court and plaintiff will have to re-plead her remaining failure to warn claim.