2015

Photo of Michelle Yeary

Twice this month we’ve reported on “the saga of Cymbalta plaintiff lawyers who keep pushing the litigation up a hill in an effort to create a class action, mass action, MDL, or whatever will allow them to park as many meritless cases in one place, only to have that litigation roll back down the hill, resulting in crushed toes, directed verdicts, and jury findings of no liability.”  Let’s make it a trifecta.  Both with our third post and with three more decisions severing the claims of misjoined plaintiffs who have nothing in common except that they each used Cymbalta and they each allege injury.  The cases are Jones v. Eli Lilly, 2015 U.S. Dist. LEXIS 141925 (S.D. Ind. Oct. 19, 2015) (15 plaintiffs from 11 states); DeCrane v. Eli Lilly, 2015 U.S. Dist. LEXIS 141924 (S.D. Ind. Oct. 19, 2015) (2 plaintiffs); Boles v. Eli Lilly, 2015 U.S. Dist. LEXIS 141922 (S.D. Ind. Oct. 19, 2015) (19 plaintiffs from 11 states).

We set out the background of plaintiffs’ counsel’s numerous attempts to create a mass tort in our prior posts here and here.  Based on theses earlier decisions, the result in these three cases is really no surprise. But, it does make for more great precedent on misjoinder and severance.  So, today we’ll throw you some sound bites.  For instance, it is hard to argue claims are properly joined when they are described as:

the claims of fifteen Plaintiffs from eleven different states whose allegations rest on distinct, unrelated factual scenarios: Cymbalta treatment over fifteen different time periods, presumably in eleven different states, for several different conditions….; use of the medicine under the care of multiple healthcare professionals from a range of medical subspecialties, affiliated with different practices and, potentially, varying degrees of exposure to the relevant product labeling; a host of potential co-medications and comorbidities; and, finally, Plaintiffs’ particular discontinuation methods (whether abrupt or tapered over varying lengths of time) which allegedly resulted in a range of symptoms of varying type, severity, and duration.

Jones, 2015 U.S. Dist. LEXIS 141925 at *16-17 (all three decisions are virtually identical, so we cite to Jones throughout).Continue Reading Another Smack Down for Cymbalta Plaintiffs’ Lawyers

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The collateral source rule rarely sits well with defense attorneys.  To us, it runs counter to a core purpose of tort law, which is to compensate plaintiffs for damages actually suffered.  Under the collateral source rule, a defendant’s liability for a plaintiff’s financial damages is not reduced by any payments that the plaintiff receives as to those very same damages from a third-party source.  So the plaintiff gets a double recovery—once from the collateral source and once from the defendant.  This happens most often in connection with a plaintiff’s medical bills.  While the plaintiff’s insurance pays all or most of those bills, the defendant remains liable to plaintiff for the entire amount.

There are policy reasons for the rule, and the Louisiana Supreme Court recently laid them out in Hoffman v. 21st Century North Am. Ins. Co., 2015 WL 5776131 (La. Oct. 2, 2015), a decision that addresses an attempt to expand the collateral source rule:

The most oft-cited reason is that the tortfeasor should not gain an advantage from outside benefits provided to the victim independently of any act of the tortfeasor.  We have also recognized the collateral source rule promotes tort deterrence and accident prevention.  Finally, absent such a rule, the reasoning goes, victims would be dissuaded from purchasing insurance or other forms of reimbursement available to them.

Id. at *2.  OK.  We get it, and we can live with it.  We’ve become somewhat numb to the effects of the rule.Continue Reading Should We Expand the Collateral Source Rule? No Thanks.

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We understand that not everyone shares our view of class actions, but we hold certain truths to be self-evident:  The government, including its courts, cannot order someone to give money to someone else without due process of law, in most cases a jury trial.  In addition, in order to win a judgment ordering a defendant to pay money, a plaintiff generally bears the burden of proof on each element of his or her claims, with very rare exceptions.  These principles are cornerstones of the protection that our laws offer to defendants who are haled into court, or at least ought to offer.

