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It’s a fairly well known double standard. If you ask your child why he or she did that rotten, terrible, awful thing and he or she responds “just because” – that’s never good enough. When a parent is faced with the question “why,” however, “because I said so” is a fairly standard, albeit a bit of a crutch, response. If your child happens to have a litigator as a parent, the lesson that “just because” won’t cut it is learned very early. Litigators like to practice their cross-examination skills. Litigator-parents get that opportunity when faced with broken windows, missed curfews, and dented bumpers. DDL Blog litigator-parents not only cross-examine, we TwIqbal (actually seems to work well as a verb). We want supporting facts and they better be sufficient to “nudge” whatever explanation is being offered “across the line from conceivable to plausible.” Ashcroft v. Iqbal, 556 U.S. 662, 680 (2009).

That’s exactly what the judge was looking for in Staub v. Zimmer, Inc., 2017 U.S. Dist. LEXIS 89109 (W.D. Wash. Jun. 9, 2017). Try as he might, however, he couldn’t find it. Plaintiff filed suit in Washington state alleging injury from the implantation of a prosthetic hip. Id. at *1. Following removal to federal court, defendant moved to dismiss.

In Washington, all products liability claims are subsumed under the Washington Product Liability Act (“WPLA”). Id. at *4. The WPLA allows a plaintiff to seek recovery for defective design; failure to warn; defective manufacture; or breach of express or implied warranty. Id. at *4-5. While a plaintiff does not have to specify in the complaint which precise theories he or she is pursuing, the complaint has to “contain sufficient non-conclusory factual allegations to support at least one avenue of relief.” Id. at *5. So, the court combed the Staub complaint to see if it met that basic requirement.

First, the court could find no indication anywhere in the complaint that plaintiff was alleging either failure to warn or breach of warranty. Id. at *5-6. The court was unwilling to read into the complaint claims that plaintiff appears to have failed to assert. As an aside the court pointed out that should plaintiff wish to pursue a failure to warn claim, it may be barred by the learned intermediary doctrine. Id. at *6n3. Perhaps a little foreshadowing?

The WPLA recognizes both the risk utility test and the consumer expectations test as bases for a design defect claim. So plaintiff’s complaint better have support for at least one of these theories. Plaintiff Staub, however, failed to adequately plead either. On risk utility, plaintiff only alleged that the product was “not reasonably safe.” Id. at *7. On consumer expectations, plaintiff only alleged that the device “failed to meet consumer expectations of safety.” Id. at *8. These are the pleading equivalent of “just because.” Parroting back the words of the elements of the claim do not suffice. Nowhere did plaintiff allege how a design element led to his alleged injury, whether there was a feasible alternative design, or how the product didn’t meet expectations. Id. at *7-8.

On his manufacturing claim, plaintiff failed to allege any facts showing that the device at issue deviated in any way from the intended design. Id. at *9. Once again, a bare bones allegation that the product was “defective and unreasonably dangerous” was far from satisfactory. Id. Plaintiff apparently made some attempt to save his manufacturing defect claim by alluding to the fact that the product had been voluntarily recalled. But without any allegations connecting the recall to plaintiff’s alleged injuries, the recall alone offers no support. Id. at *10n5.

Plaintiff is getting a do-over; he has 20 days to file an amended complaint. It’s sort of like, go to your room and when you come back you better having something better than “just because.”

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

We understand that illnesses and injuries can be emotional; sometime extremely emotional and rightfully so. We understand that some treatments can add to the stress. We certainly understand that when a treatment results in complications or does not turn out as hoped, an already tense situation can become intense. We don’t deny the “personal” side of personal injury cases. But drug and device products liability cases are not infliction of emotional distress cases. Which is what the court found in Ripple v. Davol, Inc., 2017 U.S. Dist. LEXIS 82867 (S.D. Fla. May 31, 2017).

Plaintiff brought most of the standard products liability causes of action – negligence, strict liability, failure to warn, breach of implied warranty, negligent misrepresentation, and fraud – but also included claims for both intentional and negligent infliction of emotional distress.  Id. at *2. The court dismissed the warranty claim for lack of privity, id. at *10-11, and misrepresentation and fraud for failure to satisfy the heightened pleading requirement. Id. at *11-13.

On infliction of emotional distress, the court explained that under either an intentional or negligence standard, plaintiff has to allege “conduct so outrageous in character, and so extreme in degree, as to go beyond all possible bounds of decency, and to be regarded as atrocious, and utterly intolerable in a civilized community.” Id. at *7 (citations omitted). Just read that again and let it sink in. We think it is immediately apparent that such a claim does not belong in a drug or medical device case. We are talking about products that had to be approved by the FDA before being sold and the levels of testing, analysis, monitoring, and reporting that goes along with that. Satisfying all the FDA requirements and then marketing a medical device that can only be obtained via a licensed surgeon who must also implant the device is hardly an atrocity that would offend the bounds of decency.

Plaintiff’s only response was that her infliction of emotional distress claims were based on defendant’s failure to properly test or properly design the device. Id. at *8. The opinion contains citations to the type of conduct that does rise to the “utterly intolerable” level and the horrors described even briefly in the parentheticals make it abundantly clear that failure to test/design doesn’t even come close. Id. at *8-9.

