United States: The Peaks – The Ten Best Prescription Drug/Medical Device Decisions Of 2016

Last Updated: January 6 2017
Article by James Beck

Today we're going peak bagging – no, not to the Canadian Rockies or Patagonia (we leave that to Bexis) – for the high points in this year's drug/medical device product liability jurisprudence. Last week, we visited the abyss, naming our 2016 Bottom Ten. This week we go in the opposite direction, to the mountaintops. So join us for a Happy Old Year as we revisit the top ten best judicial decisions of 2016 (along with our customary ten additional honorable mentions) involving prescription drugs and medical devices.

One caveat, since we're limiting ourselves to cases involving drugs and medical devices, we've necessarily omitted some significant 2016 decisions that, while outside the blog's sweet spot, have significant positive implications for drugs and medical devices. So on the way to the ten peaks, give a fond wave to the Supreme Court's partial elimination of the presumption against preemption, the Third Circuit's extending Mensing/Bartlett preemption beyond generic drugs, the Second Circuit's rejection of general jurisdiction by consent, and New Jersey's rejection of bogus talc experts. Some of these cases may well have more overall impact on our clients' cases than what appears on our list.

Time to start climbing.

  1. Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944 (Ariz. 2016). All in all, it was a very good year for the learned intermediary rule. With new legislation in West Virginia, we completed our learned intermediary 50-state survey this year, now with positive authority from every state. Epitomizing the renaissance of the learned intermediary rule is Watts, in which the Arizona Supreme Court resoundingly adopted the rule, after decades of spurning plaintiff-side appeals from favorable intermediate appellate decisions. Reversing a plaintiff-side sneak attack that made our 2015 lousy list (2015-6), the Arizona high court agreed with the policy foundations for the rule, rejected attacks on the rule as "outdated," and adopted the Third Restatement version (Arizona tends to follow current ALI Restatements). Turning to the peculiar rationale the lower court had used to avoid the rule, Watts held that the learned intermediary rule and Arizona's joint tortfeasor contribution statute were fully compatible. Adding an exclamation point, the court definitively trashed, once and for all, an argument based on the Arizona constitution's "anti-abrogation" clause that the other side had trotted out for decades in support of any number of expansive liability theories. For leading the learned intermediary rule renaissance, Watts gets this year's number one designation. We blogged about the good news in Watts here and here.
  2. Glennen v. Allergan, Inc., 202 Cal. Rptr. 3d 68 (Cal. App. 2016). Good appellate decisions in California are not easy to come by. Glennen affirmed dismissal on PMA preemption grounds of one of these novel causes of action that seem endemic to both the Golden State and to PMA preemption cases. Glennen embraces the "narrow gap" formulation of express and implied preemption in PMA device cases. A claim for failure to train surgeons in the product's use fails on both counts. Vague FDA regulations that do not expressly address training are "open to a particular manufacturer's interpretation," so "allowing them to serve as a basis for a claim would lead to differing safety requirements." Further, these manufacturing practice regulations only apply to the manufacturing practice itself, and not to the training of surgeons. The FDA does not regulate the practice of medicine. Further, the claim is impliedly preempted because no California state duty exists that requires medical device manufacturers to offer physician training programs. In the absence of any recognized state duty, any training-related claim must be solely based on the FDCA – but the FDCA allows no private enforcement, leading to implied preemption under Buckman. We particularly like this type of Buckman preemption because it is simultaneously a rejection of the underlying state cause of action, which in Glennen diverges from a different Court of Appeal's prior bad ruling in Scott v. C.R. Bard (2014-7). Glennen finishes by reaffirming another useful proposition, that medical device manufacturers are not responsible for how doctors using their products choose to practice medicine. This favorable California appellate decision on our clients' strongest defense (where it exists) is number two on our list. We discussed Glennen here.
