Happy New Year!

It’s been 3 ½ years since we last updated our index to our online research resources.  That’s almost ⅓ of the total life of the blog, which started in way back in 2006.  We’ve been blogging now for well over ten years.  Our first substantive research post, on the presumption against preemption, was published that November.  We are now up to over 3400 separate posts of greater or lesser import.

We use this blog regularly as a research tool, and we regularly pass posts along to others in our firms when they ask. We suspect that a lot of you do, too.  Even for us, it becomes progressively more difficult to find what we’ve already posted – particularly when we want to do it quickly.  Given that we’re the authors of (almost) all these posts, and presumably we remember at least something about them, we can only guess how difficult accessing our posts must be for the rest of our readers.  We’ve tried with categories and tags, describing the topics, but not only are they less than 100% accurate, but they’re less than 100% consistent, since each member of the blogging team treats them a little differently.  Beyond that, some of our more heavily used topics, like preemption with nearly 500 posts, are quite unwieldy to sort through.  We’d guess that over half of all of our categories have over 100 posts.

We like to know where things are too.  One of the many reasons we write the blog is to provide our clients with more value for less.  The ripple effects, of course, go beyond our clients to the industry as a whole and the defense community as a whole.  But if another law firm saves a mutual client X dollars by using one of our posts to get a leg up on a research topic, we still think we’re providing extra value, even if indirectly.  In order to do that, we can’t be re-inventing the wheel, any more than in our billable matters.  Using free – or at least non-billable – blog research seems like an eminently reasonable step for any of us to take.

The alternative would be to keep things internal and not share.  But then why blog at all?  Our basic philosophy that defense wins anywhere help defendants everywhere – whether that win is in Philadelphia or Poughkeepsie, Los Angeles or Laramie, D.C. or Des Moines.  Value is value, whether billed to a client or not.  We are acutely aware that not every defendant and not every case can independently justify the depth of research we do.  But we are egotistical enough to think our research could be beneficial to the defense of just about any case.  So we’ve decided to share … again.

What follows is 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.  For “value,” it is hard to beat “free.”

So, if you’re looking to be entertained, come back tomorrow.  But if you’re a defendant or a defense lawyer who might actually want to use the blog’s research resources, you’ll want to save this post somewhere.

Here’s how we go about this.

Our serious research is of four overall types.  First, are our scorecards.  These compile all cases that we know of, pro or con, on a topic.  Scorecards are updated on an ongoing basis, so the date of the post is not particularly important.  Keep in mind, that, because we’re not in the business of doing the other side’s research for them, scorecards only address subjects where historically the defense usually wins.  That’s why we had to retire our prescription drug preemption scorecard after Wyeth v. Levine, 555 U.S. 555 (2009).

Second, are our cheat sheets.  These address subjects where the weight of precedent 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.  When using cheat sheets, always be aware that adverse precedent exists, but is not listed in the cheat sheet.

On numerous occasions, we’ve either 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.  So, third, we’ll list our state-by-state research topics.

Fourth, and finally, we’ll follow that with our remaining nationwide research organized by topic.  We’re also including the date of the post, so you’ll know how current the research is, because with only a few exceptions, our research posts other than scorecards and cheat sheets is not updated.

SCORECARDS

Post-Riegel Pre-Market Approved Device Preemption Scorecard

Post-Mensing Generic Drug Preemption Scorecard

Innovator Liability in Generic Drug Cases Scorecard

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

Lack of Compensable Injury Scorecard

CHEAT SHEETS

Post-Bauman Personal Jurisdiction Cheat Sheet (updated through BMS)

Post-BMS Personal Jurisdiction Cheat Sheet

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 – Heeding presumption (11/7/14)

Causation – Physician failure to read warnings (10/28/11) and (10/17/13) – this second one is updated

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

Comment k/Unavoidably Unsafe Product – Non-implanted medical devices (8/4/17)

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

Consumer Fraud – Learned intermediary rule (10/10/16)

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

Duty – Corporate credo (11/18/16)

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) (updated)

Innovator Liability – Analogous bare metal defense (1/8/15)

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

Learned Intermediary Rule − Consumer fraud (10/10/16)

Learned Intermediary Rule – Financial ties as purported exception (8/3/17)

Learned Intermediary Rule – Medical device cases (7/10/08)

Learned Intermediary Rule – States adopting it by level of court (7/5/07 – occasionally updated), and again (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)

Punitive Damages – How much increase in risk is necessary (11/9/15)

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 (8/4/11)

Personal Jurisdiction – Jurisdiction through registration to do business (12/18/17)

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

GENERAL NATIONWIDE RESEARCH

Substantive law:

3D Printing (2/5/15)

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)

Artificial Intelligence (7/24/17)

Biomaterials Access Act (8/19/16)

Bulk Suppliers – Liability (11/29/12)

Causation – Duty to Report (9/19/16)

Causation – Increased risk/lost chance (11/30/15)

Causation – Individualized reliance (9/19/13)

Causation – Plaintiff conduct (9/18/17)

Causation – “Regulatory causation” (1/19/17)

Causation – Risks plaintiff never suffered (4/24/17)

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

Comment k/Unavoidably Unsafe Product – PMA devices (11/30/17)

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

Consumer Fraud – Prescription medical products not “consumer” goods (2/10/12), and again (6/25/15)

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

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

Damages – Phantom damages (discounted medical bills) (10/9/14)

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), and again (12/12/17)

Design Defect – Manufacturing defect comparison (6/30/16)

Design Defect – Pre-approval design defect (5/8/17)

Distributors – Limits to liability (2/10/15)

Duty to Report − Causation (9/19/16)

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

Duty to Update Claims (9/12/16)

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

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

FDA – Warning letters lack force of law (9/3/15)

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

First Amendment – Off-label promotion (1/13/16), and again (1/15/16)

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

Fraud On The Market – Causation (2/17/12)

Heeding Presumption – New York law (10/8/15)

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

Homeopathic Products (8/11/15)

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

Junk Faxes (7/29/15)

Learned Intermediary Rule – Adoption (3/3/16)

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

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

Learned Intermediary Rule – Non-physicians as intermediaries (2/20/17)

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)

Medicare Secondary Payer – Recovery from attorneys (1/16/17)

Medical Malpractice – Off-label use and the standard of care (11/2/12), and again (2/13/17)

Medical Malpractice – Standard of care (12/12/17)

