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.


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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

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.


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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

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

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

For some reason, we recently found ourselves comparing our favorite defenses to our favorite rock bands.  Preemption, of course, would be The Beatles, and Daubert/Frye the Rolling Stones.  The learned intermediary rule could be Bob Dylan (I know, we’re showing our age, here).  Comment k could correspond to Led Zeppelin, and state of the art might be The Who.

And it seems that, for each of these bands, there’s a song we really like that gets slighted (in our opinion) when it comes to air time on classic rock stations.  For The Beatles that would be It’s All Too Much.  For the Rolling Stones, when you discount those songs generally considered too raunchy for mainstream radio (one from Beggars Banquet, one from Let It Bleed and one from Goats Head Soup, you can guess which ones), we’d say the disrespected Stones song we like most is Child of the Moon.  For Bob Dylan, we almost never hear Desolation Row on the radio (and thanks to Zimmerman’s late-in-life conversion to copyright trolldom, you won’t find a decent studio version on YouTube, either).  For Zep, we’d award the buried treasure award to Immigrant Song.  And finally, for The Who, we’ve always been peculiarly partial to the Punk and the Godfather.

Somewhat similarly disrespected as a defense to warning causation has been the prescriber’s failure to read the relevant warnings.  One of the benefits of the learned intermediary rule is that it replaces self-interested plaintiffs with highly trained medical professionals when it comes to warnings, and in particular with respect to warning causation.  While a plaintiff with dollar signs in his/her eyes will typically testify to whatever is necessary to establish warning causation (“Oh, yes, if I had only known about that risk, I would have rejected my oncologist’s recommendation and never taken the drug.”), medical doctors are most interested in the effective treatment of their patients, and thus typically tell it like it is.  The truth often is that, for one reason or another, the prescribing physician did not rely on the particular warning in question, and thus a different one wouldn’t have made any difference.

There are a number of fact patterns that lead to physician non-reliance, the golden boy of the bunch being when a doctor (a trained professional, after all) already knew about the risk in question and thus did not need to be warned about it.  Another commonly seen warning causation defense is when the doctor testifies that none of the plaintiff’s warning sophistry matters, s/he would still treat the plaintiff the same way today.


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Several of us (the Reed Smith side, obviously) recently attended the firm partners’ retreat. All our brainstorming about how to improve client service started us thinking about the blog.  In some ways, legal blogging’s not that much different than other legal services – we just don’t get paid for it, at least not directly.  Our intended readership follows us, to the extent they do, with the expectation (realistic, we hope) of learning things that they can use to help defeat drug/device product liability litigation.  That brings value to the industry (and indirectly to various clients), since a win anywhere helps defendants everywhere.

So where can we bring, or at least preserve, value to the industry/our clients through the blog? We thought about MDLs.  Defendants spend a great deal of money slogging their way through MDLs, and where possible we’d like to preserve whatever good we get out of them.  Depending on judicial predilection (Judge Bechtle didn’t; Judge Weinstein does), MDLs often include summary judgment and (less frequently) other dispositive motions concerning individuals or groups of plaintiffs.  Some of the motions are based on Daubert, but if not, they’re usually based on state law – learned intermediary, statute of limitations, other issues.

So what?

Here’s what. State-law-based rulings in MDLs involve judges in one jurisdiction, like Judge Weinstein in New York in Zyprexa, deciding issues presented by other states’ laws – say whether a failure to warn was causal under Louisiana law.  That’s fine for the MDL, but what about the rest of us?  Also, what about anybody after an MDL is (at long last) concluded?  What legal researcher would think to look in New York for a case possibly presenting a relevant fact pattern for a Louisiana motion?

Not too many.

We speak from experience.  When we’re putting together a summary judgment motion in some other case, whether one-off or a different MDL, where do we look for supportive precedent?  Why we look in the logical place, of course – the decisions of that particular state’s courts and federal decisions in the district and appellate courts responsible for that state.  That’s where we get the most bang for our research bucks. That’s doing our clients’ work in the most efficient manner.

So we don’t look in Florida, or New York, or Pennsylvania if we’re working on a case under Texas law.  It’s simply not cost effective, given the number of other jurisdictions and the relatively low likelihood of success.  Sometimes we run across something significant through checking lists of citations (colloquially known as “Shepardizing”) to relevant cases, but we’re not systematic.

But just because it’s not worthwhile in a given case to conduct such broader searches doesn’t mean that what’s out there isn’t worth knowing about.  In Zyprexa alone, Judge Weinstein granted dozens of summary judgments applying the law of at least half the states of the union. Those cases are useful precedent – if defense counsel can locate them in a way that doesn’t waste the client’s money.

That’s where we come in.  We’re bloggers.  We’re not getting paid for this.  We don’t have to be cost effective in the narrow sense that lawyers working for client X or client Y have to be.  We just have to do the research – and we have.

What follows will be incredibly boring to many of you, but we hope equally useful.  We’ve collected individual summary judgment decisions (unless we specify a different procedural posture) in various MDLs – no matter what jurisdiction they were in.  We’ve organized them by state, omitting decisions made by MDL courts applying their own forum’s law, since those cases would be found by searching “the usual suspects.” That means, if you’re researching Mississippi law, just look under “Mississippi law cases” in the list below, and there are the cases, no matter what MDL court decided them.

Caveat #1: As we’ve said many times, we don’t do the other side’s research for them.  These lists include only cases where the defendant won everything (or almost everything) under a particular state’s law.  As far as adverse MDL precedent is concerned, we make no representations whatsoever.  Yeah, we saw some bad cases while doing this research.  We’ve intentionally omitted them.

Caveat #2. We expect this list is under-inclusive. Why? To keep the searches manageable, we reviewed only cases where “product liability” appeared in the name of the case (the usual way that MDLs are named), and “[insert state name] law” appeared somewhere in the body of the opinion.  That means we searched “Alabama law,” not just “Alabama.”  Otherwise, we’d have gotten hits for every MDL case where one of the (often scores) of attorneys was from Alabama.  Still, we think our results are a lot better than nothing. We’re not aware of this kind of list having been compiled anywhere – at least anywhere that’s public.

Caveat #3. We’ve only included issues that we could see possibly arising in drug and device product liability litigation. If an MDL decision was favorable to the defendant only on, say, asbestos exposure product identification (the most common example by far), we have not included it.

Caveat #4. We have not included decisions that were driven by federal issues, such as Daubert or preemption.  Federal issues involve different research considerations, so that decisions from MDLs in different circuits are less useful.

So here goes. For the first time anywhere, pro-defense product liability MDL decisions organized by the jurisdiction of the law being applied.


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