If plaintiff’s allegations were sufficient, “any manufacturer who is liable for strict products liability or negligence is also liable for the infliction of emotional distress upon those damaged by the product.” Id. at *9. An infliction of emotional distress claim cannot be solely premised on ordinary products liability and negligence. It must involve a degree of “physical contact” or “severely threatening behavior.” Id. at *10. Neither of which is present in this case or in any drug/device case (at least that we can think of). With no supporting case law and no supporting facts, the court dismissed the claims with prejudice.

We don’t see a lot of infliction of emotional distress claims in this arena, probably for the very reasons discussed in Ripple. But the court’s explanation for why these claims are not viable is among the best we’ve seen.

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.

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

A federal judge in Texas recently ruled that Texas law does not allow a claim for negligence per se based solely on alleged violations of the FDCA or FDA regulations. Monk v. Wyeth Pharmaceuticals, Inc., 2017 U.S. Dist. LEXIS 72477, *21-23 (W.D. Tex May 11, 2017). That seems pretty straightforward to us. Plaintiffs typically use negligence per se to try to privately enforce a provision of the FDCA, i.e., by using an alleged violation of a safety-related provision of the FDCA as the basis for their state law claim.  State law does not always allow this, but even when it does, such a claim should not withstand implied preemption under Buckman.  That is because Buckman and section 337(a) of the FDCA make it clear that litigants cannot privately enforce the FDCA, and a negligence per se claim based on a purported violation of the FDCA is an unveiled attempt to accomplish exactly that. Monk doesn’t say all of that explicitly, but it relies on cases that do. That’s good enough for us.

Plaintiff based her negligence per se claim on the defendants’ alleged failure to provide medication guides for distribution with amiodarone prescriptions.  The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Id. at *3, *6 (citing 21 C.F.R. § 208.24(b)).

And this is where things get confusing, because while the court dismissed plaintiff’s negligence per se claim based on violation of this regulation, the court reached the opposite conclusion regarding plaintiff’s negligent failure to warn claim based on exactly the same thing.  A state law failure-to-warn claim based on a violation of federal prescription drug regulations? Sounds like implied preemption to us, but the court concluded that this very federal-sounding claim was actually a parallel state law failure to warn claim. But wait. Isn’t plaintiff suing because the defendant allegedly violated the FDCA.  That’s Buckman implied preemption. As many courts have noted, plaintiffs seeking to avoid preemption have to weave their way through a “narrow gap” by alleging they are suing for conduct that violated the FDCA, but not because the conduct violated the FDCA. But the only allegation here is that defendants did not provide the medication guides as required by federal regulations.

The court’s reasoning is based entirely on dicta in the Fifth Circuit’s decision in Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674, 679 (5th Cir. 2014) that “failing to provide FDA-approved warnings would be a violation of both state and federal law, this is a parallel claim that is not preempted.” Id. But the claim that defendants provided no warnings was not alleged in the complaint and so was not allowed by the court. There is no information in Eckhardt regarding the basis for plaintiff’s claim that defendant failed to provide any warnings and so it is unknown if it was “because” defendant’s violated a federal regulation.

In Monk, the court knew precisely the basis for plaintiff’s failure to warn claim – 21 C.F.R. § 208.24(b); the same basis as plaintiff’s negligence per se claim. That the result is different on both claims is really difficult to reconcile. So we won’t try. We’ll instead reiterate – no negligence per se based on FDCA in Texas.

 

We’ve all had cases where plaintiffs try to use their prescribers and treaters as their experts on everything from failure to warn and causation to design defect and company conduct. Even on the medical aspects of the case, a treater needs to offer more than just an unsupported general conclusion in order to withstand scrutiny under Daubert. But, when a surgeon or an orthopedist, for example, starts to offer opinions on product defects; when he or she has sufficiently wandered away from the parameters of their general expertise; the bar needs to be set even higher. Or, at least the proffered opinion needs to be even more carefully scrutinized. And certainly something more than — gee, I’ve never seen this before – is required.

But – gee, I’ve never seen this before – is all plaintiffs had to offer in Whybark v. Synthes, Inc., 2017 U.S. Dist. LEXIS 67988 (W.D. Ken. May 4, 2017). And that’s why defendants were awarded summary judgment. The case involves a bone screw (a product dear to Bexis and me). Plaintiff had one implanted in his foot to correct an osteoarthritis issue. Id. at *1. Two months after surgery, x-rays revealed that the plaintiff’s bones had not yet fully healed. X-rays taken four months after surgery show the bone still not completely healed and also that the bone screw had fractured. Id.

Kentucky products liability actions are governed by the Kentucky Product Liability Act which allows three potential claims: defective design, defective manufacture, and failure to warn. Id. at *4-5. Plaintiffs abandoned both their design defect and their failure to warn claims. On design defect, the only evidence in the case was that plaintiff’s surgeon testified the product was safe and effective. Id. at *5. Nor did plaintiffs challenge that the package insert contained an adequate warning about the risk of screw fracture. Id. at *6.

