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Over three years ago (an eon in blogging time) we urged our readers – particularly those of you who are in-house – to consider joining the Product Liability Advisory Council (“PLAC”).  We believed then, and continue to believe, that PLAC membership helps pharmaceutical and medical device defendants litigate complex matters smarter and more efficiently, because of the cutting edge legal information available through PLAC’s twice-yearly conferences, online knowledge base, and defense counsel network.

More importantly, PLAC consistently churns out superior amicus curiae (“friend of the court”) briefs in cases involving product liability and complex litigation-related issues that are critical to defense success in major matters.  PLAC’s amicus briefs are crafted, not to show the flag or to say “me too,” but to affect the outcome of genuinely important cases in ways that benefit all defendants.  We use “all” advisedly.  PLAC will not brief issues that could divide defendants.

For these reasons, and on general principles, we think that every drug/device company that faces significant product liability exposure – which, unfortunately, is just about everybody these days – should join PLAC.  PLAC’s annual dues for corporate membership are $7,500, a sum that pales in comparison to a single major verdict, or indeed a settlement in a significant mass-tort matter.  To think of this another way, it usually costs PLAC many multiples of a company’s dues to file a single amicus brief, and (as Bexis knows from long experience) PLAC gets cajoles its brief writers to work on bargain-basement rates, which multiplies the “bang” for PLAC’s buck still further.

A little about PLAC.  Although it was originally founded by the auto industry back in 1982, it’s not an industry-specific group.  It’s a subject matter group, and those subjects are product liability and complex product-related litigation.  PLAC’s primary role is and always has been the filing of amicus briefs in appellate cases with issues of significant import in this kind of litigation.  Obviously, such cases usually involve product liability, but not always.  Procedural issues, such as class actions, abound (PLAC briefed punitive damages issues in Dukes).  PLAC has even filed briefs in criminal cases (on Daubert issues).

Let’s consider that a bit.  We’ve said elsewhere that the three most important defenses in prescription medical product liability litigation are, in order of importance:  (1) preemption, because if it applies it eliminates cases wholesale without regard to their factual merit; (2) Daubert, because it can eliminate entire categories of claims on causation grounds; and (3) the learned intermediary rule, because it eliminates cases individually, but potentially for several different reasons.

Take preemption.  All preemption in personal injury cases traces its roots back to Cipollone v. Liggett Group, Inc., 505 U.S. 504, 530 (1992), where the Supreme Court first rejected notion that torts were somehow different from other forms of government regulation.  PLAC briefed Cipollone.  The drafter of PLAC’s brief in that case (Mayer Brown’s Ken Geller) sits with Bexis on PLAC’s nationwide case selection committee, and outranks Bexis in seniority).  Cipollone was the case that established express preemption.  The first major implied preemption product liability preemption case was Geier v. American Honda Motor Co., 529 U.S. 861 (2000), which PLAC not only briefed, but helped organize (defense counsel was simultaneously on PLAC’s case selection committee).  PLAC was of course involved in the ensuing major drug- and device-specific Supreme Court preemption cases – win or lose: Lohr, Buckman, Riegel, Kent, Levine, etc.

Take Daubert.  PLAC helped create Daubert.  Toughening the standards for expert testimony was a PLAC project before Daubert existed.  PLAC has been in every major Supreme Court Daubert case – Kumho Tire, Joiner, Weisman and in state supreme court cases around the country where similar issues arise under state law.  PLAC has briefed expert issues involving benzene in New York, Doritos in Pennsylvania, and asbestos in a lot of places.

Take the learned intermediary rule.  In recent years, PLAC has appeared in multiple state supreme court cases where adoption of the learned intermediary rule has been on the menu. These include Connecticut, Georgia, Kentucky, and most recently Texas.  If somebody had brought the West Virginia case to PLAC’s attention, who knows? Maybe the result could have been better. Couldn’t have been much worse.