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 again (2/12/09)

Negligent Design – Alternative design requirement (2/27/17)

Off-Label Use – State authority to regulate (1/27/17)

Pharmacogenomics (5/26/15)

Preemption – 510(k) preemption post-Lohr (9/24/15), and again (4/22/16), and yet again (8/22/16), and once again (10/30/17)

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

Preemption – Design defects in branded drugs (1/1/16), and again (8/18/17)

Preemption – Failure to contraindicate claims (6/26/17)

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

Preemption – First Amendment (8/27/15), and again (12/9/15)

Preemption – Fraudulent concealment in PMA context (11/29/17)

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 – Injunction against selling FDA-approved product (2/9/16)

Preemption – OTC/monograph drugs (11/25/08), and again (12/12/16)

Preemption – Off-label warnings (12/19/13), and again (3/20/17), and yet again (9/20/17)

Preemption – Peer review material discovery (11/5/15)

Preemption – PMA devices and good manufacturing practices (9/14/14)

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 – Branded drug impossibility preemption post-Levine – non-NDA-holder, boxed warnings, major changes, failure to recall (8/22/14), and again (8/13/15)

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

Preemption – Presumption against preemption (11/15/06), and again (10/30/17)

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

Preemption – Question of law (3/28/17)

Preemption – Transitional devices (10/31/13)

Product Liability – Definition (2/16/17)

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 again (7/18/13)

Punitive Damages – Compliance as a defense (3/8/07), and again (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 – Duties when present in operating room (9/23/11)

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

Warnings – Boxed warnings as adequate as a matter of law (7/10/17)

Warnings – Causation issues (5/8/08), and again (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 again (4/1/10), and yet again (4/24/17)

Warnings – Statistics (11/13/14)

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)

Attorney/Client Privilege – Ex employees (11/28/16)

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

Class Actions – Ascertainability (1/23/15)

Class Actions – Cross jurisdictional statute of limitations tolling (3/22/07)

Class Actions – Cy pres (10/15/09)

Class Actions – Personal jurisdiction (11/20/17)

Class Actions – Punitive damages (7/17/09), and again (2/26/09)

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

Courts – Conflict in precedents (4/12/17)

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

Discovery – Cost sharing (5/15/17)

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 (5/22/13)

Discovery – Litigation holds (4/3/14)

Discovery – Lone Pine orders (8/11/08)

Discovery – Predictive coding/technology assisted review of documents (3/24/16)

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

Discovery – Scope after 2015 rules amendments (4/25/16)

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 again (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 again (6/30/11)

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

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

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

Evidence – Sham affidavits (9/25/17)

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

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

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

Expert Witnesses – Suzanne Parisian (8/9/12) and again (8/14/13), and yet again (3/30/17)

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

Expert Witnesses – Videotaping expert product examinations (4/2/15)

Joinder – Misjoinder (1/7/10)

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

Multidistrict Litigation – Direct filing (10/16/17)

Personal Jurisdiction − Class actions – (11/20/17)

Personal Jurisdiction – Consent by registering to do business (3/5/15)

Personal Jurisdiction – Dormant commerce clause (7/5/16)

Personal Jurisdiction – Litigation tourism (10/20/17)

Personal Jurisdiction – Third-party subpoenae (6/23/16)

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

Pleading – TwIqbal − “And/or” pleading (7/23/09)

Pleading – TwIqbal − Fraudulent joinder (6/15/12), and again (7/9/12), and yet again (4/19/13)

Pleading –TwIqbal − Generally (12/2/11)

Pleading – TwIqbal − “Otherwise negligent” pleading (11/23/12)

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

Pleading – TwIqbal − Product liability cases generally (8/6/09)

Pleading – TwIqbal − Removal to federal court (11/18/10)

Pleading – TwIqbal − State court (10/29/09)

Pleading –TwIqbal – Various dismissal grounds (5/16/12)

Removal – Bad faith and fraudulent joinder (7/18/16)

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

Removal – Various removal issues (misjoinder, TwIqbal, consent) (10/1/09)

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

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

Trial – Gag orders (6/28/16)

Wikipedia (1/23/17)

Ending the year on a high note is one thing that the blog tries to do – with the top ten drug/device product liability decisions of the year. Occasionally, a court will do something that ruins the party, with an eleventh-hour awful decision (the infamous Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), was decided two days before Christmas), but barring that, we’re looking for nothing but happy news in going through our list of the best decisions of the year.  And make no mistake about it, there’s plenty to celebrate this year.

Before we do, we should explain one thing. Our list is limited to cases involving drugs and medical devices.  Every year some cases significantly impact our sandbox, even though their facts put them outside the drug/device arena.  Thus, we’ll give a shout out to the Supreme Court’s BNSF Railway Co. v. Tyrrell, 137 S.Ct. 1549 (2017), decision holding once and for all that Bauman is not limited to corporations incorporated in other countries.  A couple of other jurisdictional decisions of the same ilk are Aspen American Insurance Co. v. Interstate Warehousing, Inc., ___ N.E.3d ___, 2017 WL 4173349 (Ill. Sept. 21, 2017) (litigation over a fish warehouse), and State ex rel. Norfolk Southern Railway Co. v. Dolan, 512 S.W.3d 41 (Mo. 2017) (another railroad case), both of which took long strides in shutting down litigation tourism in key states.  Given the universal importance of jurisdiction, any one of these may well have more impact on particular clients’ cases than some of the decisions appearing on our list.