Plaintiffs instead decided to place their sole focus on manufacturing defect. The court begins its analysis of the claim by determining that indeed plaintiffs needed expert testimony to support it. Knowledge of the design and manufacture of bone screws is “far outside the realm of common experience” of lay jurors. Id. at *7.   But the only expert proffered by plaintiffs was the implanting surgeon. The surgeon’s only testimony regarding defect was that “he suspected the breakage of the [defendant’s] screw was due to a manufacturing defect because he had never seen a bone screw break after surgery.” Id. at *2. While it’s reassuring to know that the doctor has had such a good track record, that tells us absolutely nothing about whether this particular screw contained a manufacturing defect.

But even before getting to the substance or basis for his opinion, the surgeon’s testimony failed Daubert because he was unqualified on manufacturing issues. The first point was obvious, he had no training, education or experience in manufacturing, metallurgy, or biomedical engineering. Id. at *12. Beyond that though, plaintiff could offer no reason for why the doctor’s clinical experience and personal knowledge of bone screws qualified him to offer an expert opinion on manufacturing defect. Id. The treater/prescriber’s testimony is generally admissible as to care, treatment, prognosis – things he observed, concluded, or formed an opinion on in the course and scope of treatment. Id. This is another reason to challenge a treater/prescriber’s testimony on causation, if not supported by an independent expert report that withstands Daubert. While causation is in the realm of the doctor’s expertise, if it’s not something he opined on during care and treatment, he shouldn’t be allowed to opine on it at trial.

Even though clearly not qualified, the court went on to assess the reliability of plaintiff’s surgeon’s opinion. Here, the doctor failed to state his opinion, such as it was, to a reasonable degree of medical certainty. Id. at *13. That is because he couldn’t. He had done no research. Reviewed no company or manufacturing documents. He could cite no principles to support his conclusion. Id. at *14-15. But, he was well aware that “it is generally accepted in the medical community that bone screws can fracture secondary to fatigue when subject to loads caused by non-union [non-healing].” Id. at *14. So, even though he’d never seen it before, he knew it could happen. As if that wasn’t enough to take the wind from his sails, he also testified that he would “absolutely” defer to a metallurgist on the issue of defect. Id. at *15. As luck would have it, defendants had a metallurgist and he opined that the screw met industry standards and contained no manufacturing defects. Id. at *2.

Finally, plaintiffs attempted to argue res ipsa loquitur – they didn’t need an expert because the circumstantial evidence justified an inference that the screw would not have fractured absent some defect. Id. at *17. But that theory only works if plaintiffs can eliminate “all other reasonable explanations for the accident;” in this case the fracture. But they can’t because plaintiff’s own surgeon and sole expert witness conceded that the non-healing of the bone may have caused the screw to fracture. Id.

This case appears to have been a loser for plaintiffs from the outset. Relying on the treater as a defect expert just sealed its fate. The defense relies on prescribers as learned intermediaries and we don’t go after them unless really forced to. If they step this far outside their expertise, we’re sort of forced to.

When this blogger hears “negligent undertaking,” my mind does not automatically turn to products liability – but rather to pre-teen children. Pre-teen children are at the age where they are asked (actually required) to “undertake” more and more duties and responsibilities. But often these duties are undertaken in a rather haphazard or lackadaisical way that some might say rise to the level of negligence. Dishes with food left on them put back in the cabinet. Wet laundry left in the dryer for more than a day. And as for cleaning up after the dog, well enough said. And as one of the two arbiters of whether such pre-teens have failed to act in good faith, I admit to guilt in an expanding definition of what constitutes negligent undertaking. The New Jersey courts fortunately have stricter and more precise guidelines than mood and level of tolerance on any given day to guide them and those rules led them to dismiss plaintiff’s negligent undertaking claim in Nelson v. Biogen Inc., 2017 WL 1382910 (D.N.J. Apr. 17, 2017).

The product at issue is Tysabri, a drug used to treat multiple sclerosis. Patients who test positive for anti-JC Virus antibodies were shown to be at an increased for developing a certain brain infection with use of the drug. Id. at *1. Plaintiff contracted the infection after being treated with the drug for three years.

It is worth pointing out some of the procedural history here to understand that his was a bit of a hail-Mary by the plaintiffs. Plaintiff’s initial and first amended complaints contained a claim for negligence that was dismissed because in New Jersey the sole remedy for products liability is the New Jersey Product Liability Act (NJPLA). Id. at *2. All products liability claims, except express warranty, are subsumed by the Act. So plaintiff’s second amended complaint alleged design defect and failure to warn under the NJPLA. Defendants moved to dismiss the design defect claim as preempted and plaintiff withdrew the claim before the court could rule on the motion. Id.   Which left plaintiff with only a failure to warn claim in his third amended complaint. After two years of discovery, plaintiff moved to amend his complaint for a fourth time, this time to add a negligent undertaking claim.

The basis for the claim, argued plaintiff, was that defendants had entered into a licensing agreement with the NIH to allow defendants to use the NIH’s JC virus antibody assay to develop the assay for commercial use. The assay would allow doctors to test for the antibodies to determine if their patients were at an increased risk for the brain infection. Id. The licensing agreement was entered into in 2006 and defendants released their JC virus antibody assay in 2012. Plaintiff alleges that when defendants entered into the licensing agreement, they were voluntarily undertaking the duty to develop the assay and that they failed to do so in a reasonable and timely manner. Id. at *3.

