Thanks to the folks over at the FDA law blog for tipping us off to interesting provisions of pending legislation that emerged earlier this week from various house committees. The bill, H.R. 5, is part of the ongoing debate over health care, and where it will ultimately go is unclear, but it contains some
Distributor Held Fraudulently Joined
Yesterday we brought you some welcome news on the pharmacy front in the never-ending struggle against fraudulent joinders. But outside of certain parts of Illinois, we’ve generally done OK where the fraudulently joined party is a pharmacy.
Today, we feature a rarer bird – a court’s decision that a claim brought against a local distributor
Seventh Circuit Shoves the S.D.Ill. Back Into Line On Removal
We’ve remarked before about the odd, detrimental position that the Southern District of Illinois has taken towards removal, fraudulent joinder, and diversity jurisdiction in cases claiming that pharmacies should be liable for prescription drugs just like any other intermediate product seller. The Illinois Supreme Court, as a substantive matter, has rejected pharmacy liability repeatedly as a consequence of the learned intermediary rule. See Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118, 1127 (Ill. 2002); Frye v. Medicare-Glaser Corp., 605 N.E.2d 557, 559-61 (Ill. 1992); Kirk v. Michael Reese Hospital & Medical Center, 513 N.E.2d 387, 392 (Ill. 1987). Yet plaintiffs in the South Illinois “hellhole” counties, Madison, St. Clair, etc., kept alleging pharmacy liability, and numerous Southern District of Illinois decisions let them get away with it – remanding the cases based upon a combination of a “presumption” in favor of remand, and something called the “common defense” exception. Funny, but that didn’t stop federal district courts in other parts of the country from finding fraudulent joinder where (as in most states) pharmacy liability was similarly barred under the relevant state’s law.
Well, we think that’s come to an end. As we also discussed before, with the Yazmin/Yaz litigation, the S.D. Ill. got its own MDL. Where a judge stands apparently depends somewhat on where s/he sits, and in that litigation, the court broke ranks and – rather than tolerate a large number of similar state-court suits trenching on the MDL – held that, contrary to a lot of other S.D. Ill. precedent – pharmacy liability claims constituted fraudulent joinder, and denied remand.
MDLs are a little different from individual litigation in other ways, too. For one thing, plaintiffs lawyers have lots and lots of “clients” and are not adverse to using them as cannon fodder when they want to make a legal point – or at least try to. That’s what happened in Yazmin/Yaz. Counsel for one of the non-remanded plaintiffs, named Walton, decided to risk tanking the client’s claim in order to appeal the failure to remand. So poor Ms. Walton defaulted on discovery obligations, the MDL court dismissed her case with prejudice as a sanction, and the plaintiff’s lawyer challenged the dismissal for lack of federal subject matter litigation.
Yeah, a plaintiff can do that.
But the plaintiff had better be right, because if s/he loses the appeal – no more case.Continue Reading Seventh Circuit Shoves the S.D.Ill. Back Into Line On Removal
Another Third Party Payer Class Action Denial
We already posted once today about third party payers and class actions, so this will be short. In the Neurontin litigation certification of a purported nationwide class of TPPs was recently denied (again) in In re Neurontin Marketing & Sales Practices Litigation, MDL 1629, slip op. (D. Mass. May 17, 2011). The rationale, which the court
AT&T v. Concepcion in Drug/Device Cases?
Like everybody else we took a look at the Supreme Court’s decision in AT&T Mobility LLC v. Concepcion, slip op., 131 S. Ct. 1740 (U.S. 2011), on the Federal Arbitration Act’s preemption of state law limiting the enforceability of class action waivers. However, just as the Capitol Steps’ first reaction to a political scandal is “what rhymes with it?” our first reaction to major new precedent is “is it useful in drug/device litigation.”
Our reaction to AT&T Mobility is “maybe.” Reading the case, we don’t think that it’s possible to restrict it’s scope just to class-action-based arbitrations, which is it’s precise factual context. Rather, since the motivating force behind FAA preemption is the “liberal federal policy favoring arbitration,” 131 S. Ct. at 1745, we’d have to say that state law purporting to invalidate limitations on non-arbitration class actions is a fortiori preempted. By that we mean that, if contractual limits on class actions in arbitration are enforceable under the FAA, given its arbitration-friendly policy, then contractual limits on class actions outside of arbitration are even more favored, since litigated class actions are even more invasive of arbitration rights.
So we think that AT&T Mobility invalidates all state law attempts to obstruct arbitration waivers involving class actions, whether the state is attempting to preserve class action in or out of arbitration.Continue Reading AT&T v. Concepcion in Drug/Device Cases?
Experts Offering Evidence of Corporate Intent, Ethics, And The Like
Returning from the ALI meeting, Bexis had sitting in his inbox the final hard copies of update 14 for his Drug/Device products liability book. For those of you that use Bexis’ book, that means there’s more to use, but for Bexis that means that it’s time to start on update 15. A legal author’s work is never done. This time he’s planning to update the chapter on evidence.
