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list (2015-6), the Arizona high court agreed with the policy foundations for the rule, rejected attacks on the rule as “outdated,” and adopted the Third Restatement version (Arizona tends to follow current ALI Restatements).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.

The “pits of hell,” “black as a pit,” a “bad feeling in the pit of my stomach” – that’s how we feel about 2016’s bottom ten decisions of the year arising from prescription medical product liability litigation. This year’s collection of coal in our collective stockings is as justifiable a cause for seasonal affective disorder as almost anything we can think of, since we do not discuss politics on the blog.

So here we go. Don’t shoot us, we’re only digital piano players.  If any of these cases is yours, we sympathize.  We’ve been there (see 2013 -2), and we know how it feels.  We can’t wait for next week we get to toast in the New Years with the best, instead of drowning our sorrows with the worst.

Continue Reading The Pits – The Worst Prescription Drug/Medical Device Decisions Of 2016

The iconic Hunger Games line, “may the odds be ever in your favor” pretty much sums up how we feel about our top ten best decisions of 2015.  These are results that put the “happy” in Happy New Year – which we wish all our readers as the year in question draws to its inevitable close.

So, with cannons sounding for the plaintiffs involved, we give to you our picks for the ten best judicial decisions of 2015 (along with our customary ten additional honorable mentions) involving prescription drugs and medical devices.

  1. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., ___ F.3d ___, 2015 WL 8538119 (6th Cir. Dec. 11, 2015).  This year’s number-one arrived relatively late, but it was definitely worth the wait. When we first read Bartlett (2013 +1), we were struck by the Court going out of its way to state expressly that the FDA-pre-approval requirement for design changes applied to all prescription drugs.  That reference to “branded or generic” had to have a purpose.  Yates is the first court of appeals expressly applying the logic that all design changes requiring prior FDA review are preempted.  Post-approval, the FDA must review all “major” or “moderate” changes to drug design, rendering simultaneous compliance with an immediate state-law duty to use a different design impossible.  A “pre-approval” design defect claim (that the defendant should have submitted a different design to the FDA in the first instance, was speculative and would have required FDA approval of the different design in any case.  This “never-start selling” claim was also preempted because it was the same as the “stop-selling” claim rejected in Bartlett.  States cannot preclude the sale of what the FDA approved.  The bad Wimbush case (2008 -1) – from the same court of appeals (indeed, both originating in N.D. Ohio) – is limited to its facts (a drug already removed from the market), and doesn’t prevent preemption of design defect claims where the FDA continues to approve the product.  Application of a good No. 1 decision to confine a bad No. 1 decision is indicative of another good No. 1 decision.  Beyond that, Yates-based preemption would erase the non-generic stop-selling claim allowed in Pennsylvania in Lance (2014 -2).  Yates suggests that design defect claims against branded prescription drugs (and eventually §510k devices) are on their way out.  We wasted no time yacking about Yates here.
  2. Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).  Over the last couple of years, there have been a lot of good trial court decisions on off-label promotion and preemption (most, but not all, involving Infuse).  None of those decisions was better than Caplinger (2013 +9).  Because it was so good (a complete dismissal), Caplinger could be appealed.  This year it was affirmed, and the affirmance was just as good.  Off-label use does not provide plaintiffs with a get-out-of-preemption-free card.  If Congress had wanted to exempt off-label use (which it knew about, see 21 U.S.C. §396), from preemption, it would have done so expressly.  Claims that would require changes to labels or design are “different from or in addition to” what the FDA approved and are preempted.  Challenges to the legality of purported off-label promotion are purely matters of federal law and thus aren’t equivalent to any recognized state-law claim.  Indeed, to the extent plaintiffs identified any federal regulations at all, their claims “substantially exceed[ed]” them.  Adulteration/misbranding are FDCA, not state-law, violations.  If Congress wishes to set a different balance, it can, but until it does, all the plaintiffs’ litany of claims about off-label use/promotion of a PMA medical device are preempted.  The fact that plaintiffs have sought Supreme Court review in Caplinger (#15-321) only underscores its significance as a preemption milestone.  We celebrated Caplinger here and here.  Full disclosure:  Reed Smith is involved in Caplinger, so consider this entry a non-RS post.
  3. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015).  Where it exists, federal preemption is the strongest defense our clients have.  So it shouldn’t be much of a surprise that our top three decisions are all appellate courts recognizing that FDCA-related preemption extends to new areas.  Celexa was the first appellate decision recognizing that Mensing (2011 +1) impossibility preemption cannot be limited to generic drugs.  Celexa was brought by some rather self-important plaintiffs seeking, under state law, to enjoin the sale of an FDA-approved drug because the efficacy data on which approval was based was allegedly wrong.  That presented a problem – the efficacy data at issue had already been reviewed by the FDA, and plaintiffs offered nothing new.  Since the rationale Levine (2009 -1) employed against preemption was that innovator manufacturers were free to change their labels based on “new” information (the changes being effected (“CBE”) exception), a label-related claim that fell outside the scope of the CBE exception, here, that involved only “old” information, was preempted.  While this type of informational claim isn’t all that common, the principle that Celexa established – that Mensing’s implied preemption logic extended beyond generic drugs – is critical.  We pointed out the broader implications of Celexa here.
  4. David v. Medtronic, Inc., 188 Cal. Rptr.3d 103 (Cal. App. 2015).  CAFA provides that actions including more than 100 plaintiffs are removable to federal court as “mass actions.”  Predictably, the other side started filing complaints with dozens (but never 100) of blatantly misjoined plaintiffs from all over the country with nothing in common except suing over the same drug/device.  There would always be a couple of plaintiffs from the forum state, and a couple of plaintiffs from the defendant’s home state to destroy diversity as another ground for removal.  This gamesmanship has been particularly widespread in California. The David decision goes a long way to putting a stop to this in the nation’s largest and most litigious state by affirming severance of all the out-of-state plaintiffs on the basis of forum non conveniens, since the defendant wasn’t based in California either.  There were Bauman personal jurisdictional problems with the case, and the court recognized that the “same transaction” standard for joinder wasn’t met by anybody anywhere in the country claiming the same injuries from the same product.  The medical treatments were different, and so were the doctors, hospitals, and the informational and temporal context in which each individual case arose.  The non-California claims could be brought in those plaintiffs’ home states, so litigation tourists go away and stop clogging our courts. Peripheral claims against nominal defendants don’t count against forum non conveniens, and if plaintiffs chose, they could continue with those peripheral claims in California.  We harmonized with David’s beautiful music here, and put the decision in perspective here.  Full disclosure:  David is a Reed Smith case, so this entry is also non-RS.
  5. Sergeants Benevolent Ass’n Health & Welfare Fund v. Sanofi-Aventis United States LLP, 806 F.3d 71 (2d Cir. 2015).  We admit we were a bit depressed after the Third Circuit went south in the Avandia decision (2015 -3).  Then along came the Second Circuit to cheer us up again.  Like Avandia, SBA was a third-party payer RICO case; unlike Avandia court of appeals shut the SBA plaintiffs down.  The allegations had a Buckman-like tinge – that a questionable clinical study supported FDA approval, and then the defendants promoted off-label.  Because RICO is a federal statute, however, preemption isn’t a defense.  But causation is.  SBA rejected the doctors-don’t-matter refrain from Avandia.  To the contrary, prescribing physicians are central where prescription medical products are concerned.  “Generalized proof of causation was impossible because of the intervening actions of prescribing physicians.”  The varying effects of differing misrepresentations on independent decision makers make causation impossible to prove on anything but an individualized basis.  Against an FDA-approved drug, plaintiffs could not claim that “nobody” would have used it had the purported “true” risks been know.  That is “stop selling” by another name.  Nor could plaintiffs avoid the learned intermediaries’ role with “simplistic” statistical analysis.  Plaintiffs could not get to a class action by dumbing down the elements of their substantive claims.  Thus some inordinately long-running litigation (more than seven years) finally came to an end.  We bid SBA adieu here.
  6. Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015). Holy cow.  Bye-bye baby.  Outta here! When we (well, Bexis) started advocating the First Amendment as a defense in the off-label promotion context twenty years ago, there wasn’t much traction.  Bone Screw cases turned out to be much easier to win on other grounds. Fast forward two decades − past WLF, Pearson, Western States, Sorrell (2011 +5), and Caronia (2012 +7) − and things sure have changed.  At least in the Second Circuit, thanks to Caronia, truthful off-label promotion is First Amendment-protected speech, which the FDA (and, by extension, private plaintiffs) cannot prosecute.  Amarin was the first case in which the regulated manufacturer went head-to-head with the FDA, stuck it out, and won in court.  The plaintiff company’s science wasn’t what the FDA considered “substantial evidence,” but it was valid science.  What the plaintiff company wanted to tell potential prescribing physicians was truthful, properly disclaimed, and thus not “false or misleading” even though it concerned off-label use.  The FDA doesn’t want to appeal.  We went yard over Amarin here and here.
  7. Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 135 S. Ct. 1378 (2015).  It’s from the Supreme Court and it involves prescription drugs, but it’s not directly applicable to product liability. It is relevant to, and reinforces, first, the Buckman preemption rationale against private enforcement of statutes like the FDCA where private enforcement is not allowed; and, second, why alleged violations of vague regulations cannot escape preemption.  Armstrong involved a Medicare statute, not the FDCA, but the reasoning is the same – indeed Buckman is a fortiori because the FDCA’s prohibition against private enforcement is express, whereas that in Armstrong was only “implied.” The implication came from the statute’s provision of a single remedy for violations, one conferring no rights to individuals.  No private enforcement was allowed because “express provision of one method” of enforcement “suggests that Congress intended to preclude others.”  On the second point, the Medicaid statute’s requirements were vague, and thus “judicially unadministrable,” providing a second basis for Congress wanting the remedy that it provided to be exclusive. The same reasoning should preempt the holdings of a number of courts allowing “parallel” claims purporting to enforce vague FDA manufacturing-related regulations.  We discussed the implications of Armstrong here.
  8. State ex rel. J.C. v. Mazzone, 772 S.E.2d 336 (W. Va. 2015).  Just as in California (see Martin, above), forum-shopping litigation tourists took it on the chin in West Virginia.  Instead of Bauman, however, this case was decided solely on old fashioned forum non conveniens grounds.  It was the same game playing, though – dozens of out-of-state plaintiffs misjoined in the same complaint.  Because neither the plaintiffs nor the defendant was from West Virginia, and plaintiffs could all sue in their states of residence, West Virginia was an inconvenient forum.  The ordinarily “great deference” given to a plaintiff’s choice of forum is diminished where a nonresident sues over matters not arising in the state.  The defendant’s difficulty in obtaining discovery from fact witnesses in plaintiffs’ home states worked sufficient “injustice” to support the forum non conveniens finding.  All of the considerations discussed by the court would be the same in any litigation tourist case against an out-of-state corporation, thus Mazzone, if followed by the trial courts of West Virginia, effectively ends multi-plaintiff, out-of-state, CAFA avoiding complaints in this state.  We explained the significance of Mazzone here.
  9. In re Zoloft (Sertraline Hydrocloride) Products Liability Litigation, 2015 WL 7776911 (E.D. Pa. Dec. 2, 2015).  The best Daubert decision of 2015 was either this one or a similar decision (both excluding the same expert) in the Lipitor MDL.  We chose this one because Zoloft involved a higher degree of Daubert difficulty, since there actually were some (older, smaller, and otherwise less persuasive) studies that reached adverse, statistically significant results. The plaintiffs, and their result-oriented statistical expert, were ultimately done in by more recent, more powerful studies that refuted the supposed connection between cardiac birth defects and Zoloft that plaintiffs’ expert tried very hard to invent.  This was a do-over – plaintiffs had their first batch of experts all excluded under Daubert − so this guy was their last chance, and they knew it.  Everything was heavily litigated, and, the lengthy opinion thoroughly addressed Daubert issues like a priori reasoning, statistical significance and p-values, cherry-picking, after-the-fact statistical manipulations, confounding, and re-analysis of published data.  Daubert is the second strongest MDL defense strategy (after preemption) and as the year draws to a close, the result here means that all the cases in the Zoloft MDL are likely subject to summary judgment.  We analyzed Zoloft here, after complaining about the do-over here.
  10. In re Incretin-Based Therapies Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 6912689 (S.D. Cal. Nov. 9, 2015).  The Levine (2009 -1) clear evidence test for implied preemption in prescription drug cases can be met – that’s the lesson of Incretin.  It’s tough, but it can be done, and successful preemption can shut down an entire MDL.  Plaintiffs claimed that the drug caused a disease (pancreatic cancer).  Trouble is, the FDA decided time and time again that any causal link was “indeterminate” and shouldn’t appear on the drug’s label.  Plaintiffs’ experts could manipulate the data (such as notoriously inaccurate – the court acknowledged this – adverse event reports) all they wanted, but the fact remained that the FDA had looked at everything and said “no.”  Hence, preemption existed under Levine’s “would have rejected” standard, which the court refused to make worse than the Supreme Court already had.  The court recognized that, when the FDA calls for data from all manufacturers of a class of drugs, it has more evidence at its fingertips than any one of the competing manufacturers, which was unlike Levine.  Nor is it necessary that the FDA definitively rule out causation; a conclusion that causation hasn’t been shown to the FDA’s regulatory standards is enough.  Finally, plaintiffs cannot avoid preemption by arguing fraud on the FDA.  That’s preempted, too, and plaintiffs can’t second-guess the FDA’s administrative process. What the FDA considers, or not, is within the discretion of the Agency.  A final plus factor in Incretin was that both federal and state judges had heard argument of the motion, and the state judge agreed.  We announced that Christmas had come early in Incretin-land here and mentioned the state-court’s concurrence 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 cracking our top ten.