First, the court held that this negligent claim, like the negligence claim in plaintiff’s original complaint, was preempted by the exclusivity of the NJPLA. Plaintiff argued that negligent undertaking was different than other negligence claims because it is not based on a pre-existing duty. Not only did plaintiff have no New Jersey or other authority for this argument, it is a distinction without merit. As the court pointed out, “the application of the NJPLA is not premised on the timing of the duties incurred.” Id. at *4. Further, most duties (unlike those in my household) are at some point voluntarily assumed. “For example, before Defendants decided to develop, market, and sell Tysabri, they had no duty to do so. Once Defendants voluntarily decided to produce Tysabri, they then had a duty to act with reasonable care in doing so.” Id. Negligent undertaking is precluded by the NJPLA.

Second, the court found it would be an unprecedented expansion of liability to use negligent undertaking to create third-party negligence obligations to non-parties to the license, or indeed to any contract.  Plaintiff cited no cases in which a party who agreed to a license was held liable for negligent undertaking. Id. at *5. Acknowledging significant policy concerns, the court suggested that the more appropriate way to address issues of the type raised by plaintiff would be to deal with them specifically in the contract. The NIH could have included a time limit by when defendants should have developed the assay or the license would be revoked. Id.

Further, plaintiff failed to allege an essential element of negligent undertaking – reliance. Id. at *6. Plaintiff alleged that his status as a third-party beneficiary to the license agreement satisfied the reliance requirement, but he cited no authority for that proposition. So, closely adhering to the Erie doctrine, the court concluded that “If the courts of New Jersey believe that such an extension is appropriate, then they are in a better position to expand their own common law in the first instance.” Id.

This means plaintiff is back to his third amended complaint – failure to warn only. And as we just reported last week, there is good precedent on the adequacy of the Tysabri warnings and on Wyeth v. Levine preemption. And precedent has much more bearing in the courtroom than in the laundry room – where when prior rulings are cited to the judges they can be summarily ignored with a simple – “that was then, and I’ve changed my mind.”

 

Just yesterday we made the following observation: a design defect claim is often a make-weight claim. How should the design have been improved? Not selling the product at all is hardly a design improvement. An entirely different product is not a safer alternative under the law of any enlightened state. Changing the molecule or the device design cannot be done without FDA approval, so preemption should apply (even if courts often miss this point).

And miss the point the court did in In re: Xarelto Prods. Liab. Litig., 2017 U.S. Dist. LEXIS 56629 (E.D. La. Apr. 12, 2017). Plaintiffs in the Xarelto MDL allege that the anti-coagulant drug caused serious bleeding events and that the drug was unreasonably dangerous due to its defective design. Id. at *3. As we noted yesterday, true design claims, as opposed to failure to warn claims, aren’t the crux of most pharmaceutical drug cases. But the Xarelto plaintiffs went that route and so defendants raised preemption as a defense. Unfortunately, to no avail.

Xarelto is an anti-coagulant drug that is taken once a day and all patients are given the same dosage without the need for routine monitoring. Id. Plaintiffs argue that patients’ reactions to the drug vary causing some to experience bleeding complications. Id. at *3-4. It is undisputed that both the dosing and monitoring specifications were approved by the FDA. Id. at *4. So, if the FDA approved the design, what do plaintiffs say the manufacturer could have done differently? Essentially, plaintiffs’ position boils down to the manufacturer should not have sold Xarelto but should have developed and sought FDA approval of a different product. Wait. We’ve been down this road before and the Supreme Court found such claims preempted. Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).

Before we get to Bartlett, let’s look at the specific design defects plaintiffs alleged in this case. First, the manufacturer should have designed an assay to allow doctors to monitor the effects of the drug on each patient. Second, the manufacturer should also have designed and marketed an antidote to counteract a major bleeding event. Third, in the absence of the first two, the manufacturer should have warned about the availability of other tests to measure anticoagulation. Id. Putting aside failure to warn, a claim that the manufacturer should have submitted a different version of the drug to the FDA for approval is the functional equivalent of the “stop-selling” claim that the Court found preempted in Bartlett.

Now that we are back to Bartlett, we should point out that the Xarelto court wrongly discounts defendants’ reliance on it, saying that it relates to generic drug manufacturers, not name brand manufacturers. Id. at *7-8. While it is true that that drug at issue in Bartlett was a generic, the rulings are in Bartlett are not so limited, and certainly not on the very issue germane to this case. The Court in Bartlett went out of its way to state, “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications.’” 133 S. Ct. at 2471 (quoting 21 C.F.R. §314.70(b)(2)(i)) (emphasis added). Instead the Xarelto court, in its discussion of design defect, relies more on Wyeth v. Levine, using that decision on failure to warn claims to suggest that preemption is not as clear for brand manufacturers. But the distinction between Bartlett and Wyeth isn’t that one involved a generic and one involved a brand. It’s that Bartlett dealt with design defect and the court’s failure to follow the preemptive logic of Bartlett in this context is an error – at least in our books.

