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The beast part may be a bit of an exaggeration, but it serves the purpose of depicting what at least on the surface are two very opposite things. But if you delve more deeply, you find a lot of similarities. So many similarities that the two things shouldn’t really be opposites at all. That’s what happens in the fairy tale. The beast is really a prince. But life’s not a fairy tale. And neither is pharmaceutical litigation. And if it were, it wouldn’t be a Disney version, it would be one of those original Grimm Brothers’ stories – the dark and twisty ones. And that’s what we have today. Two cases that come to opposite conclusions but based on the same allegations about the same failure to warn about the same drug. We should be talking about a beauty and a prince. Instead we have a beauty and a beast . . . or at least maybe a frog.

Within two days of each other, two decisions were handed down in cases involving the generic prescription drug amiodarone manufactured by the same company – Hernandez v. Sandoz Inc.,  2017 U.S. Dist. LEXIS 120938 (N.D. Ill. Aug 1, 2017) and Tutwiler v. Sandoz Inc., 2017 WL 3315381 (N.D. Ala. Aug. 3, 2017). Both were second bites of the apple. In Hernandez, defendants moved for reconsideration of the court’s prior ruling rejecting preemption and allowing a failure to warn claim premised on defendants’ failure to provide medication guides per federal regulations. We blogged about that earlier decision here. In Tutwiler, the court had previously dismissed that same claim but plaintiff included it in her amended complaint. Defendants moved to dismiss again. Both courts stuck to their prior decisions.

Our prior post on Hernandez explains how we think the court got preemption wrong – notably by applying the Seventh Circuit’s awful PMA, medical device express preemption decision in Bausch v. Stryker to a pharmaceutical drug case and finding a parallel violation claim. On reconsideration, defendants argued that the court misapplied Bausch. In response, the court cited other district courts within the Seventh Circuit to also have applied Bausch to pharmaceutical cases, including another amiodarone case that we blogged about here. Hernandez, at *5-7. The old adage two wrongs don’t make a right comes to mind.

Unable to make the court see that this is really an implied preemption case – plaintiff was seeking to enforce an FDCA requirement regarding distribution of medication guides – defendants were left to argue that the claim isn’t really parallel to a state law duty to warn. There is no Illinois state law duty to warn pharmacists so they can in turn warn consumers. In fact, in prescription drug cases, the manufacturer’s duty is to warn the prescribing physician – not the consumer. Id. at *9n.4. From the court’s description of plaintiff’s allegations, plaintiff alleges both traditional failure to warn the prescriber and failure to warn the consumer by failing to provide medication guides. Id. at *9. The court then seems to conflate all those allegations into one plausible failure to warn claim. See id. (“The court remains convinced that plaintiff has sufficiently alleged each of the elements necessary to establish a failure to warn claim under Illinois law despite focusing much of his complaint on his allegations that defendant’s actions violated the FDCA.”). By alleging both failure to comply with the FDCA and failure to warn the prescriber plaintiff got to dodge both preemption and learned intermediary. But those are two separate claims and they should both fail.

And that’s how you turn the beast/frog into a prince. You apply both preemption and learned intermediary like in Tutwiler. First, in this case the court already dismissed plaintiff’s traditional failure to warn claim – the failure to warn plaintiff’s prescriber – under Mensing. These are after all generic prescription drugs and the Supreme Court has said they don’t survive conflict preemption. Which is presumably why plaintiffs in these cases are focused on the medication guide allegation. In Tutwiler, plaintiffs argued that failure to provide the medication violated the “duty of sameness” on which Mensing rests making Mensing inapplicable. Id. at *2. As we noted above, failure to warn based on failing to adhere to an FDCA requirement should also be impliedly preempted under Buckman or the prohibition of private causes of action to enforce the FDCA.

But the Tutwiler court said it didn’t need to consider preemption because the claim is barred by the learned intermediary doctrine. In Alabama, like in Illinois, in a prescription drug the case the duty to warn runs to the physician. Id.

[I]t does not follow . . . that if the manufacturer inadequately warns the physician, it owes an independent duty to warn the patient directly. This is the reason why this Court previously stated that “it appears unlikely that Plaintiff can state a failure-to-warn claim based on Defendant’s failure to provide a Medication Guide to her pharmacy that avoids the application of both the learned-intermediary doctrine and Mensing.”

Id. And there’s the beauty.