Continue Reading “May the Odds Be Ever in Your Favor” – The Ten Best Prescription Drug/Medical Device Decisions of 2015

In the original Hunger Games movie, while Katniss and Rue are plotting to blow up the Careers’ food stash, Katniss remarks that “destroying things is much easier than making them.”  That’s how we feel about our bottom ten worst prescription drug and medical device decisions of 2015.  It’s so much easier to destroy life-saving and health-enhancing prescription medical products through litigation than to create them.  New prescription medical products have added much of the decade-plus increase in life expectancy since 1950 (from 68.2 to almost 79 years in 2013).  But the United States still trails dozens of countries that don’t tolerate the kind of litigation that we allow here – despite spending more than anyone on healthcare.  Is it mere coincidence?  We can’t say, but we doubt that litigation ever increases life expectancy.

It’s easier to denigrate products than to create them, as the cases that follow demonstrate. Hold your collective noses because here we go again.  What follows is our annual list of the ten worst court decisions of the year (2015) arising from prescription medical product liability litigation – often with reasoning worthy of tracker jacker venom.  These blood-pressure-raising decisions did nothing for our life expectancy, and even less to encourage development of new products that could help others.  We can’t justify these rulings, except to say that sometimes the rats win the rat race, and the goose that laid the golden egg gets cooked.  Before we dampen holiday spirits too much, remember that next week we get to celebrate the best, instead of bemoaning the worst.

But for now, let the bemoaning begin:

  1. Reckis v. Johnson & Johnson, 28 N.E.3d 445 (Mass. 2015).  The worst thing about this case isn’t that it affirms a $63 million (over $100 million with interest) verdict, so you know it’s pretty bad.  It’s another SJS/TENS case in which the horrific nature of the injuries all too often overcomes a jury’s common sense.  For this reason, such cases should engender heightened judicial scrutiny, but in Reckis the opposite happened.  Doing the most potential damage, long term, was the court’s ruling on preemption, an issue that has now been appealed to the Supreme Court.  The court converted the Levine (2009 -1) “clear evidence” test from what the Supreme Court said – “that the FDA would have” rejected a warning change − to an unprecedented “FDA actually did reject” the change when proposed by the defendant standard.  To do so, Reckis presumed that the FDA would violate its statutory mandate, and be more likely to approve a label change submitted by a manufacturer (the defendant) than the same label change submitted via citizen’s petition, although the substantive standards are completely identical.  The court offered no support for this total speculation. The actual Levine standard is bad enough; this one is essentially impossible to meet and only if the defendant ignores the regulatory scheme.  That’s not all.  The court allowed causation based solely on the testimony of a witness-for-hire pharmacologist who had never treated an SJS/TENS patient.  Since nobody knows what causes SJS/TENS, and plaintiffs have laid the condition at the doorstep of literally dozens of drugs in litigation, the court allowed an unqualified and inexperienced witness to offer a novel causation opinion where numerous, real physicians who had actually treated this condition were unwilling to tread.  Oh, and it appears to be the largest PI verdict ever allowed on appeal in Massachusetts history.  We lambasted Reckis here and then discussed the defense cert. petition to the Supreme Court here.
  2. Boston Scientific Medizintechnik GmbH v. AOK Sachsen-Anhalt – Die Gesundheitskasse, 613CJ0503 (CJEU 4th Ch. March 5, 2015).  This is the first time that any decision from outside the United States has ever appeared on our year-end best/worst lists. This dangerous medical device decision by the equivalent of the supreme court of Europe fully warrants the exception.  From now on, anybody recalling a product (the case goes beyond medical devices) in Europe must be very careful in wording the recall notice or else will run the risk of large damages for every device of the type involved.  Plaintiffs (here, third-party payers) no longer have to prove that the particular device alleged to cause injury even had the defect that prompted the recall.  Throughout the European Union, under its consumer expectation standard a maker of a product having life-threatening risks essentially becomes an insurer.  “In view of the life-threatening risk presented by a defective device, the patient may, in principle, reasonably expect the implanted device to have a failure rate of close to zero.”  Got that?  Zero.  Furthermore, actual warnings don’t defeat this deemed “expectation.”  And we thought communism was dead in Europe.  We brought our readers the bad news from across the Pond here.
  3. State v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 777 S.E.2d 176 (S.C. 2015).  Just about every place else – Pennsylvania, Louisiana, Arkansas, Alabama, West Virginia − where state attorney generals (or more likely no-bid, contingent fee lawyers purporting to exercise state power on their behalf) have sought (and sometimes obtained) huge verdicts through endless multiplication of statutory penalties, state appellate courts have stepped in to restore sanity.  Not so in South Carolina.  As we lamented here, after the South Carolina Supreme Court got through with the aptly sounding acronym SCUTPA, the defendant was left holding an absurdly inflated $124 million verdict, simply because the FDA ordered a correction of a Dear Healthcare Provider (“DHCP”) letter.  Between sample packs, letters, and visits (details mostly irrelevant), the various penalties were multiplied to reach nine figures.  All this without any showing of actual deception or actual injury (because the state need not prove this, only a vague “tendency to deceive”).  On the merits, the worst mistake the court made was ignoring the statutory safe harbor for “[a]ctions or transactions” such as FDA-approved labeling and DHCP letters “permitted under laws administered by any regulatory body.”  That’s how the state legislature chose to frame its statute.  That such labeling might be a “floor” for preemption purposes, as the court stated, was totally irrelevant because preemption was not an issue. The legislature chose not to punish FDA-regulated activity, but the court nullified that legislative decision, with practically no discussion.
  4. In re Avandia Marketing, Sales Practices & Product Liability Litigation, 804 F.3d 633 (3d Cir. 2015).  Until this decision, we thought the Third Circuit was one of the better places to litigate third-party payer economic loss cases.  Such cases invariably invoke statutes, here RICO, intended for much different purposes.  In all prior Third Circuit decisions of this type, the patient-specific decisions of independent professional physicians had precluded resort to aggregated statistical proof of injury and causation.  Not this time, and thus the sale and use of prescription drugs became subject to a “racketeering” statute.  Nobody claimed the drug didn’t work.  Nobody claimed any injury from the drug.  The “injury” is entirely made up – that the drug wasn’t intrinsically “worth” as much as it would have been had all the statements (which didn’t hurt anyone) been “true.”  For taking safety, effectiveness, and concrete injury out of the RICO equation, after years of getting this right, the Third Circuit’s Avandia decision nails down the #3 spot on our bottom ten.  We let Avandia have it here.
  5. Guvenoz v. Target Corp., 30 N.E.3d 404 (Ill. App. 2015).  The worst generic drug preemption decision of the year – and it isn’t close – is Guvenoz.  The court tortured two Supreme Court decisions that, between them, had held preempted practically all product liability claims involving generic drugs, and managed reached the opposite conclusion that no claims at all were preempted.  Negligence, strict liability, misrepresentation, fraud, and consumer fraud all survive.  The opinion is blatantly, unapologetically result oriented.  The court couldn’t accept that the very purpose of preemption is to bar state-law claims without regard to their state-law merit. The court allowed to proceed the same stop selling argument that Bartlett held preempted.  In the guise of preventing a “safe harbor,” the court put entirely at sea the last five years of preemption involving generic drugs.  Guvenoz is overall the worst reasoned appellate decision we read in 2015.  We took on this monstrous decision, here.
  6. Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz. App. 2015).  The learned intermediary rule (or “doctrine,” as preferred by some of us) is one of the most universally adopted tort principles there is.  Our 50-state survey of that rule reflects a margin of fully 51 jurisdictions (35 high courts) in favor to only one against.  At least that was the margin until Watts. Ignoring literally (see the survey) a half-dozen prior decisions of the same court, the opinion ousted the rule on a ground that was, frankly, bizarre – that the rule conflicted with the uniform law governing joint tortfeasors.  That law has been around for quite a while, and been adopted by dozens of states, and no court had ever found such a conflict before.  Watts added some rhetoric about DTC advertising, even though there was no such advertising of the product at issue.  The decision is another example of the law being tortured to reach some pre-ordained, pro-plaintiff result.  Fortunately, the Arizona Supreme Court has granted an appeal (pending; Bexis filed a PLAC amicus brief supporting the learned intermediary rule), so this decision is not the final word.  We addressed Watts here, and critiqued its low-wattage reasoning in more detail here.
  7. Mullins v. Ethicon, Inc., ___ F. Supp.3d ___, 2015 WL 4635573 (S.D.W. Va. Aug. 4, 2015). In Mullins, a jaw-dropping consolidated trial order (37 plaintiffs) required the most overreaching Erie prediction of the year to afford consolidation even fig-leaf plausibility.  We’ve followed tort-related consolidations, and putting that many plaintiffs together for trial just isn’t done anymore, and hasn’t been since the beginning of the century when courts cracked down on the practice in asbestos litigation.  Only “design defect” is consolidated, meaning different juries for different issues, sort of a poor man’s Rule 23(c)(4) issue class trial with all the drawbacks and none of the procedural safeguards.  As to design defect, to have even the illusion of commonality for consolidation required, in addition, the rejection of Restatement §402A, comment k as the law of West Virginia.  As we discussed here at length, states apply comment k either across the board – in which case there are no design defect cases at all – or on a “case by case” basis.  But the states do apply comment k.  Of all the states, only Alaska (1992), Nevada (1994), and Wisconsin (1984), among those allowing strict liability, ever rejected comment k.  No state had rejected comment k in over twenty years. Two prior West Virginia federal cases (one affirmed memorandum by the Fourth Circuit) predicted that the state would follow the majority rule.  Comment k has been followed by precedent in 42 other states (and DC).  But under comment k, the alternatives are no design defect at all or case by case.  Consolidation plainly could not work with 37 case-by-case adjudications, so comment k, all prior West Virginia precedent, and the principle that federal courts are not supposed to predict novel expansions of state law all went out the window.  We – the non-RS side of the blog, that is − shook our heads at Mullins here.
  8. Briggs v. Merck Sharp & Dohme, 796 F.3d 1038 (9th Cir. 2015).  After CAFA imposed a 100-plaintiff cut off for “mass actions” removable as of right to federal court, plaintiffs began filing 90+ (but never 100) plaintiff grossly misjoined complaints all over the country, but particularly in California.  Last year, it appeared that the en banc Ninth Circuit had put the brakes on this plaintiff-side monkeying with the rules with the Corber (2014 +4) decision.  Not so fast.  That court has so many judges that it often exhibits schizophrenic tendencies.  Corber was less than a year old when this case was decided, distinguishing it on very weak grounds (there’s only one kind of consolidation in California – it doesn’t matter how plaintiffs couch their requests). We groaned about the renewal of misjoinder-based gamesmanship in Briggs here.  However, as you’ll read next week, it appears that the California state courts have had enough of such tricks, as well.
  9. Drake v. Allergan, Inc., ___ F. Supp.3d ___, 2015 WL 2452947 (D. Vt. May 22, 2015).  Very little favorable drug/device law has come out of Vermont.  Vermont was Levine’s (2009 -1) state of origin, and almost everything else has been by federal courts further mangling the law.  Drake is a particularly bad example of this.  A torrent of “evidence” that most other courts reject – “totality of circumstances” expert opinion, fraud on the FDA claims, promotion never seen by the prescriber, ghostwriting − led to a $6.7 million verdict, including $4 million in punitives.  Causation was entirely speculative, since the prescriber testified he relied on his own experience, not anything said by the manufacturer. Maybe he relied “unconsciously,” guessed the court.  That would require a jury to find that company promotion could overcome a doctor’s experience and training without the doctor ever knowing about it.  The punitive damages award was almost uniquely unsupported, since there was no evidence of any degree of increased risk (the Vermont standard for punitives is “known, substantial, and intolerable”), only that the drug, having been used off-label, was “not proven to be safe and effective” for that use.  It’s almost enough to make us give up Ben & Jerry’s.  We sifted through this dreck here, and criticized the result again here.  There’s still hope, though.  An appeal is pending.
  10. Krueger v. Wyeth, Inc., ___ F.R.D. ___, 2015 WL 5839197 (S.D. Cal. Oct. 7, 2015).  In a result worthy of a Nightmare on Elm Street, this case actually certified a class action against the manufacturer of an FDA-approved prescription drug.  That doesn’t happen often, and shouldn’t have happened here.  Perhaps predictably, it’s from California.  This hormone therapy case has been kicking around since 2002, with class certification denied in the Prempro MDL (most MDL judges get things right most of the time) − talk about the possible abuse of class action tolling should this puppy ever get the reversal it deserves.  Unfortunately, that MDL failure discouraged neither the plaintiffs nor the remand court.  Everybody who ever purchased the product gets to be in the class, despite eight years of differing representations about the product.  The judge, sua sponte, removed even the barest requirement of “exposure” to the alleged promotion.  Membership may be established by a self-serving plaintiff affidavit, not to be submitted until after the class trial.  Jeez!  Ascertainability alone should have been more than enough to shoot down this lead-balloon of a class action.  Defendants face the likelihood of a trial against a class of unknown persons.  And it’s all for naught; nobody was injured. Amazingly, over a decade has been wasted, with much more apparently to come, on a class of plaintiffs defined as those experiencing no complications at all.  We engaged in some California screaming about this case here.

As for near misses, PLIVA, Inc. v. Dement, ___ S.E.2d ___, 2015 WL 7431346 (Ga. App. Nov. 20, 2015) (discussed here), might have made the list due to its demented rulings on failure to warn, “stop selling,” and publisher liability, but it was partially redeemed by a good result on innovator liability.  We also considered Gurley v. Janssen Pharmaceuticals, Inc., 113 A.3d 283 (Pa. Super. 2015) (discussed here), but the major (preemption) issues are a reprise of the earlier Maya case that received a dishonorable mention in 2014.  Flagg v. Stryker Corp., 801 F.3d 456 (5th Cir. 2015) (discussed here), was another possibility, except it was: (1) Louisiana specific, and (2) vacated last month when rehearing en banc was granted.  See Flagg v. Stryker Corp., 805 F.3d 610 (5th Cir. 2015).

That’s it; time for a good, long shower.  We’re done with our annual unpleasant task of cataloguing our side’s biggest black marks of the year.  If any of them are yours, we apologize for resurrecting bad memories.  We understand. In today’s environment, not losing tough cases means not having tough cases.  Anyone good enough to be entrusted with the defense of big cases runs the risk of showing up on this list someday.

In any event, it’s over, now, and we’re ready to move on. Next week you (and we) get the fun stuff:  when the odds are in our favor − the ten best drug/device decisions of 2015.

We at the DDLaw blog wish all our readers a Happy New Year as 2014 recedes inexorably into our rear-view mirror.  We hope that your 2014 was pleasant and (if you’re on our side of the “v.”) prosperous. We’re celebrating the new year in our usual style, with our annual top ten best prescription medical product liability litigation decisions of 2014.  Some people don’t need an excuse to throw a party.  We have many excuses here, and we’re going to tell you about a lot of them in this post.

So, to the envelopes please – we present to you our picks for the ten best judicial decisions of 2014 (and ten more honorable mentions) involving drugs, medical devices, and (if there were any) vaccines.  We do limit ourselves to drug/device litigation, as well FDA-related cases raising similar issues.  That’s why you won’t find on our list the Supreme Court’s personal jurisdiction decision in Daimler AG v. Bauman, ___ U.S. ___, 134 S. Ct. 746 (2014), even though it might end up having greater beneficial impact on drug/device mass torts than any decision we list below.  Cars are simply too far afield, so even for a United States Supreme Court decision, we won’t dilute the drug/device nature of our list that much.

Continue Reading Thumbs Up – The Ten Best Prescription Drug/Medical Device Decisions of 2014

We’re doing our duty.  We don’t have to like it.  The subject of today’s post is distasteful, but necessary.  Here is our annual compilation of the ten worst court decisions of the year (2014) that occurred in prescription drugs and medical device products liability litigation.  These are decisions that left us shaking our heads at the colossal injustice of what all-to-often passes for civil justice in this sometimes crazy country of ours.  Occasionally, the barbarians are a lot closer than at the gates.  If this is memory lane, there may be something to be said for amnesia. But take heart, next week for we’ll be in a more festive mood with our favorites.

So, now for a few words from the Grinch:

1. Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813 (Ala. Aug. 15, 2014).  So how does the same case make the bottom ten (also 2013 #-5) two years running?  By issuing a lousy opinion on a critical issue, then reconsidering (because – amazingly – the first opinion was issued without oral argument) and then doubling down on the same, ill-considered position.  In Weeks Alabama became the only state high court to recognize innovator liability (which we also call “Conte”), meaning that where the innovator didn’t even sell the product, received no economic benefit from the generic prescription the plaintiff took, and indeed may well have been driven out of the market by generic competition, it’s still liable if the generic labeling (and thus its own) is “defective.”  Being liable for purported defects in a competing product means, of course, that the costs of such liability can only be recouped by charging ones own customers more for other, non-defective products, but there are more plaintiff lawyers than innovator drug companies in Alabama.  This sort of liability, being open-ended and completely uninsurable, is the most thoroughly destructive, and irresponsible theory we’ve encountered since we started this blog, and that’s saying a lot.  Alabama getaway indeed.  For all these reasons Weeks richly deserves its designation as our #1 worst case of the year.  We (the non-Dechert side) chastised the decision here, but that was only a reprise of our original 2013 critique, here – all of which remains valid.