Class actions are an exception to these rules.  A limited exception, but an exception nonetheless.  With a class action, a defendant can become legally obligated to pay money to people who never proved their claims, or even had to try.  Instead, class representatives are allowed to stand in as proxies, and proof of their claims is deemed sufficient proof to force defendants to pay the other class members, possibly thousands of them, without any individualized proof.  On the other side of the coin, absent class members can be bound by a judgment that awards them nothing, even though they did not participate in the proceeding.  How can this be?  The potential for abuse is obvious, and that is why there are strict requirements for certifying class actions—Federal Rule 23 and its state-law analogs—and why courts should certify classes only after a “rigorous analysis” demonstrates that the proposed class meets all applicable requirements.  See Wal-Mart Stores v. Dukes, 131 S. Ct. 2541, 2551 (2011).

We wax on about these rules because a case in the Southern District of California recently departed from them in not only certifying, but expanding a class of women who allegedly purchased hormone replacement therapy products.  The case is Krueger v. Wyeth, Inc., No. 03-cv-2496, 2015 U.S. Dist. LEXIS 137548 (S.D. Cal. Oct. 7, 2015), and it has been around seemingly forever.  First filed in 2003, the case was transferred to the In re Prempro MDL, where the MDL judge denied the plaintiff’s motion to certify a class of California patients asserting claims for consumer fraud.  Id. at **5-6.  Not to be deterred, the plaintiff tried again with a different judge after the case was remanded back to California, and this time they found a more receptive audience.Continue Reading California Court Gets It Wrong On HRT Class Action

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Some of our bloggers are speaking at two more continuing legal education (“CLE”) events, one free, the other … not so free.

First, the freebie. On November 18, 2015 Reed Smith’s Life Sciences Group is hosting a half-day CLE program from 9:00 a.m. ET until 1:30 p.m. ET at the firm’s Philadelphia Office (1717 Arch Street, Three Logan Square (formerly the Verizon building)).  Here are the topics:

  • Adventures in Personal Jurisdiction: Can One Have the Bauman Cake and Eat it Too?
  • Turning the Tables – How to Secure Sanctions in the Frivolous Case
  • Tips for Proactively Defending False Claims Act Allegations by Whistleblower Employees
  • Buying Justice? An Ethical Examination of Third Party Litigation Funding

Two of our bloggers, McConnell and Bexis, will present the Bauman personal jurisdiction segment.  Blogger Rachel Weil is co-presenting the ethics segment on litigation funding.

This CLE is approved for four hours (or the equivalent) of CLE credit in both Pennsylvania and New Jersey – including an hour of ethics.  Breakfast and lunch are included.  Like we said, there’s no charge, but space is limited so attendees do have to register.  You can do that here.Continue Reading Shameless Plugs Redux − Two More Blog-Related CLE Events

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Today we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use.

First, we’ve mentioned Pacira Pharmaceuticals v. FDA before as the latest First Amendment follow-up action to Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  What we have for you now are the two industry-side amicus briefs filed in support of Pacira’s First Amendment motion against the FDA.  This one was filed by PhRMA, and this one was filed by something called the Medical Information Working Group, which is a consortium consisting of Amgen, Bayer, Boehringer, Lilly, Genentech, GSK, J&J, Novartis, Novo Nordisk, Pfizer, and Sanofi.  Impressive lineup.  And to think we can remember when nobody was willing to take on the FDA about truthful off-label promotion for fear of retaliation….  What a difference a few wins make.

We’ve read through the two amicus briefs and we heartily recommend them to anyone interested in bringing the FDA’s reign of (t)error in this area to long-overdue end.  Briefly, the MIWG brief makes the following points:  (1) the FDA’s ban is an “ambiguous tangle of regulations, nonbinding guidance documents, and severe enforcement practices”; (2) pharmaceutical promotion is First Amendment protected speech under Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011); (3) truthful off-label promotion provides valuable information to physicians and patients alike; (4) what FDA claims is “misbranding” is the same information it has pledged in other contexts to “work hard to address”; (5) Pacira’s speech is really on-label promotion that the FDA has attempted to suppress through an improperly crabbed reading of the drug’s intended use; (6) off-label use is legal, common-place, medically valuable, and sometimes the medical standard of care; (7) more truthful speech about off-label use is better than less; (8) the FDA’s ban unconstitutionally discriminates on the basis of both speaker and content; (9) the basis for the FDA’s ban is unconstitutionally vague and ambiguous; (10) FDA’s “safe harbors” are arbitrary and constitutionally inadequate; (11) the FDA has taken inconsistent positions on what off-label promotion is allowed; (12) the FDA has never even defined “promotion”; (13) the FDA’s vagueness and contradictory policies chills protected speech − truthful pharmaceutical promotion; and (14) because of this chilling effect there is both standing and justiciability.Continue Reading First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell

Photo of Stephen McConnell

A couple of weeks ago we discussed the latest entry in the “the saga of Cymbalta plaintiff lawyers who keep pushing the litigation up a hill in an effort to create a class action, mass action, MDL, or whatever will allow them to park as many meritless cases in one place, only to have that…

Photo of Rachel B. Weil

We spent the weekend in the Boston area, visiting the Drug and Device Law Rock Climber for “parents’ weekend.” Saturday’s schedule was replete with activities:  a keynote speech by the university president, lectures on topics academic and not, an informative session on the school’s “semester abroad” program (the DDLRC has informed us that she hopes to spend next spring in Australia), and dozens of presentations by student arts groups (theatre, improv, orchestra, a cappella).

We didn’t get to do any of that.  By mid-morning, the DDLRC had tired of being trailed around campus by her parents.  All were shepherded to the “T,” where, several stops down the line, our procession (and its credit cards) descended on the downtown shopping district.  But before we left campus, we insisted on attending one lecture, a sparkling presentation by the head of the theatre department.  The subject was a famous circus mogul who was one of the university’s founding trustees and whose best-remembered donation was the carcass of his equally-famous circus elephant, who has since lent his name to all of the university’s sports teams.  According to legend, the elephant died while pushing a baby elephant out of the way of a speeding train.  The truth was a less-heroic, but equally fatal, elephant vs. train collision. In any event, he was duly stuffed and sent to live in a university museum.  Years later, he was incinerated in a building fire.  Some of his ashes were scooped into a container and displayed in the rebuilt museum, but a grander tribute awaited.  Just this year, a massive bronze statue of the elephant was erected outside the building bearing his patron’s name.  We love this campus attraction, and we wax irrationally sentimental about the whole story.

We are trying to think of a smooth transition to today’s discussion, but this is the best we can do:  like legendary elephants, Daubert and Frye standards for admissibility of expert testimony, as applied by modern courts, frequently defy segregation into discrete containers.  Notwithstanding a hybrid analysis squeezed into a Frye box, the conclusion was clear: plaintiff’s causation experts in a Philadelphia Zoloft case did not meet any relevant admissibility standards, and both were properly excluded.Continue Reading A Frye Opinion By Any Other Name: Zoloft Plaintiffs’ Experts Excluded in Philadelphia

Photo of John Sullivan

The Judge in the ObTape device litigation has allowed another manufacturing defect claim to go to trial with no direct evidence that the device implanted in the plaintiff had a manufacturing defect.  See In re Mentor Corp. ObTape Transobturator Sling Prods. Liability Litig., 2015 U.S. Dist. LEXIS 140263 (M.D. Ga. Oct. 15, 2015).  In denying the manufacturer’s motion for summary judgment, the court relied solely on a review conducted by plaintiff’s experts of sample ObTape devices—that is, devices other than the one implanted in the plaintiff.  The experts found that the pore sizes of those other samples were at times outside of the alleged manufacturing requirement of 40 to 100 microns.  Relying solely on this, the court rejected the manufacturer’s argument that plaintiff had not shown a manufacturing defect in the device implanted in her.  The court explained its reasoning, which from our point of view is less than convincing:

One way to prove a manufacturing defect is to test the specific subject product against manufacturing standards.  For example, in BIC Pen Corp., the parties tested the cigarette lighter that caused the plaintiff’s injuries.  346 S.W.3d at 540-41.  But Mentor [the manufacturer of ObTape] did not point the Court to any authority that such testing is the only way to establish a manufacturing defect under Texas law.  Here, Mrs. Sanborn relies on the same evidence as the Phase I Georgia Plaintiffs, whose specific ObTape was not tested, either.  Rather, their experts tested a number of ObTape samples and concluded that a substantial portion of each ObTape tested had pores smaller than 40 microns.  In re Mentor, 711 F. Supp. at 1376.  At this time, the Court remains satisfied that this evidence is sufficient to create a genuine fact dispute on Mrs. Sanborn’s manufacturing defect claim.  Mentor’s summary judgment motion on the manufacturing defect claim is thus denied.  The Court may reconsider this issue when ruling on any motion for judgment as a matter of law that may be presented at trial.