There is one thing that both Hernandez and Tutwiler agree on – plaintiffs’ off-label promotion claims are fraud claims that must be pleaded to the heightened standard required by Federal Rule of Civil Procedure 9(b). Both plaintiffs tried to argue that these were negligent marketing claims. Hernandez, at *3; Tutwiler, at *2. But both courts were unpersuaded by those labels given the context of the allegations. Hernandez, at *4 (“Plaintiff’s complaint is a sprawling and, at times, confusing collection of largely unnecessary allegations that, for the most part, seem to attempt to assert a fraudulent misrepresentation claim as it relates to off-label promotion.”; Tutwiler, at *2 (Plaintiff “claims that Defendant engaged in a ‘concerted and systemic effort to persuade physicians’ . . . that the drug was safe and efficacious for off-label uses). Plaintiff Hernandez is getting another chance to re-plead his fraud claims with specificity. Since this was Plaintiff Tutwiler’s second attempt, and her complaint still failed “to identify a single statement in any promotional material to support [Plaintiff’s] contention that Defendant unlawfully promoted amiodarone for [an off-label use],” her claim is dismissed.

They say beauty is fleeting – and so too is a beautiful case. The beast/frog on the other hand lives to see another day.

The court may have taken a relaxed approach, but its decision has done nothing but raise blood pressures over at that DDL blog. The course of the Accutane litigation in New Jersey has been labored and we’ve posted about the whole journey. For years, we were pretty riled up. The news from the coordinated proceeding in the trial court had been very bad, including a few large plaintiff verdicts. Then the litigation got reassigned and under new management the tide began to turn. We could feel our pulse returning to normal. The new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. Indeed, the Appellate Division has vacated at least a half dozen plaintiff verdicts. After so many tortuous years, defendants in the New Jersey Accutane litigation finally had a reason to smile (actually thousands of reasons if reasons are dismissals). So we definitively can say we were unpleasantly surprised when last week the Appellate Division reversed the trial court’s order excluding certain plaintiff causation expert witnesses resulting in reviving over 2000 cases.

The to-be-published decision can currently be found at In re Accutane Litigation, 2017 N.J. Super. LEXIS 116 (App. Div. Jul. 28, 2017). It’s a long opinion with a lengthy discussion of epidemiology in general and the epidemiologic evidence pertaining to Accutane specifically. We’ll try to just hit the relevant highlights.

First a quick primer on New Jersey law on the admissibility of expert evidence. New Jersey has adopted a “relaxed” general acceptance standard for toxic tort and pharmaceutical cases. See Rubanick v. Witco Chemical Corp., 125 N.J. 421, 449 (1991). That means that if the expert’s theory is not generally accepted, it may still be admissible if it is “based on a sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field.” In re Accutane, at *47. Further, specifically in regard to reliance on epidemiology as evidence of causation, the court must address not just methodology but also the expert’s reasoning in applying or relying on that methodology to reach his/her conclusions. Id. The court should not only review the studies and other information to determine if they are the type of data experts ordinarily rely on but also “examine the manner in which experts reason from the studies and other information to a conclusion.” Id. at *51.

As we mentioned, the litigation has been handled by two different trial judges. The first judge allowed the opinions of plaintiffs’ experts based on the same type of evidence relied on by plaintiffs’ experts here. Id. at *5. But this litigation has been pending for 14 years. The science has not been stagnant during that time. From 2003 to 2009, there were no epidemiological studies regarding Accutane and irritable bowel disease (IBD) or Crohn’s disease. Id. at *8. Epidemiological studies are considered at the top of the scientific hierarchy. Experimental studies (double-blind randomized control trials) are the gold standard and observational studies (case-control or cohort studies) are the next best available evidence. Without those, plaintiffs’ experts were permitted to rely on “animal studies, human clinical studies, case reports, class effects, published scientific literature, causality assessments, and biological plausibility.” Id. In other words, they were permitted to use less reliable evidence because that is all there was.

But in 2009 and 2010, the first epidemiological studies were published – both of which found no statistically significant increased risk for developing Crohn’s disease from the use of Accutane. Id. Six more epidemiological studies followed and while the results vary, “with one exception, none of them demonstrates a statistically significant increased risk of developing Crohn’s disease.” Id. at *9. Despite the evolving state of the science, plaintiffs’ experts chose to discount the epidemiology in favor of the “other information” on which they had previously relied.