  3. Niedner v. Ortho-McNeil Pharmaceutical, Inc., 58 N.E.3d 1080 (Mass. App. 2016). Massachusetts can be another difficult jurisdiction for our clients, as both this year's (2016-7) and last year's (2015-1) bottom ten lists demonstrate. But nothing is impossible. In Niedner, the plaintiff made a frontal assault on innovative contraceptive technology with a "design defect" theory against a time-released contraceptive patch that alleged as an "alternative design" a different type of contraceptive product altogether (birth control pills). The court saw this claim for what it was – a backhanded attempt to hold the more convenient patch technology per se defective by alleging that only a different type of technology, with a different suite of risks and benefits, should have been sold. A different product, even though directed at the same general need, is not an alternative design. Bravo! The plaintiff's warning claim failed as well, because the warnings addressed the risk at issue "in no less than four places" and were thus adequate as a matter of law. As an appellate win that also strikes a blow for reproductive freedom, Niedner is our number three peak decision. We lauded Niedner here.
  4. D'Agostino v. EV3, Inc.,___ F.3d ___, 2016 WL 7422943 (1st Cir. Dec. 23, 2016). This late addition caused us to revise our list. We hate fraud on the FDA claims with a passion (Bexis thought up the preemption theory that became Buckman, and Buckman cites Bexis), so even though D'Agostino is a False Claims Act claim, rather than straight product liability, its outright rejection of a fraud on the FDA claim masquerading as an FCA action is our highest ranked federal decision of the year. The main claim was straight out of Buckman – that the defendant sought a narrow FDA approval for a device while intending to promote broader uses off-label. The allegedly defrauded party, the FDA, didn't make any reimbursement claims. Merely that the false intended use statements "could have" influenced FDA approval is not enough. The FDA knew all about these allegations for years and never instituted any enforcement action, therefore the claims flunked the "demanding" materiality standard for implied certification FCA claims. To allow fraud on the FDA claims despite Agency inaction "would be to turn the FCA into a tool with which a jury of six people could retroactively eliminate the value of FDA approval and effectively require that a product largely be withdrawn from the market even when the FDA itself sees no reason to do so." The court also discusses how this type of claim would create the same "practical effects" that supported preemption in Buckman. Here, without preemption (the FCA being a federal statute), the failure of the FDA to act on the purported fraud defeats causation as a matter of law. Fraud on the FDA claims are more properly the province of a government prosecution (FCA or otherwise) than lone-wolf private parties. As an extra, added bonus, the First Circuit also rejects: (1) a failure-to-train theory as inadequately pleaded on both the "false" and "claim" aspects of the FCA, (2) a manufacturing defect claim not tied to the submission of false claims, and (3) the proposition that design improvements render all prior designs of a device "defective" for purposes of establishing falsity. We delighted in D'Agostino here.
  5. Wagner v. Teva Pharmaceuticals USA, Inc., 840 F.3d 355 (7th Cir. 2016). Wagner was the best appellate decision on preemption in the federal system this year – although not as significant as several last year (2015+1 through 3). Wagner involved generic drug preemption, and its most significant contribution to preemption jurisprudence was as the first appellate precedential determination (something we knew all along) that nothing in the 2007 FDAAA did anything that changed the generic drug "sameness" requirement in any way that affected preemption. Wagner also recognized the comprehensive nature of generic preemption, because precluding warning, design, and stop selling claims is an extremely broad reach. Failure to update also failed. First, it wasn't pleaded, and even if it had been, it couldn't have been causal. Not bad for the same circuit the decided the awful Bausch case. We discussed Wagner here.
  6. In re Mirena IUD Products Liability Litigation, 169 F. Supp.3d 396 (S.D.N.Y. 2016). Things seem to run in cycles. While there were fewer major preemption wins this year than in the past, there were more Daubert victories. The Mirena whopper of an opinion (93 pages in F. Supp.) is the best Daubert decision of this bunch. Plaintiffs offered four general and specific causation experts, and all of them were excluded, for a litany of Daubert sins. One expert "reverse-engineered" his utterly untested theory "to fit the desired outcome." That wasn't reliable methodology. Another attempted to judge whether the product had "sharp edges" by feel. That didn't pass muster either, nor did his attempt to extrapolate from animal studies. Yet another expert speculated about an untested and unvalidated causal mechanism, relied solely on anecdotal case reports, ignored contrary literature, and had no non-litigation-related expertise. Guess what, she didn't make it earlier. The fourth opined only as to specific causation, but without any admissible general causation opinions he failed, too. Conversely, the plaintiffs barely scratched the seven defense medical experts with their Daubert motions, with all but one minor category of testimony (about "lawsuit-generated scientific misinformation") held admissible. The court also addressed regulatory experts, but with plaintiffs' causation case going down the tubes, that hardly mattered. We blogged about Mirena here, and about the MDL-wide summary judgment order that followed here.
