Most of the cases we defend involve claims of inadequate warnings.  What makes a warning inadequate?  Falsehood is the first thing that comes to mind.  But the Pontius Pilate question of “What is truth?” continues to vex.  We have seen very few drug or device labels uttering an affirmative misrepresentation.  More often the complaint is about what the warning did not say, not what it did say.  If John Lennon sang “Gimme Some Truth,” plaintiff lawyers sing (off-key) “gimme some more truth.”  To our ears, it sounds like “gimme some more money.”  Whatever.  Plaintiffs allege that the product label did not disclose all of the serious side effects, or did not recite them with sufficient detail and drama.  There is a hierarchy of warning inadequacy.  A warning can ‘fail’ for any of various reasons.  You pays your money and you takes your choice.  Did the warning:

  • Fail to grab attention?
  • Fail to persuade?
  • Fail to change action?

The last test is a slam dunk.  If the consumer heeded the warning, we wouldn’t be enjoying each other’s company in the courtroom.  There would be no complaint.  Probably.

The first warnings we remember seeing were on cigarette packs.  The United States was the first country to require such warnings.  Back in 1966, the sides of cigarette packs were adorned with the following: “Caution:  Cigarette smoking may be hazardous to your health.”  That warning did not include the word “warning.”  Change came a couple of years later.  In 1970, packs reminded us that the Surgeon General had determined that cigarettes were “dangerous.”  Still later, smokers were treated to rotating warnings.  Some packs warned of cancer, emphysema, heart disease, and pregnancy complications.  Some stated that cigarette smoke contains carbon monoxide.  Some suggested that quitting now could improve one’s health.  And some warned pregnant smokers of possible fetal injury, premature birth, and low birth weight.  We heard that one fellow filed a lawsuit alleging that cigarettes had caused his lung cancer, while also claiming he had not been adequately warned, because he had made a point of buying only the packs that talked about pregnancy complications.  That case proved at least two things:  (a) no matter what, some people will smoke, and (b) no matter what, some people will file silly lawsuits.

Continue Reading Warning: Lawyers May Be Hazardous To Your Health

It is bad enough that the mass tort system in our country approximates a system of jackpot justice that, if it ever does justice among the parties, does so accidentally. But its wild inefficiencies and inconsistencies also have macro adverse effects on things like consumer choice and the overall healthcare system.

A recent law review article offers further support for our scurvy view of mass torts by explaining how the long, inglorious history of lawsuits against contraceptives has hurt consumers and society. The article is by Eric Lindenfeld, is entitled “The Unintended Pregnancy Crisis: A No-Fault Fix,” and it appears in the Spring 2016 issue of the Marquette Benefits & Social Welfare Law Review.

The article begins by outlining the unintended pregnancy crisis, which is caused at least in part by dissatisfaction with current methods of contraceptives. The article argues that the less-than-robust portfolio of available contraceptives is attributable to a stagnant research and development milieu for new contraceptives. That stagnant milieu is attributable, in turn, to the frenzy of mass torts against contraceptives. The article recites the history of litigation against the birth control pill, Dalkon Shield, Norplant, as well as more recent litigations, such Yaz/Yasmin, Mirena, and Essure. Not all of those litigations were particularly successful for plaintiffs. Not all possessed any merit. For example, the article cites evidence that Norplant turned out to be safe and efficacious – but the expense of the litigation and the enormous adverse publicity drove the product from the market. The real losers were consumers.

Continue Reading Law Review Article Argues that Contraception Mass Torts Injured Consumers

A lot of companies rely on retired and otherwise former employees for information in litigation – including product liability litigation. Particularly where a product (such as a drug that’s now gone generic) has a long history, they are often the best source of knowledge about what happened years ago.  In dealing with ex-employees, however, defendants must keep in mind that, for purposes of the attorney/client privilege, discussions with ex-employees are subject to being treated much differently (and less protectively) than corporate communications with current employees.

The recent case, Newman v. Highland School District No. 203, 381 P.3d 1188 (Wash. 2016), although not involving prescription medical products, or even product liability, is a cautionary tale.  The defendant in Newman was a governmental entity, a school district.  The plaintiff alleged that he suffered a brain injury playing high school football, and that the injury occurred because the plaintiff was allegedly allowed to play in a game the day after suffering a concussion in practice.