The way the court appears to get around Bartlett is by drawing an artificial distinction between “pre-approval” and “post-approval” design defect claims. Id. at *10. But, as noted above a pre-approval design defect claim is the same thing as saying the manufacturer should stop selling the current product – that it never should have been brought to market. But it was. And only after the FDA reviewed and approved it, including its dosage and monitoring specifications. A design defect claim is about whether the product at issue – the one that was sold and marketed and used by plaintiffs – was defectively designed and whether there is a feasible alternative design. By focusing on the “pre-approval” time period, the court is basically inviting the jury to second guess the FDA’s approval of the drug — a question clearly not meant for a jury. If the court had focused on the “post-approval” product, the actual product at issue, the design defect claims would fall squarely into Bartlett preemption.

But the court didn’t and so we add this to the list of cases that simply miss the point.

Today we give you something rare from the Philadelphia Court of Common Pleas — a defense win on preemption. The Philadelphia CCP has been the source of some rather vexing decisions over the years and has certainly taken its share of criticism. Criticism that we think has been rather overstated. Don’t get us wrong, we’ve vehemently voiced our disapproval of several Philadelphia CCP decisions over the years. But there are plenty of times when Philadelphia judges get it right. That happened two weeks ago in Caltagirone v. Cephalon, Inc., 2017 WL 1135576 (Pa. CCP Mar. 23, 2017).

Plaintiff was prescribed an opioid medication to treat his migraines. The drug was approved for use to treat pain related to cancer, so the prescription was off-label. We use that term a lot, but it is worth stopping to remind ourselves what that really means. The FDA-approved labeling for the drug says its intended use is for treating pain in cancer patients. In other words, that was the patient population in which the drug was studied and the data presented to and examined by the FDA and therefore, the indication for which it was approved. Once a drug or device is on the market, however, doctors, who are not governed by the FDA, are free to use those products for any reason they find is medically necessary. Indeed, much of what we know today about drugs and devices comes from physicians using them in the field in ways that they were not originally intended (aspirin as a blood thinner being among the most well-known example). When you break it down like that, it is not surprising that doctors treating patients with migraines who have not been receptive to standard treatments would look to alternative pain medications, such as an opioid with proven success in alleviating pain in cancer patients. In this context, the drug is still being used to treat pain, just a different type of pain.

Back to Caltagirone. The opioid prescribed to plaintiff, in addition to being labeled for use with cancer patients, was also known to be highly addictive. Id. at *1 & 5. The drug was prescribed to plaintiff for 7 years during which time he was in and out of drug treatment programs due to opioid and other drug addictions. Plaintiff ultimately died from his drug addiction. Id. at *1.

Plaintiff’s claims were for negligence, fraud, misrepresentation, and violation of the UTPCPL. The basis for each claim was an allegation that defendants illegally promoted the drug for off-label uses, which was forbidden by the FDA. Id. at *2. The first thing the court does is negate plaintiff’s premise by holding that “generally off-label sales, promotions and prescriptions are proper.” Id. at *3. Further, at the motion to dismiss stage, the court had to accept as true the material facts pleaded by plaintiff. But a critical material fact was missing from plaintiff’s complaint – any allegation that any off-label promotion was false. A false or misleading statement or omission is a requirement for each of plaintiff’s claims under state law. However, plaintiff only alleges that defendants marketed the drug off-label, not that that off-label promotion was false in any way. Because there is no state-law duty to avoid off-label promotion, plaintiff’s claims “could not exist in the absence of federal laws and regulations.” Id. In other words, plaintiff is suing “because the conduct of promoting the drug for migraine headaches violates the FDCA,” not because defendant has breached any state-law duty. Therefore, plaintiff’s action is a private attempt to enforce the FDCA; the type of action that is barred by Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

While the court dismissed the case with prejudice as preempted, because defendants also asserted that it was barred by the learned intermediary doctrine, the court addressed that issue as well.

Plaintiff argued that the doctrine should not apply because plaintiff’s doctor was not learned because he was given “misinformation” by defendants. Id. at *4. The court saw that for the disingenuous argument that it was. Not only did the prescribing doctor have access to the risk and precaution information provided by defendants and his own medical training and judgment – in this case, the doctor had “actual knowledge” that his patient had become addicted and continued to prescribe the drug for many years. Id. at *5. The physician is the customer under the learned intermediary rule. Id. And it is the physician’s “duty to read and consider the materials from [other medical sources] and writings from the Defendant manufacturers.” Id. The fact that the prescriber may also have read or seen off-label promotion, didn’t change the fact that it was his duty to use all his training and experience, combined with his personal knowledge of the patient, which here included knowledge of addiction (the harm complained of), to treat the plaintiff. The court usefully also noted that the treater has a duty to know what other medications the patient is taking. Id. Keep in mind this strong statement of the learned intermediary’s duty the next time you are arguing this issue in Philadelphia.

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

Last week the Third Circuit overturned the dismissal of thousands of cases in In re: Fosamax Products Liability Litigation, — F.3d –, 2017 WL 1075047 (3rd Cir. Mar. 22, 2017), finding that the trial court had improperly granted summary judgement on preemption grounds by misapplying the Supreme Court’s “clear evidence” standard announced in Wyeth v. Levine. It should come as no surprise that we firmly believe the trial court got it right and have lauded its decision in the past. So, it should be equally unsurprising that the Third Circuit’s abysmal “clear evidence” preemption decision is a front-runner for our list of the ten worst cases for 2017.