Enough preliminaries. Time to start celebrating good decisions:

  1. Bristol-Myers Squibb Co. v. Superior Court of California, 137 S. Ct. 1773 (2017). To the surprise of absolutely nobody who has been a regular reader of the blog, the “BMS” decision is our pick for the best decision of the year.  After the Court said “we really mean it” about the “at home” requirement of general personal jurisdiction in Bauman, litigation tourist plaintiffs simply shifted the same broad jurisdictional arguments to specific jurisdiction.  The California appellate courts immediately signed on, with a “sliding scale” that in practice allowed jurisdiction over all mass torts anywhere. That decision, which we tagged as the worst of 2016, is no more.  In BMS an 8-1 majority put the kibosh on what it described as a “loose and spurious form of general jurisdiction.”  Plaintiffs cannot obtain specific jurisdiction by osmosis – because some other plaintiffs who actually lived in the state in question could bring the same type of claim.  Rather, the conduct “giving rise” to the suit, such as the injury and the alleged tort, must happen in the state, so that there is “harm” in the state and to the state’s residents.  Equally significant, plaintiffs’ “last ditch” argument based on the presence of an in-state co-defendant, also failed.  Personal jurisdiction requirements “must be met as to each defendant” separately.  Merely “contracting with” an in-state entity failed miserably.  The beneficial effects of BMS in curbing litigation tourism have been immediate and widespread, if not total.  The abusive 99-plaintiff complaints, with a one or two plaintiffs in the jurisdiction and a the same in the defendant’s home state to defeat diversity, are being carved up and dismissed.  BMS jurisdictional issues caused havoc with the plaintiffs’ litigation strategies in both talc litigation and the Pinnacle Hip MDL.  BMS is forcing mass torts to change.  It’s not perfect, but a massive improvement on where our clients were before.  We celebrated BMS here, and to help our side, have written quite a few posts on how BMS can be beneficial in various situations.
  2. Trejo v. Johnson & Johnson, 220 Cal. Rptr.3d 127 (Cal. App. 2017).  Our second case also arises from California, and is a major preemption win for non-generic drug manufacturers (in this case, OTC) post-Levine (2009-1).  Typical for California at the time, plaintiffs were litigation tourists from overseas.  They won $55 million for SJS-TENS – a condition that tends to produce big verdicts and big decisions.  Most significantly, Trejo all but dooms design defect claims in the nation’s largest state.  Mensing/Bartlett preemption, using the “independence principle,” rendered such claims “impossible” because significant design changes (here, changing the active ingredient) require prior FDA approval.  Trejo was the first appellate court to apply this reasoning to OTC drugs (we’re 4-0 overall outside generics), and did so although “product liability” claims were expressly saved from express (not implied) preemption.  Trejo also came down hard on plaintiff’s “alternative design” being an active substance not approved by the FDA, holding such an alternative design to be no alternative at all, but merely an indirect argument for removing an FDA-approved drug from the market.  Also, Trejo made an important state-law ruling, that only “risk/utility,” and not “consumer expectation,” is a viable design defect theory for a complex product such as an OTC drug – a holding that should apply a fortiori to products that require a doctor’s prescription.  Finally, as to warnings, the court held that a defense verdict on strict liability and a plaintiff verdict on negligence were fatally inconsistent – providing some level of deterrence against plaintiffs seeking multiple bites at the liability apple.  Trejo is final.  Plaintiff unsuccessfully appealed to the California Supreme Court.  We toasted Trejo here.
  3. Cerveny v. Aventis, Inc., 855 F.3d 1091 (10th Cir. 2017).  Affirming last year’s ninth best decision, the Tenth Circuit’s opinion attests to the revived strength of implied preemption in prescription drug cases after Levine (2009-1).  Although summary judgment for the defendant was reversed in part on a minor point (warning causation – but only because the issue hadn’t been litigated in the district court), the big-deal preemption arguments were affirmed:  (1) “clear evidence” established that the FDA would not have entertained plaintiff’s proposed warning; (2) the FDA’s rejection of a citizen’s petition (a harassment technique favored by plaintiff-side organizations) was “clear evidence” that a manufacturer’s similar attempt would also be rejected, since the scientific standards are identical; and (3) an FDA rejection, for lack of scientific evidence, necessarily preempts tort claims from all earlier times, since even less data would exist at those earlier times.  Item two created a split with the Massachusetts high court in Reckis (2015-1), but the Cerveny plaintiffs did not seek certiorari in the Supreme Court.  Plaintiffs also tried to interpose Fosamax (2017-1), but the Tenth Circuit affirmed preemption anyway, given the “smoking gun” strength of the citizen’s petition evidence.  Cerveny created a much needed “bright line” in the murky post-Levine preemption landscape, eliminating older claims.  When we celebrated Cerveny here, we opined that the surviving warning claim was extremely weak, since it turned on risks the plaintiffs did not encounter.  We have since been proven right about that, so the only drawback in this powerful pro-preemption decision has disappeared.
  4. In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, 858 F.3d 787 (3d Cir. 2017).  Next to preemption, Daubert is the strongest defense available to the good guys – capable (in our personal experience) of ending entire MDLs with a single motion.  That’s what happened with this MDL claiming that Zoloft (similar allegations have been made about this entire class of drugs) causes birth defects.  The science says the opposite, the district court followed the science (2015+9), and this year the Third Circuit affirmed.  Even with an uncalled-for second chance, plaintiffs could not offer scientifically valid general causation evidence.  Plaintiffs lost on several grounds.  Their claims of teratogenicity had no epidemiologic support.  What they did have – statistically insignificant results and cherry-picked “trend analysis” – couldn’t support a Bradford-Hill, or even weight-of-the-evidence (which the court did not adopt), analysis.  The expert’s meta-analysis was result-driven, with no inclusion/exclusion criteria beyond what would help plaintiffs win.  Generally, the methodology was inconsistent and unexplained.  As the most significant Daubert decision of the year, signaling the end of an entire MDL, we rate it number four, although we could do without some of the dictum.  We examined Zoloft here.
  5. United States ex rel. Nargol v. DePuy Orthopaedics, Inc., 865 F.3d 29 (1st Cir. 2017).  Fraud on the FDA was eliminated as a viable theory in Buckman, right?  Largely, but not entirely.  Applying basic preemption principles, Buckman held that state-law claims alleging that, but for “fraudulent” information, the FDA would have done something different than it actually did were inherently preempted, since only the FDA has authority to decide if it has been defrauded.  But the False Claims Act is a federal statute, and preemption does not apply between two competing federal requirements, so FCA plaintiffs have attempted to use fraud on the FDA as a basis for statutory liability.  In Nargol the First Circuit, expanding upon the rationale it first adopted in D’Agostino (2016+4), said “no” – and that is one of the most plaintiff-friendly FCA courts around.  Unless the FDA actually found fraud, causation is entirely speculative, since the FDA hasn’t changed its decision, plaintiffs are necessarily pursuing a counterfactual hypothesis.  Also, if the “fraud” had been material, the FDA would have done something, so that’s another necessary FCA element that such claims lack.  Materiality is a “demanding standard.”  Nargol had no patience with plaintiffs dissing of 510(k) clearance – that “process constitutes the government’s method of determining whether a device is safe and effective,” through which “the FDA affirmatively deemed the product safe and effective.”  Nargol also analogized to Buckman, finding the same concerns also weighed against allowing the FCA to become a vehicle for second-guessing FDA regulatory decisions.  Because Nargol stands in opposition to decisions like Cisson (2016-2) on the import of 510(k) and Fosamax (2017-1) on letting juries second-guess the FDA, it made our list even though it’s not classic product liability.  We gave Nargol our nod here.
