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While 2019 is solidly under way, we’re still catching up on a sizable number of favorable decisions to have come down right before the new year.  That’s certainly not a complaint.  We love a full plate of defense wins.  So, for today’s post we’re reaching back a few weeks to tell you about a decision coming out of Middlesex County Superior Court in New Jersey in what we believe is the first ever decision on a motion to dismiss in a case alleging breast implant associated-anaplastic large cell lymphoma (BIA-ALCL).  BIA-ALCL has been receiving a decent amount of publicity recently as well as significant regulatory activity since 2011.  And this is one of several BIA-ALCL cases pending in New Jersey.  So, the decision is significant as a case of first impression with hopefully trend-setting implications.

The case is Cashen v. Johnson & Johnson, 2018 WL 6809093 (N.J. Super. Law Div. Dec. 24, 2018).  Plaintiff underwent surgery in 2008 during which defendant’s breast implants were implanted.  In 2016, plaintiff was diagnosed with ALCL requiring surgery to remove infected lymph nodes and chemotherapy.  Id. at *2.  The parties agreed that Ohio law governed plaintiff’s claims as that is where the alleged injury arose.  Plaintiff brought claims for fraudulent misrepresentation, fraudulent concealment, consumer protection, design/warning/manufacturing under the Ohio Products Liability Act (“OPLA”), and express warranty.  Defendant moved to dismiss all claims on both preemption and substantive state law grounds.  Id.

Because the breast implants are pre-market approved medical devices, they are subject to express preemption under Riegel v. Medtronic, 552 U.S. 312 (2008) if plaintiff’s claims seek to impose state law requirements that are different from or in addition to the federal requirements imposed as part of the PMA process.  Id. at *5.  The court found that was the case with respect to plaintiff’s fraudulent misrepresentation and concealment claims:

Inherent in the FDA’s approval of the product is its finding that the product and its label have met the federal requirements as a Class III medical device. Therefore, it stands that any claims of fraudulent misrepresentation and fraudulent concealment seek to either (1) impose different or additional requirements to those that the FDA has already determined to have been satisfied or (2) stand in the place of the FDA and enforce federal requirements. The former would make the claims expressly preempted while the latter would be impliedly preempted.

Id. at *7.  Plaintiff attempted to bypass preemption by arguing that her fraud claims were “not based on the safety or effectiveness of the implants.”  Id.  Which was belied by the allegations of the complaint that focus on “serious physical harm” and misrepresentations about “safety” of the product.

The court also found that under Ohio law, plaintiff’s fraudulent misrepresentation and fraudulent concealment claims were abrogated under the OPLA.  The text of the OPLA provides that it abrogates all common law products liability claims.  Id. at *8.  And Ohio courts have determined that fraud claims premised on a failure to warn or a duty to make additional warnings are products liability claims subsumed under the OPLA.  Again, plaintiff attempted to re-write her complaint and argued that her fraud claims were premised on a general duty not to deceive rather than on a duty to warn.  Id.  But the court again found that argument contradictory to the allegations of the complaint which were clearly focused on concealments regarding safety – like a failure to warn claim.

Next up was plaintiff’s claim for violation of the Ohio Consumer Sales Practices Act (”OCSPA”).  Here the court opted not to decide the federal preemption question, instead relying on the abrogation of the claim by the OPLA.  The court noted that under Ohio law, medical devices are not considered consumer goods under the OCSPA.   Id. at *9.

Which then brings us to the plaintiff’s OPLA claims for design, warning, and manufacturing defect.  Because the implants were PMA approved, they have “satisfied the FDA’s strictest requirements for medical devices.”  Id. at *10.  Therefore, any claim for design defect must be preempted “because any alternative design would violate the product’s PMA.”  Id.  As for plaintiff’s manufacturing defect claim, it was premised on “generic allegations” lacking the specificity required to overcome preemption.  Plaintiff’s warning claim likewise failed because the FDA had already approved the implant’s warnings, making any state law finding that the warning was inadequate a different requirement.  Id.

Plaintiff’s breach of express warranty claim suffered the same fate.  The claim would ask the jury to find that the product was not safe and effective as labeled – which would be in direct conflict with the FDA’s PMA conclusions.  Id. at *11.

As if that wasn’t enough – the icing on this cake is that the dismissals were with prejudice.  Plaintiffs had sought leave to amend but it appears the court concluded that amendment would be futile given the preemption analysis.

Congratulations to Dustin Rawlins, Peter Choate, Monee Hanne, and Rachel Byrnes at Tucker Ellis and Michael Zogby and Jessica Brennan at Drinker Biddle on this excellent decision.

It’s been a long road.  Well after product liability litigation over Accutane and inflammatory bowel disease (“IBD”) had been thoroughly debunked everywhere else in the nation, such litigation lived on in New Jersey – for year after interminable year.  First, a number of trials occurred, but literally every verdict for the plaintiffs was reversed on appeal.  Here are some of our posts on that phase of the litigation.  Then, once the trial court had had enough and began dismissing large numbers of cases, the intermediate appellate court reversed those decisions, too.  Here are some of our posts on that phase of the litigation.

Ultimately, it was up to the New Jersey Supreme Court to step in and figure everything out.  We blogged recently about it reversing the Appellate Division and entering a landmark decision on the admissibility of expert testimony in New Jersey.  See In re Accutane Litigation, ___ A.3d ___, 2018 WL 3636867 (N.J. Aug. 1, 2018).  Well, the defendant went back to the well on the adequacy of the drug’s warnings, and yesterday it rang the bell again.  In In re Accutane Litigation, ___ A.3d ___, 2018 WL 4761403, slip op. (N.J. Oct. 3, 2018), the court unanimously reversed the Appellate Division and affirmed the grant of summary judgment against another 532 cases brought mostly by litigation tourists.  “Of the 532 plaintiffs, 18 are New Jersey residents and 514 are residents of 44 other jurisdictions.”  Id. at *5.

The trial court had told the tourist plaintiffs that they were stuck with the consequences of choosing to descend on New Jersey like a plague of locusts – New Jersey law applied, including the presumption of adequacy that the state’s Product Liability Act (“PLA”) gives to FDA-approved warnings.  The warnings were adequate as a matter of law because “plaintiffs failed to overcome the presumption of adequacy.”  2018 WL 4761403 at *5.  The Appellate Division held that the law of each of the plaintiffs’ home states, 45 states altogether, governed, and reversed summary judgment under the laws of most of those states (all but eight).  Id.

Choice of Law

The New Jersey Supreme Court first said “you’ve got to be kidding” to the Appellate Division’s multifarious choice of law result.  The plaintiffs made their bed and thus had to sleep in it:

[W]e hold that New Jersey has the most significant interests, given the consolidation of the 532 cases for MCL [multi-county litigation] purposes. . . .  The aggregation of hundreds of cases under MCL allows the resolution of common issues of law.   A trial judge cannot be expected to gain a mastery of the law of forty-five different jurisdictions.  Construing New Jersey’s PLA is challenging enough.  New Jersey’s interest in consistent, fair, and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many cases that share common issues of fact.