PLAC keeps statistics on the kinds of issues it briefs.  Here they are, out of somewhat more than 1,000 total PLAC briefs (some briefs fit more than one category):

Preemption (including drug and medical device) = 172

Punitive Damages = 149

Class Action = 138

Experts (mostly Daubert and state-court analogies) = 113

Design Defect (including comment k) = 109

Compensatory Damages = 46

Warnings (including learned intermediary rule) = 39

Discovery of Trade Secrets = 38

Tort Reform (including compliance defense statutes) = 26

Similar incidents/adverse events = 19

Everyone of these issues – even design defect – is of importance to drug and device defendants.

We don’t want to rehash what we said in 2011, so here’s a list of most (we omitted some state court writs) of the drug/device cases that PLAC has briefed since then.  These include the good, the bad, the settled, and the petition denied, so they didn’t all produce opinions.  But every one of them raised serious issues that any drug/device company could find itself facing.  PLAC has demonstrably been on the front lines of prescription medical product liability litigation throughout this period:

  • Bartlett v. Mutual Pharmaceutical, U.S. Supreme Court & First Circuit  – implied preemption of design defect and “stop selling” claims against generic manufacturers
  • Hutto v. McNeil-PPC, Inc., U.S. Supreme Court & Louisiana Supreme Court – OTC drug preemption, Mary Carter settlement evidence
  • Matrixx Initiatives Inc. v. Siracusano, U.S. Supreme Court – materiality of non-statistically significant adverse drug reaction reports
  • Scofield v. Wyeth LLC, U.S. Supreme Court – constitutionality/remittitur of punitive damages in bifurcated action
  • Smith v. Bayer Corp., U.S. Supreme Court – collateral estoppel effect of denial of class certification on second identical class filed in different jurisdiction
  • Stengel v. Medtronic, Inc., U.S. Supreme Court & Ninth Circuit (x2) – PMA preemption and novel state parallel violation theories
  • Werner v. Novo Nordisk, U.S. Supreme Court – personal jurisdiction of non-U.S. parent based on activity of separate corporate subsidiary
  • Weeks v. Wyeth, Inc., Alabama Supreme Court (x2) – whether an innovator drug manufacturer can be liable for allegedly inadequate/fraudulent warnings where the plaintiff took only a generic drug (Conte issue)
  • State ex rel. McDaniel v. Janssen Pharmaceuticals, Arkansas Supreme Court – gigantic ($billion+) state AG action verdict on novel theory in statutory quasi-class action
  • Garrett v. Howmedica Osteonics Corp., California Supreme Court – state-court expert admission standards
  • Gaston v. Schering-Plough Corp., California Supreme Court – existence of “presumption of reliance” in consumer fraud class actions
  • Caldwell v. Janssen Pharmaceuticals, Louisiana Supreme Court – overturning huge state attorney general verdict in statutory quasi-class action
  • Graphic Communications Local v. CVS, Minnesota Supreme Court − third-party payer non-reliance consumer fraud action against pharmacists; no private right of action issues
  • Daniel v. Wyeth Pharmaceuticals, Inc., Pennsylvania Supreme Court – propriety of punitive damages where defendant complied with all FDA regulations
  • Lance v. Wyeth, Pennsylvania Supreme Court – existence of negligent design theories in prescription drug cases where no alternative design exists, comment k
  • Hamilton v. Centocor Corp., Texas Supreme Court – whether Texas should adopt the learned intermediary rule; whether a direct-to-consumer exception existed
  • West Virginia ex rel. McGraw v. Johnson & Johnson, West Virginia Supreme Court – state AG consumer fraud quasi-class action, res judicata finality of FDA warning letters
  • Wyeth v. White, West Virginia Supreme Court – availability of consumer fraud remedies in cases involving FDA-approved products, non-reliance causation
  • Romo v. Teva Pharmaceuticals, Ninth Circuit (en banc) – application of CAFA to mass actions
  • Carrera v. Bayer Corp., Third Circuit – propriety of class action certification of consumer fraud claims in OTC product case
  • Plubell v. Merck & Co., Fifth Circuit – All Writs Act prohibition of duplicative, successive class actions
  • In re Vioxx Products Liability Litigation, Fifth Circuit – secondary payer state AG, fraud on the market, non-reliance causation theories
  • Merck Corp. v. Conway, Sixth Circuit – constitutionality of state attorney general hiring private counsel to sue drug companies on contingent fee basis
  • Caplinger v. Medtronic, Tenth Circuit – PMA medical device preemption in context of off-label use and claimed off-label promotion
  • Dobbs v. Wyeth Pharmaceuticals, Tenth Circuit – implied preemption under Levine “clear evidence” standard for prescription drugs
  • Teague v. Johnson & Johnson, Tenth Circuit – fraudulent misjoinder to defeat diversity jurisdiction
  • In re Pelvic/Gynecare Litigation, New Jersey Superior Court, Appellate Division – defense ability to consult with plaintiffs’ treating physicians and use them as expert witnesses in mass tort context
  • Polett  v. Zimmer, Inc., Pennsylvania Superior Court (en banc) − excessive compensatory damages in medical device case

