MDL

Subscribe to MDL via RSS
Photo of John Sullivan

This post comes from the non-Reed Smith side of the blog.

It landed with a concussing thud that surprised no one. The $498 million verdict came last Thursday after weeks of evidence that included suicide, racism, tobacco pseudo-science, cancer, the proliferation of pelvic mesh litigation, Saddam Hussein, and alleged fraudulent practices in foreign countries. You might be wondering what type of case the jury was considering. That evidentiary line-up might make you think it was a wrongful death civil rights trial, or something worse. But it wasn’t. It was a Pinnacle hip implant trial. Really.

Before the verdict came, we were worried that something like this could happen. We wrote about it just as the jury was beginning deliberations. And then it happened, which should have been no surprise given the grouping of five separate plaintiffs for one bellwether trial and the noise that defendants were making about evidentiary rulings.

The question now is, what does it mean? Will it promote the ultimate resolution of the mass tort? Well, there’s little to suggest that it will. In fact, it seems more likely to do the opposite.Continue Reading Trouble in Texas II

Photo of Bexis

Here’s a significant post-rules-amendments discovery decision out of the Xarelto MDL.  In In re Xarelto (Rivaroxaban) Products Liability Litigation, 2016 WL 311762 (E.D. La. Jan. 26, 2016), the court (Fallon, J.) cited both new Rule 26’s heightened proportionality emphasis, as well as privacy issues, in rejecting the plaintiffs’ discovery demand for the personnel files of a large number of the defendant’s employees. This was not a demand for custodial files, call notes or anything peculiarly relevant to the litigation – but for personnel files.

No way, José.  Not after December 1, 2015.

A personnel file, unlike a work-related custodial file, is not the kind of thing that any company wants its litigation opponents rummaging through:

[T]he personnel file is not maintained by the employee.  The personnel file is maintained by the Human Resources department of an employer, and is likely to contain confidential employer evaluations which the employee may have never seen.  The personnel file also may include other sensitive information, such as salary, information concerning physical or mental health issues, alimony and child support garnishment, tax records, and drug test results.

Xarelto, 2016 WL 311762, at *1 (citations and quotation marks omitted).Continue Reading Disproportionate Discovery, Even in an MDL

Photo of Bexis

What?  You were expecting another of our insensitive blogpost headlines?

Nope, we’re playing this one straight down the middle.  In In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286 (N.D. Ill. Nov. 9, 2015) (“TRT”), the court ruled that all claims against all makers of generic testosterone replacement drugs were preempted.  Indeed, except for those generic manufacturers who were also designated by the FDA as “reference listed drugs,” the plaintiffs did not even contest dismissal.  Id. at *1.

Maybe the word is getting through to the other side that the Supreme Court meant what it said in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).

The main issue in TRT was whether a generic manufacturer somehow lost the protection of impossibility preemption because the FDA designated that manufacturer’s product as a “reference listed drug” (“RLD”) after the original branded drug left the market.  This issue has been out there for some time, and we discussed in detail in our post on the aberrant Pennsylvania Superior Court metoclopramide-related decisions.  Indeed, we noted that that the FDA had confirmed – on the very day that we wrote that post – that designated generic RLDs remained generic drug manufacturers and were unable to use the preemption-destroying “changes being effected” process to modify their labels.  Id. (citing and quoting “FDA, Guidance for Industry, Safety Labeling Changes − Implementation of Section 505(o)(4) of the FD&C Act, at 7 n.10 (FDA July 30, 2013)).Continue Reading Generic Preemption Prevails in Testosterone MDL

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 Michelle Yeary

This case is from the non-Reed Smith side of the blog only.

Today’s case is a simple and straightforward message to plaintiffs – you can’t use §1404 transfers to create an MDL after the Judicial Panel on Multidistrict Litigation (“JPML”) has said no.  That is precisely what plaintiffs were asking the court to do in Krupp v. Eli Lilly and Co., 2015 U.S. Dist. LEXIS 83762 (M.D. Fla. Apr. 6, 2015).  Apparently two plaintiffs’ firms had filed 47 Cymbalta cases in 29 different federal courts around the country (presumably plaintiffs’ home jurisdictions) and then petitioned the JPML for the creation of an MDL, alleging an additional 2700 claims in the pipeline.  The JPML declined finding that the cases were in different procedural postures, the bulk of the common discovery had already taken place and with only 2 plaintiffs’ firms, coordination should not prove burdensome.  Id. at *3.

Not happy with that result, plaintiffs appear now to be asking the 29 federal courts with pending Cymbalta cases to transfer them to the Southern District of Indiana – defendant’s home jurisdiction.  Plaintiffs allege that they will then also file the rest of their cases there to create “a de facto MDL.”  Id. at *4.  Plaintiffs argue that transfer of all cases (i) will allow plaintiffs to share costs, (ii) will be more convenient to defendant, and (iii) will promote judicial efficiency.  Id.  Even assuming these are true assertions – they don’t justify a plaintiff’s request for a §1404 transfer.Continue Reading MDL Shenanigans Disallowed

Photo of Michelle Yeary

Multidistrict Litigation – the name says it all.  It is an amalgamation of related cases from multiple federal district courts across the country.  Think about the journey a single case in an MDL may take.  Plaintiff files in state court.  Defendants remove the case to federal court based on diversity.  But as soon as the…

Photo of Bexis

Appealability issues in multi-district litigation can  present knotty problems.  While we (that is, Bexis) came up with the preemption argument that killed off fraud on the FDA claims, the realities of MDL practice meant that, even after winning, there was no appeal.  Only when a peripheral defendant – an FDA consultant facing no other claims – filed a “me too” motion was an appealable order created. The consultant’s name was Buckman.