  6. Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644 (S.D.N.Y. 2017).  Did we mention already that preemption is powerful enough to shut down an entire MDL with a single ruling?  That’s exactly what happened in Utts, the only trial-level decision to make our top-ten list this year.  Not only that, Utts stomped all over litigation against new-generation blood thinners, which we think is particularly meritless, since bleeding is about as well-known and inherent risk of these products as anything imaginable.  Utts engaged in the most extensive discussion we’ve yet seen of implied preemption of warning claims for lack of “newly acquired evidence” (the prerequisite to allowing unilateral warning “strengthening” under the FDA’s CBE regulations).  MDLs, in particular, are likely to spawn “newly acquired evidence” preemption arguments, because they have many plaintiffs spread out over the product’s entire timeline.  Supposed “deficiencies” in the earliest information are thus the only warning-related claims that can benefit all plaintiffs in an MDL.  In Utts none of the nine different types of risk information that plaintiffs alleged should have been beefed up differed materially from the information the FDA considered in approving the drug; hence no information was “newly acquired”; hence preemption.  Nor could Fosamax (2017-1) apply, since “clear evidence” only becomes an issue after a plaintiff demonstrates “newly acquired evidence.”  Aside from preemption, Utts also features defense-friendly discussions of:  (1) the FDA’s reporting system; (2) the drawbacks of overwarning; (3) comparative claims; (4) California’s state-of-the-art defense; and (5) warnings being adequate as a matter of law. Utts is a long opinion, and every word is worth reading.  We went nuts over Utts here.
  7. Johnson & Johnson v. Fortenberry, ___ So.3d ___, 2017 WL 4699593 (Miss. Oct. 19, 2017).  The Mississippi Supreme Court reversed a multi-million dollar plaintiff verdict for two important reasons.  First, the label’s warnings about the risk in question were adequate as a matter of law.  That’s a significant victory in and of itself – before we point out that the drug was an atypical antipsychotic, the risk was tardive dyskinesia, and the warning was classwide labeling.  The high court declared a lot of labels adequate in a lot of cases.  As we pointed out, that means that the defense wins without even having to consider physician-specific causation arguments.  Second, a state high court declaring that the purported tort of “negligent marketing” does not exist is also a big deal.  Plaintiffs use this claim as a vehicle for admitting “marketing” evidence, that is, irrelevant promotional evidence to which the prescriber was not exposed, and for seeking punitive damages.  In Mississippi, at least, that cause of action has failed.  Oh, yes, the court also affirmed the trial court’s determination that, as a matter of law, plaintiff failed to make a case for punitive damages.  We let out a rebel yell over this result, here.
  8. Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. 2017).  Say you bought a product.  It had exactly the characteristics it was represented to have, worked in the manner it was supposed to, and didn’t hurt you in the slightest.  Could you then sue because the product wasn’t designed in some other way that might somehow have made it more efficient or “better”?  Can you then generalize your complaint across an entire class action?  If you say yes, then you agree with the Third Circuit in Cottrell (2017-4).  If you say no, then keep reading.  In one of Judge Posner’s final opinions, he reversed class certification in a case alleging that eye-drops (yes, the drops themselves) were too large, and thus were a suboptimal use of the fluid.  The drops were exactly as represented and not injurious.  Eike found the claim bogus in several ways.  It attacked an FDA-approved design.  It purported to invoke a duty not just to make a safe and effective product, but to make the “best” product possible – with “best” being unobtainable because it is only defined by plaintiffs’ experts.  There was no standing because there had been no injury.  “[T]hat a seller does not sell the product that you want, or at the price you’d like to pay, is not an actionable injury; it is just a regret.”  We eulogized Eike (and Posner) here.
  9. State ex rel. Bayer Corp. v. Moriarty, ___ S.W.3d ___, 2017 WL 6460354 (Mo. Dec. 19, 2017).  Very late in the year, the Missouri Supreme Court recognized that Bauman and BMS have changed the parameters of personal jurisdiction, and unanimously granted mandamus  – a much tougher standard than ordinary appeal – holding that a multi-plaintiff, misjoined complaint (92 plaintiffs, 85 from out of state) against a device manufacturer could not create jurisdiction over the claims of non-resident plaintiffs against a non-resident defendant.  The court ordered the existing complaint dismissed.  “At home” means a lot more than just doing business, so no general jurisdiction.  As the court had ruled previously, registering to do business does not constitute consent to general jurisdiction, because it would “result in universal personal jurisdiction for corporations complying with registration statutes in many states.”  Nor was there specific jurisdiction, since the contacts of “other plaintiffs” was not enough to create the necessary “affiliation between the forum and the underlying controversy.”   Plaintiffs would have to show some specific facts about their claims and Missouri that would not “simply be another way of gaining general jurisdiction over [defendant] in the many states,” and could try on remand.  Because Moriarity was so recently decided, we haven’t blogged about it yet, but we expect to.
  10. In re Depuy Orthopaedics, Inc., 870 F.3d 345 (5th Cir. 2017).  Wait a cotton-picking minute here.  The defendant lost; mandamus denied.  What is this case doing in a pro-defense top-ten list?  Why?  Because the defendant didn’t really lose, although the relief sought was denied.  Mandamus is very hard to get.  The writ requires three elements, and one of them is that an eventual ordinary appeal is not an adequate remedy.  Waste of time and money between here and there doesn’t count, and the Depuy defendant didn’t clear that hurdle.  But the defense won the other two, more substantive, elements.  A majority held that the MDL-wide order concerning waiver of jurisdictional defenses was not only wrong, but “patently erroneous” and a “clear” abuse of discretion.  Waivers must be explicit; this one wasn’t; resulting in “grave error.”  Second, mandamus was “particularly appropriate” because the error had ramifications “beyond the immediate case” because the MDL ruling purported to extend to almost 10,000 MDL cases.  Reminds us of the original Batman.  These rulings – embodied in a precedential decision – were a huge loss for the MDL plaintiffs, which they recognized, since they moved for rehearing en banc, even though not technically “aggrieved.”  Although not an order (because mandamus was denied), the panel “requested” the MDL judge to vacate the offending order and halt further “bellwether” trials pending resolution of other, pending appeals.  That request was refused, and what in all likelihood was a pointless trial thereafter ensued.  All in all, this result was a rare appellate intervention into the workings of an MDL, and given what happened afterwards, it appears that one such intervention will not be enough.  We covered the oral argument, and then delighted in Depuy, here.