Regrettably, since Wyeth v. Levine, successful applications of preemption against warning claims asserted in litigation involving branded drugs have been few and far between. That is due in large measure to the both dauntingly high and utterly ill-defined preemption standard set by the Court in Levine, which requires an intensive fact-based analysis and a powerful regulatory case. So when the standard has been met, it is usually with facts that can hardly be described as equivocal. The district court in In re Fosamax, found as much and therefore a somewhat detailed recitation of the regulatory history is warranted.

Fosamax was approved by the FDA in 1995 for the treatment of osteoporosis in postmenopausal women. In re Fosamax, 2017 WL 1075047 at *4. Over the next 15 years, scientific studies were published concerning a possible link between long-term Fosamax use and atypical femur fractures (“AFF”). Merck kept the FDA aware of these studies and in June 2008, FDA asked Merck and other manufacturers to submit whatever data they had on the issue. Id. at *4-5. In September 2008, Merck submitted a “Prior Approval Supplement” (“PAS”) – the same thing as the “Changes Being Effected” (“CBE”) process discussed in Levine, only involving prior FDA review − seeking FDA approval to add information about AFF to both the Warnings & Precautions and Adverse Reactions sections of the Fosamax label. Because it is important to the arguments and the court’s conclusion, we quote some specific language from the requested change and the FDA’s response. Merck’s proposed language included:

Low-energy fractures of the subtrochanteric and proximal femoral shaft have been reported in a small number of bisphosphonate-treated patients. Some were stress fractures (also known as insufficiency fractures) occurring in the absence of trauma. . . . Patients with suspected stress fractures should be evaluated, including evaluation for known causes and risk factors . . . and receive appropriate orthopedic care. Interruption of bisphosphonate therapy in patients with stress fractures should be considered, pending evaluation of the patient, based on individual benefit/risk assessment.

Id. at *5. In April 2009, the FDA responded that Merck could add the information to the Adverse Reactions section of the label, but as to the Warnings/Precautions section, “more time [was] need[ed] for FDA to formulate a formal opinion on the issue of a precaution around these data.” Id. at *5. In its formal response the FDA wrote:

Identification of “stress fractures” may not be clearly related to the atypical subtrochanteric fractures that have been reported in the literature. Discussion of the risk factors for stress fractures is not warranted and is not adequately supported by the available literature and post-marketing adverse event reporting.

Id. at *6.

Almost a year later, the FDA issued a public statement that the data to date “had not shown a clear connection” between Fosamax and a risk of AFF. The FDA commissioned a task force, which after another six months (September 2010) reported a “relationship” between AFF and the class of bisphosphonate drugs, but not anything “proven to be causal.” Id. The FDA responded to the task force’s report with a statement also indicating that causation “is not clear,” and that the Agency was “considering label revisions.” Id. After another month, the FDA announced revised labeling for AFF for this class of drug. Causation was described as “not clear.” Id. at *7. The FDA’s proposed label change stated “[c]ausality has not been established.” Id. In response, Merck proposed adding additional language advising doctors to rule out stress fractures. The FDA ultimately rejected the addition of the term “stress fractures,” finding that the term “represents a minor fracture and this would contradict the seriousness of the atypical femur fractures associated with bisphosphonate use.” Id. The FDA’s approved language, including lack of causality, was added to the Fosamax label in January 2011. Id.

Against this regulatory background, the district court found that the claims of all MDL plaintiffs with injury dates before September 14, 2010 – when the FDA last reaffirmed its position that it did not have enough evidence of a causal association to allow a warning change – were preempted. Id. at *8. The district court ruled that the regulatory history “provided clear evidence that the FDA would have rejected a stronger Precautions warnings because the FDA did reject a stronger Precautions warning.” Id. at *9.

The Third Circuit clearly saw things differently. On appeal, it considered two questions: What is clear evidence? And who should determine whether clear evidence exists? Id.

As to the first question, and perhaps most significantly, this is the first case formally to make the leap from Levine’s amorphous “clear evidence” requirement for implied preemption of warning claims involving branded drugs, to a “clear and convincing” evidence standard for proof of preemption, which required a “highly probable” result. Our problems with Levine are many, and among them has always been this ill-defined standard. Coupled with the Court’s describing impossibility preemption as a “demanding defense,” district courts knew that the standard was high, but just how high was left completely open-ended and has resulted in a lineage of case law that is highly fact-specific with no clearly established definitions or guidelines.

