We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”).  We continue to believe that PLAC membership helps pharmaceutical and medical device defendants litigate stronger (through inter-industry cooperation on shared issues of concern), smarter (through cutting edge CLE and webinars), and more efficiently (utilizing PLAC’s online knowledge base and other resources).

PLAC’s first and foremost feature is its amicus curiae (“friend of the court”) briefing program, which is second to none in the product liability space.  Since its founding, PLAC has filed more than 1200 amicus briefs (Bexis has written 89 of them).  These briefs are not limited to drug/device cases, since PLAC members are involved with practically every type of product there is.  Thus, PLAC addresses critical product liability-related issues across-the-board in major litigation.  PLAC writes to win, not just to show the flag or to say “me too,” in important cases where favorable results stand to benefit all defendants in all kinds of product liability litigation.

Here’s a snapshot of some of PLAC’s recent activity just from 2021 and early 2022:

Drug/Device Issues

  • Boehringer Ingelheim Pharmaceutical, Inc. v. Cartee, No. 21-1035 (11th Cir. filed Nov. 10, 2021).  This appeal is from the Zantac MDL decisions we discussed here and here that rejected innovator liability, a preemption avoidance theory that we have often argued poses an existential threat to the branded drug industry.  The appeal remains pending.  FYI, PLAC has briefed this issue repeatedly, going back to the original Cal. App. case (Conte) in 2009.
  • Glover v. Bausch & Lomb, Inc., No. SC20607 (Conn. filed Oct. 15, 2021).  Courtesy of the Second Circuit, as we blogged here, Connecticut will be the second state high court to determine whether state law allows a “warning” claim based on another of the other side’s favorite preemption avoidance theories − allegations of failure to report adverse events to the FDA.  The appeal remains pending.  FYI, PLAC successfully briefed the first state supreme court decision (Conklin, in Arizona) that decided this issue.
  • In re Bair Hugger Forced Air Warming Devices Products Liability Litigation, No. 19-2899 (8th Cir. filed Sept. 4, 2021).  The defendant first sought PLAC’s help on en banc rehearing, after suffering a loss on admission of expert testimony that we considered to be the worst decision of 2021.  On very short notice, PLAC submitted a brief in what was procedurally a long shot case.  Rehearing was denied, but PLAC will be filing in support of an appeal to the United States Supreme Court in 2022.
  • Janssen Pharmaceuticals, Inc. v. A.Y., No. 20-1069 (U.S. filed March 4, 2021).  Supreme Court petitions for certiorari are always long shots, but the payoff can be huge (see prior PLAC cases, including TransUnion (below), Metro-North (medical monitoring), Geier, Buckman, Riegel, Bartlett, and Albrecht (all preemption)).  PLAC argued that the FDA’s pre-authorization requirements for any statement in product labeling about off-label uses preempted state-law claims demanding such statements.  Unfortunately certiorari was denied.
  • State ex rel. Hunter v. Johnson & Johnson, 499 P.3d 719 (Okla. 2021).  Our #1 best case of 2021 was also a PLAC case.  In late 2020, PLAC briefed the issue of whether public nuisance was a viable theory of liability against product manufacturers.  In 2021, the Oklahoma Supreme Court agreed with PLAC’s longstanding position (asserted previously in lead paint and firearms cases) that it was not.

General Issues of Interest to Prescription Medical Product Manufacturers

  • Cooper Tire & Rubber, Co. v. McCall, No. 21-926 (U.S. filed Jan. 21, 2022).  As we discussed, the Georgia Supreme Court held that mere registration to do business subjected a company selling products nationwide to general personal jurisdiction, meaning that any plaintiff from anywhere could sue the defendant in Georgia.  Continuing its participation in every major Supreme Court personal jurisdiction decision since Bauman, PLAC argued in support of a Supreme Court certiorari petition that this overexpansive jurisdictional theory claim is unconstitutional.  The appeal remains pending.
  • Coates v. R.J. Reynolds Tobacco Co., SC 21-175 (Fla. filed Jan. 5, 2022).  In this tobacco case, PLAC is opposing imposition of multiple punitive damages awards for the same conduct.  The appeal remains pending.
  • Johnson & Johnson v. Fitch, No. 21-348 (U.S. filed Oct. 4, 2021).  This talc-related petition for certiorari raised two preemption issues of general importance:  abolition of the presumption against preemption and what constitutes “official,” preemptive FDA action.  Unfortunately certiorari was denied.
  • Monsanto Co. v. Hardeman, No. 21-241 (U.S. filed Oct. 1, 2021).  Supporting another certiorari petition, in a pesticide case, PLAC argued that the Supreme Court should take a look at the Ninth Circuit’s lax and pro-plaintiff Rule 702 expert exclusion decisions.  The appeal remains pending, and the Court has asked for the Solicitor General’s views.
  • Abbott v. E.I. du Pont de Nemours & Co., No. 21-3418 (6th Cir. filed July 28, 2021).  Opposing MDL abuse, PLAC argued in this environmental pollution litigation against recognizing the results of a few bellwether trials as non-mutual offensive collateral estoppel in favor of thousands of MDL plaintiffs.  The appeal remains pending.
  • Finnerty v. NCAA, No. 20A-CT-01069 (Ind. filed June 18, 2021).  What’s PLAC doing in a suit over college sports?  Opposing the plaintiffs’ attempt to take apex depositions of a corporation’s chief executives, that’s what.  In 2021 PLAC likewise opposed apex depositions in an automobile case in Georgia (brief filed Nov. 22, 2021).  Both appeals remain pending.
  • Johnson & Johnson v. Ingham, No. 20-1223 (U.S. filed April 2, 2021).  In another talc-related certiorari brief, PLAC argued that the Supreme Court should examine whether consolidation of multiple unrelated plaintiffs in a single trial – resulting in a billion-dollar nuclear verdict − violated the defendant’s due process rights.  Unfortunately certiorari was denied.
  • Sardis v. Overhead Door Corp., 10 F.4th 268 (4th Cir. 2021).  In a Rule 702 counterpoint to the awful Bair Hugger decision, this PLAC case involving a workplace product affirmed exclusion of implausible plaintiff-side expert testimony, in particular agreeing with PLAC on the need to enforce the proponent’s burden of proof on all the Rule’s admissibility requirements.
  • TransUnion LLC v. Ramirez, 151 S.Ct. 2190 (2021). A certiorari long-shot that paid off.  TransUnion wasn’t even a product liability case, but class actions are another PLAC “crown jewel” issue.  The Court agreed that mere threatened injury to class members was not sufficient to establish standing because a bare risk of harm was speculative.

