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.

A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity.  That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from the Northern District of New York.  We have all suffered through opinions in which judges (or their clerks) painstakingly flog possible outcomes, arguments, and counter-arguments before finally reaching their decisions. And as (once again) McConnell recently pointed out, the result has been some spectacularly bad preemption decisions.  But Olmstead v. Bayer Corp., 2017 WL 3498696 (N.D.N.Y. Aug. 15, 2017), arising in the relatively clear jurisprudence surrounding so-called “PMA preemption,” was what we fondly call a “slam-dunk,” and the court treated it accordingly.

In Olmstead, the plaintiff was implanted with an Essure device, an implantable birth control device manufactured by the defendant.  She alleged that, after she was implanted with the device, she experienced months of pain, fatigue, and excessive bleeding culminating in a hospital visit for an episode of severe abdominal pain.  Though an initial ultrasound appeared normal, a subsequent ultrasound allegedly revealed that “one of the coils of the Essure was sticking out of the uterus by about one inch.” Olmstead, 2017 WL 3498696 at *2 (internal punctuation and citation omitted).  The plaintiff sued in state court, asserting claims for negligent misrepresentation, strict liability, failure to warn, and breaches of express and implied warranties.   The defendants removed the case to federal court and moved to dismiss it, arguing that the plaintiff’s claims were preempted by the Medical Device Act (“MDA”).

As the court explained (and as we have discussed in these pages many times before (like here, also in the context of Essure litigation), Class III medical devices like Essure must undergo FDA’s “rigorous” premarket approval (“PMA”) process before they can be marketed to the public. Id. at *1.  Under the MDA, once a Class III device obtains PMA, the manufacturer may not make changes to the device’s design, specifications, or labeling without FDA permission.

The MDA also includes an express preemption clause. Under this clause, as construed by the Supreme Court in Riegel v. Medtronic, 522 U.S. 312 (2008), state laws that impose obligations that are different from or in addition to the requirements of the MDA are expressly preempted. Id. at *3 (citations omitted).  A common-law claim challenging the safety of an FDA-approved medical device survives only if it alleges a parallel violation of federal law for which state law provides a damages remedy.  Id. (citations omitted).

As such, the Olmstead court explained, the plaintiff’s “onerous task” first required her “to identify a parallel federal law upon which she [had] based her state law claims.” Id. at *4.   In response, the plaintiff cited the Current Good Manufacturing Processes (“CGMPs”) described in 21 CFR § 820.1 et seq..  But she failed to explain how the defendants had violated the CGMPs, which, in any event, were intended “to serve only as an umbrella quality system providing general objectives medical device manufacturers must seek to achieve.” Id. (internal punctuation and citations omitted).  The court emphasized, “Since these regulations are open to a particular manufacturer’s interpretation, . . . allowing a suit to continue on the basis of the CGMPs would necessarily impose standards that are ‘different from, or in addition to’ those imposed by the MDA – precisely the result that the MDA provision seeks to prevent.”  Id. (internal punctuation and citations omitted).

Thus, the court held, because the plaintiff had “failed to identify a single parallel federal statute or regulation related to any of her claims,” the MDA expressly preempted the suit as a matter of law. Id. The court commented that it ordinarily would have allowed the plaintiff to amend her complaint to “attempt to allege a plausible claim that [was] not preempted.” Id. But, in yet another layer of certainty, the court held that New York’s three-year statute of limitations barred the plaintiff’s claims.

Nothing but net. And we are told that this is the twenty-fourth time that an Essure suit has been dismissed or narrowed on preemption grounds.  Short, sweet, and correct – hard to beat that.  We will keep you posted on further developments.

Last week appears to have been a bit of a slow week in the drug and device litigation arena. It was after all a short work week. It was back to school week (at least in the North East), which while bringing delight to parents everywhere also brings the chaos of last minute school supply shopping, discovering sneakers no longer fit, and the start of chauffeur season where parents essentially become Uber drivers between school, lessons, practices, and games. And we know our friends in the South had a few other things on their mind as they prepared for Irma.