Despite 8 years of court rulings all over the country using the facts of Levine as a benchmark against which to assess the facts of a given case (if stronger facts than Levine then preemption might be possible, if less than Levine, no preemption), the Third Circuit retroactively undertook to read the Supreme Court’s mind, deciding that what Levine really meant when it used the term “clear evidence” was to announce a standard of proof. Id. at *11. The court parsed the ruling in Levine – that absent clear evidence that the FDA would not have approved the label change, it cannot be ruled that it is impossible for a manufacturer to comply with both federal and state law – into three parts. First, it established the legal rule — a manufacturer is “absolved of state-law liability” where it is impossible to comply with both federal and state law simultaneously (impossibility preemption). Second, it established the factual showing needed to satisfy the legal rule – the FDA would not have approved the label change. Third, it established the standard of proof specifying “how convincing the factual showing must be” – by clear evidence. Id. So, according to the Third Circuit:

The term “clear evidence” therefore does not refer directly to the type of facts that a manufacturer must show, or to the circumstances in which preemption will be appropriate. Rather, it specifies how difficult it will be for the manufacturer to convince the factfinder that the FDA would have rejected a proposed label change. The manufacturer must prove that the FDA would have rejected a warning not simply by a preponderance of the evidence, as in most civil cases, but by “clear evidence.”

Id.

The principal problem with this aspect of Fosamax is that it flies in the face of other, binding United States Supreme Court precedent. Because the Third Circuit reached its conclusion without even mentioning the Supreme Court precedent that explicitly rejects any “special burden” in implied preemption cases, one wonders if the Third Circuit went off on its own adventure, beyond the scope of the parties’ briefing. The controlling case is Geier v. American Honda Motor Co., 529 U.S. 861, 872-873 (2000), which held that imposition of any “special burden” on the implied preemption defense both lacks “basis . . . in this Court’s precedents” and creates “practical difficulty by further complicating well-established pre-emption principles.” Geier not only rejected imposition of purported “special burdens” in the implied preemption context, but did so on a stronger set of facts for creating such a burden, where Congress had expressly spoken to preemption with both statutory preemption and savings clauses. In the FDCA, by contrast, Congress was merely silent.

Fosamax thus did just what Geier held was not the law. The Third Circuit determined that when the Court said “clear evidence” it really meant “clear and convincing evidence” as a heightened standard of proof requiring a defendant asserting a preemption defense to prove that it is “highly probable” or “reasonably certain” that the FDA would have rejected a label change. Id. at *12.

The court then moved on to the question of whether deciding what the FDA would have done was a question of law or fact. Disregarding uniform precedent since Levine that has treated the issue as a question of law, the Third Circuit determined it was a question of fact. The court found that none of those other cases explicitly addressed the issue and so could not be the basis for concluding that the “clear evidence” test is a legal question. Id. at *13. But if it sounds like a duck, and walks like a duck . . . . In so ruling, Fosamax violated 3d Cir. I.O.P. 9.1 on a truly epic scale. IOP 9.1 provides:

It is the tradition of this court that the holding of a panel in a precedential opinion is binding on subsequent panels. Thus no subsequent panel overrules the holding in a precedential opinion of a previous panel.

Fosamax conceded that its finding that preemption was a matter of fact for jury consideration was contrary to a number of prior Third Circuit statements, which the panel dismissed as “off-hand.” 2017 WL 1075047 at *12. That is not a legitimate characterization. Relegated to an “e.g.” citation in footnote 106 was the standard of review that controlled in In re Federal-Mogul Global Inc., 684 F.3d 355, 364 n.16 (3d Cir. 2012): “The scope of preemption presents a pure question of law, which we review de novo”; as well as the prior FDCA preemption case, Horn v. Thoratec Corp., 376 F.3d 163, 166 (3d Cir. 2004), which likewise held that preemption was a matter for “plenary review” because “it is a question of law.” But Fosamax ignored a lot more precedent than that, including the en banc decision in Orson, Inc. v. Miramax Film Corp., 189 F.3d 377 (3d Cir. 1999), which held specifically that, because it was not bound by “prior decisions, the court was “free to consider the preemption issue as a matter of law.” Id. at 380. Preemption being a matter of law was plainly the holding of the court in Taj Mahal Travel, Inc. v. Delta Airlines, Inc.:

[Plaintiff] argues that [defendant] waived the preemption defense by not raising it until it moved to dismiss [a different] claim, which occurred [later]. . . . However, the preemption defense is a pure issue of law . . . and could be dispositive. Since the parties have briefed and argued preemption on appeal, we will consider it.

164 F.3d 186, 190 (3d Cir. 1998). See also: South Jersey Sanitation Co. v. Applied Underwriters Captive Risk Assurance Co., 840 F.3d 138, 143 (3d Cir. 2016) (“preemption determinations are questions of law”); Roth v. Norfalco LLC, 651 F.3d 367, 374 (3d Cir. 2011) (“preemption … determinations [a]re based on questions of law”); Elassaad v. Independence Air, Inc., 613 F.3d 119, 124 (3d Cir. 2010) (“[w]e also exercise de novo review of a preemption determination, as it is a question of law”); Deweese v. National Railroad Passenger Corp., 590 F.3d 239, 244 n.8 (3d Cir. 2009) (“a preemption determination . . . is a question of law”; Travitz v. Northeast Dep’t ILGWU Health & Welfare Fund, 13 F.3d 704, 708 (3d Cir. 1994) (“[t]he issue of preemption is essentially legal”); Pennsylvania Medical Society v. Marconis, 942 F.2d 842, 846 (3d Cir. 1991) (“[t]he question of preemption involves an issue of law”); Ayers v. Philadelphia Housing Auth., 908 F.2d 1184, 1188 (3d Cir. 1990) (“we determine that as a matter of law the federal regulations . . . preempt the application of [state law]”) (citations and footnote omitted); Pokorny v. Ford Motor Co., 902 F.2d 1116, 1119 (3d Cir. 1990) (“the question of whether [plaintiff’s] action is pre-empted . . . involves a pure issue of law”). These are not “off-hand” statements or dicta of any sort. Some of them are even West case headnotes. In deciding, after decades of contrary precedent, to convert preemption into a factual issue, Fosamax blatantly disregarded the “tradition” of the Third Circuit and did what panels are forbidden to do by IOP 9.1. We have said many times before that strange things happen in tort preemption cases, but Fosamax goes beyond “strange.” If precedent means anything, this aspect of Fosamax is a lawless decision.