Want more?  We describe PLAC’s history and additional significant PLAC amicus cases in our 2011 and 2014 posts.

And PLAC does not do amicus work only.  Notice how admissibility of expert testimony under Fed. R. Evid. 702 popped up several times in our bullet points.  As we’ve discussed, the federal judiciary’s Advisory Committee on Civil Rules has recognized lax judicial gatekeeping as a major problem and has proposed amending Rule 702 to tighten up the existing standards and to emphasize the proponent’s burden of proof – precisely what cases like Bair Hugger and Hardeman have abused.  Just last month PLAC filed a lengthy and scholarly comment in favor of those amendments.  Thus, PLAC is advancing defense interests in areas relevant to prescription medical product liability litigation in other ways beyond its stellar amicus program.

There will soon be more.  PLAC is in the process of putting together a specific PLAC Life Sciences/Drug & Device working group that will focus on issues specific to our industry, through webinars, forums, bulletins, etc.  This working group will be officially announced at this year’s PLAC Spring Conference.  It is yet another way that PLAC’s organizational resources can help drug, device, and vaccine companies address legal issues of mutual concern.  Now is an excellent time for prescription medical product companies to get in on the ground floor.

So if issues like MDL abuse, expert witness abuse, discovery abuse, class action abuse, personal jurisdiction abuse, innovator liability, preemption, and/or punitive damages are keeping your company’s legal department (or your clients) up at night, joining PLAC is both a way to fight back, and a place to turn when something goes south in a company’s own litigation.

For these reasons, and on general principles, we continue to think that all drug/device companies that face significant product liability exposure – which, unfortunately, in the current MDL- and class action-mad environment, is just about every company – should join PLAC.  PLAC’s annual dues pale in comparison to a single major verdict, or settlement, in mass-tort or product liability litigation.  To talk actual numbers, any amicus brief that PLAC writes costs several times the $7500 annual PLAC dues amount, and PLAC never charges anyone (member or not) anything extra to write a brief.  As Bexis can attest, PLAC gets bargain-basement rates from its brief writers.

PLAC corporate members receive preferential amicus consideration – more than half of PLAC’s briefs are filed on behalf of PLAC member companies, and well over half of corporate members’ requests for amicus support are approved.  In addition, corporate members may bring as many in-house counsel as they want to PLAC’s twice-a-year, two-day conferences.  Aside from networking, the two annual conferences provide some of the most current and in-depth product liability-focused CLE around, and enough CLE credits to meet the yearly hour requirements of every state we know of.  In between its conferences, PLAC conducts webinars approximately monthly on other current product liability-related issues.  Members also get access the members-only section of PLAC’s website, with an interactive knowledge base that has just about all PLAC amicus briefs as well as PLAC Announce, providing email communication with hundreds of PLAC “sustaining” members (individual product liability defense attorneys) from most, if not all, of the nation’s most active product liability defense firms.

In sum, if you’re a pharmaceutical company, or a medical device manufacturer, or a vaccine manufacturer, PLAC has your back.  Conversely, we think pharma/medical device companies need to have PLAC’s back.  Only budgetary constraints prevent PLAC from doing even more.  By each year’s end, PLAC’s case selection process confronts hard choices driven, not by the importance of particular cases, but by limited resources.  PLAC and this blog share the same philosophy that a defense win anywhere helps defendants everywhere, but PLAC can only brief significant cases, and can only do the other important things it does, when supported by dues-paying members, especially corporate members.

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 Kim Condon or Rita McConnell, who are, respectively, PLAC’s executive director, and manager of programs and initiatives.  Or you can email them at kcondon@plac.com or rmcconnell@plac.com.  They have plenty of information they can send you.  If you want to discuss PLAC with Bexis (Jim Beck), a 25+ year PLAC sustaining member and member of PLAC’s Case Selection Committee, feel free to contact him through the link on the blog.  Finally, if your company has a big appeal, and thinks it might need amicus support, you can access PLAC’s Case Selection Questionnaire here.

Who knows, maybe the next nuclear verdict that PLAC helps overturn, or the next litigation-winning summary judgment the PLAC helps get affirmed, might have your company’s name on it.