So there you have it, the drug/medical device decisions that we consider to be the ten best of 2017.  But we like good decisions, and 2017 featured a lot more than ten blogworthy outcomes favorable to the right side of the “v.”   As usual, we’re listing another ten good decisions for 2017 that fell just short of cracking our top ten.

These are our Honorable Mentions:  (11) Sidney Hillman Health Center v. Abbott Laboratories, 873 F.3d 574 (7th Cir. 2017).  Rejecting proof of causation of causation/damages in RICO off-label promotion suit as inadequate as a matter of law.  We applauded adherence to traditional causation standards here.   (12) In re Mirena IUD Products Liability Litigation, ___ F. Appx. ___, 2017 WL 4785947 (2d. Cir. Oct. 24, 2017).  Another affirmance of an MDL-ending Daubert order (2016+6) that, if precedential, would almost surely have made the top ten.  We cheered exclusion of plaintiffs’ ipse dixit, ginned up for litigation opinions here.  (13) M.M. v. Pfizer, Inc., 806 S.E.2d 800 (W. Va. 2017).  A state high court deciding that Michigan plaintiffs couldn’t escape adverse applicable statutes.  Plaintiffs brought that on themselves, as we explained here.  (14) United States ex rel. Ibanez v. Bristol-Myers Squibb Co., 874 F.3d 905 (6th Cir. 2017).  The FCA is an “awkward vehicle . . . for punishing off-label promotion schemes.”  The relators’ lack of personal knowledge meant they couldn’t overcome TwIqbal, as we discussed here.  (15) Inge v. McClelland, 257 F. Supp.3d 1158 (D.N.M. 2017).  A detailed and articulate reaffirmation of the principle that plaintiffs can’t recover for injuries caused by their own criminal acts, which the rise of opioid litigation makes all the more timely.  See our post here.  (16) Wolicki-Gables v. Doctors Same Day Surgery Center, Ltd., 216 So. 3d 665 (Fla. App. 2017).  This Florida appellate court has forgotten more Florida law than the Eleventh Circuit (2017-8) ever knew, particularly on negligence per se issues, as we explained here.  (17) In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 226 F. Supp.3d 557 (D.S.C. 2017) & In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 227 F. Supp.3d 452 (D.S.C. 2017).  Another MDL-ending Daubert decision, holding that, while a viable claim could exist for a particular dosage at certain times, not one of the scattershot solicited plaintiffs in the entire MDL met those criteria.  We loved Lipitor here.  (18) Barraza v. C.R. Bard Inc., ___ F.R.D. ___, 2017 WL 3976720 (D. Ariz. Sept. 11, 2017).  In over twenty years, not a single product liability/personal injury class action has survived a contested appeal.  That losing streak was not broken by medical monitoring allegations involving a medical device, as we reported here.  (19) In re Zofran (Ondansetron) Products Liability Litigation, ___ F. Supp.3d ___, 2017 WL 3448548 (D. Mass. Aug. 4, 2017).  As we explained here, innovator liability poses an existential threat to branded drug manufacturers.  Thus, a decision rejecting such liability in six states is worthy of attention, which we gave here.  (20) Aston v. Johnson & Johnson, 248 F. Supp.3d 43 (D.D.C. 2017).  Judicial Watch specializes in vast conspiracy theories, but the conspiracy alleged in its first foray into product liability was only half-vast.  Here, we tallied up the resulting favorable preemption, TwIqbal, and other substantive law rulings as the entire complaint was dismissed with prejudice.

Perusing our best and worst from 2016, the worst of 2016 became the best of 2017 with the BMS loss at the California Supreme Court turning into a win in the United States Supreme Court.  Of our ten “worst of the year” cases between 2007 and 2016, fully half of them are no longer good law (BMS and Bartlett (2012-1) outright reversed; Weeks (2014-1) and Karl (2007-1) overturned by statute; and Wimbush (2010-1) limited to its facts after Bartlett (2013+1).  Given what it takes to get to number one (either the best or the worst) that’s not a bad track record at all for the good guys.  Also, as we’ve mentioned, 2017’s worst stinker remains pending in the United States Supreme Court, with decent prospects.  By contrast, every single one of our top ten best over the past decade is still standing tall.

Going down last year’s list, we already mentioned (2017-3) the Missouri affirmance of Barron (2016-3).  An appeal in T.H. v. Novartis (2016-5) is pending, and that California Supreme Court decision – good or bad − will certainly make next year’s lists (unless decided before the end of this year).  The Pinnacle Hip entry from last year (2106-6) is on appeal, representing another decision likely to make one of next year’s lists. Certiorari was denied in another adverse jurisdictional decision (2016-8), and as far as we can tell none of the other baddies are going anywhere.  On our good list, we already mentioned the Mirena (2016+6) and Cerveny (2016+9) affirmances, an appeal in Lipitor (2016+7) is pending (4th Cir. #17-1140) and will be argued early in 2018.  Further appellate review was denied in Niedner (2016+3).  Everything else appears final.

Looking over earlier top/bottom ten lists, we lost Incretin (2015+10) to a non-substantive, unpublished reversal just a couple of weeks ago.  Jeez, the Ninth Circuit is slow.  We lost Fosamax (2013+7) to the Third Circuit’s horrible decision (2017-1) that leads this year’s bottom 10 list.  MDLs move even more slowly.  None of the other top/bottom ten cases had their status changed in 2017.

Going forward, as we’ve already discussed, 2018 could go down as the “year of innovator liability” – good or bad – with two more state high courts poised to decide the same issue that California went south on the other day.  On that same subject, there’s also that Case That Must Not Be Named in the Seventh Circuit.  The Fifth Circuit will finally have its say on the Pinnacle Hip (2016-6) rulings, and other appeals arising from that MDL.  The New Jersey Supreme Court will be reviewing several aspects of the long-running Accutane litigation.