So, that leads us to look beyond our normal comfort zone to see what else might be going on. Sure, enough we found a discussion of Buckman preemption in an automobile emissions case.

The case comes out of the In re: Volkswagen “Clean Diesel” Marketing, Sales Practices, and Products Liability Litigation, MDL 3354 and specifically the case of Wyoming v. Volkswagen Group of America, Inc., 2017 U.S. Dist. LEXIS 142586 (N.D. Cal. Aug. 31, 2017). Volkswagen’s “clean diesel” issues have been widely publicized and were the subject of significant criminal penalties and civil settlements having to do with Volkswagen’s installation in its diesel cars of software to defeat emissions testing which allowed the vehicles to acquire the necessary new-vehicle certifications from the EPA. Id. at *805-806. Under EPA regulations, the installation of such a “defeat device” is prohibited and the EPA has authority to bring a civil action for violation of that regulation. 42 U.S.C. §§7522(a)(3)(B); 7524(b). Wyoming, among other states, sued Volkswagen alleging the defendant violated Wyoming’s State Implementation Plan (“SIP”). Trying not to delve too deeply into the law, essentially the Clean Air Act requires each state to develop a SIP to enforce the EPA’s national air quality standards. The individual states are supposed to focus on stationary sources (factories, plants) and are limited in how they can regulate motor vehicles. Id. at *810. Considering how freely and frequently (daily) motor vehicles cross state lines, we understand why individual state plans regulating car emissions would be almost impossible to enforce.

So, the Clean Air Act allows states to regulate the use of “registered or licensed motor vehicles” as opposed to new vehicles Id. at *823, citing 42 U.S.C §7543(d). For instance, states can require testing after sale to ensure cars continue to meet emissions standards. Along those lines, Wyoming’s SIP includes provisions that say you cannot remove or render ineffective any air pollution control device and you cannot use a device that conceals an emission. Id. at *810-811. It is these two provisions which Wyoming argues Volkswagen is liable for violating.

The Clean Air Act, however, also contains an express preemption clause:

No State or any political subdivision thereof shall adopt or attempt to enforce any standard relating to the control of emissions from new motor vehicles or new motor vehicle engines subject to this part. . . .

42 U.S.C. § 7543(a). “States accordingly may not adopt their own rules prohibiting defeat devices in new vehicles, nor may they attempt to enforce EPA’s rule barring defeat devices in new vehicles.” Id. at *829. If you interpret Wyoming’s SIPs the way Wyoming is asking, they would run afoul of the express preemption clause. The SIPs are fine if you are talking about a mechanic tampering with a device so a car passes emissions inspection. That’s something for the state to regulate.

The court found additional support for its preemption analysis in Buckman. Wyoming is essentially bringing a fraud-on-the-EPA claim. Like the authority vested to the FDA for drugs and medical devices, Congress has given the EPA the same authority to both regulate and enforce new-vehicle emissions standards. Id. at *832-834.

If, despite this authority, States could bring actions against vehicle manufacturers based on deceit of EPA during new-vehicle certification, manufacturers would be forced to comply with EPA regulations “in the shadow of 50 State” regimes, which would “dramatically increase the burdens” manufactures would face in bringing new vehicles to market.

Id. at *833-34 (quoting Buckman).

Therefore, the court dismissed Wyoming’s claims as preempted and perhaps foreshadowed a similar demise for claims brought by other states. And while that is a great result, there is one glitch in the decision. This court apparently missed our post on the demise of the presumption against preemption in express preemption cases. As it begins its preemption analysis, the court states that part of its “interpretative framework” would include the presumption against preemption. Id. at *819. Fortunately, the presumption plays no further role in the court’s analysis and ultimate conclusion – because it shouldn’t it. The court even quotes Medtronic v. Lohr, that the presumption applies “unless [preemption] was the clear and manifest purpose of Congress.” Id. at *818 (quoting Lohr 518 U.S. 481, 485 (2006)). An express preemption clause like the one quoted above is fairly clear and manifest. And, if that wasn’t enough, the Supreme Court has been even more explicit:

[B]ecause the statute “contains an express pre-emption clause,” we do not invoke any presumption against pre-emption but instead “focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016). Done and done. So, while we laud the conclusion, we also use the decision to remind our readers that the presumption against preemption has been definitely knocked out of express preemption cases.