This three-year activity (28 cases. some with more than one PLAC brief) list shows PLAC being engaged on practically every major product liability/complex litigation issue that currently exists in prescription medical product liability litigation:  all three kinds of preemption (medical device, generic drug, and innovator drug); class actions; attorney general actions; punitive damages; expert testimony; Conte claims; the learned intermediary rule; consumer fraud; CAFA, contact with plaintiff’s prescribers.  Go back further, or look more broadly, and you’ll find PLAC’s name on a host of other issues – market share liability, public nuisance, successor liability, confidentiality in discovery – you name it, if it’s important to defending product liability and other complex product-related cases, you’ll find PLAC’s fingerprints.

And there’s something else of great practical value.  PLAC has a new and improved (and secured) interactive website with a knowledge base that includes all of its amicus briefs (and a bunch of other stuff).  That website also supports communication between hundreds of active PLAC “sustaining” members (individual product liability defense attorneys) at most of the nation’s most active product liability defense firms.  Need to know about an opposing expert?  Need to find an expert?  Need to know about a jurisdiction, or opposing counsel?  Want to run some peculiar issue past a bunch of really knowledgeable litigators (including Bexis) who share the same “rising tide” philosophy as this blog – that defense wins anywhere help defendants everywhere?  PLAC’s interactive website is the place to be.  Indeed, the sharing of information that had always gone on inside of PLAC was one of the major inspirations for the founding of this blog back in 2008 – we’ve tried to take some of what PLAC does and apply it to the defense community at large.

In sum, if you’re a pharmaceutical company, or a medical device manufacturer, PLAC has your back.  In fact, if you are any manufacturer, PLAC has your back.

Conversely, we think that pharma/medical device companies should also have PLAC’s back.  As many amicus briefs as PLAC writes, by the end of every year budgetary constraints prevent PLAC from doing even more.  PLAC and this blog share the same philosophy, but PLAC can only brief important cases, can only provide some of the most sophisticated CLE seminars anywhere, and can only run its members’ communication network, if supported by contributing members, especially corporate members.  The $7,500 annual dues are a bargain, and once a company really needs amicus help, downright trivial. Finally, while PLAC briefs important cases that don’t involve its members, it does help to be a PLAC member to get cases accepted for briefing, especially when the budget gets tight.

For the $7,500 annual PLAC corporate dues a PLAC corporate member gets sympathetic review (no guarantees) of requests for amicus support in major appellate cases, unlimited attendance at PLAC’s two annual meetings (enough CLE to satisfy any state’s requirements and interesting enough that you won’t be tempted to take a nap), the PLAC electronic knowledge base, and the PLACconnect member’s exchange.

So we encourage all of our in-house readers whose companies aren’t current PLAC members to join.  Any company interested in joining (for us out-house defense attorneys there’s a substantial queue) can call PLAC at (703) 264-5300, and ask for Hugh Young, PLAC’s President, or email him at  If you want to discuss PLAC with Bexis (Jim Beck), a 20-year PLAC veteran, feel free to contact him through the links on the blog.

Who knows, maybe the next eight, nine, or even ten-figure verdict that PLAC helps overturn, or the next litigation-changing summary judgment the PLAC helps get affirmed might have your name on it.