The plaintiff in Newman didn’t sue until some three years after the injury. Id. at 1189-90.  By then, most of the coaching staff had turned over, and the individuals with the best knowledge of what had happened were employed elsewhere.  The school district’s litigation counsel contacted the ex-coaches and when they were deposed, claimed to represent them.  Id. at 1190.  Plaintiff challenged that representation as a conflict of interest and “sought discovery concerning communications between [the defendant] and the former coaches.”  Id.  The defendant resisted discovery with a claim of attorney/client privilege, and plaintiff opposed.  The defendant lost, and appealed denial of its motion for a protective order.  Id.

Continue Reading A Reminder To Be Careful With Ex-Employees And Confidential Information

We’re pleased to report the demise of a plaintiff’s firm’s attempt to punish the FDA for rejecting the firm’s attempt to force the agency to create evidence helpful to plaintiffs in litigation. The ploy began in 2012, when “a law firm that represents hundreds” of plaintiffs in prescription drug mass tort litigation “on a contingency fee basis” “filed a citizen petition with the [FDA].”  Sheller, P.C. v. U.S. Dep’t of HHS, 119 F. Supp.3d 364, 368 (E.D. Pa. 2015). Plaintiff sought agency action that it could, in turn, parade before juries in the underlying mass tort, specifically: “that the FDA immediately revoke the [relevant] indication for the . . . [d]rugs” at issue or alternatively “require that labeling for those drugs include a black box warning based on the lack of sufficient data to prove their safety.”  Id.  In addition, the plaintiff law firm sought to enlist the FDA in evading a confidentiality order (originally agreed to by the law firm) that protected discovery which the defendant in the underlying litigation had provided.  Id.

So far, so what?  While annoying, attempts of this nature to embroil the FDA in mass tort prescription medical product litigation are part of the other side’s play book.  (((Bexis))) recalls similar machinations during the Bone Screw litigation whereby the plaintiffs did everything they could (ultimately unsuccessfully) to prevent the Agency from adding to those products’ labeling previously off-label uses that had become the medical standard of care – because the Bone Screw plaintiffs’ litigation strategy was based on the procedures in question being off label.

The Bone Screw plaintiffs failed, 63 Fed. Reg. 40025-41 (FDA Jul. 27, 1998) – as did the law firm plaintiff in Sheller (119 F. Supp.3d at 368) – since the FDA normally has little patience for the junk science that the other side routinely peddles in mass tort litigation.  The plaintiff law firm in Sheller would have been off not filing the petition at all, since according to plaintiff, “the FDA decision to deny its petition “has been used as the basis to assert federal preemption and other [defense] arguments against [plaintiff’s] clients in [mass-tort] litigation.”  Id.

No kidding.  That’s the down side this sort of litigation strategy.  Attempts to involve the FDA in litigation have the risk that, if one loses, the FDA’s actions can create a positive narrative for the other side.

But plaintiffs believe in the doctrine of “heads I win; tails you lose.”

So in Sheller the plaintiff law firm attempted to gin up, from their failed strategy, a tort cause of action – not an administrative claim – against the FDA.  Talk about a bootstrap.  The plaintiff law firm was the one that involved the FDA in the first place.  The bizarre theory of liability postulated that, if the FDA wouldn’t cooperate in creating pro-plaintiff evidence/themes in the underlying litigation, that required the plaintiff law firm to work harder and spend more money to come up with something that juries might believe.  So the law firm sued the FDA to recover its purportedly increased litigation costs:

Plaintiff [claims] . . . that the FDA denial of [its] citizen petition increased [its] costs in litigating [because] . . . the defendant . . . has argued that the FDA’s denial of the Petition proves, as a matter of law, that the [drug’s] label is adequate. . . . Plaintiff argues that it must continue to expend resources in defending against that argument, and it faces the risk that a Court will accept it, lowering [plaintiff’s] contingent fee recovery.

Sheller, 119 F. Supp.3d at 369-70 (quotation marks omitted).

Continue Reading Bootstrapped Claim Against the FDA Gets the Boot

Today we have a guest post from Reed Smith‘s Jaclyn Setili, about one of our pet peeves – MDL plaintiffs (and their counsel) who think they don’t have to do any work at all on their cases, and simply show up come settlement time with their hands out.  In this instance, they received a much deserved comeuppance.  As is the case with all our guest posts, Jaclyn deserves all the credit for what follows, as well as any blame.