 

We depend on young associates to perform most of the legal research that supports the arguments we make on behalf of our clients.  By and large, those associates do an excellent job.  On those rare occasions when we find ourselves grousing about the quality of research, it usually has something to do with reliance on overly-specific computer searches.  Sometimes it seems as if the lawyers punch a search term into Lexis or Westlaw that would capture only cases that are precisely on point.  The problem with that approach is the possibility of missing cases that support general principles, or offer other oblique ammunition for one’s position.  Today’s case, Canale v. Colgate-Palmolive Co., 2017 U.S. Dist. LEXIS 97506 (S.D.N.Y. June 23, 2017), is an example of that kind of helpful, albeit indirect, authority.  The plaintiffs in Canale filed a class action attacking the defendant for allegedly overstating the whitening power of its toothpaste.  The toothpaste contained hydrogen peroxide, and its advertising bragged of deep whitening – more than three shades.  The plaintiffs asserted that the hydrogen peroxide was not strong enough and was not in contact with tooth enamel long enough to achieve the promised results.  The causes of action were based on breach of warranty and violations of New York’s General Business Law sections 349 and 350, which outlaw deceptive practices and false advertising.

What can this case possibly have to say for drug litigation?  To begin with, the toothpaste’s peroxide content meant that it was both a cosmetic and an over-the-counter (OTC) drug.  A product qualifying as both a cosmetic and drug is subject to the stricter requirements applicable to drugs.  Either way, such a product enjoys the preemption protections in the Food, Drug and Cosmetics Act,  21 U.S.C. sections 379r and 379s.  The FDCA forbids state law (including jury verdicts) or regulations that would impose a requirement on cosmetics or OTC drugs that are “different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable” via the FDCA.  Thus, the defendant filed a motion to dismiss the case in its entirety, and preemption was one of the grounds. The plaintiffs ultimately evaded preemption because the court found no FDA requirement regarding the tooth whitening claim, so there was nothing federal that the state laws against deceptive advertising  contradicted.

Okay, you’re still probably wondering why a drug defense hack would care about this case.  If an associate failed to find this case in her research, who cares?

There are two preemption points in Canale that are valuable:

1. The plaintiffs’ opposition to the defendant’s motion rested solely on implied preemption cases.  That is, the plaintiffs argued that there was no impossibility preemption.  That is, the plaintiffs had completely missed the point.  The defendant was not arguing impossibility preemption.  Rather, the defendant argued that Congress had expressly manifested an intent to preempt state law.  The plaintiffs had confused express preemption with implied preemption, but the Canale court kept the distinction straight.  So should you.

2.  The plaintiffs, predictably, argued that there was a presumption against preemption.  But, consistent with point 1 above, the Canale court held that “where, as here, Congress has expressly manifested its intent to preempt state law, no presumption against preemption arises.”  It is nice to have in your pocket such a clear statement on this issue from SDNY.

Still, as we mentioned, the preemption argument did not carry the day for the defendant.  So was this a win for the plaintiffs?  Not at all.  The issue of whether or not the advertising for the whitening toothpaste was deceptive had already been addressed to the Federal Trade Commission.  The issue was pending. The FTC had at least as much expertise as the court in deciding whether the hydrogen peroxide in the toothpaste had sufficient whitening power (let’s face it, the FTC has more expertise), the FTC is specifically tasked with discretion to police allegedly deceptive labeling, there was a risk of inconsistent rulings, and the FTC had gotten the issue first.  Consequently, the Canale court – after observing that “primary jurisdiction” is something of a misnomer because it isn’t , strictly speaking, jurisdictional – decided to stay the litigation to allow the FTC to do its job and determine whether the toothpaste advertising really was deceptive.