Finally, on the administrative front, the FDA’s proposal (discussed here and here) to amend the “intended use” regulations has been in limbo for some time, with the Agency – under new management – having to formulate a First Amendment position on truthful off-label promotion that is reflective of current jurisprudential realities.  Congress has before it a bill, passed by the House of Representatives, that (as we discussed here) would alleviate some of the worst mass tort abuses that we unfortunately have to live with every day.  Maybe the Senate will pass something similar in 2018, but we’re not counting any chickens just yet.

Now it’s time to ring down the curtain on 2017 – barring something big happening in the next couple of days.  We wish all our readers good health and good cheer in 2018.  To our readers on the right side of the “v.,” we also wish a productive and successful New Year.

Sometimes it happens.  For eleven years, we have published our annual “worst of” the year post on the Thursday before Christmas and our annual “best of” the year post on the Thursday before New Year’s.

Guess what?  In a development that we weren’t entirely surprised to see happen, the California Supreme Court recognized not only innovator liability, but innovator liability in perpetuity, later during the same day that our 2017 “worst of” post was published, which coincidentally was the first day of winter.  Winter is not just coming, it’s now here.  California’s tort climate just became much colder for our pharmaceutical clients.

So we’re publishing this addendum to this week’s “worst of” post.  This year there will be two number one worst of the worsts.  Given everything else that’s happened in 2017, we suppose that is appropriate.

  1. T.H. v. Novartis, 2017 WL 6521684, slip op. (Cal. Dec. 22, 2017).  Innovator liability, which effectively shifts 100% of potential liability for drug injuries to the 10% of the drug market that branded drugs represent, received the nod of all seven justices in this 4-3 decision. Y et, remarkably, the majority took the view that “the burden on brand-name drug manufacturers” to warn “those who are prescribed the generic version of the drug is zero.”  That attitude, an insouciance towards any policy supporting prescription drugs (Brown cited not at all by the majority, and only once, parenthetically, by the somewhat less restrained concurrence) was apparent throughout.  The result is pharmaceutical companies being disfavored, even compared to asbestos manufacturers. The same dismissively pro-plaintiff attitude that recently caused the same court to invite all mass tort plaintiffs to sue in California (2016-1) rears its ugly head again.  T.H. defined negligence “duty” broadly and vaguely – “each person has a duty to use ordinary care and is liable for injuries caused by his failure to exercise reasonable care in the circumstances” – so that it could characterize even this vast expansion of liability to non-manufacturers as some sort of “exception” to the a general rule that allegations of negligence make anyone liable to everyone for anything.  But then T.H. inconsistently discounted a mountain of contrary federal precedent because federal courts aren’t supposed to predict novel expansion of state-law liability.  At least Sindell, bad as it was, was honest about its unprecedented result.  T.H. is not the first time we’ve seen an opinion putting the “duty” rabbit in the hat like this to support a novel liability theory; Lance (2014-2) did the same to allow a stop-selling “negligence” theory.  Lance has preemption problems, and T.H. might, too, at least on the case-specific off-label use facts.  The majority appears to believe that off-label risk warnings can be added “unilaterally,” which they can’t.  Somewhere, Justice Traynor, who conceived of product liability as ensuring the liability followed profit from product sales and ability to control product quality, must be spinning in his grave.  Innovator liability violates both principles, and also lets off the hook the party that profited from the product and directly controlled its risk.  Almost as bad – and even more extreme – is the second holding that innovator liability is effectively perpetual.  Bookending California’s expansive “product line” form of successor liability, T.H. creates “product line” predecessor liability; so that even sale of all rights to the product before (here, six years before) the relevant product sale does not extinguish liability.  It must have been a clear day, since the majority was able to foresee forever.  On this issue T.H. was 4-3 (with the vote of a randomly selected “assigned” justice being the difference), with the dissenters rightly focusing on:  (1) lack of control over a successor’s warnings; (2) overwarning of scientifically questionable risks; (3) insufficient deterrence of the actual product manufacturers; (4) “destabilization” of the pharmaceutical industry by perpetual, unlimited liability; (5) liability spillover to other products; (6) an unrealistic attitude towards corporate transactions; (7) relative lack of moral blame; and (8) unavailability of insurance for risks of competing products and the resultant increase in the price of branded drugs.  Although T.H. is a bit less blunt in expressing the motivations for its novel liability holding than Weeks (2014-1), the California court’s underlying intent to use common-law liability to hold branded drugs hostage to federal action eliminating generic preemption is found in both in the majority’s footnote 2 and the first paragraph of the concurrence.  We trashed T.H. here, and will undoubtedly be doing that again.

The second most successful college basketball coach of all time (in terms of NCAA Division 1 national championships) has said “All of life is peaks and valleys. Don’t let the peaks get too high and the valleys too low.”  We’re remembering that today because, frankly, dealing with all the lows at once can get depressing.  That, however, is the purpose of today’s post.  We’re looking at the bottom ten worst prescription medical product liability litigation decisions of 2017.

All these lumps of coal in our defense-oriented stockings is enough to give us all a case of seasonal depression.  These cases, while hardly candidates for a Hallelujah Chorus, do remind us of a different sort of Hallelujah – the kind we want over with as soon as possible.  So let’s get on with it already.  If you were on the receiving end any of these cases atrocities, we feel your pain.  We’ve been there (see 2013 -2), and we know what you went through.  That said, we’ll feel better next week, when we welcome the New Year with the our best decisions, after having taken this week’s purgative.