Id. at *8-9.Continue Reading MDL Judge Allows Manufacturing Defect Claim to Go to Trial with No Direct Evidence of a Defect in the Device Actually Implanted in Plaintiff

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We have posted many times about cases where a manufacturer of a regulated product is sued over alleged violations of a state consumer protection or deceptive trade practices act because of something allegedly amiss in the product’s name, labeling, advertising, or sales practices.  We know that drug and device manufacturers like the ones we represent can spend resources dealing with state attorneys general over the threat that such suits will be brought.  We cannot recall seeing, let alone posting on, a case where the manufacturer sued the state attorney general because its threat of suit—relayed to major retailers, who stopped selling the product—allegedly hurt its business and constitutional rights.  There would seem to be lots of reasons why an action like this might not be taken by a company that wants to keep doing business in the particular state for other products it manufacturers.  But if you are a one product, dietary supplement company and your presumably large market in Texas disappeared after letters went out based on a determination by the Texas AG’s office, not by a court, then you might be the one to bring suit preemptively.  That is what happened in NiGen Biotech, L.L.C., v. Paxton, No. 14-10923, 2015 U.S. App. LEXIS 17223 (5th Cir. Sept. 30, 2015).

The unusual posture of the case—in comparison to those we usually handle or read—means that it delves into constitutional issues that we knew better back when we clerked and the docket was sprinkled with cases against state actors.  The ones brought by prisoners are remembered more for their unique fact patterns and brand of advocacy than for the constitutional principles they implicated.  NiGen, likewise, holds our interest not because its treatment of sovereign immunity, federal question jurisdiction, and standing has direct implications for the sort of cases that normally fill our posts.  Rather, it shows that a manufacturer can go on the offensive against a state AG who probably thought it could do just about whatever it wanted prior to bringing its own suit.  It is not that we think the manufacturer NiGen is right on the underlying issue of whether the product’s label was deceptive, which touches on some complex constitutional issues, especially since Amarin has come down since this case started.Continue Reading Going on Offense against State Deceptive Trade Practices AG Actions

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Here is a guest post on an interesting case.  It’s the first decision that we’re aware of in which a 3D printed medical device (or any 3D printed product) has been the subject of litigation that involves product liability principles.  This post is submitted by Matt Jacobson of Reed Smith, who is particularly interested in 3D printing issues.   As always our guest blogger gets all the credit, and any blame, for the analysis that follows.

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October 21, 2015, the day Marty McFly, Doc, and their flux capacitor-charged Delorean arrived in the future.  The future was filed with flat screen TVs, self-lacing shoes, flying cars, cold fusion, Pepsi Perfect, and, of course, hover boards.  While the future is only a week away now, in the 1980s, when Back to the Future, Part II hit movie theaters, it seemed like a long way off.   However, a surprising amount of Back to the Future tech and non-tech (the Cubs are in the playoffs after all) are now part of our everyday lives—flying cars and cold fusion, not so much.  One thing, the movie did not predict was 3D printing.  3D printing is turning science fiction into reality, and as the technology continues to develop, we may soon realize the future really is here.

This blog is not a stranger to 3D printing, as we have posted about it here, here, and here.  But as the writers of Back to the Future could not actually predict the future, neither can we predict how courts will handle 3D printed medical devices.   A glimpse into that future may be found in Buckley v. Align Technology, Inc., No. 5:13-cv-02812-EJD, 2015 U.S. Dist. LEXIS 133388 (N.D. Cal. Sept 29, 2015)—which, as far as we can find, is the first even semi-product liability case dealing with a 3D printed product.Continue Reading Guest Post – First Contact – 3D Printing Meets the Learned Intermediary Rule

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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