Staying a class action is definitely a good result for the defendant.  Despite the setback on the preemption front, we bet the Canale result put smiles on the faces of the defendant and its lawyers – nice, big, shiny smiles.

We have a point of view. Our readers understand that we represent folks on the right side of the v., and our posts tend to read cases and legal trends with a pro-defense bent, although you can rest assured that we put a lot of thought into it.  From time to time, however, we see an opinion that is just plain wrong, and we have to call it out.  That is the case today with Mink v. Smith & Nephew, Inc., No. 16-11646, 2017 WL 2723913 (11th Cir. June 26, 2017).  The plaintiff sued the manufacturer of a metal-on-metal hip replacement device for negligence and strict product liability, among other claims, alleging that the manufacturer did not meet federal requirements in the manufacture of the device, that it improperly trained surgeons, and that it failed to report adverse events. Id. at **6-8.

The device is a Class III device approved through the FDA’s rigorous premarket approval process. That means express preemption applies, and because the plaintiff was suing to enforce federal requirements on the manufacturing of a device, implied preemption applies, too.  The district court so ruled and dismissed the plaintiff’s claims. Id. at *2.  But the Eleventh Circuit came to the opposite conclusion, and the opinion caught our eye for two reasons.  First, the Eleventh Circuit professes to know more about Florida law than the Florida courts.  What do we mean by that?  Well, the Medical Device Amendments state that federal law preempts all state law requirements “different from or in addition to” federal requirements.  Under the widely misunderstood “parallel claim” exception, plaintiffs can sometimes pursue state law claims that “parallel” federal claims, but this requires that state law actually recognize such a cause of action.

Here, the Eleventh Circuit allowed the plaintiff’s manufacturing defect claims to proceed as “parallel claims” because Florida recognizes a strict product liability claim based on a manufacturing defect and the plaintiff alleged that the defendant “violated the Florida common law duty to use due care in manufacturing a medical device.” Id. at *7.  This is okay as far as it goes, but what was the basis for the manufacturing defect and the alleged breach of duty?  The manufacturer did not comply with the FDA’s requirements. Id. at *8.  The plaintiff was suing because the manufacturer allegedly violated federal requirements.

That is federal preemption. Moreover, a Florida court recently held in the context of MDA express preemption that neither federal law nor Florida state law creates a private right of action to enforce federal medical device requirements. Id. at *5 (discussing Wolicki-Gables v. Doctors Same Day Surgery Ctr., Ltd., 216 So. 3d 665 (Fla. Dist. Ct. App. 2017)).  To make matters worse, the Florida Supreme Court held more than twenty years ago that penal and regulatory laws do not create a private right of action under Florida law absent a clear legislative intent to do so. See Murthy v. N. Sinha Corp., 644 So. 2d 983, 986 (Fla. 1994).  Congress has expressly said that the FDCA and the Medical Device Amendments do not create a private right of action, and the Florida legislature has never created such a right of action either.  The Eleventh Circuit apparently knows better.

The second reason this opinion caught our eye is the Eleventh’s Circuit’s apparent motivation—that unless it reversed the district court’s order dismissing the plaintiff’s claims, the plaintiff would not be allowed to proceed. Id. at *5.  We sometimes characterize opinions as “result oriented,” but rarely are circuit courts so blunt.  This court took umbrage with the idea that a plaintiff would not be able to pursue product liability claims against the manufacturer of a premarket approved device.  The Supreme Court thought differently in Riegel.

The court did hold that claims based on inadequate training were expressly preempted because no such claim exists under Florida law (i.e., there is no “parallel”), and the claim based on the failure to report adverse events was impliedly preempted because it was similar to a “fraud on the FDA” theory, per Buckman. The district court, however, came to correct result for the correct reasons when it dismissed the plaintiff’s claims.  The Eleventh Circuit should have affirmed it.