2. Lance v. Wyeth, 85 A.3d 434 (Pa. 2014).  Poor Wyeth, having the two worst decisions of 2014 inflicted on it.  The year wasn’t very old when Pennsylvania Supreme Court decided that it didn’t need strict liability to impose essentially the same thing under negligence.  After taking close to three years to decide this fen-phen case, the theory the court settled on was a real stinker.  Would you believe negligent design – with no alternative design requirement?  In so doing it all but adopted Restatement Third §6(c) in a prescription drug case, which is also unique for a state high court. We don’t know of any other decision, in Pennsylvania or elsewhere in the country, that does away with the alternative design requirement in a negligence case.  To add insult to injury, the court had the chutzpah to claim that this unique, novel result was really just an extant, but utterly unrecognized, part of negligence “duty” all along.  What really happened was the creation out of whole cloth of “negligence” liability that amounts to a failure to recall claim – that the product was “too harmful to be used by anyone,” and thus should not be marketed, notwithstanding FDA approval. Maybe the theory is limited to already-withdrawn products (footnote 33 suggests that it might), but maybe not. If not, we think that, eventually, the theory will fall to Bartlett (2013 #+1) preemption (Bartlett was decided just before Lance was decided and was not briefed to the court), for prescription medical products (but not others).  All this is bad enough, but there’s also disruptive dicta in Lance questioning (musing about, is more like it) the “underpinnings” of the learned intermediary rule.  So we’ll be dealing with that, too, for the foreseeable future.  Under the rubric “if this is negligence, who needs strict liability,” we (the non-Dechert side) lacerated Lance here.

3. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 4364832 (W.D. La. Sept. 2, 2014).  Much could be said about this 100+ page opinion, and we said some of it here).  We slot this particular Actos decision as our #3 worst decision of 2014.  For some reason (perhaps embarrassment) the opinion fails to mention in its 52 Westlaw pages or 285 footnotes that the runaway verdict it was upholding was for $9 billion.  At trial, the plaintiff was allowed to try a blatantly preempted fraud on the FDA claim under another name.  That’s not hard to show, since the opinion states no fewer than 37 times (yes, we counted) that the defendant supposedly “concealed,” “misinformed,” “obfuscated,” “withheld,” or other-similar-verbed information from the FDA.  Neither the court nor the plaintiffs are the least bit subtle in their fraud on the FDA rhetoric, so we’re hopeful for an appellate reversal, but in the interim, this outlier verdict will waste everyone’s time and money.  That’s the opposite of what an MDL was supposed to do.

4. Mississippi ex rel. Hood v. AU Optronics Corp., ___ U.S. ___, 134 S. Ct. 736 (U.S. 2014). In this case the United States Supreme Court held that a state attorney general action (really brought by contingent fee counsel proceeding in an AG’s name), ostensibly on behalf of all the citizens of a state, did not qualify as a “mass action” under the Class Action Fairness Act (“CAFA”) so as to allow removal to federal court.  So state AG actions remain in state court where, combined with the usual “home cooking,” they can generate monstrous verdicts – practically all of which have so far been overturned (more on that next week).  Hood is it not ranked higher because, frankly, we always thought this CAFA argument was a very long shot (the Court unanimously rejected it). Since the defense position was already a distinct minority view, Hood didn’t change the legal landscape much.  Hood would have been a great victory had it gone the other way, but this result basically continued the status quo.  It’s the Supreme Court, so it belongs on the list, but we found other decisions to be worse.  We alerted readers to the adverse result here.

5. Hardin v. PDX, Inc., 173 Cal. Rptr.3d 397 (Cal. App. 2014).  Hardin has to take the cake for the weirdest liability theory held to state a claim by an appellate court in 2014.  It’s a generic drug case (no surprise there), so the plaintiff has a serious preemption problem.  When all else fails, use Restatement §324A “Good Samaritan” liability to punish somebody for doing something intended to be helpful.  Here, that somebody, or rather those somebodies, had prepared a monograph about the drug that was distributed by the plaintiff’s pharmacist.  Plaintiff did not sue the pharmacist, since California law holds that pharmacists don’t have a duty to warn about prescriptions that they properly fill.  Plaintiff sued the publisher of the monograph.  That didn’t work because of the First Amendment, which is enforced in California by an anti-SLAPP (“strategic lawsuit against public participation”) statute.  Plaintiff was as undaunted as the appellate court was credulous of new liability theories. A software manufacturer, whose program allegedly truncated the monograph’s original 8-paragraph text to 5 paragraphs, was also sued, and the court allowed that claim to proceed – despite two layers of intermediaries closer to any purported failure to warn (pharmacist and publisher) both having no duty to the plaintiff as a matter of law. This unfortunate defendant did not make the product, did not write the monograph, and never had any contact with the plaintiff.  As we said in our post criticizing Hardin, it was like holding (in pre-electronic times) a maker of white out liable for someone else’s deletion.  Another loose nut slides to the coast.

6. Payne v. Novartis Pharmaceutical Corp., 767 F.3d 526 (6th Cir. 2014).  The name says it all.  The Sixth Circuit reversed the “strong” application of warning causation principles that had made the district court opinion in Payne a #17 honorable mention last year.  The problem with this Aredia/Zometa case was the same as with most such cases – no evidence that there was any choice but to prescribe this drug, which was effective against cancer, under the circumstances (plaintiff had bone-metastasized cancer).  Yes, this drug could cause osteonecrosis, a nasty but not fatal condition, but the prescriber was trying to save the plaintiff’s life.  So, the prescribing oncologist testified that he would have prescribed no matter what, but now he gives warnings that patients should have a dental exam because of the osteonecrosis risk.  With benefit of hindsight, plaintiff was willing to testify that she would have taken her chances with cancer, and not used the drug at all, had she known about the lesser condition.  While admitting that the plaintiff’s testimony was “speculative,” the appellate court found it sufficient, drawing from malpractice and informed consent cases where the physician-patient relationship was implicated. We were pained with that result here.

7. Scott v. C.R. Bard, Inc., ___ Cal. Rptr.3d ___, 2014 WL 6475366 (Cal. App. Nov. 19, 2014). This is a dangerous case for two reasons.  First, it used “Good Samaritan” liability (a California favorite) to hold a medical device manufacturer liable for negligently undertaking to train surgeons in the use of its device.  Training doctors is a good thing, but if liability can be predicated on allegedly doing it “negligently,” companies will be less likely to do it at all, since they have no training duty (except where imposed by the FDA).  Second, it allowed subsequent remedial measures – FDA regulatory actions post-dating the plaintiff’s surgery – into evidence.  While an old, loopy California decision from the glory days of strict liability (Ault, decided in 1974) still allows such evidence for “policy” reasons, this wasn’t a strict liability case.  Strict liability is not recognized in California for design defect claims against prescription medical products.  Thus, the jury learned that the product was later removed from the market.  Harmless? No way; the court was California dreaming.  We (the non-RS side, that is) discussed that Thanksgiving turkey here.

8. Messick v. Novartis Pharmaceutical Corp., 747 F.3d 1193 (9th Cir. 2014).  This is one ugly Daubert decision, reversing a favorable district court ruling.  Sure, “fit” requires relevancy, but the “relevancy bar is low.”  How low?  How about a causation expert who wouldn’t even come out with an opinion that the drug caused the injury?  That’s poor. Daubert is supposed to exclude ipse dixit, but Messick allowed in what passed for “differential diagnosis” because the expert “repeatedly referred to his own extensive clinical experience as the basis for his differential diagnosis.”  And so the ipse dixit spider was allowed to weave its web in Messick.  Sole cause is cast into the dustbin of medico-legal history.  A supposedly scientific opinion can be based on “substantial factor” causation.  Association thereby morphed into causation.  We castigated Messick here.

9. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 355995 (W.D. La. Jan. 30, 2014).  This terrible decision imposed discovery sanctions based on conduct that occurred many years before Actos litigation – about bladder cancer – ever existed.  Given that timing, whatever the defendant did with respect to this MDL couldn’t be worse than negligence, since nobody plausibly intends to impede unknown future litigation.  About the only good thing that could be said about this opinion is “Never again.” Fed. R. Civ. P. 37(e) is being amended to prevent this result in two ways:  (1) sanctions must be predicated on “intent” to interfere with “the litigation,” and (2) negligence (Zubulake) is no longer sufficient for sanctions. We discussed this Actos decision (and other issues relating to litigation holds) here.

10. Hornbeck v. Medtronic, Inc., 2014 WL 2510817 (N.D. Ill. June 2, 2014).  We’ve settled on Hornbeck as the worst InFuse case of the year.  There was competition, particularly from Coleman, an appellate case in California, but for sheer all-around awfulness, Hornbeck takes the cake.  Despite the status of InFuse as a pre-market approved device entitled to preemption under Riegel (2008 #+1), Hornbeck refused to preempt anything (even Coleman, bad as it was, preempted a majority of the plaintiff’s claims).  That wasn’t even Hornbeck’s most egregious failure.  The utter lack of support for its rulings was.  Hornbeck is a monument to “I don’t care what the law is, I don’t like preemption, and that’s that.”  As readers of this blog know, there are literally dozens of InFuse preemption cases on our device preemption scorecardHornbeck cites precisely none of them – not a single InFuse opinion − even those that might support aspects of its outcome.  The opinion interprets Bausch as allowing plaintiffs to call anything a “violation.”  Hornbeck also gets Illinois law 180° wrong on FDCA-based negligence per se (the Illinois Supreme Court actually rejects it), and even allows component by component analysis, effectively denying physicians any discretion to use components separately.  Some opinions simply don’t get it, and Hornbeck is one of those.  We didn’t “get” Hornbeck either, and didn’t write a post about it, except for including it in our scorecard.