  7. In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 174 F. Supp.3d 911 (D.S.C. 2016). Right behind the Mirena Daubert decision (only three weeks later) is the one in Lipitor. Once again, plaintiffs offered four causation experts; once again all four went down, in whole or in part. The "part" had to do with dosage. While there was scientific evidence for causation (diabetes) at the highest dose, there was none at the three lower dosage levels, which the vast majority of the plaintiffs in the MDL had taken. As to the three lower doses: (1) plaintiffs' epidemiologist had no epidemiology; (2) a second expert's only apparent methodology was cherry-picking anything that supported his a priori conclusions and ignoring the rest; (3) a third expert violated a court order requiring separate consideration of all four dose levels and offered a "methodology" that consisted solely of "reading articles" and picking those that supported her a priori conclusions; (4) the fourth and final expert copied the methodological failings of the third expert, and likewise failed to segregate his opinions by dose. As a result, the great majority of another MDL bites the dust. We rate Lipitor slightly below Mirena because of the remainder left behind. We discussed Lipitor here.
  8. Flagg v. Stryker Corp., 819 F.3d 132 (5th Cir. 2016) (en banc). En banc decisions by federal appellate courts are rare, and those relating to removal issues even rarer. Flagg decided a longstanding removal issue affecting literally hundreds of cases in Louisiana – whether the state-law requirement to present medical malpractice claims to a state review panel before suing meant that non-diverse Louisiana doctors joined as defendants in violation of state law were fraudulently joined and could not defeat diversity jurisdiction. A Fifth Circuit panel held, sua sponte, that joinder was not fraudulent and thus no jurisdiction existed, in a decision that garnered a dishonorable mention from us in 2015. By an 11-4 margin, the en banc court reversed, refusing to reward plaintiffs who deliberately violated state law. Joinder was illegal under state law, and since the propriety of removal is decided as of the date of removal, the possibility that a claim might later be found to exist didn't matter. Thus, jurisdiction exists, and hundreds of plaintiffs don't get a second bite at the apple in state court (remember, subject matter jurisdiction is non-waivable). We don't rank Flagg any higher because, while important, the issue is limited to (as far as we know) Louisiana. We raised Flagg here.
  9. Cerveny v. Aventis, Inc., 155 F. Supp.3d 1203 (D. Utah 2016). In the wake of last year's big win in Yates (2015+1), 2016 saw a steady stream of favorable implied preemption cases involving non-generic drugs (collected here). Cerveny is the most significant of that group, in that it adds some clarity to the Supreme Court's Levine (2009-1) "clear evidence" standard. In contrast to mostly "know it when I see it" decisionmaking, Cerveny draws a preemptive line whenever the FDA rejects scientific support for a purported product risk as insufficient. From that moment backwards, all warning claims regarding that risk are preempted, since the FDA's rejection is "clear evidence" that it would have also rejected a warning about that risk at any earlier point, since the quantum of evidence at all earlier times would necessarily be at least as deficient (if not even more paltry). Nor did it matter that the FDA's rejection came in the context of citizen's petition, since the scientific standards governing both are the same. Other risks that the plaintiff did not suffer were irrelevant because no change in the warning could have been causal. We celebrated Cerveny here.
  10. In re Accutane Litigation, 2016 WL 5958374 (New Jersey Super. Law. Div. Oct. 12, 2016) ("Accutane I"), and In re Accutane Litigation, 2016 WL 5958375 (New Jersey Super. Law. Div. Oct. 12, 2016) ("Accutane II"). Yes, they're state trial court orders, but between them they grant summary judgment on learned intermediary rule causation to an impressive 160 of 162 plaintiffs. Practically every permutation of learned intermediary warning causation is addressed. Accutane I held under the laws of 35 jurisdictions that warning causation under the learned intermediary rule necessarily fails where the death or disappearance of the actual prescriber precludes the affirmative testimony necessary to satisfy a plaintiff's burden of proof. The heeding presumption by itself was insufficient to establish a prima facie causation case. Accutane II finds causation lacking as to 74 plaintiffs in fifteen states where affirmative prescriber testimony established one or more of the following situations: (1) the prescriber already knew the risk; (2) the prescriber did not read the warnings at all; (3) the prescriber did not think risk was severe enough to matter; (4) the prescriber made an affirmative decision not to warn the particular patient; and (5) nothing the prescriber learned afterwards would have changed the prescription decision or the warnings given to the patient. We detailed the Accutane rulings here.