Accutane, 2018 WL 4761403 at *6 (summarizing ruling).  See Id. at *15-20 (lengthy discussion of rationale for applying New Jersey law to all cases).

The court “proceed[ed] under the assumption” that true conflicts existed – that “application of New Jersey’s PLA may lead to an outcome different from the application of the laws of those other jurisdictions.”  Id. at *17 (citation and quotation marks omitted).  Even so, the most “significant relationship” for choice of law purposes in all cases was New Jersey.  First, as to alleged failures to warn, the corporation’s principal place of business “is where the alleged conduct causing the injury occurred − the manufacturing and labeling of [the product].”  Id. at *18 (citation and quotation marks omitted).

Second, in mass torts, “ordinary choice-of-law practices should yield in suits consolidating large numbers of claims and that courts should apply a single law in such cases.”  Id. at *17 (citation and quotation marks omitted).

The two most significant Restatement factors in this MCL matter are . . . “certainty, predictability and uniformity of result” and . . . “ease in the determination and application of the law to be applied”.  Applying a single standard to govern the adequacy of the label warnings in the 532 individual cases will ensure predictable and uniform results − rather than disparate outcomes among similarly situated plaintiffs.

Id. at *20 (discussing factors under Restatement (Second) of Conflict of Laws §6 (1971)).  Litigants cannot expect “[a] single judge . . . to gain a mastery of the laws of forty-five jurisdictions.”  Id.  If mass tort plaintiffs don’t want New Jersey law to apply they should “bring suit in the state where they reside.”  Id.  Under this new, mass-tort-specific application of choice of law, the plaintiffs in Accutane were stuck with New Jersey substantive law, which “is not as beneficial to their cause as the laws of other jurisdictions.”  Id.

We recommend that defense counsel study the court’s choice of law rationale.  It is no accident that, in its discussion of choice of law, the court cited Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017).  Accutane, 2018 WL 4761403 at *20.  Save for Delaware, more major pharmaceutical manufacturers are probably “at home” in New Jersey than anywhere else.  Thus, if the other side in the future chooses to congregate in New Jersey, they’ll have to put up with New Jersey substantive law, at least if the defendant makes motions in the aggregate.  Query, however, if the practicality rationale still applies in a single “bellwether” case where the alternative is application of one other state’s law, rather than the multi-state muddle the court faced in Accutane.  We think defendants have another opportunity to exercise some strategic discretion here.

Presumption of Adequacy

On the merits, the Supreme Court agreed with the trial court, that the defendant’s warnings were adequate as a matter of law under the PLA’s presumption of adequacy of FDA-approved labeling.  Initially, we get another shout out for the learned intermediary rule from the court:

[T]he PLA codifies what is commonly referred to as the learned intermediary doctrine – . . . that the physician acts as the intermediary between the manufacturer and the patient.  The prescribing physician − as a learned intermediary − generally is in the best position to advise the patient of the benefits and risks of taking a particular drug to treat a medical condition.  Under the learned intermediary doctrine, a pharmaceutical manufacturer generally discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with information about the drug’s dangerous propensities.

Accutane, 2018 WL 4761403 at *21 (citations and quotation marks omitted).  We’re always on the lookout for high court reaffirmations of the learned intermediary rule.

As to the statutory presumption of the adequacy of FDA warnings, the court reached the right result, but not before a lengthy detour based on a questionable source (a law review article written by plaintiff-side professional expert David Kessler) and the infamous decision in Wyeth v. Levine, 555 U.S. 555 (2009).  2018 WL 4761403 at *21-24.  The upshot is a ruling on how the PLA’s “rebuttable” presumption of adequacy can be rebutted:

[T]he rebuttable presumption of adequacy attaching to an FDA-approved drug label is overcome when a plaintiff presents clear and convincing evidence that a manufacturer knew or should have known, based on newly acquired information, of a causal association between the use of the drug and “a clinically significant hazard” and that the manufacturer failed to update the label accordingly.

Id. at 26.  Notably, the substantive aspects of this rebuttal standard are based on federal regulations, including the notorious Levine “CBE regulation,” 21 C.F.R. §314.70.  This result leaves little daylight between the PLA presumption and implied preemption under Levine, except for the burden of proof.  Preemption is also based on “newly acquired information” – specifically the lack of it.  So any claim that would be preempted in other jurisdictions because plaintiffs can’t point to anything new that the FDA hadn’t already considered is independently barred in New Jersey by the PLA presumption.  However, while defendants bear the burden of proving preemption, in New Jersey the PLA presumption means that plaintiffs bear the burden of proving the presence of the necessary “new” information, and must do with clear and convincing evidence, which Accutane defined as “evidence so clear, direct, weighty in terms of quality, and convincing as to cause one to come to a clear conviction of the truth of the precise facts in issue.”  Id. at *26 (citation and quotation marks omitted).

The Accutane court added “one caveat” – regardless of anything else:

A manufacturer that acts in a reasonable and timely way to update its label warnings with the FDA, in accordance with its federal regulatory responsibilities, will receive the protection of the rebuttable presumption.

Id.

The Accutane court acknowledged that this “is a standard protective of responsible drug manufacturers.”  Id.

The PLA’s rebuttable presumption of adequacy that attaches to label warnings gives pharmaceutical companies the protection necessary to research and develop the drugs that will improve and extend the lives of people around the world.  The presumption of adequacy protects manufacturers from unmeritorious lawsuits.

Id.

Plaintiffs’ Failure of Proof

Finally, Accutane applied the law to the facts, and found that none of the 532 plaintiffs came close to overcoming the statutory presumption of adequate warnings.  “[M]ultiple warning tools,” the package insert, the patient package insert, the medication guide and “blister packaging,” all warned about the possibility of IBD.  Id. at *27.  “Association” was the proper description of the drug’s relationship to the plaintiffs’ injuries; “cause” would have been too strong.  Defendant “had reports that some patients, after taking [the drug], developed symptoms of IBD.  That one followed the other does not prove cause and effect.”  Id. (citing Accutane, 2018 WL 3636867, at *8-10).  Plaintiffs offered only “isolated examples” that had been “culled from the voluminous discovery.”  Id. at *27-28.  “To be sure,” that evidence “is not clear and convincing evidence that [defendant] knew or should have known that the use of the word ‘associated’ was inadequate.”  Id. at *28.

Nor is there any evidence that [defendant] avoided necessary label changes for economic reasons.  [Defendant’s] marketing personnel certainly expressed an interest in Accutane’s financial success; it would have been surprising if it were otherwise.  However, there is no evidence that [defendant’s] financial interest in Accutane’s success led it to withhold necessary IBD-related warnings.

Id.