It’s also time for our Thursday long post – time to kill two birds with one stone.
Right now the book has a short subsection on corporate intent evidence in drug and device cases. That section states simply that corporate motive and intent evidence (usually offered by some purported “expert”) has generally been found inadmissible by courts trying drug and medical device product liability cases. There’s one footnote, citing four cases from three jurisdictions: Smith v. Wyeth-Ayerst Laboratories Co., 278 F. Supp.2d 684, 700 (W.D.N.C. 2003); Figueroa v. Boston Scientific Corp., 2003 WL 21488012, at *4 (S.D.N.Y. June 27, 2003); In re Diet Drugs Products Liability Litigation, 2001 WL 454586, at *2 (E.D. Pa. Feb. 1, 2001); In re Diet Drugs Products Liability Litigation, 2000 WL 876900, at *9 (E.D. Pa. June 20, 2000).
We think Bexis can do better than that with this update – and we think we can make a blog post out of it as well. So let’s take a look. What have courts held about corporate motive and intent evidence lately?
Probably the best treatment of the subject, of the cases coming down since this part of the book was updated, is in In re Rezulin Products Liability Litigation, 309 F. Supp.2d 531 (S.D.N.Y. 2004). There, three purported corporate ethics “experts” were excluded for a variety of reasons. First, their ethics opinions were “speculative” in the sense that they were based upon “subjective belief.” Id. at 543-44. Second, ethical matters were not relevant to product liability litigation, as it was unrelated to the alleged defects being claimed. “While the defendants may be liable in the court of public opinion, or before a divine authority . . ., expert opinion as to the ethical character of their actions simply is not relevant to these lawsuits.” Id. at 544. Third, ethics evidence was argumentative and prejudicial. Id. at 545. Fourth, expert witnesses aren’t really qualified at divining corporate intent, which is something that lay jurors are equally competent to judge, should it be relevant to anything. Id. at 546-47.Continue Reading Experts Offering Evidence of Corporate Intent, Ethics, And The Like
New Sharkey Preemption Article
Catherine Sharkey, one of the leading academic commentators on preemption in the administrative context, has released a new article on the subject, entitled “Inside Agency Preemption.” The Sharkey article has a broad scope, and includes a proposal for a state notification procedure for preemption similar to that process outlined for AG notification in the Class
How Is Generic Preemption Like Fraud On The FDA?
A couple of months ago, we provided our stream-of-consciousness impressions of the Mensing/Demahy generic preemption argument to the Supreme Court. As we mentioned then, we were all set to write an obituary on generic preemption. After all, since Wyeth v. Levine, 555 U.S. 555 (2009), generic preemption had lost in every court of appeals to consider the issue, and the government (the Solicitor General) had weighed in on the anti-preemption side as well.
As we remarked then, the generic side appeared to do much better than expected during the oral argument. Not only were they sympathetically received by the three justices (Roberts, Scalia, Alito) who had dissented in Levine, but two critical swing justices (Kennedy, Breyer), seemed to be of the view – we say “seemed” because oral argument prognostication is only a little better than reading tea leaves – that Mensing fell under the aegis of preemption as recognized in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). Here are some excerpts from that post:
Justice Kennedy made a startling statement – that this case may even be “a fortiori” from Buckman. Whoa. Justice Kennedy is another crucial swing preemption vote. If that was really what he thinks, then that sounds like good news indeed for the generics, since he voted against preemption in Levine.
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We then get an interesting observation from Justice Breyer that, rather than Levine, the case is more like Buckman, because any supposed duty to tell the FDA something, amounts to a claim that private plaintiffs can enforce that duty, as opposed to the FDA “enforcing their own stuff.”
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So two key swing justices, Kennedy and Breyer, each made comments during oral argument equating generic preemption, and the “take steps” rationale, with Buckman rather than Levine. That bears watching.
Since then, we’ve had the opportunity to discuss this aspect of Mensing with a couple of lawyer friends whose opinions on these sorts of issues we respect a lot. They’ll have to remain nameless because we don’t have permission to identify them, and can’t get it on short notice. But the upshot is that they also noticed the same thing and think that there’s a good chance, maybe even 50-50, that enough members of the Court might buy the Buckman argument to tip the balance in Mensing.Continue Reading How Is Generic Preemption Like Fraud On The FDA?
Federalism Revisited And Reinforced
To our readers:
Sorry about that. Blogger was down for almost 24 hours yesterday and this morning. In almost five years, we’ve never experienced that during business hours. Anyway, that combined with Bexis having to fly to the west coast for the ALI annual meeting, kept us from posting until now.
Here’s the post we
The Colossus of Rhodes – Part II
Yesterday, we reported on the federalism aspects of Rhodes v. E.I. du Pont de Nemours & Co., 636 F.3d 88 (4th Cir. 2011). We mentioned in that post that another interesting aspect to Rhodes involved the dismissal of the medical monitoring claims. Here’s what that’s about.
What happened is this:
First, the trial court