Applying even the New Jersey “relaxed” standard, the trial court found that plaintiffs’ experts reasoning and methodology “slanted away from objective science and in the direction of advocacy.” Id. at *53-54. After reviewing the evidence and conducting a full Kemp hearing (New Jersey’s version of a Daubert hearing), the trial court concluded that the epidemiologic evidence did not support a reasonable inference of a causal link between Accutane and Crohn’s disease. Plaintiff’s experts ignored the studies’ authors own conclusions, excluded the larger population based studies, and made assumptions to “bridge an analytical gap in his methodology.” Id. at *54-55.

We’ve blogged before about the risk of allowing litigation to march ahead of science. As the United States Supreme Court explained in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993), the goal of “reaching a quick, final, and binding legal judgment” on matters that are “often of great consequence” is not advanced by accepting hypotheses and conjectures in the place of reliable scientific evidence. But that is exactly what the New Jersey Appellate Division seems determined to do. The court announced its guiding principle as the antithesis of Daubert: “legal decision making in toxic tort and similar cases may vary from scientific decision making.”  Id. at *69. This doesn’t even reconcile with the New Jersey standard that requires general acceptance in the scientific community of an expert’s methodology and reasoning.

And what happens when “legal decision making” supplants the scientific process? Experts get to do things differently in the courtroom than in practice. They can ignore big epidemiologic studies not finding a statistically significant relationship for little ones that do, as long as they come up with some critique of the larger studies that lets them.  They can use data further down the “hierarchy” even though top tier evidence is against them.  They can rely upon their clinical experience in deciding what evidence accords with it. Precisely the types of things Daubert, Rubanick, and Kemp say should not be permitted.

Further, while giving lip service to the fact that “science is constantly evolving” and that “legal decisions need to be made based on the best evidence available at the time of the decision” – the court seems to be mired in the past. Id. at *69. It concludes that despite the overwhelming epidemiological evidence that demonstrates no statistically significant increase in the risk of Crohn’s disease from taking Accutane, plaintiffs’ experts can continue to rely on “other types” of evidence – “which in this same MCL docket they were previously permitted to use.” Id. at *70. Why is that part of the equation? As much as litigation shouldn’t lead science, it shouldn’t lag it either. It should move with it. The state of the science is vastly different than it was 14 years ago, and the court seems to be willing to overlook those developments. The opinion states that the decision “must be viewed in the context of this particular MCL litigation” and “concern[s] the survival of plaintiffs’ cause of action in the face of new scientific information.” Id. at *68-69. Exactly. Plaintiffs’ claims need to be assessed on the basis of the new scientific evidence. And if the claims can no longer survive based on the evolving scientific evidence, then that is the result. Ultimately, however, what seemed to matter more than accurately applying the law to the current state of the science, was “[t]he opportunity of thousands of plaintiffs, claiming injury from Accutane, to have their day in court.” Id. at *69.

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

There is always a level of uncertainty when a case gets remanded from an MDL. New judge; new interpretations of prior rulings; new rulings. It can be the cause of much anxiety on both sides. And the biggest question is – what’s left to be done? That might seem simple. The case was remanded for trial. But cases rarely go back completely trial ready. Legal issues that turn more on state law are often left to the remand court to decide, as are case specific evidentiary decisions. There are also often questions as to whether a particular issue was raised in the MDL or not. If so, what was the ruling? If not, was it waived? So, there is definitely wiggle room for remand judges to imprint their reasoning and conclusions on a case. And where you’ve made progress in the MDL, you certainly don’t want to lose momentum post-remand.

Which was likely the thinking of defendants in Walker v. Ethicon, Inc., 2017 U.S. Dist. LEXIS 112738 (ND IL Jun. 22, 2017) when faced with expert reports that went beyond the scope of what was deemed permissible by the MDL court in the mesh litigation. In this case, plaintiff served an expert report from Dr. Shull, a gynecologic surgeon. Dr. Shull had previously been challenged by defendants in the MDL but certain issues were reserved for the remand court. Certain issues had also been ruled on by the MDL court in the context of other cases and other experts – in defendants’ favor. Defendant here asked the court to apply those rulings. Generally speaking the remand court found plaintiff offered no justification not to.