*          *          *          *

This latest Accutane decision is a great result and should finally drive a stake through this vampire of a litigation.  Still, a couple aspects of this ruling give us pause.  As for choice of law, the application of multiple states’ laws was one means of defending against class actions, since doing so defeated both proportionality and manageability.  Many other reasons for rejecting class actions in personal injury litigation remain, but like practically everything else about choice of law, this could be a two-edged sword.  Second, the continued willingness of New Jersey courts to craft extra-statutory “exceptions” to the New Jersey legislature’s presumption of adequacy of FDA warnings bothers us doctrinally.  The statute says what it says, and we think that – as with all other statutory provisions (including preemption clauses) – courts should enforce statutes as written, and not use subsequent developments to change what the legislature did.  Short of a constitutional issue, courts should not encroach on the legislature’s prerogative to draft legislation.

Today’s post is an update to our post from just a few weeks ago regarding McWilliams v. Novartis AG, No. 2:17-CV-14302 (S.D. Fla.). At that time, the court denied summary judgment on plaintiff’s failure to warn claims, but applying New Jersey law dismissed plaintiff’s claim for punitive damages. Since the case involves an FDA-approved prescription drug, having found that New Jersey law applied to the punitive damages claim, the decision to dismiss seems very straightforward to us because according to the New Jersey Products Liability Act (“NJPLA”):

Punitive damages shall not be awarded if a drug or device or food or food additive which caused the claimant’s harm was subject to premarket approval or licensure by the federal Food and Drug Administration.

N.J. Stat. Ann. § 2A:58C-5. But plaintiff didn’t think that was where the story should end, so she filed a motion for reconsideration. Look before you leap. Be careful what you ask for. You don’t always get what you want. Whatever adage you want to use, the bottom line is still no punitive damages.

Plaintiff’s argument was solely focused on the exception to the NJPLA’s ban on punitive damages for prescription drugs. That exception says that the prohibition on punitive damages does not apply “where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency’s regulations, which information was material and relevant to the harm in question.” N.J. Stat. Ann. § 2A:58C-5. In its decision last month, the court held that plaintiff had not argued that the exception applies and so the court did not have to address it. McWilliams v. Novartis AG, 2018 U.S. Dist. LEXIS 113862, *22 n.3 (S.D. Fla. Jul. 9, 2018).

In her motion for reconsideration, plaintiff pointed to a footnote in her opposition to the motion for summary judgment in which she did argue that she had adduced evidence of information withheld from or misrepresented to the FDA that made whether the exception applied a triable issue of fact. McWilliams v. Novartis AG, 2018 WL 3637083, *2 (Jul. 31, 2018). That footnote also stated plaintiff’s belief that “punitive damages under New Jersey law are not preempted.” Id. (citations omitted).

The court agreed that it had not considered plaintiff’s argument regarding the punitive damages exception and so granted plaintiff’s request to consider it. Id. And upon considering it, promptly concluded that it was indeed preempted.

If we’re talking about a misrepresentation to the FDA, we’re talking about fraud-on-the-FDA, so we’re talking about Buckman. It feels like a direct line to us. An express even. No stops, twists, turns, or curves. The exception to the punitive damages ban in the NJPLA is a fraud-on-the-FDA claim and Buckman says those are not allowed.  The federal circuit courts that have considered the issue (in the context of similar provisions of Michigan and Texas law) are split with the Fifth and Sixth Circuits finding the exception preempted and the Second Circuit not. Compare Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) and Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012) with Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008). We discuss the split in more detail here, and we’re guessing we don’t need to tell you on which side of the issue we come down.

Fortunately the court in this case was persuaded that the punitive damages exception is “substantially the same” as fraud-on-the-FDA and therefore preempted by Buckman – noting that that was in fact the position of the majority of courts to have considered the issue. McWilliams, 2018 WL 3637083, *3. Another notch on the Garcia/Lofton side of the divide.

Today, in In re Accutane Litigation, No. A-25-17, slip op. (N.J. Aug. 1, 2018), the New Jersey Supreme Court unanimously upgraded the state’s standards for admission of expert testimony.  This decision, we hope, will finally break the back of the long-running – and scientifically bogus – Accutane litigation that has plagued New Jersey courts.

The gist of the opinion can be appreciated in the court’s summary:

HELD: There is little distinction between Daubert’s principles regarding expert testimony and New Jersey’s, and Daubert’s factors for assessing the reliability of expert testimony will aid New Jersey trial courts in their role as the gatekeeper of scientific expert testimony in civil cases.  Accordingly, the Court now reconciles the standard under N.J.R.E. 702, and relatedly N.J.R.E. 703, with the federal Daubert standard to incorporate its factors for civil cases.  Analysis of the record in this case leads to a clear result:  the trial court properly excluded plaintiffs’ experts’ testimony.  Moreover, the Court reaffirms that the abuse of discretion standard must be applied by an appellate court assessing whether a trial court has properly admitted or excluded expert scientific testimony in a civil case.  In this matter, the trial court did not abuse its discretion in its evidential ruling and, therefore, the Appellate Division erred in reversing the trial court’s exclusion of the testimony of plaintiffs’ experts.

Accutane, slip op. at 2-3.

Specifically, after Accutane, the trial courts’ “gatekeeping role” for expert testimony must “assess both the methodology used by the expert . . . and the underlying data.”  Id. at 5.  New Jersey now is close to being a Daubert state.  Id. (“not much light between New Jersey’s standard and . . . the federal sphere under Daubert”; but “stops short of declaring New Jersey a ‘Daubert jurisdiction’”).  Non-exclusive “general factors” applicable to expert admissibility are:

(1) Whether the scientific theory can be, or at any time has been, tested; (2) Whether the scientific theory has been subjected to peer review and publication, noting that publication is one form of peer review but is not a “sine qua non”; (3) Whether there is any known or potential rate of error and whether there exist any standards for maintaining or controlling the technique’s operation; and (4) Whether there does exist a general acceptance in the scientific community about the scientific theory.

Id. “[P]roper gatekeeping . . . requires the proponent to demonstrate that the expert applies his or her scientifically recognized methodology in the way that others in the field practice the methodology.”  Id. Finally, the Appellate Division’s “less deferen[tial]” standard of appellate review is rejected, and the trial court’s dismissal of over 2000 cases for lack of scientific validity is affirmed under an abuse of discretion standard.  Id. at 4; id. at 6 (“we reaffirm that the abuse of discretion standard must be applied by an appellate court assessing whether a trial court has properly admitted or excluded expert scientific testimony in a civil case”).

Under proper Daubert-like standards, the result wasn’t even close.  The “clear result” was exclusion of the “expert” testimony purporting to link the drug to Crohn’s disease.  Id. at 6.

The opinion is 85 pages long. In the interest of brevity (and getting our other work done) we’re simply bullet pointing anything we find of particular interest.  We heartily recommend that all defense counsel with matters in New Jersey read the whole thing.