Thus we read with interest the resolution of the MDL appealability issue in Gelboim v. Bank of America Corp., 135 S. Ct. 897 (2015).  Gelboim has nothing to do with drugs and devices; it was an anti-trust case.  The substantive issue was “anti-trust injury,” which doesn’t matter here except to the extent that the district court held that the plaintiffs didn’t have any cognizable injury.  Since the plaintiffs in question didn’t have any other claims, that meant their action was kaput.  Time to appeal, right?  The district court thought so.  135 S. Ct. at 903-04 (discussing procedural history).  In addition, the MDL court issued an order under Fed. R. Civ. P. 54(b), allowing certain other plaintiffs to appeal, even though they had other claims remaining.  (A use of Rule 54(b) also produced the Buckman appeal.)

Not so fast!  The court of appeals said no. Based on a “strong presumption” that appeals in “consolidated cases” were not final, the Second Circuit (the appeal was from the S.D.N.Y.) dismissed the appeal.Continue Reading Supreme Court Clarifies MDL Appealability Issues

Photo of Bexis

If anyone gave out prizes for the most incomprehensibly named multi-district litigation, the one currently proceeding as “In re Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation” would be right up there.  Rarely have we encountered a case name with four words in a row that, without a dictionary, we didn’t know what they meant.  Basically, this is product liability litigation about two dialysis solutions (Granuflo and Naturalyte) over alleged serious adverse reactions related to effects on blood chemistry.

This MDL is currently pending in the District of Massachusetts.  Just after the new year the Fresenius MDL (that’s all the designation really needed) made some news with a quartet of decisions.  We’ll describe them for you briefly.

First Decision

In In re Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 44589, at *1 (D. Mass. Jan. 2, 2015), the court denied remand to a batch of California plaintiffs.  As is so often the case in removal/remand, there was a lot of gamesmanship going on.  The defendant proved, to the court’s satisfaction, that the principal place of business of the target defendant, Fresenius, USA, had been its Massachusetts for almost a decade, since a merger.  Id. at *2.  It satisfied the relevant “nerve center” test (see here for more on that) for personal jurisdiction.Continue Reading Fresenius Potpourri

Photo of Bexis

The Eleventh Circuit’s recent decision in In re Engle Cases, ___ F.3d ___, 2014 WL 4435893 (11th Cir. Sept 10, 2014), although involving cigarettes rather than prescription medical products, rips the scab off shoddy practices that plague many mass torts and are inherent in the other side’s solicitation-based approach to such litigation.  Basically, the…

Photo of Eric Alexander

In our post on the worst decisions of 2013, we highlighted two trilogies of dreck, the First Circuit’s Neurontin decisions and the Pennsylvania Superior Court’s Reglan decisions.  Today, we discuss a rare pentalogy of drecky decisions from the same court in the same litigation issued over nine days.  See In re Actos (Pioglitazone) Prods. Liab. Litig., MDL No. 6:11-md-2299, 2014 U.S. Dist. LEXIS 4808 (W.D. La. Jan. 10, 2014); In re Actos (Pioglitazone) Prods. Liab. Litig., MDL No. 6:11-md-2299, 2014 U.S. Dist. LEXIS 5289 (W.D. La. Jan. 14, 2014); and three slip ops. concerning experts Panigrahy, Southgate and Grossman.

Like the Lance decision in yesterday’s post, the five Actos MDL Daubert decisions make a strong early case to be included with the worst of whatever else comes down the pike in 2014.  Last week, we posted on the same court’s overly narrow construction of conflict preemption.  Before that, we noted some better—from our perspective—decisions from the same court involving  smacking around a plaintiff lawyer for discovery nonsense, referring a state law question to the Arkansas Supreme Court, and even knocking out speculative medical monitoring opinions under Daubert.  We infer from this progression, and from the repeated and vehement chastising of the Defendants in the five Daubert decisions, that there has been shift in how the court views the parties that is coming through in its decisions.  We have been known to do some chastising of our own, but we never claimed to be neutral.  We also have not seen so many “cautions” to parties—there is but one to plaintiff’s counsel (about framing questions at trial) amid dozen or more to Defendants—or so many characterizations that arguments in motions were false, disingenuous, anemic, borderline specious, or hyperbolic.  You really have to read these decisions to get the full flavor, but it is hard to separate the substance from the delivery.  It is also hard to discern a single explanation for all the strange rulings in the five decisions on five experts in different areas.

We start with the disclaimer that we did not read the briefs of the respective parties or review the studies and liability evidence.  Like many with televisions or at least passing interest in the regulation of drugs, we have some understanding about how the evidence on the association of Actos and bladder cancer and the warnings about that issue have changed over time.  We would not begin to say whether the Court’s characterizations of the evidence and argument from the Daubert briefs are correct, any more than we would say whether an opinion that Actos causes bladder cancer or that the drug’s sponsor should have taken some additional action is correct.  As the Actos court and others before it got wrong, the admissibility of expert opinion testimony under Rule 702 and Daubert is a matter of procedure.  Daubert is applied in all federal court cases, because it is about procedure, not substance.  (Some requirements for expert testimony really are substantive state law, but that is a different issue.)  Without knowing the substance of the litigation, let alone whether a particular proffered expert opinion is correct, we can tell that the decisions misapply the proper standards, including the ones they correctly outline in the matching “Applicable Law” section of each decision.Continue Reading At First Face, the Actos Rule 702 Decisions Make No Sense

Drug & Device Resources

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.
Learn more about this book