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At last, friends, it’s that time of year again. Time to dust off the sweater vest, memorize your favorite college football team’s schedule (Go Blue), and indulge in the ubiquitous pumpkin-spice-flavored everything.  In fact, just the other day as we were jogging along the Schuylkill River Trail, after an oppressively hot and humid summer, we glimpsed the first few yellow leaves of the year as they gently, and gracefully, made their journey to the asphalt, and our heart leapt with joy and relief.

Unlike spring, however, autumn is not a time for fresh hope or new beginnings.  Rather, the season reminds us of the inescapable promise that another year is nearing its eventual terminus.  A recent opinion from the Southern District of Florida, In re Denture Cream Products Liability Litigation, — F. Supp.2d —-, 2016 WL 4582185 (S.D. Fla. Aug. 31, 2016), encapsulates that idea:  the fundamental truth that every summer—like every lawsuit—must come to an end.  Winter, friends, is always coming.

In re Denture Cream is another order from the denture cream MDL, which we have covered on several prior occasions, i.e. here and here.  To remind you, the JPML consolidated multiple cases in MDL 2051 on September 12, 2011, finding that they all shared common questions of fact concerning allegations that the level of zinc found in certain brands of denture cream may cause copper deficiencies and neurological injuries.  The opinion we discuss today, however, involves a frequent bane of MDL defendants – the plaintiffs who try to lie back, hide in the weeds, do as little as possible, and share in an eventual settlement.  This time, it didn’t work out so well for those plaintiffs.

Continue Reading Guest Post – With No General Causation Experts, Denture Cream Plaintiffs Drop Like Leaves In Autumn

An article forthcoming in the California Law Review has been posted on SSRN and is worth reading:  Bradt & Rave, “The Information-Forcing Role of the Judge in Multidistrict Litigation.”   The authors describe how MDL proceedings have come to dominate the federal civil docket – making up nearly half the caseload.  MDLs have to some extent supplanted class actions, while sharing some of the principal-agent problems that plague class actions.  The authors insist that the most serious problem is that the plaintiff lawyers making many of the key decisions in an MDL (usually adorned with the regal title of “the plaintiff steering committee”) do not represent all the plaintiffs.  That problem rears its head in a particularly ugly fashion when it comes to settlements.  Individuals get treated as an aggregate and some make out better than others for no reason grounded in rationality or fairness.  It can hardly arrive as news that plaintiff lawyers might steer more dollars toward their cases than others.  But while a class action judge has a well-defined role/duty to approve or disapprove class action settlements, MDL judges lack such authority.  The authors are distressed by this state of play, because, in their view, MDLs are built for settlement:  “The MDL statute was developed as a judge-centric model – its framers intended that judges would wrest control of cases from the litigants and guide the litigation to a conclusion that would relieve the federal courts of potentially crushing caseloads.”

What’s the solution to the principal-agent dilemma in MDLs?  The authors point with favor to the judge in the World Trade Center Disaster Site Litigation who expressed the view that a proposed settlement was not enough.  That judge, according to the authors, based his authority to reject the settlement on a quasi-class action theory created by Judge Weinstein the Zyprexa MDL.  The WTC judge acted as an ‘information intermediary.”  Once he put it out there that the settlement was, by his lights, unfair, it was not possible to cram down the settlement when most of the plaintiffs would have heard what the judge said.  Bradt & Rave argue that this information intermediary role is an important one for MDL judges, because the MDL lawyers are not reliable sources of information.  It is hard to argue with that last point.

But how reliable are judges?  To the authors’ credit, they acknowledge points made by other scholars questioning the quasi-class action model.  Many (most? all?) judges have a strong interest in settling cases.  The danger of that predilection is, according to the authors, that judges might approve settlements that are unfair to some plaintiffs.  That’s true as far as it goes.  Nevertheless, there is another unfairness danger, and it  does not seem to bother the authors much or at all:  judges in some aggregated proceedings do their utmost to strong-arm settlements that are unfair to defendants.  In the conclusion of the article, the authors tell us that “Settlement is good.”  That’s sort of a Mom and apple pie sentiment, isn’t it?  Yes, there is a Lincoln quote out here somewhere praising the concept of settling litigation.  Fine.  We know we’ll get a reaction as if we passed gas in church when we say this, but, hey, Not All Settlements are Good.  Some are neatly wrapped packages of extortion.   A sentence or two later, the authors write that “the beauty of MDL is that, by gathering all of the players into a single forum under the watchful eye of a coordinating judge with substantial flexibility, it creates a fertile environment to facilitate a comprehensive resolution.”  Fertile, indeed.  There is a lot of fertilizer in that field. Most of the cases in any MDL inventory are meritless – plaintiffs who suffered no injury, or suffered the injury before they used the product, or never used the product at all.  And yet far too many MDL judges act as if any defendant who does not gallop over to the plaintiff steering committee with a settlement offer, a grid, and an open checkbook needs a spanking.  We have seen judges rule against defense motions, or fail to rule at all, as a way of punishing defendants who seem insufficiently eager to settle.  Even more commonly, when a judge wants to inspire defendants to settle, the judge will order absurd trial schedules, often with cases consolidating plaintiffs so as to maximize prejudice and the specter of huge verdicts.  Information forcing?  Call it what it really is: settlement forcing.