Having decided that preemption doesn’t necessarily have to be a question of law, the court’s next awful conclusion was that juries are to determine what the FDA might have done with a different warning. The court looked at the specific question to be answered under Levine – would the FDA have rejected the label change plaintiffs argue was required – and determined it was the type of fact question that could be decided by a jury. The court’s reasoning was threefold: (1) the question asks about the probability of a future event; (2) the question requires the decision maker to weigh conflicting evidence and draw inferences; and (3) the question requires predicting FDA’s actions which requires assessments of FDA official’s motives and thought processes. All of which the court says are functions left to juries. 2017 WL 1075047 at *15-16. Which leads to the court’s ultimate conclusion that “[a] state-law failure-to-warn claim will only be preempted if a jury concludes it is highly probable that the FDA would not have approved a label change.” Id. at *18. Thus the decision opens the door to dueling FDA experts speculating about how the FDA would have viewed some hypothetical proposed label change, while discovery from actual FDA employees is mostly prohibited. See United States ex rel. Touhy v. Ragen, 340 U.S. 462, 468 (1951); Giza v. HHS, 628 F.2d 748, 751-52 (1st Cir. 1980).

This kind of jury second-guessing creates the kind of practical problems that drove the preemption decision in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) (also not cited in Fosamax). It “will dramatically increase the burdens facing potential applicants-burdens not contemplated by Congress,” id. at 350, by encouraging plaintiffs to nit-pick FDA decisions – such as those involving bisphosphonates that we discussed above – without regard to the FDA’s actual decision-making process. It will expose “would-be applicants” to unpredictable civil liability,” id. for doing what the FDA directed them to do. Looking at how the plaintiffs in Fosamax discounted the FDA’s “don’t say that” decision, it is likewise plain that allowing such claims to survive preemption will “also cause applicants to fear that their [interactions with] the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.” Id. at 351. Allowing jury speculation about what the FDA might have done, had it received a different submission from a regulated company is, as a practical matter, no different than allowing the same jury speculation about what the FDA might have done, had it not been “defrauded” in Buckman.

Since the court in Fosamax was no longer addressing a question of law, its role at the summary judgment stage was “therefore limited to determining whether there are genuine issues of material fact that preclude judgment as a matter of law.” Id. at *13. Remember, the court is imposing a heightened standard of proof, so to affirm summary judgment the court concluded it would have to find “that no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected Plaintiff’s proposed atypical-fracture warning had Merck proposed it to the FDA in September 2010.” Id. at *19. Sure sounds like a “special burden” on preemption to us.

What does that mean in the context of Fosamax? Despite the FDA’s rejection of the defendant’s proposal to warn about the particular risk, the court, enforcing the clear and convincing standard against the defendant (preemption being an affirmative defense), holds that plaintiffs can get to the jury on their contention that the FDA’s rejection, after 10 months of review and back-and-forth, was merely a semantic quibble that the defendant could have fixed. See id. at *21 (“a reasonable jury could also conclude that the FDA rejected [defendant’s] proposed warning about femoral fractures in 2009 not because it denied the existence of a causal link between Fosamax and fractures, but because [defendant] repeatedly characterized the fractures at issue as “stress fractures.”). And when you read the court’s view of what Levine requires to get summary judgment, it leaves us very concerned that such a standard will ever be met: “Because the [Levine] test requires the factfinder to speculate about hypothetical scenarios using inferences drawn from historical facts, reasonable jurors could reach a broad range of conclusions.” Id. at *22.

White the Third Circuit claims its adoption of a clear and convincing standard of proof is less than proof beyond a reasonable doubt, id. at *12, the piling of a special burden of proof atop the standard for summary judgment certainly sounds very close to indisputable proof. We used to be concerned that courts would only find “clear evidence” in the context of an outright rejection of a label change. But even that wasn’t enough in Fosamax to allow the court to find that jurors might not differ in their interpretation of that rejection. And it is those differences which bring us back to the fact that this should be a question for the court, not a jury. For a defense like preemption that is equally operative for all plaintiffs, there should be some element of consistency – which will be eradicated if the decision is left to multiple juries to decide. Moreover, deciding federal preemption is an analytical process where legal training adds value and where testing credibility, something usually reserved for a jury, is not as material.

There remain many questions about how this decision and the Fosamax MDL will play out and we’ll be watching it all closely. Definitely more commentary to come.

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