  • The court relies heavily on the federal Reference Manual on Scientific Evidence (here’s a link to the manual). Id. at 12-18, 24, 73-74, 77-78. That means that defense counsel should feel comfortable citing the Manual in New Jersey state courts.
  • “A majority of states have adopted some form of the Daubert standard, either explicitly or implicitly.” Id. at 65 (citing cases).
  • That N.J.R.E. 702 – unlike the federal rule − has not been amended to include the “Daubert factors” is not dispositive. Id. at 66-67.
  • Expert admissibility is “not credibility,” but rather a “legal determination” as to which “rigor [is] expected of the trial court.” Id. at 67.
  • “The gatekeeping role necessitates examination of a methodology espousing a new theory in medical cause-and-effect cases,” and “properly exercised,” it “prevents the jury’s exposure to unsound science through the compelling voice of an expert.” Id. at 68-69.
  • “[T]he gatekeeping role must be rigorous.” Id. at 69.
  • Anything less than “abuse of discretion” appellate review “is not appropriate in the context of a civil mass tort case.” Id. at 71.
  • “[T]his Court has continued to apply a pure abuse of discretion standard in civil matters concerning expert testimony.” Id. at 72.
  • “[C]ase reports are at the bottom of the evidence hierarchy, and other courts have been skeptical of their value in proving causation.” Id. at 73 (citations and quotation marks omitted).
  • “[A]nimal studies” are “far less probative in the face of a substantial body of epidemiologic evidence.” Id. at 74 (citations and quotation marks omitted).
  • “[E]xperts cannot selectively choose lower forms of evidence in the face of a large body of uniform epidemiological evidence.” Id. at 77 (citations omitted).
  • Bradford-Hill criteria “are invoked only after an association between an agent and a particular disease has been determined to be present,” and “their pointed purpose . . . is not to create an association that has not already been detected through appropriate studies.” Id. at 78.
  • “It is not for a trial court to bless new ‘inspired’ science theory; the goal is to permit the jury to hear reliable science to support the expert opinion.” Id. at 80 (citation omitted).
  • “[B]oth our law and the Daubert trilogy are aligned in their general approach to a methodology-based test for reliability.” Id.
  • “[B]oth standards look to whether that reasoning or methodology properly can be applied to facts in issue. Id. at 81 (citations omitted).
  • “[A] technique with minimal support [is] to be viewed with skepticism.” Id. at 82 (citation omitted).
  • “[T]he factors identified originally in Daubert should be incorporated for use by our courts.” Id.
  • Daubert is not “adopted” because “[w]e hesitate to sweep in adherence to the various approaches taken among the circuits and state jurisdictions when applying the Daubert factors.” Id. at 83.
  • “[A] methodology-based approach to reliability for expert scientific testimony requires the proponent to demonstrate that the expert applies his or her scientifically recognized methodology in the way that others in the field practice the methodology.” Id. at 84.
  • “When a proponent does not demonstrate the soundness of a methodology, both in terms of its approach to reasoning and to its use of data, from the perspective of others within the relevant scientific community, the gatekeeper should exclude the proposed expert testimony on the basis that it is unreliable.” Id. (citations omitted).
  • Plaintiffs’ theories “fl[y] in the face of consistent findings of no causal association as determined by higher levels of scientific proof” and were properly excluded. Id. at 85.

Given the size of New Jersey’s medical products industry, and the tightening of personal jurisdiction, the New Jersey courts are likely to be one of those jurisdictions seeing a greater number of mass torts involving injury claims against prescription medical products.  The importance of today’s Accutane decision cannot be overstated.

And to top it all off, for Roche, this huge victory occurred on Switzerland’s national day.

 

We spent yesterday in New York City, helping the Drug and Device Law Rock Climber (now the “Drug and Device Law Software Engineer” – yes, we are kvelling) move from one sublet to another as she continues her quest for the perfect apartment. The day was challenging, as these things tend to be. We lost count of the times we heard, “Why didn’t you tell me?” (That it was going to rain, that we would have to use the freight elevator, that we would be forced to keep moving the borrowed van because here was no legal place to leave it, that the refrigerator would bear the detritus of multiple unintentional science experiments – you get the idea. ) Each time, we responded with, “What difference would it have made?’

The plaintiff in today’s case, a tidy appellate decision in a medical malpractice case out of New Jersey Superior Court, asked the same question, and got the same answer. In Hopper v. Progressive Motion Med. Prod. Solutions, 2018 WL 2270839 (N.J. Super. Unpub. July 18, 2018), the defendant doctor performed arthroscopic knee surgery on the plaintiff. Following surgery, the doctor prescribed a cryotherapy device for the plaintiff to use at home to help control pain and swelling. The device worked by creating a flow of cold water across the plaintiff’s bandaged knee. The doctor and his staff instructed the plaintiff to use the device continuously for the first seventy-two hours after surgery and as needed thereafter, and to contact the doctor with any “issues” involving “drainage, redness, [or] warmth.” Hopper, 2018 WL 2270839 at *2.

The plaintiff used the device for seventy-two hours and intermittently for the next several days. On the fifth day, he saw the defendant doctor for complaints of swelling and bleeding. The doctor reassured the plaintiff that fluid buildup was common after surgery, aspirated the fluid from the knee, and instructed the plaintiff to return in a week. When the plaintiff returned, fluid had accumulated again, and the knee was painful. The doctor drained the fluid, but, he testified, was not “overly concerned.” He instructed the plaintiff to continue to use the device as needed.

Over the next several weeks, the plaintiff developed increased pain and swelling along with black skin and blisters on the knee. About five weeks after surgery, the plaintiff went to the emergency room complaining of nausea and increased knee pain. He was admitted, and ended up remaining in the hospital for a number of weeks. At the time of admission, the plaintiff had “eschar” – dead, necrotic tissue – over a wound in his knee. The eschar was surgically debrided, but it returned. Ultimately, the plaintiff was diagnosed with osteomyelitis, an infection of the bones in his knee. He was in danger of losing his leg, though doctors were able to save the leg by fusing the plaintiff’s knee.

The plaintiff sued the doctor for medical malpractice, alleging that the doctor deviated from the accepted standard of care during the postoperative period and that the deviations proximately caused his injuries. At trial, the plaintiff’s experts testified that the cryotherapy device caused “freezer burn” – a thermal injury – to the plaintiff’s skin, which the doctor did not recognize. According to the plaintiff’s experts, the untreated thermal injury destroyed the skin on the plaintiff’s knee. When the knee was debrided, the plaintiff’s experts testified, bacteria in the hospital environment infected the knee and eventually the bones, necessitating the fusion. The plaintiff’s experts testified that the doctor deviated from the standard of care by, inter alia, failing to warn the plaintiff of the risk of thermal injury and failing to personally instruct the plaintiff on how to use the cryotherapy device instead of allowing his staff to perform this task.