That's our top ten, but as usual our side's noteworthy wins in 2015 didn't stop with ten. Thus, we're acknowledging ten more favorable decisions this year that fell just short of climbing our ten peaks.

Here are our Honorable Mentions: (11) In re Bard IVC Filters Products Liability Litigation, ___ F.R.D. ___, 2016 WL 4943393 (D. Ariz. Sept. 16, 2016). Major discovery decision imposing "proportionality" limits to discovery even in MDLs, and calling out other opinions for subverting the new "relevance" scope of discovery. We applauded this shot across the judiciary's bow here. (12) De la Paz v. Bayer Healthcare LLC, 159 F. Supp.3d 1085 (N.D. Cal. 2016). De la Paz also came very close to making our top ten, due to detailed causation discussions about several oddball claims often asserted to avoid PMA preemption, but a leave to replead (never acted upon) dropped it to honorary mention status. We praised De la Paz here. (13) In re Zoloft (Sertraline hydrochloride) Products Liability Litigation, 176 F. Supp. 3d 483 (E.D. Pa. 2016). Daubert defeats an entire MDL, but since the most critical ruling was last year (2015+9), it's in our honorable mentions this time. We celebrated the demise of the Zoloft MDL here. (14) Brazil v. Janssen Research & Development LLC, ___ F. Supp.3d ___, 2016 WL 3748771 (N.D. Ga. July 11, 2016). A number of 2016 opinions preempted claims against innovator drugmakers under Mensing/Bartlett. Brazil is the best of them (except maybe for a case just decided this week). We discussed what went right, here. (15) In re Testosterone Replacement Therapy Products Liability Litigation, 164 F. Supp.3d 1040 (N.D. Ill. Feb. 18, 2016). The definitive take-down of the bogus concept of "pendent personal jurisdiction." We pumped the Testosterone decision here. (16) Hochendoner v. Genzyme Corp., 823 F.3d 724 (1st Cir. 2016). We don't like duty to supply claims involving shortages of non-defective drugs. Here the court found no standing because no particularized injury (except for one plaintiff) could be traced to the shortage. A nice appellate win, but on an esoteric issue. We hailed Hochendoner here. (17) Carista v. Valuck, ___ P.3d ___, 2016 WL 6237855 (Okla. App. Oct. 20, 2016). Another somewhat esoteric appellate decision – applying the learned intermediary rule to pharmacies. We prescribed Carista here. (18) In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 3281032 (N.D. Ill. June 10, 2016). It's rare to get Lone Pine order in a drug/device product liability MDL, so savor this one. We did, here. (19) Aaron v. Medtronic, Inc., ___ F. Supp.3d ___, 2016 WL 5242957 (W.D. Ohio Sept. 22, 2016). Another favorable and comprehensive PMA preemption dismissal, this time involving off-label promotion issues. We (the non-RS side, that is) added Aaron here. (20) DeBons v. Globus Medical, Inc., ___ F. Appx. ___, 2016 WL 4363171 (9th Cir. Aug. 16, 2016). Had DeBons been published, it probably cracks our top ten. DeBons explains why prescription medical products can't be subjected to the class action mania that has engulfed the food industry in California, which is important. We detailed DeBons, here.

Looking over our 2015 lists, we're already mentioned the Arizona Supreme Court's reversal in Watts (2015-6) and the favorable subsequent proceedings in the Zoloft (2015+9) MDL. In Amarin (2015+6), the FDA raised the white flag and settled. On the minus side, certiorari was denied in Reckis (2015-1), and it looks like Drake (2015-9) settled, since the appeal we mentioned last year was dismissed.

The best news on older cases, however, was the demise of another bottom-ten number one, State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007) (2007-1), this time at the hands of a West Virginia statute explicitly restoring the learned intermediary rule. This is our tenth year preparing top/bottom 10 lists, and of our previous worst of the worst, the bad boys from 2014 (Weeks, by statute), 2012 (Bartlett, reversed), 2010 (Wimbush, limited to its facts by Yates (2015+1), and now 2007 have all been overturned. That's a 40% reversal rate on the biggest stinkers out there – not bad at all, while not losing any of our own. We hope by next year, we'll be up to half, by adding 2008 (Conte) to our scalp collection, but it being California, anything can happen.

Going forward, the California Supreme Court's Bristol-Myers-Squibb atrocity (2016-1) is being appealed to the United States Supreme Court. Here's hoping.... We've already mentioned T.H. v. Novartis (2016-5) pending in the California Supreme Court (see prior paragraph). The Pinnacle Hip (2016-6) rulings will eventually be appealed, but not quite yet. Perhaps some others will be appealed as well, but we have no solid information.

Finally, on the administrative front, as we predicted, the FDA's proposal to change the rules to eliminate generic drug preemption is effectively dead, given the election results (and even before that). The FDA's proposal (discussed here) to amend the "intended use" regulations is still hanging fire, with First Amendment-related comments that the Agency will have to address. The FDA also has off-label promotion on its plate after last month's two-day conference. We're not holding our breath, but politically things could be much different in the coming year (and not just with the FDA). Maybe we get to play a little offense on legislative matters, for once.

We thus close our books on 2016 – barring some last minute development. To all our readers – particularly those on the right side of the "v.", we wish a happy and productive New Year.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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