So let’s start purging:

  1. In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  It’s hard to screw up the our most important defense – preemption − law in more different ways in one case than Fosamax did. The MDL court had found preemption because the FDA had actually considered the risk in question, several times, after obtaining classwide information, leading to a detailed section on that risk in 2011. Plaintiffs, as always demanded more, a causal warning that the FDA had rejected. They lost, under Levine’s (2009-1) “clear evidence preemption standard, back in 2014, and scores of claims were dismissed. Typical of the muddle that MDLs make of litigation these days, an appeal took three years to decide. Definitely not worth the wait. To avoid preemption on facts where the FDA had actually rejected the warning the plaintiff wanted, the Third Circuit did two things. First, ignoring prior Supreme Court precedent, the Third Circuit created an unprecedented heightened evidentiary standard for implied preemption, converting Levine’s requirement of “clear evidence” into a requirement for “clear and convincing” evidence. In eight years since Levine, no court had gone there (and no court has since). Second, to make things even worse, after putting a thumb on the evidentiary scale, the court then declared preemption – the determination that the FDA “would have” rejected a label change – was a question of fact, not law. That’s right, juries get to speculate, after hearing both side’s warring FDA “experts” (current FDA employees can’t be called as witnesses without the Agency’s consent) about what the FDA might have done. That ruling goes beyond unprecedented, since it flies in the face of more supposedly binding Third Circuit precedent than we have fingers. Nor could anything be more destructive of FDA authority than to let juries speculate about what the agency might have done with hypothetical warnings, and reach differing conclusions about the same drug in different cases. Under Fosamax, summary judgment on preemption is possible only when “no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected Plaintiff’s proposed . . . warning.” In other words, never – since the FDA had, in fact, rejected it. We decried this “lawless” result here. In addition, we cheered on the defendant’s certiorari petition and supporting amicus briefs, while pointing out other courts that rejected the Third Circuit’s misguided reasoning. And there is a glimmer of hope. The Supreme Court has asked for the Solicitor General’s views on the case, which tells us that this appeal has a pretty decent chance of being granted.
  2. Eghnayem v. Boston Scientific Corp., 873 F.3d 1304 (11th Cir. 2017).  Eghnayem is the year’s outstanding example of MDL abuse.  Leery of MDL “bellwether” cases turning into  Stalinist show trials, featuring multi-plaintiff consolidation and punitive damages, the defendant declined to waive its Lexecon rights limiting MDL trials.  Didn’t work.  Shades of Stalin chasing Trotsky to Mexico: the MDL judge chased the defendant back to Florida, obtained a temporary commission and tried the case there – with four plaintiffs, punitive damages claims, and all of the adverse evidentiary rulings that have come to characterize that MDL.  All four plaintiffs won nearly identical (two exactly $6,722,222) verdicts of over $6 million apiece.  We have pointed out elsewhere at length how multi-plaintiff consolidations are inherently prejudicial to defendants, hence their use in MDLs as a means of pressuring defendants to pay big bucks to settle.  In Eghnayem, the Eleventh Circuit let it stand – despite the almost identical verdicts that should be a red flag demonstrating that the jury abandoned any effort to consider the cases separately.  “Confusing or not,” it was not an abuse of discretion to consolidate product liability cases (including warning claims, which change over time) involving similar injuries from similar products.  Contrary to almost every other case, even “identical damage awards” “are not sufficient evidence of juror confusion.”  Nor did admission of otherwise inadmissible warning (state of the art) and damages evidence preclude consolidation.  It’s a terrible appellate precedent, we think the first allowing product liability consolidation outside of asbestos.  Compared to that, the court’s affirmance of exclusion of §510k clearance evidence – another unfortunate hallmark of this litigation, although virtually unheard-of previously – is secondary.  We excoriated Eghnayem here, and recommended changes to the MDL statute to prevent such abuses here.
  3. Barron v. Abbott Laboratories, Inc., 529 S.W.3d 795 (Mo. 2017).  The intermediate appellate decision in this case alone was enough to make #3 on our bottom ten list last year. But for a couple of colossal federal appellate screw ups, affirmance of the $38 million ($23 million in punitives) verdict by the Missouri Supreme Court would have moved up a notch or two.  The big problem was venue and joinder – the trick of Missouri forum shopping that allowed a Minnesota plaintiff to have her case tried in St. Louis.  The Missouri Supreme Court dodged the issue holding that any error “by either failing to transfer venue or failing to sever the claims” was harmless because no “prejudice” from trial in St. Louis was shown.  How one would ever show prejudice, short of a lynch mob at the door, is unclear.  Rulings like this are what keep plaintiffs coming back to certain jurisdictions for more.  On warnings, the court held that because the defendant did not trash its own product as being riskier than other similar products, the warning wasn’t “accurate.”  As to punitive damages, the court held that a “black box warning is not relevant” because all contrary evidence is to be “disregarded” in evaluating the verdict.  Incredible – millions in punitives for a risk with a boxed warning.   We blasted Barron here as a poster child for why Missouri needs tort reform to put an end to blatant forum shopping.  That didn’t happen, but something else did (wait till next week) that has made a big difference.
  4. Cottrell v. Alcon Laboratories, 874 F.3d 154 (3d Cir. 2017).  Two Third Circuit cases are in the bottom five this year, and sure enough, the composition of the panels, here and in Fosamax, overlapped substantially.  The question in Cottrell was standing, specifically whether an otherwise uninjured consumer of a product could sue because the product wasn’t made and priced in a way that the consumer thought would be better or cheaper.  The same theory had been called “absurd” in a prior Third Circuit (unfortunately nonprecedential) opinion, but this panel never found a novel tort theory it couldn’t adopt.  Creating a circuit split, Cottrell allowed a would-be class action (all these ridiculous cases start as class actions) alleged “injury in fact” because the claims arose from consumer protection statutes. That the claim made no practical or economic sense, because consumers can’t force manufacturers to make different products, was irrelevant because when considering standing the merits didn’t matter. TwIqbal, what TwIqbal? Calling the defendant’s actions “unfair” was enough. When we started writing this blog, the Third Circuit had strong standing requirements that barred no-injury class actions; after Cottrell, the court has fallen to the bottom. At least in this case, unlike Fosamax, there was a dissent. We castigated Cottrell here.
  5. Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017).  The learned intermediary rule means that the duty of the manufacturer is to provide an adequate warning to the plaintiff’s treating physicians, right?  Not if you’re the Washington Supreme Court.  In an unprecedented ruling, Taylor opens up an entirely new front in prescription medical product litigation by ruling that, despite the rule, there exists a separate duty to provide warnings to a hospital, where the product actually was sold to the hospital, which many drugs and devices are.  This ruling potentially opens up hospitals to claims that they failed to stop doctors from using/prescribing products, and creates a second chain of warning causation that now must be negated.  On top of that, Taylor deviated from what had been consistent Washington precedent applying comment k to all prescription drugs and medical devices (Bexis filed an unsuccessful amicus brief on this issue), and held that strict liability can apply anytime a plaintiff asserts that warnings were inadequate.  We trashed Taylor here.