First up was the expert’s opinion that different surgical procedures – ones not involving the use of the product — were safer alternatives to the defendant’s mesh product. Id. at *5. In addition to the vast body of case law holding that non-use is not an “alternative design” for the product, the mesh MDL court had so held in another case. Id. The remand court agreed. The remand court also considered the impact of Illinois state law because Illinois does not require plaintiff to prove the existence of a safer alternative design, but such evidence may be relevant. Id. at *7. Plaintiff tried to argue that because a product could be found unreasonably dangerous without evidence of a safer alternative design, it follows that a product could be found unreasonably dangerous with evidence of a safer alternative regardless of whether that was a different design or a different surgical procedure. Id. But that disregards that what is relevant but not required under Illinois law is evidence of a safer alternative design. Plaintiffs offered no support for interpreting “safer alternative design” in Illinois any differently than any other state. Nor did they explain how the alternative procedure was relevant to any element of any of plaintiff’s claims. Without relevance, the testimony was excluded. Id. at *8.

Next were the doctor’s opinion on the duties of medical device manufacturers – testing, pharmacovigilance, and training. The court excluded them all. Defendants challenged the opinion on adequacy of research and testing of the product on both the relevance and the doctor’s qualifications and competence. This is one of the topics on which the MDL court provided guidance but ultimately left the decision to the remand court. On relevance, the MDL court found it doubtful, but was willing to leave the call to the trial court based on nuances in state law. Id. at *10. Pertinent to defendants’ motion, the MDL court had also ruled that an expert “may not offer testimony that is solely a conduit for corporate information.” Id. On the qualification challenges, the MDL court did not exclude an expert on those grounds if the request for exclusion did not provide “specific content or context.” Id. at *11.

Applying those rulings to the specific case, the remand court found that defendants had properly challenged Dr. Shull’s qualifications with enough specificity and so that challenge was not denied, but reserved for the remand court. Id. So, on qualifications, Dr. Shull “is not qualified to testify regarding the standard of care for medical device testing.” Id. at *13. Plaintiffs, however, argued that they were only offering testimony from Dr. Shull regarding what testing defendants did or did not do – the extent of the testing rather than its adequacy. Id. at *12. The court took that as a concession, but went on to exclude that testimony as well. That is information found in company documents – don’t need the expert for that. Id.

Plaintiffs also wanted Dr. Shull to testify about how the defendants monitored adverse events. They claimed he was not offering an opinion as to what systems defendants should have been using just that what they were doing was “woefully inadequate.” The court found this was a “distinction without a difference.” Id. at *14-15. Dr. Shull’s experience as a surgeon does not give him the expertise to testify on the standard of care for adverse event reporting. Id. at *15. And, again if he planned to talk generally about adverse events, that’s company documents and not an area for expert testimony.

Finally, Dr. Shull’s report included an opinion on whether defendants appropriately trained physicians. On this point, the MDL court had already ruled that Dr. Shull could not testify about what should or should not be included in the Instructions for Use for the product – and that covers training of physicians. Dr. Shull could testify to the risks of the product and whether such risks were included in the product materials. Id. at *16. That’s it.

We’re not sure what remains in Dr. Shull’s report, but we certainly agree that the above portions were appropriately trimmed away.

We commented last week that we were not surprised by the numerous post-BMS personal jurisdiction decisions we were seeing. Lots of courts and parties around the country were watching and waiting for this one. So, let’s add some more. This time from another of plaintiffs’ favorite “magnet jurisdictions” – Missouri. Historically, product liability plaintiffs bringing pharmaceutical and medical device cases have flocked to Missouri (the City of St. Louis in particular) among other notoriously plaintiff-friendly venues as litigation tourists. They would file multi-plaintiff complaints against drug and device companies not located in Missouri, including at least 1 Missouri plaintiff – to tie the case to the state — and at least 1 plaintiff from defendant’s home state – to destroy diversity.

So, when defendants would remove these multi-plaintiff complaints, which we always do, we would have to argue misjoinder and simultaneously move to dismiss all of the out of state plaintiffs for lack of personal jurisdiction. Previously, pre-BMS, the Eastern District of Missouri was rather hostile to such removals. Swiftly remanding case after case for lack of subject matter jurisdiction, opting to completely skip the personal jurisdiction issue altogether. Apparently, BMS is changing that – which frankly, we expected. But now we have some decisions.