We’re also sure that Bristol-Myers Squibb Co. v. Superior Court, 2014 WL 3747250 (Cal. App. July 30, 2014), would have made our bottom ten list, had a further appeal not been accepted by the California Supreme Court, thus wiping that personal jurisdiction atrocity (discussed here) from the books.  Other near misses were the OTC drug case Maya v. Johnson & Johnson, 97 A.3d 1203 (Pa. Super. 2014) (discussed here), and In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2014 WL 1632149 (S.D. Ill. Apr. 24, 2014) (discussed here), which would import “parallel claims” into generic drug preemption based on impossibility.

You can come out now, we’re done.  If you lost one of these monstrosities, you have our condolences.  If you haven’t – there, but for the grace of God….

We’re glad this is over, too.  Next week you (and we) get the fun stuff:  our thumbs up list of  the ten best drug/device decisions of 2014.

We’ve been blogging now for well over seven years.  Our first substantive posts went up on November 15, 2006, and by now about 2450 have followed. We use this blog regularly as a research tool.  A lot of you probably do, too.  Even for us, it’s getting hard and harder to find what we’ve already posted.  And since we wrote (almost) all these posts, and presumably remember at least something about them, we can imagine how hard it must be for the rest of our readers.  We’ve tried with the topic tags, but they’re something of a blunt instrument, and by now some of those are getting unwieldy, with more than 300 posts on preemption, and over 100 on all of our other heavily covered categories.

We like to know where things are too.  Our clients inform us regularly that they expect us to provide them with more value for less.  One way to do that is not re-invent the wheel in researching for our billable matters.  Being able to take advantage of free – or at least non-billable – research conducted for the blog seems like an eminently reasonable step to take.  Of course, for competitive reasons, we could just do that internally and not share anything.  But then why have a blog at all?  That would run counter to our basic philosophy that defense wins anywhere help defendants everywhere.  Not all “value” has to be billed.  Nor does every defendant and every case justify the kind of research we do.  But we’re just egotistical enough to think that the defense of any case where our research is relevant could benefit from it.  So we’ve decided to share … again.

That means this is going to be a really boring post.  We’re lawyers, not librarians, but we’re going to try to organize things so that people who want to use our research posts (as opposed to our single-case posts and other stuff) can find them.  More value for less.  It’s hard to beat “free.”

Thus, if you’re looking to be entertained, come back tomorrow.  But if you’re a reader who thinks you might actually want to use the blog’s research resources, you’ll want to save this post somewhere.

Here’s how we’re going about this.

Most of our serious research has been of four types.  The first type is our scorecards.  These compile all cases that we know of, pro or con, on a topic.  Scorecards are updated on an ongoing basis, so you don’t need to worry about the date of the post.  Because we’re not in the habit of doing the other side’s research for them, scorecards only address subjects where the defense usually wins.

Next are our cheat sheets.  These address subjects where the decisional record is more mixed.  Cheat sheets only contain favorable precedent – that is, where the defense side won.  Cheat sheets are also updated on an ongoing basis, although often not as religiously as our scorecards.

On numerous occasions, we’ve discussed other topics, frequently on a nation-wide basis. Sometimes we’ve organized such research in 50-state fashion, with the headers formally divided on a state-by-state basis. We’ll keep to that division here. In our third category, we’ll list our state-by-state research topics, and fourth we’ll finish with other nationwide research organized by topic.  With these posts, we’re also including the date, so you’ll know how current the research is.  With only a few exceptions, our research other than scorecards and cheat sheets is not updated.  What you see on any given date is what you get.

SCORECARDS

Post-Riegel Pre-Market Approved Device Preemption Scorecard

Post-Mensing Generic Drug Preemption Scorecard

Innovator Liability in Generic Drug Litigation (Conte)Scorecard

Cross-Jurisdictional Class Action Tolling (of the statute of limitations) Scorecard

Lack of Compensable Injury Scorecard

CHEAT SHEETS

Post-Levine Drug/Vaccine Preemption Cheat Sheet

Class Action Denial In Federal Court Cheat Sheet

Class Action Denial In State Court Cheat Sheet

TwIqbal Cheat Sheet

FDA Adverse Event Reports Cheat Sheet

Duty to Test Cheat Sheet

E-Discovery for Defendants Cheat Sheet

Lone Pine Cheat Sheet

STATE-BY-STATE NATIONWIDE RESEARCH

Substantive Law:

Causation – Physician failure to read warnings (10/28/11) and (10/17/13)

Comment k/Unavoidably Unsafe Product – How states have applied Restatement §402A, comment k (10/8/08) and
(4/28/11)

Consumer Fraud – Extraterritoriality rejected (9/13/07)

Consumer Fraud – Recovery of damages for personal injury (4/15/11)

Duty to Recall – States rejecting duty (8/11/11)

Fraud on the Market – Cases rejecting fraud on the market causation theories outside of the federal securities law context (1/25/10)

Hospitals – Strict liability (11/16/12)

Innovator Liability (7/18/14)

Learned Intermediary Rule – Applicability to exempt pharmacists from liability (2/24/11

Learned intermediary rule – Medical device cases (7/10/08)

Learned Intermediary Rule – Who’s adopted it and who hasn’t (7/5/07 – occasionally updated), and (6/2/11)

Market Share Liability – Who has it, who doesn’t (7/15/10)

Medical Monitoring – Who has it, who doesn’t (4/15/09)

Misuse – In pari delicto defense (8/23/07)

Nuisance – Municipal cost recovery rule (5/3/07)

Preemption – Embedded fraud on the FDA claims (9/3/09)

Product Liability – Adoption of the Restatement (Third) of Torts, Products Liability §2 (9/10/10)

Punitive Damages – Adoption of one-to-one ratio in large-damage cases (8/18/11)

State of the Art Defense – Precedent applying defense in prescription drug/medical device litigation (3/20/09)

Procedural law:

Discovery – Informal physician interviews, who allows them and who doesn’t (12/18/08 – sometimes updated), and here (8/16/07)

Expert Witnesses – Whether defense experts, because defendants do not bear the burden of proof, must testify to a reasonable degree of medical certainty (8/4/2011)

Online Appellate Judicial Websites – how to get online opinions from every federal and state appellate court (4/29/10)

Removal – Pre-service removal (10/1/09) and (5/26/11)

GENERAL NATIONWIDE RESEARCH

Substantive law:

Administrative law – Exclusion of administrative standards that are more lax than legal standards (4/8/10)

Administrative law – No private FDCA right of action (2/18/10)

Bulk Drug Suppliers – Liability (11/29/12)

Causation – Individualized reliance (9/1913)

Comment k/Unavoidably Unsafe Product  – Application to medical devices (1/12/12)

Consumer Fraud – Lack of damages (2/5/09)

Consumer Fraud – Prescription medical products not “consumer” goods (2/10/12)

Consumer Fraud – Regulatory compliance as defense (5/24/07) and (3/6/14)

Co-Promoters – Cases rejecting liability (12/7/11)

Decisions in MDL – State law decisions in out-of-state MDLs (4/25/13)

Design Defect – Alternative design requirement in medical device cases (8/8/13)

Duty to Train or Advise Physicians – Decisions rejecting (9/15/11) and (5/30/13)

Emotional Distress – Defeating emotional distress claims in drug/device litigation (2/3/11)

Experimental/Investigational Drugs – No duty to supply (3/15/12)

First Amendment – Defense to tort liability (12/14/12)

Fraud – Promotion of off-label use not fraudulent (7/27/12)

Fraud on the market – Causation (2/17/12)

Heeding presumption – Precedent rejecting presumption (7/2/09)

Informed Consent – Off-label use need not be disclosed (6/21/07) and (1/14/10) and (10/20/11)

Learned Intermediary Rule – Burden of proof when prescriber testimony nonexistent (3/10/14)

Learned Intermediary Rule – Direct to consumer exception (1/20/11)

Learned Intermediary Rule – Physician as “consumer” in consumer expectation test (5/7/12)

Learned Intermediary Rule – Policy reasons for rule (7/6/07)

Learned Intermediary Rule – Warning causation cannot be proved by “reasonable doctor” expert (4/19/07)

Medical Malpractice – Off-label use and the standard of care (11/2/12)

Medication Guides – Claims about (2/21/14)

Negligence – Duty (9/17/09)

Negligence per se – State-law defenses to FDCA-based negligence per se actions (2/7/08) and (2/12/09)

Preemption – Buckman applies to fraud on agencies other than the FDA (9/25/08)

Preemption – Failure to recall claims (9/28/12)

Preemption – FDA prosecutorial discretion (10/5/12)

Preemption – Generic drugs, various topics (4/5/12)

Preemption – HIPAA and informal defense interviews of treating physicians (2/15/07)

Preemption – OTC drugs (11/25/08)

Preemption – PMA devices where the classification has arguably changed (10/7/10)

Preemption – PMA plaintiffs can’t establish parallel FDCA violation by res ipsa loquitur (1/26/12)

Preemption – Post-Riegel parallel violation claims (6/26/08) and (12/18/08), and (7/30/09)

Preemption – Product development protocol (9/6/11)

Preemption – Transitional devices (10/31/13)

Preemption –Warnings about risks of off-label use (12/19/13)

Publisher Liability – Is a publisher of a pharmaceutical warnings, who is not a drug manufacturer, liable for substantive errors or omissions in what it publishes? (4/7/11) and (7/18/13)

Punitive Damages – Compliance as a defense (3/8/07) and (11/5/09)

Punitive Damages – No constitutional right to obtain (4/30/12)

Punitive Damages – Territoriality (12/29/06)

Punitive Damages – Warnings as a defense (2/24/12)

Recalls – Duty to recall, subsequent remedial measures and other recall-related issues (9/24/09)

Res Ipsa Loquitur – Broken medical devices are not ipso facto defective (12/31/09)

Restatement (Third) §6(c) – adoption or rejection (5/3/11)

Sales Representatives – Tort duties when present in operating room (9/23/11)

Sales Representatives – fraudulent joinder (7/14/09)

Warnings – Causation issues (5/8/08) and (10/2/08)

Warnings – Expert proof requirement in learned intermediary rule cases (6/11/09)

Warnings – No duty to warn about competing products (7/19/07)

Warnings – Overwarning (1/9/14)

Warnings – Plaintiffs can’t assert failure to warn of risks they never suffered (10/26/07) and (4/1/10)

Warranty – Application of learned intermediary rule to bar claims (11/10/11)

Procedural law:

Adverse Event Reports – rejecting their use, either as evidence or as a basis of expert testimony (6/7/07)

Bankruptcy – Judicial estoppel of plaintiff not listing tort claim as asset (9/25/12)

Class Actions – Cy pres (10/15/09)

Class Actions – punitive damages (7/17/09) and (2/26/09)

Class Actions – single issue certification (11/19/09)

Daubert – 2.0 relative risk standard for more likely than not (12/28/07)

Daubert – Differential diagnosis as faulty methodology (5/7/09)

Discovery – Counsel’s ability to speak with his/her own during an ongoing deposition (2/10/11)

Discovery – Deposing current FDA employees (5/22/14)

Discovery – Litigation holds (4/3/14)

Discovery – Lone Pine orders (8/11/08

Discovery – Protection of customer lists from discovery (4/2/09)

Discovery – Translation of non-English documents not required (7/9/08)

Erie Doctrine – Obligation to be conservative in making state-law predictions (11/28/06) and (5/13/11)

Evidence – Exclusion of animal studies (7/19/07)

Evidence – Exclusion of corporate ethics expert (7/19/07)

Evidence – Exclusion of foreign regulatory standards (8/7/07) and (6/30/11)

Evidence – Exclusion of fraud on the FDA evidence (7/19/07)

Evidence – Exclusion of FDA warning letters (4/21/10)

Evidence – FDA §510k clearance (7/5/12)

Evidence – Warning changes as subsequent remedial measures(2/2/10)

Expert Witnesses – Legal conclusions are inadmissible (2/9/08) and (3/14/08)

Expert Witnesses – Postmortem redistribution (4/18/12)

Expert Witnesses – Suzanne Parisian (8/9/12) and (8/14/13)

Expert Witnesses – Testimony on corporate intent, ethics, and similar subjects is inadmissible(5/19/2011)

Joinder – Misjoinder (1/7/10)

Judicial Notice – FDA-related materials (9/20/07) and (4/17/08) and (7/2/09)

Pleading – Moving to dismiss MDL master complaints (8/20/09)

Pleading – Allegations barred by TwIqbal (12/2/11)

Pleading – TwIqbal and fraudulent joinder (6/15/12) and (7/9/12) and (4/19/13)

Pleading – TwIqbal barring “and/or” pleading (7/23/09)

Pleading – TwIqbal barring “otherwise negligent” pleading (11/23/12)

Pleading – TwIqbal in cases removed to federal court (11/18/10)

Pleading – TwIqbal in PMA preemption cases (12/9/10)

Pleading – TwIqbal in product liability cases generally (8/6/09)

Pleading – TwIqbal in state court (10/29/09)

Pleading – Various TwIqbal issues (5/16/12)

Removal – “Order or other paper” (3/22/13)

Removal – Several removal issues (10/1/09)

Standing – No private FDCA cause of action (6/7/12)

Trial – consolidated multi-plaintiff trials (12/16/11)

This is a relatively short post because a(nother) snowstorm has closed the ReedSmith Philly office and we’re working remotely.  Over the week or so we’ve been sent a couple of articles that we think could be useful to defense counsel, so we’re passing them along today.

The first is a law review article, “The Odd State of Twiqbal Plausibility in Pleading Affirmative Defenses,” sent to us by its author, Charleston School of Law professor Bill Janssen.  While he sent it to us in hard copy (the cite is 70 Wash. & Lee L.R. 1573), it’s also available online, here.  The issue it addresses is not of cosmic importance, but it’s an annoyance – whether the other side can try to TwIqbal our affirmative defenses.  We’ve touched on this issue before, here, but only briefly, stating:

We won’t go any further than to re-emphasize the point that the Twombly/Iqbal requirements apply to every allegation governed by Rule 8(a) – which includes class action allegations, but presumably not affirmative defenses governed by Rule 8(c), which doesn’t contain the same “short and plain statement” language.  See, e.g., Davis v. Indiana State Police, 541 F.3d 760, 763 (7th Cir. 2008) (Twombly inapplicable to affirmative defenses).

Professor Janssen’s law review article takes on the issue of TwIqbal and affirmative defenses comprehensively – complete with a district-by-district chart of every decision he could find.  His conclusion:

The majority view held by the Nation’s district courts that have considered the question join Weddle v. Bayer AG Corp. [2012 WL 1019824 (S.D. Cal. March 26, 2012)] in holding that Twiqbal “plausibility” does not apply to the pleading of affirmative defenses. . . .  The persistent minority view . . . holds that TwIqbal applies.

70 Wash. & Lee L.R. at 1634.  So if some plaintiff tries to TwIqbal your affirmative defenses, you can save yourself considerable research time by checking out this article.

A second time saver is a 50-state survey – complete with helpful charts – of the comparative fault/contributory negligence law of every state and the District of Columbia.  This article was compiled by the (primarily subrogation) law firm Matthiesen, Wickert & Lehrer.  It separates out the various states by pure contributory negligence, pure comparative fault, modified comparative fault, and “slight/gross” comparative fault.  This article is the kind of thing we would have done, if we’d focused on this question – which we haven’t.  Because this other firm has, we’re passing their article along as a helpful resource.

Happy New Year from all of us here at DDLaw!  And happy old year, too.  Was it a happy old year?  In many ways it was, and it’s the purpose of this post, to list some of our top reasons why. So here are our choices for the best prescription medical product liability decisions of 2013.  These are the decisions that put us in a most festive mood during this festive time of the year.  And we are festive.  This is the first time that our #1 best decision, has overturned last year’s #1 worst decision.  It’s hard to beat that.  The Supreme Court was good to us this year, but so were quite a few other courts.

So, the envelopes please – let’s get down to handing out this year’s DDL judicial Oscars. Here are our ten favorite judicial decisions (and some honorable mentions) involving drugs, medical devices, and vaccines in 2013.

1. Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).  Well, duh.  The Supreme Court agreed with our assessment last year of the First Circuit’s decision.  We posted that the “rationale . . . that nothing requires a manufacturer actually to sell a drug that the FDA has approved . . . like the lobbying argument rejected in Mensing . . . proves way too much.”  The Supreme Court held that “[i]n every instance in which the Court has found impossibility pre-emption, the ‘direct conflict’ between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting.”  133 S. Ct. at 2477.  Adding Bartlett to Mensing, means that warning claims are preempted, design claims are preempted, and plaintiffs can’t argue that a generic drug manufacturer should either go to the FDA to get its label changed or get out of the market.  There’s not much left that generic plaintiffs can argue.  About the only hope they have left is that the FDA might change the rules – which we think is a long shot − and even the FDA modifying its regulations wouldn’t apply to any prescription written before any new rule was effective.  But there’s more.  The implied preemption rationale that design claims demand the “impossible” because design changes require FDA preapproval isn’t limited to generic drugs.  Nor is the Court’s rejection of the “stop selling” rationale.  Preemption of these sorts of claims should extend to all prescription drug and medical device litigation.  Indeed, tying impossibility preemption to the need for prior Agency action, should eventually have a variety of beneficial preemption consequences – on everything from off-label warnings, to comparative labeling.  So Bartlett is our #1 decision of the year, and it wasn’t close.  As you might expect, we blogged about Bartlett a lot, including here and here.

2. Strayhorn v. Wyeth Pharmaceuticals, ___ F.3d ___, 2013 WL 6224337 (6th Cir. Dec. 2, 2013). In cases involving generic drugs, our preferred outcome is the “one-two punch,” with generic manufacturers winning on preemption grounds coupled with a ruling that innovator manufacturers did not make the product that the plaintiff used, and therefore cannot be liable under any tort theory.  Strayhorn is the best of a number of similar 2013 post-Bartlett decisions of this sort.  For one thing, it considered and found “unpersuasive” the no-preemption non-rationale of the Reglan Trilogy (2013 #-4).  For another, it held that “consumer expectations”-based design defect claims were also preempted because prescribers relied on warnings in forming expectations.  On the innovator side, all informational claims, including oddball ones bases on alleged ghostwriting, “sponsored” CME, and seminars, fail in the absence of use of the defendant’s product.  Also, Strayhorn relies on our favorite Erie principle – that federal courts are not to predict adventuresome expansions of state-law liability.  We hailed Strayhorn here.

3. Perez v. Nidek Corp., 711 F.3d 1109 (9th Cir. 2013).  Just when we thought that preemption in the Ninth Circuit had gone to hell in a handbasket in Stengel (2013 #-2), along comes Perez. First, the court held as a matter of law that off-label use was not “medical experimentation” under a California statute, but it was just getting warmed up.  Distinguishing Stengel, Perez found all of the plaintiff’s claims concerning alleged off-label promotion of a PMA medical device preempted – in particular the demand for special labelling concerning off-label use. As we pointed out earlier this month, that’s squarely within the FDA’s bailiwick.  We praised Perez here.

4. Carrera v. Bayer Corporation, 727 F.3d 300 (3d Cir. 2013).  Carrera is the best class action case of the year in the FDA-related products field, although it technically involves a dietary supplement rather than a prescription medical product.  Carrera puts teeth in the aspect of manageability requiring that a class must have a membership that is ascertainable without that, too, becoming a long, drawn out, and individualized process.  The defendant (like most drug and device manufacturers) didn’t sell directly to end users.  The defendant had no lists of purchasers, and there was no evidence that consumers themselves kept any records that would make up for this glaring absence of proof. The Third Circuit reversed certification, requiring that there be “objective criteria” for ascertaining class membership.  Otherwise, a defendant has no way of defending against a mass of unprovable claims, and class certification could amount to a due process violation.  A defendant having the right to defend – what a novel concept in class actions.  Anyway, Carrera ranks high on our list, despite being a supplement case, because it imposes significant restrictions on remote end-user consumer class actions, where arbitration clauses are less likely to be useful.  We analyzed Carrera here.

5. United State ex rel. Ge v. Takeda Pharmaceutical Co. Ltd., ___ F.3d ___, 2013 WL 6399780, (1st Cir. Dec. 6, 2013), which affirmed 2012 #+20, demonstrates that there are some claims against drug companies that even the First Circuit can’t stomach.  Specifically, the court rejected as woefully inadequate the plaintiff’s (relator’s) attempt to cobble together “false claims” out of allegations amounting to nothing more than accusations of fraud on the FDA (remember, the FCA is a federal statute, so there’s no preemption) by means of underreporting of adverse drug events.  For once, the First Circuit enforced pleading rules regarding causation that, if applied consistently, should preclude such allegations from being pursued en masse.  If this type of claim can’t survive even in the First Circuit, it doesn’t have much of a future – if it can’t make it there, it can’t make it anywhere. We discussed Ge here.

6. Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013).  Shortly after the First Circuit’s frolic and detour in Bartlett, when we most needed appellate fortification of generic preemption, Morris provided it.  Most critically, it gave the back of the judicial hand to that dangerous “just stop selling the product altogether” argument, when that treatment was most needed. But, not only did Morris reaffirm preemption and hold that there’s no state-law duty to adopt a label that the plaintiffs still allege is “inadequate,” it was also the first appellate decision to reject the notion that an FDA reference listed drug designation somehow made a difference.  We applauded Morris here.

7. In re Fosamax Products Liability Litigation, ___ F. Supp.2d ___, 2013 WL 3270387 (D.N.J. June 27, 2013).  After the debacle in Wyeth v. Levine (2009 #-1) favorable preemption decisions involving warnings for innovator drugs have become quite uncommon.  Fosamax is a welcome exception.  The kind of Levine-mandated “clear evidence” that the FDA wouldn’t have approved a label change was provided by the Agency’s rejection of a pre-approval supplement concerning the same claimed risk and under the same standard of scientific evidence also utilized in determining when a CBE submission is required.  The FDA had been reviewing all the drugs in the same class and, unlike Levine, had more overall information than any particular manufacturer.  We’ve heard that, under the recent Fosamax settlement, this case won’t be appealed, so we’re pleased to put this one in our pocket. We cheered Fosamax on here.

8. Solomon v. Bristol-Myers Squibb Co., 916 F. Supp.2d 556 (D.N.J. 2013), along with Cooper v. Bristol-Myers Squibb Co., 2013 WL 85291 (D.N.J. Jan. 7, 2013), Begley v. Bristol-Myers Squibb Co., 2013 WL 144177 (D.N.J. Jan. 11, 2013), LaBarre v. Bristol-Myers Squibb Co., 2013 WL 144054 (D.N.J. Jan. 11, 2013), aff’d, ___ F. Appx. ___, 2013 WL 6053840 (3d Cir. Nov. 18, 2013), Carr-Davis v. Bristol-Myers Squibb Co., 2013 WL 322616 (D.N.J. Jan. 28, 2013), and Mattson v. Bristol-Myers Squibb Co., 2013 WL 1758647 (D.N.J. Apr. 24, 2013).  This batch of similar summary judgment decisions all arose out of the Plavix MDL.  They employ excellent reasoning, viewing each state’s law separately, refusing to allow novel claims (such as warning claims based on “lack of efficacy”), finding the label adequate as a matter of law, trashing bad experts, and properly applying warning causation issues under the learned intermediary rule – and the only appeal so far has produced an affirmance.  But more broadly, they exemplify what we think even-handed MDL practice should be. Too often, MDL judges postpone case-specific, or state-specific legal issues until after cases are remanded (years later) to the courts from which they came.  Allowing weak cases to persist, cases that would have been dismissed if litigated individually, puts an pro-plaintiff thumb on the scale in MDLs by preventing the ordinary winnowing process.  Not in Plavix.  This judge acts like a judge and decides cases, instead of behaving like a glorified settlement master.  We blogged about these Plavix cases several times, here, here, and here, and here.

9. Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206 (W.D. Okla. 2013).  We’ve pointed out that Medtronic’s Infuse litigation has generated a lot of favorable precedent about preemption and off-label use recently.  You know how much we love preemption and off-label use.  Caplinger was the first (and still arguably the best) of the lot, accepting propositions that PMA preemption applies to devices, not uses; that “off-label promotion” is not a proper parallel claim; that any claim dependent on the scope of the FDA’s label is really a disguised FDCA violation claim; and any claim premised on a PMA device’s safety and effectiveness is preempted.  Full disclosure, Caplinger is an RS case.  We, or should we say the non-RS part of “we,” blogged about Caplinger here.

10. Atwell v. Boston Scientific Corp., ___ F.3d ___, 2013 WL 6050762 (8th Cir. Nov. 18, 2013). Large-scale misjoined multi-plaintiff complaints are one of the banes of a mass tort defense lawyer’s existence. There are many reasons why plaintiffs do this (including cheating courts out of filing fees), but the chief one is to keep themselves out of federal court despite suing diverse defendants. After CAFA, most plaintiffs pursuing this strategy take care to keep the misjoinders under the 100-plaintiff CAFA limit for “mass actions.”  However, plaintiffs want to have their cake and eat it too, so they try to “coordinate” these actions in state court.  Atwell said “no dice” to the subterfuge and held that a request to coordinate cases involving the same product and defendant created a “mass action” when the plaintiffs wanted to imitate an MDL and have bellwether trials. Into federal court they went – and stayed.  We lauded this result here.

Those are our top ten, but as in other years we also can’t ignore other favorable results that didn’t quite make our top ten.  So, as they say in NOLA, laissez les bon temps rouler.  To round out the festivities, here are our Honorable Mentions:

(11) Lamere v. St. Jude Medical, Inc., 827 N.W.2d 782 (Minn. App. 2013) – because a lot of medical device companies are based in Minnesota, it was particularly gratifying to see that state’s appellate court restrict “parallel claims,” particularly with respect to vague GMP regulations.  See our post here;

(12) Guarino v. Wyeth, 719 F.3d 1245 (11th Cir. 2013) – another good “one-two punch” generic drug affirmance, just not as timely as Morris, being decided the day after Bartlett. See our post here;

(13) Kiobel v. Royal Dutch Petroleum Co., 133 S. Ct. 1659 (2013) – what’s a Supreme Court case doing down here? Well, it’s not a product liability case. Held: the Alien Tort Statute doesn’t create tort liability for acts taken overseas.  That eliminates awful decisions like Abdullahi (2009 #-2 (after only Levine)), and that’s something.  But it’s not something we see a lot, so it’s not more highly ranked.  See our post, here;

(14) Calisi v Abbott Laboratories, 2013 WL 5441355 (D. Mass. Sept. 27, 2013) – when you’re in mass tort litigation, getting your label declared adequate as a matter of law is a big deal.  That and more took place in Calisi. See our post here;

(15) In re Fosamax Products Liability Litigation, 707 F.3d 189 (2d Cir. 2013) – it’s not very often that an appellate court comes right out and calls the testimony of a plaintiff’s expert (a treater turned plaintiff’s expert) an outright “sham,” but that’s what happened in this case.  See our post here;

(16) Goldin v. Smith & Nephew, Inc., 2013 WL 1759575 (S.D.N.Y. April 24, 2013) – there were a number of good TwIqbal decisions in 2014, particularly in New York federal courts. Goldin led the way.  See our post here;

(17) Payne v. Novartis Pharmaceuticals Corp., 2013 WL 4779571 (E.D. Tenn. Sept. 6, 2013) − probably the strongest application of warning/causation we’ve seen all year.  See our post here;

(18) Jenkins v Medtronic, ___ F. Supp.2d ___, 2013 WL 6172234 (W.D. Tenn. Nov. 21, 2013) – a while ago we surmised that PMA medical device cases raising primarily “parallel claims” might be removable under a Grable federal question basis; in Jenkins that finally happened;

(19) In re Pelvic Mesh/Gynecare Litigation, No. ATL-L-6341-10, slip op. (N.J. Super. Law Div. Dec. 3, 2013) – we’ve been critical of the lack of a level playing field in New Jersey with respect to informal interviews with treating physicians for quite some time.  But things in New Jersey changed last year (2012 #+5).  Now even Judge Higbee is requiring plaintiffs and defendants to play by the same rules.  See our post, here;

(20) In re Fosamax Products Liability Litigation, ___ F. Supp.2d ___, 2013 WL 4306434 (S.D.N.Y. Aug. 15, 2013) – a “bullseye” in our estimation.  The court bluntly recognizes the pickle generic plaintiffs are in after Bartlett.  Preemption bars demands for changes to both design and warnings, and also removes removal from the market claims.  What’s left? Nothing, according to this decision. See our post here.

Looking back, all of our top ten from 2012 remain intact, with only POM Wonderful (2012 #+8) still at risk – a certiorari petition is pending, but the Solicitor General recently opined that the Supreme Court should not take the case.  All of our honorable mentions from last year have survived as well with the Ge case (as mentioned) being affirmed.  As for our bottom ten, as we mentioned above, Bartlett (2012 #-1) was reversed.

Looking ahead, Weeks (2013 #-5) has been argued on rehearing, and we await a decision. In the Supreme Court, we’re looking forward to decisions whether:  (1) the reliance requirement in fraud claims can be finessed by a “fraud on the market” presumption, in Halliburton Co. v. Erica P. John Fund, Inc., No. 13-317; and (2) CAFA (in accordance, we believe, with how the Founders intended diversity jurisdiction to work) puts state AG actions against out-of-state corporate defendants into federal court, in Mississippi v. AU Optronics Corp., No. 12-1036.  We are also following an Attorney General’s action before the Arkansas Supreme Court (State ex rel. McDaniel v. Janssen, No. 13-102) that hasn’t generated any opinions yet, but did produce a $1.2 billion verdict.  From this year’s lists, Stengel (2013 #-2) has a certiorari petition pending and the Solicitor General’s office has been asked for its view.  Caplinger (2013 #+9, above) is on appeal to the Tenth Circuit. At least some of the Reglan Trilogy (2013 #-4) and Malander (2013 #-6) will be appealed to their respective state high courts.  From last year, the Caldwell false claims act case (2012 #-2) remains pending before the Louisiana Supreme Court.  The perpetually pending Lance case (2010 #-6) remains undecided by the Pennsylvania Supreme Court, some three years after oral argument.

Next year, we’ll also start to see the fall-out from the FDA’s proposal to change the rules to eliminate generic drug preemption, although we doubt that process will run its course in 2014.

So next stop, 2014. We wish an equally Happy New Year to all our readers on the right side of the “v.”.

