We recently received a copy of Pfaff v. Merck & Co., No. 12-md-02331 (BMC), slip op. (E.D.N.Y. Sept. 9, 2022), and the decision has a number of useful – for our side – rulings concerning branded drug preemption post-Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).
Continue Reading Another Favorable Post-Albrecht MDL Preemption Decision
We begin with the news that the Drug and Device Law Rock Climber has a new puppy. He is six months old and already over 60 pounds – a rescued Australian Shepherd mix. He is also white with blue eyes, a color pattern linked to deafness in dogs and cats. And he is totally deaf,
Bexis has lots of opinions on what’s wrong with mass-tort (especially drug/device) MDLs. Heck, Bexis has even proposed amendments to the MDL statutes to correct the many severe problems that exist. Now, Congress has before it possible statutory changes (not holding our breath) and Civil Rules Committee is looking into the same problems. Maybe something
A multidistrict litigation (MDL) can be a sound way of managing a mass tort. Efficiencies are available (e.g., deposing company witnesses only once) and the U. of Chicago part of us dreams of economies of scale. Then again, an MDL can be vexing, as plaintiff lawyers park their weak cases in the MDL and find ways to push their relatively few strong cases up front. Think of the MDL as a vast kennel, with all of the associated dangers and bad smells. Then again, an MDL can be an out-and-out disaster, as the old If-you-build-it-they-will-come model oft-described by blogger emeritus Mark Herrmann takes hold. The very existence of the MDL itself makes the mass tort massive. The MDL becomes a magnet for the meritless. Plaintiff lawyers resist any discovery of individual cases – there are too many! – and insist on dedicating the MDL to endless discovery of company conduct, as that is common to all cases and, viewed through the MDL lens, is always proportional, no matter how intrusive or expensive. (At least that is the plaintiff argument. But now some courts have finally grown weary of MDLs becoming festivals of discovery about discovery, and decided that proportionality applies even when the MDL case inventory has reached four or five digits. See here, for example.)
We have gone through this evolution of thought in the course of a single MDL, watching good intentions morph into an extortion racket. We have also seen courts gradually catch on to what has gone wrong with the MDL system. Is this an instance of phylogeny recapitulating ontogeny? Legislation has been revived in Congress that aims to cabin the insanity of MDLs and class actions. And, mirabile dictu, some MDL judges have started to rein in asymmetrical discovery and have even demanded that plaintiff lawyers furnish evidence of such niceties as usage of the product and medical causation. We’re not saying let’s make MDLs great again, but can we at least make them less miserable? Or maybe just make them less. Perhaps we don’t need an MDL every time there’s an alarming study or an uptick in adverse events.
Continue Reading JPML Refuses MDL for Proton Pump Inhibitor Kidney Injury Cases
This post comes from the non-Reed Smith side of the blog.
We suggested in our most recent post on the Pinnacle Hip Implant MDL that, the sooner the Fifth Circuit weighs in on the evidentiary and procedural concerns being raised by the defense, the better. The defense is trying for sooner.
On Thursday, the defense filed in the Fifth Circuit a Petition for a Writ of Mandamus to the MDL court. This isn’t a petition asking the Fifth Circuit to review the evidentiary and procedural rulings that the defense has been raising since the second bellwether trial was scheduled. It couldn’t do that. But the petition does ask the Fifth Circuit to order the MDL court to do the things that are necessary to allow the Fifth Circuit to conduct that review. And it asks that, in the meantime, the Fifth Circuit stop the bellwether process:
Petitioners seek a writ from this Court directing the district court to: (1) vacate its Order on Bellwether Trials, dated June 10, 2016, which scheduled a trial for September 6, 2016 (Exhibit A); (2) rule promptly on petitioners’ pending post-trial motions in the last bellwether trial; and (3) enter judgment in those cases so that an appeal may follow, see Fed. R. Civ. P. 58(b).
Petition at 1.
It seems that a significant amount of paperwork has been piling up on the MDL court’s desk. The MDL court hasn’t entered final judgment on the first bellwether trial, even though that verdict will soon be two years old. The MDL court has also not ruled on the post-trial motions from, or entered judgment on, the second bellwether trial, the one that raised so many procedural and evidentiary concerns and resulted in a half-billion dollar verdict.
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.
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).
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
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
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.