Put a New Yorker and a Californian in a room together and the debate will begin almost immediately. Hollywood v. Broadway. Atlantic v. Pacific. Dodgers v. Yankees or Giants v. Forty-Niners. Shake Shack v. In-N-Out (or is Five Guys overtaking both?). And more generally speaking that east coast/west coast divide extends beyond those two urban hubs. Laid back v. fast-paced lifestyle. Deserts v. low country. Golden Gate v. Sunshine Skyway. Disneyland v. Disney World. And let’s not forget – the west coast may be synonymous with California sunshine, but the east coast gives you actual seasons.

While failure to report adverse event claims are not limited to the west coast, we think of them as Stengel claims. In case you need reminding, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims with indirect third-party warning claims where the third party is a governmental agency – that is, the FDA. Since Stengel is a Ninth Circuit case and the Ninth Circuit includes the entire west coast – we’re going to saddle the west coast with that one. And we’re going to praise an east coast court for saying, thanks but no thanks.

We’ve talked about Burrell v. Bayer Corporation before when earlier this year the court ruled that allegations of parallel claims in plaintiff’s complaint conferred federal question jurisdiction. After winning on removal, the defendants next moved to dismiss the entire case on preemption. Round 2 goes to defendants as well.

The product at issue is the Essure birth control medical device. It is a pre-market approved device so preemption shouldn’t be a big surprise. Burrell v. Bayer Corp., 2017 WL 1955333, *1 (W.D.N.C. May 10, 2017). As is true of the vast majority of drug and medical device products cases, failure to warn is at the heart of the case. But as we already know, traditional failure to warn claims are preempted in PMA device cases. So, plaintiffs pushed for a Stengel-claim. Plaintiff’s argument is failure to warn premised on failure to provide adverse event reports to the FDA is a non-preempted parallel claim. Unpersuaded by the reasoning of that west coast court, Burrell found that the requirement to report adverse events exists under the FDCA rather than state law and therefore, plaintiff’s failure to warn claim is “being brought because the [] defendants allegedly failed to meet these reporting requirements.” Burrell, at *5 (emphasis added). And where a claim is being brought solely based on a violation of the FDCA – that’s Buckman implied preemption. Traditional failure to warn is expressly preempted, failure to report to the FDA is impliedly preempted. Score one for the east coast for getting this.

But the court didn’t stop there. Analyzing the claim under state law, it still didn’t hold up because plaintiff’s allegations didn’t support a finding of causation. This is where most Stengel claims. By the time the device was implanted in plaintiff, the FDA had received and analyzed the adverse event reports and the subsequent warning did not contain any new information. Id. at *5 (although a black box warning was required, that was a new “type” of warning, the substance of the warning was unchanged). So there was no causal nexus between the alleged failure to report and plaintiff’s injury.

None of plaintiff’s remaining claims fared any better. On failure to train, the claim only survives preemption if premised on allegations that defendant failed to train in accordance with federal requirements. Plaintiff made no such allegations. Id. at *6. Moreover, plaintiff again failed to allege any facts to support a causal connection between the failure to train and her injury. Id. Plaintiff’s negligent manufacturing claim suffered the same fate – no alleged violation of federal requirements and no facts to support causation. Id. Plaintiff’s design defect claim was dismissed as expressly preempted. As a PMA device, the “FDA made its determination of this products safety and effectiveness for its given use. As the plaintiff cannot allege that [defendant] departed from its FDA-approved design of this product, these design defect claims are preempted.” Id. at *7. Even if not preempted, North Carolina does not recognize strict liability claims for products liability. Id.

            Moving on to warranty claims, plaintiff alleged that defendant expressly warranted the product was safe. To find that defendant breached that warranty, a jury would have to conclude that the product was unsafe – which is contrary to the FDA’s conclusion in its pre-market approval that the device was in fact safe and effective. So, express warranty is expressly preempted. Id. Since plaintiff’s implied warranty claim also turned on whether the product was reasonably safe, it too was expressly preempted. “The FDA, under the FDCA and the MDA, has the express authority to make such determinations as to the safety and effectiveness of Class III medical devices.” Id.