The complaints in Siegfried v. Boehringer Ingelheim Pharm., Inc., 2017 WL 2778107 (E.D. Mo. Jun. 27, 2017) and Jordan v. Bayer Corp., 2017 U.S. Dist. LEXIS 109206 (E.D. Mo. Jul. 14, 2017) look pretty much as described above. Each case had 94 plaintiffs, of which only a handful were residents of Missouri (8 in Siegfried and 7 in Jordan). The remaining plaintiffs were from different states all over the country, including the states where defendants are citizens. Siegfried at *1; Jordan at *1-2. At least 1 to get personal jurisdiction and at least 1 to defeat diversity.

As do most courts when faced with competing issues of subject matter and personal jurisdiction, these courts cited Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574 (1999) for the proposition that the court has discretion to determine which to consider first. Siegfried at *2; Jordan at *5. While federalism usually tips the scales toward deciding subject matter jurisdiction first, where personal jurisdiction “turns on federal constitutional issues” and/or “judicial economy” concerns, personal jurisdiction can be prioritized. Jordan at *5. Put even more simply, post-BMS, “[p]ersonal jurisdiction is now the more straightforward inquiry.” Siegfried, at *3. That’s because BMS is “dispositive of the specific personal jurisdiction issue” regarding out-of-state plaintiffs suing an out-of-state defendant. Jordan at *9. Specific personal jurisdiction is lacking.   Therefore, reasoned the Siegfried court

Remanding this case for lack of complete diversity, only to have the case removed again later once the non-Missouri plaintiffs are dismissed, would be a waste of judicial resources.

Siegfried at *2. After BMS, neither the Eastern District of Missouri nor the original Missouri state court can exercise personal jurisdiction over the non-residents, so why remand the case to reach the same conclusion. Siegfried at *5. It would be an unnecessary extra step.

Applying a “straightforward” BMS analysis, both courts dismissed all of the out of state plaintiffs with no connection to Missouri. Siegfried at *5 (“nonresident plaintiffs did not ingest the drug in the forum, nor do they claim to have suffered resulting injuries in the forum. The personal injuries of the non-Missouri plaintiffs have no connection with Missouri. They did not arise out of, or relate to, defendants’ activities in Missouri.”); Jordan at *10-11 (“the non-Missouri plaintiffs do not allege that they acquired the [] device from a Missouri source or that they were injured or treated in Missouri . . . . And the general exercise of business activities in the state cannot create an adequate link between the claims and the Missouri forum.”). Because the dismissal of the non-Missouri plaintiffs negated any challenge to complete diversity, the motions to remand in both cases were denied. Siegfried at *5; Jordan at *11. Yet another post-BMS victory.

 

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

Usually when we are talking about Michigan, it’s to praise the Michigan Products Liability Act which cuts off civil liability for drug manufacturers “if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller.” M.C.L. § 600.2946(5). However, under Michigan law, the distinction between a drug and a device is significant. That is because device manufacturers are not afforded the same immunity. See M.C.L. § 600.2945(b).  Of course, device manufacturers do have the broad preemption provided by the Medical Device Amendments. See Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008). So it’s somewhat rare to get to post on a Michigan law case that isn’t focused on the statute or preemption, but we found one – Avendt v. Covidien, Inc., 2017 WL 2868487 (E.D. Mich. Jul. 5, 2017).

Avendt involves a biologic (as opposed to synthetic) mesh product that was used by plaintiff’s surgeon in plaintiff’s hernia repair surgery. Plaintiff suffered complications following surgery, including an infection and chronic non-healing wound that required multiple revision surgeries and eventual removal of the product. Id. at *1. The biologic mesh product at issue was approved by the FDA via the 510(k) substantial equivalence process. It was cleared to market for use only in “Class I/Clean wounds.” Id. at *17. Plaintiff did not dispute that his wound was Class I and clean, in other words this is an on-label use case. Id. at *19.   In addition, the product’s labeling contained a warning that the mesh could weaken or breakdown if used in a contaminated or infected wound or if exposed to “high concentrations of digestive enzymes.” Id. at *17.

Against this background, plaintiff filed suit alleging that defendant’s product was defective due to failure to test and subsequent failure to warn. Id. at *1. More specifically, plaintiff argued that defendant’s insufficient testing led it to market the product as a “biologic mesh,” when in fact it performs like a synthetic mesh which was the characteristic of the product that led to plaintiff’s injuries. Id. at *22.