Continue Reading MDL Judges: Information-Forcing or Settlement Forcing?

This weekend, the Drug and Device Law Rock Climber hosted a sleepover to say goodbye to her friends as she headed back to college. Somehow, between our last survey of heads on pillows and the convergence on the breakfast table, the number of non-resident young adults increased, prompting the logical question (as we cracked a few more eggs), “How did you guys get here?”

In In re Mortgage Electronic Registration Systems (MERS) Litigation, 2016 WL 3931820 (D. Ariz. July 21, 2016), the United States District Court for the District of Arizona asked a similar question.  This is obviously not a drug or device case, but it is relevant to all of us who defend clients in MDLs. In MERS, cases related to the formation and operation of the subject mortgage registration systems were consolidated in an MDL.  After the court dismissed a number of associated cases, the plaintiffs filed a Consolidated Amended Complaint (“CAC”). One of the named plaintiffs in the CAC had not been named in the previous complaint and “had never filed a lawsuit that the Judicial Panel on Multidistrict Litigation transferred to [the court].” MERS, 2016 WL 3931820 at *1.

A complicated procedural sequence ensued. The district court dismissed the CAC for failure to state a claim upon which relief could be granted.  In its discussion of its dismissal of Count I of the CAC, the court stated, “[The new] alleged Plaintiff . . . is not a named Plaintiff in any member case of this MDL.  Accordingly, Plaintiffs’ claim cannot rest on allegations relating to [this plaintiff].”  Id. at *1.  The Ninth Circuit affirmed the dismissal of the CAC except that it reversed and remanded as to Count I.  And so, the parties ended up back before the MDL court, where the defendants moved for summary judgment on the new plaintiff’s claims.  The defendants argued, “[This plaintiff] never filed a lawsuit that the [JPML] transferred to this Court.  Rather, [he] was joined when Plaintiffs filed their Consolidated Master Complaint – which is impermissible – and thus, this Court’s jurisdiction has not been invoked.” Id. at *2 (citations omitted).  In the alternative, the defendants asked that the new plaintiff’s claims be dismissed for lack of jurisdiction.

The court requested supplemental briefing on the following questions: 1) Does a transferee MDL court have the authority to join ‘new’ plaintiffs in an MDL when such plaintiffs never filed their own case (nor paid the filing fee) and never had their cases transferred to this Court by the panel on multidistrict litigation; and 2) what was the basis for federal subject matter jurisdiction over the new plaintiff’s case. Id. In their supplemental brief, the plaintiffs argued that the new plaintiff’s case was properly joined in the MDL because, like other plaintiffs, the defendants were allegedly involved in recording false documents related to the new plaintiff’s property.  Plaintiffs also argued that the court had diversity jurisdiction over the new plaintiff’s claims.  The defendants countered, “The jurisdictional issue relating to [the new plaintiff] does not involve whether there was diversity jurisdiction or federal question jurisdiction relating to [his] claims.  Rather, the issue is whether the Court’s jurisdiction is sufficiently invoked because [the new plaintiff] never filed a lawsuit in this federal court or in any other federal court that was then transferred to the MDL Court by the [JPML].” Id. at *3.