The defendant’s infectious disease expert opined, based on testing performed on tissue removed from the plaintiff’s knee, that the plaintiff was suffering from bullous cellulitis, blistering caused by a staph infection of the knee – not a thermal injury – when he presented to the emergency room, and that the infection would have occurred whether or not the plaintiff used the cryotherapy device. The defendant’s “standard of care” expert conceded that the doctor deviated from the accepted standard of care when he failed to warn the plaintiff of the risk of thermal injury. He testified that it was more likely than not that the plaintiff had sustained a thermal injury, but he did not opine that such injury was the proximate cause of the plaintiff’s damages.

The jury agreed, finding that the defendant had deviated from the applicable standard of care but that the deviations were not the proximate cause of the plaintiff’s injuries. On appeal, the plaintiff argued, inter alia, that, because it was ruled that the learned intermediary doctrine applied (the medical device manufacturer was no longer in the case when it was tried) and because there was sufficient evidence that thermal injury was a risk, the trial court committed error by failing to charge the jury about informed consent. The plaintiff argued that this error was “clearly prejudicial [because] defendant admitted he did not warn plaintiff of the risk of thermal injury.” Id. at *16.

The court disagreed, distinguishing between the product liability concept of “learned intermediary” and the medical monitoring theory of informed consent, explaining that “to prove a physician was negligent premised upon a theory of lack of informed consent, a plaintiff must show (1) the physician failed to comply with the applicable standard for disclosure; (2) the undisclosed risk occurred and harmed the plaintiff; (3) a reasonable person under the circumstances would not have consented and submitted to the [procedure] had he . . . been so informed; and (4) the [procedure] was a proximate cause of plaintiff’s injuries. Id. at *17 (citation omitted).

In any event, the court concluded that, because the jury had found that the doctor’s deviations from the standard of care were not the proximate cause of the plaintiff’s damages, the court’s failure to charge the jury on informed consent was harmless error. Verdict affirmed, and doctor off the hook for failing to warn. Wish it were that easy for the mother of a certain software engineer.

Since Conte in 2008, we have not made a secret of our view that innovator liability is a bad idea, contrary to traditional tort law principles and to sound public policy.  We, especially Bexis, may even be accused of being somewhat obsessed with chronicling the decisions, big and small, on this issue over close to a decade.  We have kept a scorecard of the decisions and commemorated the one-hundredth decision.  We tracked when the Alabama legislature got sick of the turbulent expansion by the courts and kept product liability limited to the product designed, manufactured, or sold/leased by the defendant.  We have peppered our top and bottom ten lists with these decisions and we expect they will find places on our august enumerations for the eleventh year in a row this December.

The decision in In re Zofran (Ondansetron) Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, 2018 WL 2317525 (D. Mass. May 21, 2018), has familiar ring to it.  Among the claims presented in this MDL are those against the branded manufacturer from the offspring of women who received generic versions of a prescription antiemetic.  These plaintiffs sought to impose innovator liability on the theory that the branded manufacturer had made misrepresentations to unspecified doctors that somehow encouraged the off-label prescription to pregnant women for morning sickness without disclosing a purported risk of birth defects.  (As an aside, while not in the decision, this is considered an essential medication by WHO and the current labeling suggests that FDA rejects that any birth defect risk has been established.)  Last year, the court ruled on a motion to dismiss this version of innovator liability under Georgia, Indiana, Kentucky, Massachusetts, New York, and Oklahoma law.  We discussed it here  and it took on honorable mention on last year’s top ten list.  Other plaintiffs persisted with these claims and the branded manufacturer defendant filed a motion for judgment on the pleadings.  After some voluntary dismissals, the court considered the issue under the law of Oklahoma (again), Connecticut, and New Jersey.

Why is this worth a post instead of just an update to our scorecard? Well, there have been two really big, bad decisions on innovator liability since the court’s prior decision and we like to make sure the majority position continues to hold after such dreck.  The first innovator abomination was T.H. v. Novartis Pharm. Co., which we railed about here and took over the spot of worst case of 2017 in a rare supplemental shuffling of the list.  We have said quite a bit about why this decision, and the Court of Appeals decision before it, were especially bad, extending innovator liability into perpetual liability under the guise of foreseeability.  A few months later, the Massachusetts Supreme Judicial Court a mile away from the Zofran MDL issued its own stinker in Rafferty v. Merck & Co., Inc., reversing a lower court rejection of innovator liability.   Even with the “limitation” that innovator liability would only for “reckless” conduct in failing to update the branded drug’s label, there is a good chance that this will find a place on the list of 2018’s worst come December.  There was also a good decision a few weeks ago from the West Virginia Supreme Court soundly rejecting innovator liability in McNair v. Johnson & Johnson, which may end up with a place on 2018’s best list.  More important than our lists—breathe, Bexis, breathe—is that the Zofran court reviewed and considered these decisions before addressing the merits.

The Oklahoma plaintiff’s claim was easy, given the court’s evaluation of Oklahoma law less than a year ago. “While it is true that the minority view has gained ground in the last year with the California and Massachusetts opinions, that is not sufficient under the circumstances to tip the balance.”  2018 WL 2317525, *4.

The court had not previously considered Connecticut law and the Connecticut state courts had not previously considered the issue. The Sixth Circuit had, though.  Connecticut was one of the 22 states at issue in In re Darvocet, which we lauded here before giving it the top spot in our 2014 list.  The Darvocet analysis was that the Connecticut Product Liability Act provided the sole remedy for misrepresentation claims asserted and it required the product at issue to be the defendant’s to impose liability.  While not binding, “In re Darvocet is a 2014 decision by a federal appellate court that addresses the issue in comprehensive terms, and there appears to be no Connecticut authority suggesting a contrary result.” Id. at *5.

Predictably, In re Darvocet (in the district court) had addressed New Jersey law and New Jersey lower courts have addressed the issue a few times, even if the New Jersey Supreme Court has not.  They all came out against innovator liability, with pre-Conte cases followed post-Conte.  (See here and the New Jersey part of this.)  The New Jersey PLA also limits liability to the manufacturer or seller of the product that allegedly hurt the plaintiff and misrepresentation claims like the plaintiffs assert against the branded manufacturer are subsumed by the NJPLA. Id. Thus, there is no innovator liability under New Jersey law.

Despite our retrospective here, we do not see this decision making this year’s top ten list. However, the First Circuit could certainly take high honors by affirming this or the prior Zofran MDL decision.  Just saying.

Prescription drug manufacturers are not insurers of injuries sustained while taking their products. Even in the most plaintiff-friendly jurisdictions, there needs to be some fault—whether framed in negligence, strict liability, or something else—and causation between the fault and the injury. It is surely not easy to stomach for someone who sustains such an injury while taking a drug, but sometimes there is no fault even if there is a significant injury related to the use of the drug. If the drug’s manufacturer warned about the risk of plaintiff’s ultimate injury consistent with the available evidence, which it examined and shared with FDA appropriately in connection with approval and after approval, and the prescribing physician(s) gave due consideration to the risk in treating the patient, then the manufacturer did what it was supposed to do and the patient might suppress the urge to sue someone. Often, of course, such patients become plaintiffs and courts are faced with deciding summary judgment in cases with a real injury, related in some way to the use of the drug, but no real claim against the manufacturer. In those situations, the courts often get it wrong and allow some claim to get past summary judgment. Nelson v. Biogen Idec, No. 12-7317 (JMV) (MF), 2018 WL 1960441 (D.N.J. Apr. 25, 2018), got it right. Joe Blute and Yalonda Howze of Mintz Levin, who defended the case and told us about it, deserve some credit for that.