Plaintiff’s final claims against the manufacturer were for fraud and unfair trade practices. The court first noted that most of the allegations on these claims were just a re-packaging of the allegations pleaded with plaintiff’s other claims. Since the allege misrepresentations were largely “indistinguishable from FDA-approved labeling statements” – they too were preempted. Id. at *8.

Nice job North Carolina. In the east coast v. west coast debate, we’ll side with an anti-Stengel jurisdiction every time.

Back in October we posted about the Eastern District of Pennsylvania decision McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016) saying that while we liked the ultimate result – tossing out most of plaintiffs’ claims – some pieces of the decision weren’t as strong as we would have liked. Well, McLaughlin’s back and it’s still not a slam dunk, but plaintiffs’ don’t have too much left of their cases either.

As a reminder, this is actually a decision in 5 cases each alleging injury from plaintiffs’ use of a Class III, PMA contraceptive device, Essure. McLaughlin v. Bayer Corp., 2017 WL 697047, at *1 (E.D.Pa. Feb. 21, 2017). Several of plaintiffs’ original causes of action were dismissed with prejudice, but they were given an opportunity to amend to try to salvage their claims for negligent training, negligent risk management, breach of express warranty, fraudulent misrepresentation, and negligent manufacture. Negligent misrepresentation and failure to warn premised on failure to report survived the first motion to dismiss.

The decision methodically goes through each cause of action.

Negligent Training: In its first decision, the court opined it was possible to state a parallel claim for negligent training, but since plaintiffs failed to specify how defendant’s training deviated from federal training requirements or how those deviations caused plaintiffs injuries, the claim had to be dismissed as insufficiently pled. Id. at *3. In the amended complaint, plaintiffs alleged 6 such failures by defendant. As to 3, the court couldn’t find any federal directive that required defendant to do what plaintiffs alleged it failed to do. So, as to those 3 allegations, the claim was dismissed as expressly preempted. Id. at *4-5. As to the remaining 3 alleged violations, defendant challenged them on causation grounds but was unsuccessful. The court found the complaint sufficiently alleged that because defendant failed to properly train the doctors, the doctors in turn did not properly place the device causing it to migrate and cause plaintiffs’ injuries. Id. at *5. The complaint, however, lacked any specific allegations about the actual doctors who performed plaintiffs’ surgeries. The court didn’t find that fatal at the pleadings stage – that was for discovery. Id. at *6. But if you look at what the 3 bases for the failure train claim are, they appear to all be things plaintiffs could have asked their doctors about before filing these lawsuits. Did the doctor successfully complete 5 preceptorings? Did the doctor read and understand the training manual? Did the doctor successfully complete the simulator training? If the answers to those 3 questions are yes in each case – this claim is over.

Continue Reading PMA Preemption Revisited in Pennsylvania

Today’s guest post is by Aggie Lee of Tucker Ellis, about a PMA preemption win that she briefed in California.  The medical device is a hemostatic matrix, which is unusual, and this type of device isn’t usually targeted in product liability litigation.  As is always the case, our guest posters are 100% responsible for their submissions, so Aggie deserves all the credit (and any blame) for what follows.

**********

Judge Gonzalo P. Curiel in the Southern District of California has been in the national spotlight since then-candidate Donald Trump questioned his impartiality in the then-pending Trump University lawsuits.  While now-President Trump might not number among his admirers, we like Judge Curiel’s recent contribution to Premarket Approval (PMA) preemption, where he recently dismissed with prejudice all of plaintiffs’ claims in Weaver v. Ethicon, Inc., No. 16CV257-GPC(BGS), 2017 WL 680725 (S.D. Cal. Feb. 21, 2017).

But it took a long time and many motions to get there, specifically four complaints, one personal jurisdiction-based motion to dismiss, and three preemption-based motions to dismiss. Defendant Ethicon, Inc., finally prevailed when the Court dismissed Plaintiffs’ Third Amended Complaint with prejudice.