Continue Reading MDL Court Says “You Don’t Belong Here” to Plaintiff “Added by Amendment”

This is our vacation week, so it’s time once again to play the game of “Where in the World is Stevie Mac?”  Last year, we wanted to visit a place with nice sights, great beer, and, most of all, zero chance of terrorism.  We chose Belgium.  Let that sink in for a moment.  This year should be easier.  The animating factors in 2016 — fear of jet-lag, fear of poverty, and, yet again, fear of terrorism – conspired to keep us fear-ly close to home.  Enjoy these hints:

  • Hello misnomer!
  • It never ratified the 18th amendment (prohibition – so, yes, this is our kind of place).
  • There is a specific law against biting off someone’s leg.  (The legislators here have obviously gotten a little too into The Walking Dead.)
  • The first American ever jailed for driving his car too fast earned that distinction by going a rip-roaring 15 mph here in 1904.
  • Cap guns are illegal in this state.
  • You will be fined if you throw pickle juice on a public trolley.  That rule will frustrate the DDL Son to no end.
  • Finally, our all-time favorite basketball player, Marvin Barnes, hailed from these parts.   Barnes (nicknamed “Bad News”) was part of a gang of high schoolers arrested for robbing a bus.  The victim had no trouble identifying Barnes, who had been wearing a letter jacket with his name embroidered on it.  That brush with the law did not stop Bad News (later shortened to “News”) from having a remarkable hoops career.  Barnes began his professional career with the ABA’s St. Louis Spirits.  Once upon a time, his team was scheduled to fly home from Louisville at 8 o’clock.  Because of the East-to-Central time zone change, the flight was scheduled to arrive in St. Louis at 7:56.  Barnes refused to board the flight.  In his immortal words, “I ain’t getting on no time machine.”  Instead, he rented a car and drove home.  Sadly, Barnes died way too young (62) a couple of years ago.  Let’s pour out a little White Ship Lovecraft IPA in his honor this week.

Continue Reading DDL Summer Vacation: Another Sequel

This is one of those stories you simply cannot make up.

We were using technology to get some ideas about technology. That is, we were surfing around the internet to find descriptions of the successful use of technology in litigation. Our eyes grew weary as we scrolled from screen to screen. There was a lot of same-old-same-old. Then we found an article in the Legal Times from 2005 entitled, “Jurors, Watch the Screen.” You can see the article here. Even as far back as 2005 it was becoming clear that one could use snazzy technology without suffering from the Goliath effect – the perception that your client must have deep pockets. After all, both sides at trials and depositions were using PowerPoints, videos, and arresting graphics. Jurors had come to understand that anyone with a laptop could put on a multi-media show. (Lawyers used to talk about a trial-in-a-box. But by 2005, we went up against a plaintiff lawyer who had a trial-in-a-laptop. He was smooth. He was impressive. He lost.)

Continue Reading Seen on the Screen

It was right after our selfie with Minion Captain America that we saw it. We were marching up and down the aisles, dodging empire storm troopers. Bright lights and backbone-rattling sounds shot out of the Nickelodeon and Star Trek pavilions. A tractor beam pulled us toward a booth hawking books on manga, the Golden and Silver Ages of DC Comics, the Benedict Cumberbatch Sherlock series on BBC … and a modest-looking blue book authored by our Constitutional Law professor. We waited for a phalanx of zombies to pass by so that we could move in for a closer look. What was a law text doing at Comic Con? (Maybe we are in no position to ask that question. After all, we spurned the long lines for the Hall H and Ballroom 20 Warner Bros. and Simpsons panels for a discussion by the Comic Book Legal Defense Fund on “Sex, Violence, and the Law.” Verily, we were a nerd among nerds.)

It is a bit hard to believe that someone is compiling statistics on law professor citations. Was it Kissinger who said that academic disputes are so vicious precisely because they are so trivial? In any event, Cass Sunstein leads the legal citation league standings by light years. When we took his class, he was a relatively humane practitioner of the Socratic method. He was considered one of the few liberals on the Chicago faculty, though that is a gross oversimplification both of his views and of those supposedly sitting on the other side of the spectrum. (Is Posner really a conservative?) Sunstein later went to his alma mater, Harvard Law School (aka the Death Star). He also worked for a while in the Obama administration. His mission was to make regulations more rational. Sunstein was well-suited for this mission, because he had been noodling over ways in which behavioral economics could inform the law. He was co-author of a somewhat controversial book, Nudge. That work explores how laws and regulations can steer people in better directions while preserving freedom of choice. It is a kind of Jedi mind trick. And now Sunstein has given us a charming little (under 200 pages) book, The World According to Star Wars.

The book is clearly a labor of love. Sunstein has always been a busy guy, but fatherhood afforded him an opportunity to catch up on the Star Wars saga. He dedicated the book to his son. Much of the book supplies interesting back-stories to Star Wars, and how so much of it was accidental. For example, if George Lucas’s father had his way, his son would never have gone into anything as frivolous as the film business. We never would have heard of Lucas, or certainly of Luke Skywalker.

Continue Reading Book Review: The World According to Star Wars