The facts of Nelson do not exactly scream failure to warn, even with the severity of the injury claimed by the plaintiff, who received Tysabri, a prescription medication for his multiple sclerosis. He claimed to have developed progressive multifocal leukoencephalopathy (“PML”), a condition about which the drug’s labeling contained black box warning, multiple other warnings in physician labeling, and warnings in a medication guide that the drug’s Risk Evaluation and Management Strategy (“REMS”) program required the patient acknowledge when receiving the drug through infusion provided by a healthcare provider. With such extensive warnings also comes the expected developed record of interacting with FDA about PML, which we will attempt to summarize. The medication was approved in 2004, but withdrawn because of PML cases the next year. PML results from exposure to the JC virus, which is prevalent in humans but only causes PML in vulnerable patients. Before seeking to bring the drug back to market, the manufacturer conducted FDA-requested research on testing for the JC virus. After taking an advisory committee recommendation, FDA re-approved the drug in 2006 with a slew of robust warnings on PML and a REMS program that essentially documented understanding and/or acceptance of the PML risk at each step of the prescribing chain every time the patient received the drug. The label was updated in August 2008, November 2009, and July 2010 to provide more information on the PML risk. Meanwhile, the manufacturer worked to develop a better assay to detect exposure to the JC virus. After years of research and interaction with FDA, in 2012, a new assay was approved and the label was amended to reference it.

Meanwhile, plaintiff was prescribed the drug for his MS in April 2008 after being advised of the PML risk. Plaintiff moved and continued on the drug when prescribed by two other physicians, each of whom also warned him of the risk of PML. Plaintiff was negative for the JC virus in 2009, but started demonstrating signs of PML in 2010, which was confirmed later that year by brain biopsy. Plaintiff sued and was on the fifth version of his complaint when the court considered summary judgment on plaintiff’s remaining claim for failure to warn under the New Jersey Product Liability Act (along with a Daubert motion that was denied as moot).

The court started its analysis with a discussion of three prior decisions on similar claims with the same drug. We will skip that, partly because we have discussed these cases before.  Because this was under the NJPLA, the first issue was whether the “super-presumption” of the adequacy of the PML warnings would apply given plaintiff’s argument about post-approval compliance. The presumption did not look to be dispositive, as the court noted that the substance of the warnings to both the prescribing physicians and the patient were clear, strong, and effective. Yet, the court found that there was no evidence of “manipulation of the post-market regulatory process,” the basis of the so-called “McDarby exception,” noting the interaction between the manufacturer and FDA on an assay that could be used to detect the JC virus in connection with the use of the drug. (The court also assumed without deciding that the McDarby exception could apply.) In the face of this presumption, plaintiff relied on proposed expert testimony that only indirectly addressed the adequacy of warnings. His expert claimed a better assay could have been developed and approved in time to affect the various physicians’ decision to prescribe the drug to plaintiff. Even if his testimony were admissible and if he took the next step of connecting a new assay to the content of the drug’s label—which he did not and could not as a non-physician—there were still obvious issues with relying on this testimony to establish an inadequate label and proximate cause for failure to warn, including that the prescribing physicians were aware of the PML risk and discussed it with the plaintiff on multiple occasions. Put it all together and there was no evidence to carry a failure to warn claim, with or without a presumption of adequacy

As a bit of overkill, the court went ahead and considered the manufacturer’s preemption defense, which argued that the proposed changes to the drug’s label would have been impossible to make during the relevant time. The prior decisions that we elided above also found impossibility preemption, but they were not decided in the Third Circuit after the Fosamax decision tried to make the application of Levine’s once-novel “clear evidence” standard just a question for juries. Even acknowledging the high standard and the decision in Fosamax (albeit with a recurring, and surely unintentional, misspelling), the court still found “There is clear evidence that FDA would not have approved an earlier change to the Tysabri label or have approved the JC Virus assay.” FDA specifically rejected similar proposals twice in 2010, before approving the assay and corresponding labeling change in 2012 after additional research had been committed. That was pretty clear evidence of impossibility back when plaintiff was taking the drug.

So, the manufacturer won summary judgment thrice over. The co-developer also won because it had no ability to change the label, a useful nugget as innovator liability and other theories to impose liability on other defendants continue to get raised when the logical defendant is not liable. In Nelson, no defendant was liable to an injury that, while unfortunate and serious, was warned of about as thoroughly as is possible with a prescription drug. We would prefer such a case never to have been brought or to have been dismissed for failure to state a claim, but summary judgment is still the right result.

 

This post does not come from the Reed Smith side of the blog.

 

Favorable New Jersey appellate court decisions in product liability cases are almost always worthy of mention here. So we bring you Goodson v. C.R. Bard, 2018 WL 1370652 (N.J. App. Div. Mar. 19, 2018). To be truthful, we’re bringing it back to you. Bexis discussed the trial court’s decision to grant summary judgment to defendants last year.

As we discussed then, this is a case involving mesh used in hernia procedures. The particular mesh product involved in this case is not involved in the pelvic mesh MDL proceedings. And that may be reflected in the strength of the plaintiff’s expert reports, which is to say that they are not strong at all.  While the plaintiff used experts who have been involved in the pelvic mesh MDL, not one of them seemed to give the right opinions.

In particular, even though plaintiff brought a design defect claim, none of his experts gave an opinion that the design of this particular product was actually defective or that such a defect caused the plaintiff’s injuries. Id. at *4-5. Rather, his experts simply described various alleged risks of the product. This is not even close to sufficient to support a design defect claim. Id. Nor did any of the experts opine that there was a safer, feasible alternative design. Id. Similarly, even though plaintiff also brought a negligent failure to wan claim, none of the experts gave an opinion on the standard of care for issuing a warning or whether defendants met that standard. Id. at *5-6. In other words, plaintiff didn’t have a warnings expert to opine on whether the warning was adequate.

In short, plaintiff’s experts struck out looking.

To make matters worse, the treating doctor testified that he was aware of the potential risks of this mesh product and informed plaintiff of them. Id. at *6. There goes proximate causation under the learned intermediary doctrine.

Accordingly the New Jersey appellate division upheld the trial court’s grant of summary judgment to defendants. Unfortunately, it designated its opinion “not for publication.” That’s too bad. But rest assured: it happened. Westlaw already has it on-line. And the trial court’s decision, which Bexis’s post from last year lays out in considerable detail, has an excellent analysis of all the weaknesses in plaintiff’s case, an analysis that was essentially adopted by the Appellate Division. And, of course, we’ve written on it twice now. With all of that, we’re confident that you’ll find some way to make use of this appellate decision in your cases.