Today’s post contains our annual list of those court decisions concerning prescription drugs and medical devices that are so bad and ugly that they leave us talking to ourselves – or even to the furniture.  With the thirteenth year of the millennium drawing to a close, these opinions demonstrate that – yes, indeed – thirteen can be an unlucky number.  You’ll have to wait until next week for the good, because our custom is to start with the judicial Razzies and end the year with our list of judicial Oscars.  Here are the jurisprudential dross of 2013.

1. Kaiser Foundation Health Plan, Inc. v. Pfizer, Inc., 712 F.3d 21 (1st Cir. 2013), Aetna, Inc. v. Pfizer, Inc., 712 F.3d 51 (1st Cir. 2013), and Harden Manufacturing Corp. v. Pfizer, Inc., 712 F.3d 60 (1st Cir. 2013).  It was close, but due to the amount of money involved and the Supreme Court’s recent decision denying certiorari, this Neurontin Trilogy stands as the buzzard on this year’s pile of. . . .  As last year’s Bartlett decision demonstrated, the First Circuit has recently been an extreme outlier on a variety of matters having to do with pharmaceutical liability.  Nowhere has that status been more pronounced than with aggregation of economic loss claims.  Unlike just about any other jurisdiction, the Neurontin Trilogy allowed causation in these third-party payer actions to be determined on an aggregated and probabilistic fashion – according to the opinion of a statistical “expert” whose work otherwise has been almost universally excluded, both in our pharmaceutical sandbox and elsewhere.  Over $140 million in purported damages was affirmed despite every prescriber who actually testified swearing that the defendant’s conduct had no influence on his/her prescriptions.  This trilogy effectively declared an irrebuttable heeding presumption, at least in RICO cases.  That’s not all.  Another of the Trilogy (Harden) vacated and remanded a decision denying certification of a nationwide class of various TPP claims, 712 F.3d at 70, thus raising the specter of even more massive litigation of a sort not permitted by any other federal Court of Appeals.  With certiorari now denied, the most we can hope for is that the Trilogy’s fraud on the market rationale might fall with a favorable decision on that theory in the Halliburton securities case.  We explained the outlier nature of the Neurontin Trilogy here.

2. Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc).  2013 was not a happy new year very long.  The year was but ten days old when the Ninth Circuit issued this awful decision that, if allowed to stand, robs two Supreme Court opinions of much of their substantive effect.  (Full disclosure, RS was one of the defense counsel in Stengel).  The first of those is Riegel.  If a state’s general tort law on adequacy of warnings, or post-sale duty to warn, is sufficiently close as to constitute a “parallel” violation claim, then “parallel” has lost its meaning, and the Riegel dictum about parallel claims has swallowed Riegel’s holding whole. The second is Buckman.  If a claimed state-law warning or fraud claim alleging failure to notify a third person (such as the FDA) is sufficient to get around the unanimous holding in Buckman that fraud on the FDA claims are preempted, then none of the policy reasons that supported the result in Buckman matter anymore. Because the Ninth Circuit’s decision is incompatible with two Supreme Court decisions and two different forms of preemption, it comes in at #2 on our list.  There’s still hope, though, as the Supreme Court has asked the Solicitor General for his views of the certiorari petition in Stengel.  However, as the Old Perfessor once said, it’s a bad idea to make predictions, especially about the future.  We expressed our dislike for Stengel here.

3. Howard v. Zimmer, Inc., 299 P.3d 463 (Okla. 2013).  Howard is the ugliest FDCA-based negligence per se decision that we’ve seen out of any state supreme court in many a year.  The court has effectively allowed litigants to federalize Oklahoma tort law through the guise of negligence per se based on violations of essentially any federal statute or regulation.  With respect to the FDCA, Howard flies in the face of congressional intent by allowing what is really private enforcement of the statute despite 21 U.S.C. §337(a).  Most states, including Oklahoma until Howard, as a matter of inter-branch comity, decline to apply negligence per se to statutes (state or federal) where the legislature has not evinced an intent to allow private enforcement, and §337(a) is an emphatic expression of precisely that intent with respect to the FDCA.  Howard is an example of the common-law being modified by improper, extraneous factors, since the express purpose of this expansion of negligence per se is to get around the preemptive effect of Riegel. 299 P.3d at 470.  We lambasted Howard here.

4. In re Reglan/Metoclopramide Litigation, ___ A.3d ___, 2013 WL 3874905 (Pa. Super. July 29, 2013) (reconsideration pending), Hassett v. Dafoe, 74 A.3d 202 (Pa. Super. 2013), and In re Reglan/Metoclopramide Litigation, 74 A.3d 221 (Pa. Super. 2013). Another trilogy, and this year’s equivalent of the First Circuit’s Bartlett decision in terms of downright refusal to follow binding Supreme Court precedent.  Pennsylvania is saddled with a very pro-plaintiff Superior (intermediate appellate) Court, and in the Reglan Trilogy, that court  ignored what even it called a “tsunami” of contrary precedent to hold practically all (except for pre-2007 warning claims) the generic drug-related claims before it were not preempted.  Uniquely, the Trilogy allowed post-FDAAA claims to escape preemption, without bothering to identify what in those amendments could possibly make a difference.  Uniquely the Trilogy (or at least one of the cases) held that claims against a generic “reference listed drug” holder could escape preemption.  Uniquely, the Trilogy took allegations of absolute liability seriously.  Uniquely, the Trilogy let design defect claims slide after Bartlett – including a gratuitous footnote about innovator drugs.  Unlike the Supreme Court, the Trilogy applied a “presumption against preemption” in generic drug cases.  The Trilogy also makes a general hash of preemption law, thoroughly jumbling express and implied preemption cases and concepts together.  A dissenting judge aptly pointed out that the Trilogy is almost entirely lacking in legal reasoning and violates the mandate that lower courts “must adhere to extant Supreme Court jurisprudence.”  We vented our spleen at the Reglan Trilogy here.

5. Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013), reconsideration granted, No. 1101397 (Ala. June. 13, 2013), even though the Alabama Supreme Court thankfully agreed to reconsider the case, Weeks was such a terrible ruling – the only state high court to recognize innovator drug liability (which we also call “Conte”) where the innovator didn’t even sell the product that the plaintiff used − that we give it our #5 spot even after the reconsideration.  But for the reconsideration, Weeks almost certainly achieved opprobrium as our #1 worst case of the year.  Product liability is just that, liability for products, and imposing liability on other people’s products turns upside down all the reasons why product liability was created in the first place.  Prior to reconsideration, we let Weeks have it here.

6. Medtronic, Inc. v. Malander, 996 N.E.2d 412 (Ind. App. 2013).  This is another example of courts distorting tort law to get around preemption.  “Good Samaritan” liability under Restatement Second §324A is one of those “last refuge of a scoundrel” theories of liability, and here it was applied to impose liability for the alleged statements of a “clinical specialist” and telephone “hot line” that the defendant voluntarily supplied to answer surgeon questions about an implantable PMA device.  No good deed went unpunished in a case where everything else was preempted.  Section 324A is supposed to be reserved for actions (like poorly performed first aid) that actually make risks worse, but that didn’t stop the court in Malander from misapplying it to a situation where risks allegedly were not revealed, rather than aggravated, and where the surgeon is necessarily the “captain” of the surgical “ship.”  We maligned Malander here.

7. Arters v. Sandoz Inc., 921 F. Supp.2d 813 (S.D. Ohio 2013).  An ugly decision from beginning to end, ignoring TwIqbal (literally, the opinion cites to Conley v. Gibson, 355 U.S. 41 (1957), which Twombly expressly “retired”), applying a presumption against preemption where it doesn’t belong, endorsing the “stop selling” argument later rejected in Bartlett, ignoring a state-law alternative design requirement, and improperly expanding state law in a diversity case by finding a heretofore elusive tort “duty” not to engage in off-label promotion.  We went through the spherical error in Arters here.

8. Neeley v. Wolters Kluwer Health, Inc., 2013 WL 3929059 (E.D. Mo. July 29, 2013).  We really don’t like it when federal courts make up new state-law causes of action.  It’s bad enough when they do it to their own states, so it’s even less justified when they do it to other states.  Then again, the other state might just ignore the loopy out-of-state prediction.  In Neeley a federal court in Missouri predicted that Kentucky would adopt publisher liability – a set of theories every state confronted with it has in fact rejected, as we pointed out hereNeeley then proceeded to mess up generic preemption as well, leaving design defect claims standing because they were based on “consumer expectations.” So what?  You can’t change the design without FDA approval, and the only way a defendant can be responsible for a physician’s “expectations” about the designs of a PMA medical devices is through the information supplied about it. For getting these two “big picture” issues wrong, Neeley lands on our bottom ten.

9. Ramirez v. Medtronic Inc., ___ F. Supp.2d ___, 2013 WL 4446913 (D. Ariz. Aug. 21, 2013). This is the ugliest off-label use case of the year.  Burdened by Stengel, the court viewed off-label promotion allegations as pretty much throwing Riegel preemption out the window – ruling that such promotion created a new “intended use” that the FDA didn’t regulate at all.  That’s totally at odds with how the FDA’s regulations actually treat warnings about risks of off-label use, but there you have it.  On top of that, Ramirez disagreed with the Second Circuit’s treatment of off-label use and off-label promotion in Caronia (2012 top ten #7).  We (or should we say the non-RS side, since RS represented the defendant) tried to avoid gagging when discussing Ramirez here.

10. McLane v. Ethicon Endo-Surgery, Inc., 2013 WL 5556147 (Mag. M.D. Fla. Oct. 8, 2013), terrible discovery result concerning “substantially equivalent” predicate devices.  McLane is our latest poster-child for why the Fed. R. Civ. P. 26 needs to be amended to eliminate its much abused “reasonably calculated to lead to admissible evidence” phrasing.  In McLane the court ordered discovery under that standard of not only other adverse events involving the actual device in question (cleared for marketing and labeling under §510k) but also about adverse events involving the device’s “substantially equivalent” predicate device – a device that in many cases could either no longer be on the market or else could be a product marketed by a totally uninvolved third party.  We carped about the fishing expedition allowed in McLane here.

So there they are. Hopefully none of these not-just-wrong-but-loud-wrong losses were yours – if so, we sympathize, since we know how it feels.  We considered several other candidates – coming closest to making the cut was Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013), but failure to update claims just aren’t likely to be all that widespread in the future.

Now we can stop holding our noses and do something that’s more fun.  Next week we’ll be listing our top ten best drug/device decisions of 2013.