  6. In re Accutane Litigation, 165 A.3d 832 (N.J. App. Div. 2017).  At 15 years, Accutane litigation may well be the second longest running mass tort (after asbestos, of course) in New Jersey.  For a long time that was due a certain one-woman wrecking crew in Atlantic County.  She was kicked upstairs shortly after the defendant in Accutane sought recusal, and the mass tort has outlived her.  However her ghost haunts Accutane still, as Accutane (particularly footnotes 5 and 9) demonstrates.  New Jersey’s approach to expert evidence has sometimes been called “relaxed.”  However, Accutane goes from relaxed to supine.  Plaintiffs’ experts were allowed to avoid and discount multiple epidemiologic studies finding no statistically increased risk at all.  Far from the law lagging science, as is the case (at least rhetorically) with Daubert in the federal courts, Accutane declared that “legal decision making in toxic tort and similar cases may vary from scientific decision making.”  It disregarded the usual hierarchy of scientific evidence, putting animal studies and single-patient case reports on the same level as statistically significant epidemiology.  Where did “general acceptance” go?  Everywhere else but New Jersey, Accutane cases alleging intestinal issues have been dismissed as a matter of law for lack of scientific basis.  Here, some two thousand cases have been resuscitated. We abhorred the Accutane result here, and praised the defense appellate arguments here.  Now, as with Fosamax there is hope.  Earlier this month the New Jersey Supreme Court granted the defendant’s appeal and will decide the scientific issues in Accutane for itself.
  7. Christiansen v. Wright Medical Technology, Inc., 851 F.3d 1203 (11th Cir. 2017).  Christiansen is another example of the problems with bellwether trials in MDL litigation, illustrating how trial and appellate courts will bend over backwards to obtain and affirm plaintiff verdicts.  In Christiansen the jury initially returned a defense verdict.  That was not the result the MDL judge wanted, so he told the jurors that perhaps they did not “fully understand” the case and instructed them to try again, because a no defect finding was supposedly “inconsistent” with a finding of misrepresentation.  Duly admonished, the jury changed its mind and returned a verdict for the plaintiff.  Amazingly, the Eleventh Circuit let that second verdict stand.  In and of itself, that would be bad, but probably too much of a one-off situation to warrant the bottom ten.  However, the Eleventh Circuit went on to disregard the across-the-board application of comment k decreed by the relevant state’s (Utah) highest court.  Comment k only applies to drugs, not medical devices (or at least 510k medical devices) because only drugs are “approved.”  No Utah – indeed no court anywhere – has ever distinguished between prescription drugs and prescription medical devices in this fashion.  Utah law had never even required proof of FDA approval of anything for comment k to apply.  This kind of liability-enhancing, Erie-ignoring ruling on state law is, we believe, a consequence of the bellwether system, which causes disproportionate investment of time and effort in particular trials, which in turn pressures appellate courts to find some way to affirm, so that investment is not wasted.  We chastised Christiansen here.
  8. Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017).  A terrible trifecta for the Eleventh Circuit.  Shades of Bush v. Gore – this time Mink thinks that it knows more about Florida law than the Florida state courts do.  As a general proposition, the Florida Supreme Court has required, for over two decades, that before any use of negligence per se, such use must be consistent with legislative intent.  That means, as a matter of state law, FDCA-based negligence per se claims fail, because the FDCA famously included §337(a), which expressly provides for exclusive government enforcement.  This legislative intent requirement further means that “parallel claims” of FDCA violations do not exist in Florida, and so an unbroken string of state and federal decisions had held.  Until Mink.  The court’s reasoning was bluntly result oriented.  Florida law could not be that way, Mink declared, because otherwise plaintiffs suing over allegedly defective PMA medical devices would be out of court. That’s true, but as the Supreme Court noted in Riegel, that is precisely what preemption does. For taking a blunt instrument to a long-standing requirement of state law for no reason other than to preserve an exception to preemption that this particular state has chosen not to recognize, Mink belongs in this list.  We skinned Mink here.
  9. Wendell v. GlaxoSmithKline, LLC, 858 F.3d 1227 (9th Cir. 2017).  In an ugly decision, the Ninth Circuit reversed a Daubert exclusion in Wendell.  Given the appellate abuse of discretion standard applicable to Daubert decisions, that amounts to a decree that this type of expert testimony must be admitted.  What type of opinion was it?  It was litigation-driven, without a scrap of independent research.  It was unsupported by epidemiology, or even animal studies.  Even the “science” cited by the excluded experts did not address the drug combination plaintiff had used.  Nor had the experts excluded, as a possible cause, the underlying condition that the drug was used to treat.  Instead of science, Wendell was blinded by the supposed “highly qualified” credentials of the experts.  Qualification and methodology are supposed to be separate inquiries under Daubert.  Linus Pauling, for example, won two Nobel prizes, but as to cancer cures he was a quack.  Ditto William Shockley and eugenics.  Further, the “differential diagnosis” technique is notoriously lax, and Wendell was far to credulous about what a proper differential diagnosis must include – and exclude.  The worst Daubert decision of the year in our sandbox.  We whacked Wendell here.
  10. Dunson v. Cordis Corp., 854 F.3d 551 (9th Cir. 2017).  Back in 2014, we awarded a Ninth Circuit en banc decision, Corber v. Xanodyne, our #4 best case rating.  Corber held that a California request for “coordination” triggered CAFA’s mass action provision and supported removal to federal court.  Unfortunately, with Dunson, Corber has now been distinguished into seeming oblivion.  Apparently en banc doesn’t matter much in the Ninth Circuit.  It certainly didn’t in Dunson.  Request for “pre-trial” consolidation – no CAFA.  Request for bellwether trials – no CAFA unless the result would be “binding” on the other cases, which is vanishingly rare.  Basing the bellwether request on need to avoid inconsistent results?  Not specific enough.  After Dunson, we wonder how much is left of Corber.  Form appears to be triumphing over substance.  We derided Dunson here.

So that’s the bottom ten. Unfortunately, the other side did better than usual this year – this is the first time in blog history that every one of the dregs cases has been an appellate decision.  As for the near misses, we’d put United States ex rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017), at the top of the list, since it allowed fraud on the FDA theories in False Claims Act cases, and we hate cases that purport to give private plaintiffs ways to get around Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).

That’s quite enough, thank you.  We’re ready to bring this exercise in the gnashing of teeth and rending of clothes to a close.  Stay tuned, however.  Next week, we take the litigation roller coaster up rather than down when we review the ten best drug/device decisions of 2017.

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.