This post is from the non-Dechert side of the blog.

While the recent Pennsylvania Superior Court Risperdal decision is not a defense victory, it is certainly not as favorable for plaintiffs as they are making it out to be. While several issues were presented for appeal in Stange v. Janssen Pharms., Inc., 2018 Pa. Super. LEXIS 11 (Pa. Super. Jan. 8, 2018), the most important one was whether the trial court was incorrect in applying New Jersey law to plaintiff’s punitive damages claim. While plaintiffs are characterizing the decision as answering that question in the affirmative, what the court really said was maybe.

In the consolidated In re Risperdal litigation pending in the Philadelphia Court of Common Pleas, the coordinating judge granted defendants’ motion for summary judgment on punitive damages finding that the law of New Jersey, defendant’s principal place of business, applied and that under the New Jersey Product Liability Act, punitive damages are precluded in cases involving FDA approved products. Id. at *32-33. In opposition to defendants’ motion, plaintiffs argued the law of the case doctrine or in the alternative that the court should apply Pennsylvania law instead. Id. Their law of the case argument was based on the judge’s decision in three prior Risperdal cases to apply the punitive damages law of plaintiff’s home state. Id. at *35n.6. The trial court ruled that those cases were separate cases and therefore law of the case did not apply or if they were considered the same case as In re Risperdal, the same judge made all four rulings and a judge is entitled to revisit his earlier rulings “without running afoul of the law of the case doctrine.” Id. (citation omitted).

With that ruling in place, the Stange case went to trial with no punitive damage claim. Stange is a resident of Wisconsin which is where he was prescribed Risperdal and treated for his alleged injury, gynecomastia. Unlike New Jersey, Wisconsin does not have a bar on punitive damages for FDA approved products. Under Wisconsin law, however, punitives would be capped at twice the amount of any compensatory damages or $200,000, whichever is greater. Id. at *42. So, there is a clear conflict of law.

On appeal, plaintiffs argued that the trial court’s global ruling on punitive damages was improper because Pennsylvania law on choice of law requires an analysis of which state has the greatest relationship and interests in each individual plaintiff’s case and that that analysis supports applying plaintiff’s home state’s punitive damages law. Id. at *33. Plaintiffs did not argue for application of Pennsylvania punitive damages law on appeal. Id. at *43n.8. Defendants argued that plaintiffs’ choice of law argument had been waived because it was first raised in plaintiffs’ motion for reconsideration of the global punitive damages ruling. Id. at *37. The Superior Court, however, found plaintiffs’ arguments preserved. In the context of their law of the case doctrine argument which urged the court to follow its earlier decision to apply plaintiff’s home state law, plaintiffs “argued more generally that the law of the plaintiffs’ various home states should apply to punitive damages.” Id. at *39.

So, what the Superior Court concluded was that the choice of law analysis was not waived and that a choice of law analysis as between New Jersey and Wisconsin needed to be undertaken:

the trial court only considered whether New Jersey or Pennsylvania law should apply, not the law of the individual plaintiff’s home state. We agree with Stange that it is necessary to remand for the trial court to allow Stange to develop an individual record on choice-of-law as it relates to his unique circumstances and to set out the facts and state interests important to his particular case.

Id. at *45. Nowhere in the decision does the court make any finding with regard to what the outcome of the choice of law analysis should be on remand, only that the analysis needs to be done. There is nothing prohibiting the trial court from reaching the conclusion in Stange that it did in In re Risperdal globally – that New Jersey has the more significant relationship and interests on the punitive damages claim. Indeed, having reached that decision once already we struggle to understand how the facts of any particular case will impact the court’s analysis. For the underlying substantive claims, most choice of law analyses will favor plaintiff’s home state – where he was prescribed, where he suffered his injury, where he was treated. But the alleged corporate misconduct giving rise to the claims for punitive damages occurred in New Jersey. It is there that the company developed the Risperdal labeling and its marketing and sales strategy and from there that it had communications with the FDA. Id. at *44.  So, even on a case-by-case basis, there is ample support for a finding that in a failure to warn case, the proper focus for purposes of a choice of law analysis on punitive damages is the place where the alleged corporate misconduct occurred.

So we think plaintiffs are celebrating a bit prematurely. The Stange decision may have removed the foil and even loosened the wire cage, but the cork remains in place.

As we noted at the outset, punitive damages choice of law was not the only issue on appeal and so we make passing mention of two other noteworthy aspects of the case. First, defendants challenged the trial court’s admission of certain expert testimony on the grounds it did not meet Frye standards. Id. at *8-9.  The Stange, court however erroneously applied the novelty limitation from Trach v. Fellin, 817 A.2d 1102 (Pa. Super. 2003) – that Frye only applies to the most “novel” of scientific testimony. That narrow interpretation was rejected by the Pennsylvania Supreme Court in Betz v. Pneumo Abex LLC, 44 A.3d 27 (Pa. 2012), a case not cited in Stange.

Second, it was agreed that Wisconsin law governed the substantive claims in the case. While examining the issue of proximate cause on failure to warn, specifically whether plaintiff had carried his burden of proving a different warning would have changed plaintiff’s prescribing physician’s decision to prescribe, the court applied the learned intermediary rule which has never been adopted by any appellate court (only trial courts, which have split) under Wisconsin law. Id. at *22n.4 (no conflict between Pennsylvania and Wisconsin law on the scope of learned intermediary doctrine). We’ll add it to our learned intermediary “head count.”

This guest post is by Kevin Hara, an associate at Reed Smith and relatively frequent contributor to the Blog.  Here, he discusses two recent favorable procedural developments in further appeals from two really awful decisions by intermediate courts of appeals.  As always, our guest posters are 100% responsible for what they write – due 100% of the credit, as well as any blame.  Take it away Kevin.

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SCOTUS Calls For Solicitor General’s Views In Third Circuit Fosamax Case

Friday December 8 was a day with two items that are particularly noteworthy because of their potentially momentous implications. Remember the Blog’s previous lambasting of the Third Circuit’s unprecedented Fosamax preemption decision and the haymaker that court unleashed on the drug and device industry, in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017)?  Now, there is positive news to report. The Supreme Court has invited the Solicitor General “to file a brief in this case expressing the views of the United States.” Merck, Sharp & Dohme Corp. v. Albrecht, et al., No. 14-1900 (Order, Dec. 8, 2017).

What is that? Here is SCOTUSBlog’s description:

“CVSG” stands for “call for the views of the Solicitor General.”  In most cases in which someone is seeking review of the lower courts’ decision, the Court will issue a straightforward grant or denial.  But sometimes the Court will want the government’s views on what it should do in a case in which the government isn’t a party but may still have an interest — for example, because the interpretation of a federal statute is involved.  So the Court will issue an order in which it “invites the Solicitor General to file a brief expressing the views of the United States.”  It isn’t an “invitation” in the sense that the federal government gets to decide whether it wants to file a brief at all, because the Court expects the government to file.  There is no deadline by which the government is required to file the brief, however.  And the government’s recommendation, although not dispositive, will carry significant weight with the Court.