Continue Reading Guest Post – The Matrix Preempted

Over the years, comedian Adam Carolla has played the “Germany or Florida” game on his various radio and tv programs and podcasts. The game is based on the observation that many of the most bizarre stories of human ineptitude come from Germany or Florida.  Callers describe News of the Weird headlines, and Carolla and guests try to guess whether the events happened in Germany or Florida.  You can listen to this segment from the old Loveline radio show.

Here are some examples of “Germany or Florida” clues:

  1. Man ate his dog.
  2. Carjacker forced to flee after realizing he could not drive a stick-shift.
  3. Trio shoots at imaginary foe, thereby attracting police to their homegrown meth lab.
  4. Naked swimmer hospitalized after angler hooks his penis.
  5. Man dies after blowing up condom machine.
  6. Sister assaults twin over sexy toy.
  7. Government creates blatant ex post facto law depriving tobacco companies of basic tort defenses.

Okay, you probably know about that last one.  The answers to the others are below.  By the way, Carolla is not alone in identifying The Sunshine State as also being The Sublimely Strange State.  30 Rock had a running gag about Florida craziness.  See examples here.  Also, Seth Meyers on the Late Show runs a “Fake or Florida” bit that can, at best, be charitably labeled as being derivative of Carolla’s gag.  On last Sunday’s Last Week Tonight, John Oliver reported a story about a Florida man who planned to bomb Target stores up and down the east coast, with  the idea of buying up Target stock on the cheap afterwards.  After pointing out how the story involved home-made explosives, a big box store, and a terrible get-rich-quick scheme, Oliver noted that if the story also had a snake on meth, we would have full-on Florida Bingo.

Even before we earned our law license, we were aware that there is something … different … about Florida’s legal system.  In our law school library, you could pull the 12 So. 2d volume off the shelf and it would automatically open up to the Lason v. State case, in which the Florida Supreme Court upheld the conviction of a 76 year old man for “abominable and detestable crimes against nature.”  Some law school libraries have needed to insert photocopies of the Lason case after the original pages were worn out completely.  Good times.

Last week there was a mini-eruption of Florida case law, and we will cover some of those opinions this week.  It is not quite Shark Week for our blog, but it is close.  Today’s case, Wolicki-Gables v. Doctors Same Day Surgery, Ltd., 2017 WL 603316 (Fla. DCA 2d Feb. 15, 2017), is unusual.  The case is ostensibly about spoliation, but it is really about preemption and the dreaded parallel claim exception.  Luckily, the case comes out the right way.  But getting there was like doing a couple of laps on Mr. Toad’s Wild Ride. (You didn’t think you were getting out of this blogpost without at least one Disney World reference, did you?)

Mrs. Wolicki-Gables claimed a physical injury from a failed pain pump system.  She and her husband initially sued the manufacturer of the pain pump, alleging causes of action for strict liability and negligence.  The case was filed in state court, but was then removed to federal court.  The pain pump system had received pre-market approval from the FDA.  Because of that fact, and because of the Supreme Court’s decision in Riegel, the federal court held that the Wolicki-Gables’ product liability claims against the manufacturer were preempted by federal law.  The Eleventh Circuit affirmed the summary judgment in favor of the manufacturer.

Continue Reading Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim

We’re serious – we’re not planning to give a flip answer like “an extortion racket.”  No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?”  (Hint – that’s discussed in Frigaliment Importing Co., Ltd. v. BNS International Sales Corp., 190 F. Supp. 116 (S.D.N.Y. 1960)).  The question of “what is product liability” is of interest to us primarily, but not exclusively, because of 21 U.S.C. §379r(e), which creates an exception for “product liability law” to what is otherwise a rather broad preemption provision governing over-the-counter (also called “monograph”) drugs.

We wrote a post in the early days of the blog – 2008 – about that particular provision, entitled “Preemption Without a Prescription,” where we discussed cases that, up to that time, had addressed the scope of §379r(e)’s saving clause.  That boundary of that clause, as we explained it then, was that “suits for purely economic loss – primarily, but not exclusively, brought under state consumer protection statutes – are not ‘product liability’ actions.”