In support of his claim, plaintiff disclosed only one expert, Dr. Michael J. Rosen. Dr. Rosen was plaintiff’s treating surgeon who performed the surgery removing the mesh. Plaintiff opted not to have Dr. Rosen prepare a full Rule 26 expert report, the consequences of which were that he would be limited to testifying as a treating physician and so only permitted to testify as to those opinions that were formed “for purposes of, and within the scope of, his care and treatment of [plaintiff].” Id. at *2. Most of Dr. Rosen’s opinions were not.

For example, Dr. Rosen’s opinion that the mesh was unsafe for use in Class I wound was excluded as not being related to his care and treatment of the plaintiff. That may have been an opinion he held at the time he treated plaintiff, but it was not formed for the purpose of or within the scope of his care and treatment of plaintiff. Id. at *23. He had no reason to form a safety opinion to care for and treat plaintiff and he didn’t include any such opinion in his medical records or in any discussion with plaintiff or any of his colleagues. Id. Moreover, Dr. Rosen did not report plaintiff’s case to the FDA as an adverse event. Id. Dr. Rosen’s opinions on the sufficiency of the testing and adequacy of the warning suffered the same fate – to even be considered potentially admissible Dr. Rosen needed to prepare a proper Rule 26 expert report “setting forth the scientific or experiential basis” of his theories. Id. at *25.

But that wasn’t the only fatal flaw for Dr. Rosen’s opinions. His opinions were also unsupported. Unlike his litigation opinion that defendant’s biologic mesh was unsafe for Class I wounds, Dr. Rosen had opined in numerous peer-reviewed articles that defendant’s product was acceptable in that precise situation. Id. at *23-24. The blatant contradiction was another ground for exclusion. Id. at *25. These same peer-reviewed publications also discussed the need for further study of the biologic mesh for treating Class II and III wounds, but nowhere suggested that further testing was needed regarding treatment of Class I wounds such as plaintiffs. So, Dr. Rosen’s opinions on adequate testing were also unsupported. Id. at *26.

As to the adequacy of the warning, plaintiff argued that the product’s labeling should have included a warning to remove the mesh in the event of a seroma (what plaintiff had) or an infection. Id. Dr. Rosen, however, could only opine that “there should be more information” about the types of cases for which the mesh should be used. Id.  That was not enough to clear plaintiff’s hurdle of proving as a matter of law that defendant had a duty to warn. Id. Moreover, as noted above, the label did warn about weakening and breakdown – the very side effects plaintiff suffered. Id.

Finally, Dr. Rosen also offered an opinion on causation. He testified that he saw the mesh “sitting on a bed of pus,” removed it, and concluded that the mesh caused the infection because the infection cleared up after removal. Id. at *29. The court didn’t question that Dr. Rosen knew an infection when he saw it.  But “the ability to diagnose medical conditions is not remotely the same … as the ability to deduce … in a scientifically reliable manner, the causes of those medical conditions.” Id. (citation omitted). Bottom line – nowhere in his opinion did Dr. Rosen rule out the other potential causes of plaintiff’s infection and failure to heal; such as his diabetes, obesity, blood pressure, and use of immunosuppressants. Id. *29-30.

But Dr. Rosen wasn’t the only problem with plaintiff’s case. Plaintiff’s failure to warn claim also failed for lack of causation. First, the learned intermediary doctrine applies to a medical device. Id. at *21-22. So any duty to warn ran to plaintiff’s surgeon. Second, there was no evidence that plaintiff’s surgeon read the product’s labeling. Id. at *29.   He had not met with the defendant’s representative, had not read the instructions for use, and had not read any of the literature about the product. Under this circumstance, no additional or different warning would have made a difference because the doctor wouldn’t have seen it. No failure to warn.

Defendant also had no duty to conduct a randomized prospective clinical trial before marketing the product. There was no evidence that such a clinical trial was the standard of care for 510k mesh products at the time defendant’s product was approved. Id. at *27.

Plaintiff paid dearly for failing to serve a Rule 26 expert report for their sole medical expert, although it appears that even with a report very little of what their expert was offered to opine on would have been admissible under Daubert anyway. And with no causal nexus between the doctor and the warning, plaintiff’s failure to warn claim was dubious regardless of whether the expert testimony was admissible or not. While any one of these things would have sunk the case, we’re glad the court explored them all. The opinion is loaded with good precedent.