In Fosamax, this development is important because it signals that the case stands out from the general certiorari pool, meaning that review is more likely to be granted.  Statistics are surprisingly hard to come by, but a law review article, Thompson & Wachtell, “An Empirical Analysis of Supreme Court Certiorari Petition Procedures:  The Call for Response and the Call for the Views of the Solicitor General,” 16:2 G. Mason L.R. 237 (2009), analyzed ten years of Supreme Court cases (1994-2004) and concluded:

The overall grant rate increases from 0.9% to 34% following a CVSG from the Court; in other words, the Court is 37 times more likely to grant a petition following a CVSG.  For petitions on the paid docket, the grant rate increases even more, to 42%; a paid petition is 47 times more likely to be granted following a CVSG.

Id. at 245 (emphasis added).  If those somewhat dated statistics are even close to currently accurate, the Fosamax CVSG is a big deal.

Recall that the Third Circuit grossly misinterpreted the “clear evidence” preemption test from Wyeth v. Levine, which held that without clear evidence that the FDA would not have approved the label change, a court cannot rule a manufacturer’s compliance with federal and state law is impossible, and thereby preempted, already an exacting defense.  As the Blog explained in praising the petition for certiorari, the Third Circuit distorted Levine, applied an unprecedented standard, and ruled that a manufacturer could not invoke preemption without “clear and convincing” evidence that the FDA would have rejected a proposed warning.  Thus, not only did the Third Circuit reverse summary judgment for the manufacturer in more than 1000 cases, it rendered impossibility preemption even more difficult than the anti-preemption justices in Levine intended.  The Blog also discussed the Product Liability Advisory Council’s amicus brief in support of the petition here, which explained that the Third Circuit’s decision invites further lower court confusion, obliterates the district court’s ruling that was supported by undisputed evidence, encourages pharmaceutical manufacturers to flood the FDA with proposed label changes, and threatens to stifle the innovation necessary to develop new, potentially life-saving drugs.

This latest development raises defense hopes that SCOTUS will grant the petition, and finally reverse one of the worst decisions of 2017, which would be a huge win for the manufacturer in particular, and of greater significance for the big picture for pharmaceutical companies and consumers in general. Stay tuned.

New Jersey Supreme Court Grants Review of Accutane Cases

Also on December 8, the New Jersey Supreme Court granted the appeals in all of the Accutane cases that the appellate court revived back in July. The Blog has monitored the Accutane litigation through many of the twists and turns of its tortuous existence for more than a decade, first with the Accutane MDL, and then with the New Jersey cases.  As a resident of the San Francisco Bay Area, when I think of the Accutane litigation, I automatically picture Lombard Street, often touted “The Crookedest Street In The World,” with its eight hairpin turns and switchbacks that span the 600 feet of the street’s natural 27° grade.  In fact, Lombard Street is not even the most crooked street in San Francisco, because Vermont Street, has a greater sinuosity at 1.56 versus 1.2 for Lombard, though Vermont at seven turns, has one fewer than its more famous cousin.   Lombard Street and its adornment of brick red and beautiful flowers attracts thousands of tourists per year.  This meandering avenue is difficult to traverse, requires careful navigation, has been around a long time, and produced extreme frustration for those who occupy it: if it sounds familiar, bear in mind that the Accutane litigation likewise has a lengthy history, ongoing since 2003, has zigged and zagged, and neither side is particularly thrilled with the results.  The Blog has discussed many of the good aspects here, (vacating plaintiff verdicts) here, (dismissals based on learned intermediary doctrine) here, (MSJ granted) and here (warnings adequate as a matter of law), as well as the very bad Appellate Division decisions earlier this summer, when the court reinstated more than 2000 causation based dismissals.

With that in mind, here is a very brief summary of the mind-bending history of the Accutane saga and the battle over the proper expert testimony that has hopefully neared its dénouement.  As already discussed at length, the Appellate Division reversed the trial court’s decision that excluded plaintiffs’ expert causation testimony, reviving more than 2000 lawsuits.  Not surprisingly, the manufacturer appealed, supported by amicus briefs from 21 of New Jersey’s largest employers, including many Roche competitors, the HealthCare Institute of New Jersey, the New Jersey Chamber of Commerce, the American Medical Association, and eight scholars and professors of law.  When it comes to expert testimony, New Jersey unfortunately travels The Road Not Taken, applying a “relaxed” standard of expert testimony in toxic tort cases, as set forth in Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), rather than the more rigorous federal Daubert standard.  Under Rubanick, expert testimony may be admitted “even though it is controversial and its acceptance is not widespread,” only if “it is based on a sound methodology that draws on scientific studies reasonably relied on in the scientific community and has actually been used and applied by responsible experts or practitioners in the particular field.”  Id. at 447.  In Kemp v. State, 174 N.J. 412, 425-426 (2002), the court ruled that the inquiry was not based on reasonableness, but instead examines “whether comparable experts in the field [would] actually rely on that information.  Kemp, 174 N.J. at 426 (citations and quotations omitted).  Since Rubanick and Kemp, New Jersey courts have continued the state’s unique application of scientific expert testimony with an approach distinct from the more exacting federal standard, resulting in inconsistency, confusion, and the morass of the Accutane litigation.

As the Blog discussed, and the amici explained, the Accutane trial judge applied a standard similar to Daubert, but the Appellate Division reversed the decision based on Rubanick. In so doing, the appellate court essentially ignored the gold standard of scientific evidence, epidemiological studies all but one which failed to “demonstrate[] a statistically significant increased risk of developing Crohn’s disease.”  In re Accutane Litigation, 451 N.J. Super. 153, 168  (App. Div. July 28, 2017).  Nonetheless, the Appellate Division allowed the plaintiffs’ experts to rely on evidence that should have been excluded as unreliable, such as animal studies, anecdotal case reports, and analogous medicines – in other words, scientifically unsound data.  Id. at 165-166.  Similarly to the Fosamax decision, this represents not only bad law and bad precedent, but also has far-reaching implications.  Pharmaceutical manufacturers and health professionals resoundingly decried the Accutane decision as one that will stifle research and development, and the practice of medicine out of the uncertainty of scientific evidence, and fear of legal reprisals.  The amici implored the New Jersey Supreme Court to adopt Daubert’s methodology to reaffirm the trial court’s role as a gatekeeper to ensure that only reliable scientific evidence informs the jury’s decision.  Again, the industry can take heart in the court’s order granting review of the Appellate Division’s abysmal decision, and hope that the New Jersey Supreme Court will allow modern scientific principles, rather than the unreliable and questionable methods, to govern expert testimony.  If that occurs, no doubt will the New Jersey high court reinstate the trial court’s ruling, and order dismissal of the more than 2000 cases for lack of  causation evidence.