That’s still true.

We’re not repeating the 2008 post, but we will update it.  Here is a list of cases not discussed in that post, which likewise hold that preemption defeats OTC drug litigation that does not involve personal injury claims:  Wiltz v. Chattem, Inc., 2015 WL 3862368, at *1-2 (C.D. Cal. May 8, 2015); Bowling v. Johnson & Johnson, 65 F. Supp.3d 371, 376-77 (S.D.N.Y. 2014); Gisvold v. Merck & Co., 62 F. Supp.3d 1198, 1202-03 (S.D. Cal. 2014); Crozier v. Johnson & Johnson Consumer Cos., 901 F. Supp.2d 494, 503-05 (D.N.J. 2012) (discussing scope of §379r(e)); Delarosa v. Boiron, Inc., 818 F. Supp.2d 1177, 1188 n.7 (C.D. Cal. 2011) (discussing scope of §379r(e)); Eckler v. Neutrogena Corp., 189 Cal. Rptr.3d 339, 357-61 (Cal. App. 2015) (discussing scope of §379r(e)).

Thanks to this recent blogpost, however, we’ve become aware of another way that the definition of “product liability” is important.  Down in Texas, they have a unique indemnification statute, Tex. Civ. Prac. & Rem. C. §82.002(a) that provides:

A manufacturer shall indemnify and hold harmless a seller against loss arising out of a products liability action, except for any loss caused by the seller’s negligence, intentional misconduct, or other act or omission. . . .

We’d vaguely heard of this statute before, in connection with a case, Hadley v. Wyeth Laboratories, Inc., 287 S.W.3d 847, 849 (Tex. App. 2009), which we liked because it held that prescribing physicians weren’t “sellers” of the drugs they prescribed, which means they can’t be sued for strict liability.

But §82.002(a) also means that, in Texas, the ability of an intermediate seller to recover indemnity (including counsel fees) requires that the underlying action to be one for “products liability.”  That’s where the blogpost comes in.  It discussed a recent case, vRide, Inc. v. Ford Motor Co., 2017 WL 462348 (Tex. App. Feb. 2, 2017), that also addressed the definition of “product liability.” vRide involved an indemnity claim brought by a lessor of a motor vehicle from the defendant, which manufactured the vehicle.  The underlying claim had not been for strict liability, but rather for misrepresentation – that the vehicle did not have the attributes that the original defendant (the lessor) claimed that it did.

The court in vRide held that a misrepresentation claim did not fall within the meaning of “product liability”:

The [plaintiffs’ complaint] did not allege that the [product] was unreasonably dangerous, was defective by manufacture or design, was rendered defective because it lacked certain safety features, or was otherwise defective. Instead, the petition alleged that [defendant] represented [that the product] had certain safety features when in actuality [they] did not have those safety features. . . .  In short, the [complaint] did not contain allegations that the damages arose out of personal injury, death, or property damage allegedly caused by a defective product.

2017 WL 462348, at *7. We can imagine situations in which this definition could come in useful in litigation involving OTC preemption, since it excludes from “product liability” even some actions involving (as did vRide) personal injury.

The most significant hypothetical involves a situation where the plaintiff’s injuries were caused by a generic OTC drug. In that situation, given the broad scope of preemption available in generic drug cases, one could expect plaintiffs to attempt to assert innovator liability against the branded drug manufacturer.  But innovator liability is based (like vRide) on the (we believe phony) proposition that “misrepresentation” is not “product liability” and thus can extend to non-manufacturers.  But if misrepresentation is not “product liability,” then the savings clause in §379r(e) would not apply, and innovator liability claims would be expressly preempted whether or not they involved personal injury. vRide would thus be precedent in favor of preemption.

That would be a good thing.  And so is cross-fertilization – where a definition in a completely unrelated statute can be utilized in support of preemption.