The New Jersey Supreme Court has ruled that once the Attorney General declines to take over a qui tam action, he can no longer use administrative subpoenas to compel testimony and documents from defendants and witnesses. In the Matter of the Enforcement of New Jersey False Claims Act Subpoenas, __ A.3d__, 2017 WL 2458163 (N.J. June 7, 2017).

The background of the case is set out in the Appellate Court’s decision at 134 A.3d 1012 (N.J. Super. App. Div. Mar. 18, 2016). The underlying complaint in federal court is a qui tam action alleging that a pharmacy benefits manager defrauded the state by retaining rebates that were supposed to be passed along to its clients in violation of the federal False Claims Act and the New Jersey False Claims Act (“NJFCA”). Id. at 1013. When a private citizen brings a qui tam action seeking to enforce the NJFCA on behalf of himself and the state, the complaint must be filed under seal and served on the Attorney General. The Attorney General then has 60 days to decide whether to intervene and take over the action. That time can be extended upon the Attorney General’s request and upon a showing of good cause. Id. at 1015.

In this case, that extension provision was liberally and repeatedly applied to afford the Attorney General approximately 600 days to decide whether to intervene, with the “final” intervention deadline set for June 2, 2015. Id. at 1014. The appellate decision mentions in passing that it was both not convinced and need not decide whether defendants engaged in delay tactics as “it neither explains nor excuses the Attorney General’s failure to proceed more expeditiously for such an extraordinary length of time. Id. The final deadline passed and the Attorney General did not exercise his option to take over the case. Id. at 1015. After June 2, however, the Attorney General sought enforcement of a subpoena previously served on the defendant and two subpoenas served after June 2 on additional witnesses. The federal court decided that the issue of the enforceability of the subpoenas was best resolved by the New Jersey state courts. Id.

The Attorney General argued that his right to investigate the claims did not disappear with the passing of the intervention deadline citing his statutorily granted subpoena power. But the court concluded that was not an “additional or separate font of power” once the Attorney General declines to intervene. Id. at 1016. The Attorney General has a duty to investigate possible NJFCA violations and is given tools to do so, but is also given a time period in which to do so. The Attorney General’s broad interpretation would mean that he could investigate “for so long as he cared” and “seek leave to intervene . . . at any time up until the entry of final judgment.” Id. That would render the 60-day deadline meaningless and it is the goal of the court to interpret statutes “in a way that gives meaning to every part.” Id. The court also pointed out that the Attorney General’s repeated requests for extensions of the 60-day deadline contradict his argument that his right to continue his investigation and enforce subpoenas survives that deadline. Id. at 1017. Why else would he need the extensions?

Indeed the landscape changes once the Attorney General decides not to proceed. From that point forward, the person who initiated the action has the right to conduct the action and the Attorney General’s decision to opt out is final and not reviewable. Id. In other words, “there is no turning back.” Id. The Attorney General then becomes a bystander. He can request copies of the pleadings, motions and depositions only at his own cost. And finally, he remains on the sidelines unless he can convince the court that he has “good cause” to intervene at a later date. Id. The Attorney General urged a broad reading of that final provision, but the court said it had to be construed with the other three provisions, all of which heavily favor a legislative intent that the relator be allowed to control the qui tam action uninhibited. Id.

The appellate court also found that the Attorney General should not be allowed to proceed with a separate investigation that might interfere with the federal judge’s management of the qui tam action to which the Attorney General is not a party. Id. at 1018.

The New Jersey Supreme Court adopted the reasoning of the appellate decision, but elaborated on an additional argument advanced by the Attorney General that NJFCA does not contain the same provision as the federal False Claims Act which expressly bars U.S. Attorney Generals from enforcing subpoenas after electing not to intervene. In the Matter of the Enforcement of New Jersey False Claims Act Subpoenas, __ A.3d__, 2017 WL 2458163 at *4. Because the NJFCA does not contain the same provision, the Attorney General argued that the New Jersey legislature must have intended to allow the issuance of administrative subpoenas after opting out.

But the FCA and the NJFCA differ in many ways. The NJFCA was not modeled on the FCA such that deletion of a specific provision would be evidence of a specific legislative intent to diverge from the federal approach. Id. The NJFCA tracks neither the structure nor the text of the FCA. So instead the court must look to the provisions of the NJFCA. As set out above, those provisions all support that the Attorney General’s right to enforce subpoenas ends with the decision not to take over the action. Id. at *5. So defendants don’t have to defend NJFCA violation allegations on competing fronts, thankfully.

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.