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JAMES M. BECK is Reed Smith's only Senior Life Sciences Policy Analyst, resident in the firm's Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LinkedIn page is here.

The moment we saw the Supreme Court’s First Amendment decision in Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), we knew it had implications for the FDA’s suppression of truthful commercial speech concerning off-label uses, and we said so.  Not only that, the dissent in Sorrell caught the FDA angle, too.  Id. at 2678. Only the dissenters didn’t like it – we did.
It appears that the first place that the Sorrell rubber is likely to meet the off-label promotion road is in our old friend, the Caronia case, which has been on appeal in the Second Circuit for what seems like forever.  As readers may recall, Caronia was an FDA “sting” where a doctor, wearing a wire, affirmatively sought out off-label promotion, and (through the manufacturer’s representative (Caronia)) drew another doctor (Dr. Gleason) who worked for a drug company, into a discussion of an off-label use.  Both the other doctor, and the rep, who facilitated the conversation, were prosecuted.  Nothing false was said, but the government went ahead anyway, and obtained a conviction.
Caronia had already been argued after Sorrell was decided.  The court (we think) on its own motion asked for additional briefing on Sorrell.  Those briefs were filed this past week.  The government’s brief – arguing in favor of criminal suppression of truthful promotion of off-label use – predictably takes the position that Sorrell doesn’t change anything.  Since we like to gripe, we’ll spend most of our time on that one.Continue Reading Caronia, The Latest

A couple of Texas Supreme Court developments of interest.  (1) the court reversed the adverse Vioxx decision in Garza – holding that the plaintiffs did not provide sufficient epidemiological evidence in a low dose case.  A copy of the opinion, which requires two epidemiological studies showing a relative risk of 2 or more, is available

The Third Circuit has decided Gates v. Rohm & Haas Co., No. 10-2108, slip op. (3d Cir. Aug. 25, 2011).  Although not a pharmaceutical case, it’s something our readers would want to know about.  Gates was decided under Pennsylvania law – somewhat bizarre because the contamination occurred in Illinois.  It pretty much kills medical

We’d thought, because that’s what we’d seen, that subject-matter jurisdiction/fraudulent joinder issues in would-be diversity cases in federal court are to be decided early in the litigation.  Turns out that’s not necessarily so – at least according to the Second Circuit’s recent decision in a Zyprexa case, Brown v. Eli Lilly & Co., ___ F.3d ___, 2011 WL 3625105, slip op. (2d Cir. Aug. 18, 2011).
Brown was originally filed in Mississippi state court, and the plaintiff purported to bring negligent discharge claims against two local hospitals – along with the usual Zyprexa allegations – in order to destroy diversity and keep the case out of federal court.
The procedural posture (how the case got where it was) can only be described as “convoluted.”
Brown was originally filed in Mississippi state court in October, 2007.  Before removal, both hospitals filed dispositive motions in state court on statutory issues unique to:  (1) malpractice claims, and (2) Mississippi community hospitals.
Brown was removed to federal court in January, 2008.  That’s more than 30 days after suit was filed, which is usually a no-no, but apparently the plaintiff didn’t notice, so timeliness of removal was waived.  Fraudulent joinder of the hospitals was alleged, tracking the hospitals’ pending motions.
A couple of months later, in rather leisurely fashion, the plaintiff moved to remand.
Later, in August, 2008, the MDL got involved and the case was transferred to the Zyprexa MDL – with all of the various motions still pending (nobody – plaintiff, defendants, or the court – seemed to have pressed things much during this seven-month period).
The Zyprexa MDL judge, of course, is Hon. Jack Weinberg, who rarely does things the same way as any other judge.  All these preliminaries are recounted at 2011 WL 3625105, *2-3.Continue Reading The Long And Weinstein Road To Fraudulent Joinder

Bexis was away on vacation last week.  When he returned, he found four more reasons why we (on the defense side) should love TwIqbal. These four opinions have been duly added to our TwIqbal Cheat Sheet, but they deserve more mention than that:

Maybe An Advisory Opinion – But A Good One

In

Bone screws.  Yeah, we’d have to say we know a bit about them.  And Pennsylvania law – we know something about that as well.  Put those two together, and that’s why the Pennsylvania Superior Court’s recent decision in Wiggins v. Synthes (U.S.A.), ___ A.3d ___, 2011 WL 3524286 (Pa. Super. Aug. 12, 2011), just

The goal for the other side in MDL litigation is to file as many complaints as possible and after that do as little work as possible – while waiting around for the almost inevitable settlement, be it large or small.  Thus, MDL plaintiffs want only one-way discovery.  Their side gets to discover the living daylights

This is a post about one of our least favorite subjects – punitive damages.  We had to conduct some research recently that we thought we’d share with you.  It has to do with the lowest constitutional limit on punitive damages ratios that the Supreme Court has mentioned.  That occurred in State Farm Mutual Automobile Insurance

Cross-jurisdictional class action tolling.  Even though Bexis invented the phrase, we hate it.  We’ve lambasted that concept many times on this blog, see here.  Basically:  (1) the law should not reward the filing of meritless class actions by tolling the statute of limitations; (2) lawyers and courts in one jurisdiction should not be allowed to manipulate the statutes of limitations of other jurisdictions; and (3) each state is a sovereign, and should be able to set its own tolling (and other) rules without outside interference.  In fact, we’re so anti-cross-jurisdictional class action tolling that we maintain a scorecard concerning this rather arcane legal topic.
Another peeve that we’ve occasionally petted is the tendency of some courts – particularly in the Second Circuit – to assume that they know more about the law of other states than do those other states’ courts.
Those two threads come together in Casey v. Merck & Co., ___ F.3d ___, 2011 WL 3375104 (2d Cir. Aug. 5, 2011), where for once the Second Circuit decided not to play the “New Yorkers know best” card and instead certified the cross-jurisdictional class action tolling question to the Virginia Supreme Court.
Once again, the issue in dispute goes back to our Bone Screw days – when we first learned to hate cross-jurisdictional class action tolling.  The Bone Screw MDL plaintiffs filed an unsuccessful nation-wide class action (which back then was a lot less futile than personal injury class actions have since become).  Despite losing class certification, tardy Bone Screw plaintiffs around the country still claimed that their states’ statutes of limitations should be considered tolled by the unsuccessful MDL class action.
They lost.Continue Reading Cross-Jurisdictional Tolling Certified

We talk about a lot of law on this blog, but sometimes, we have to admit, the law doesn’t matter, and cases are decided simply on the basis of good lawyering and bad witnesses.  Exactly this happened in Zundel v. Johnson & Johnson, No. A-3984-08T1, slip op. (N.J. Super App. Div. Aug. 5, 2011) (unpublished).  In Zundel, the jury – and then the appellate court – found for the defense because, essentially, the other side’s witnesses were exposed as liars.
Zundel involved bad injuries, no doubt about it.  Stevens-Johnson syndrome – especially the worst kind, toxic epidural necrosis – basically makes your skin fall off, as if burnt.  Zundel, slip op. at 4-5.  The other side has created a cottage industry taking what are essentially rare idiosyncratic reactions (id. at 5 – TEN incidence is at most one in a million) to almost any drug (and maybe other foreign substances as well) and turning them into failure to warn cases.  In order to avoid the learned intermediary rule, among other reasons, the other side prefers to target over-the-counter products in SJS/TEN cases.
That has its advantages, but there are disadvantages also.  Disinterested doctors are more likely to be credible witnesses than plaintiffs and their family members, who testify with dollar signs in their eyes.  That’s what happened in Zundel.
Once the unfortunate minor plaintiff suffered (and we on the defense side don’t use the word “suffered” lightly) from SJS/TEN, the family, with legal assistance, went looking for some medication to target.  Motrin was the target of choice.
One slight little problem cropped up as the case proceeded, however.
It turned out that the plaintiffs’ aim was bad – really bad.  How bad?  Well, the minor plaintiff didn’t start taking Motrin until after already exhibiting the first symptoms of SJS/TEN:

The record shows that [minor plaintiff] was afflicted with TEN on January 5, 1998, when she was first examined by [treating physician] and before she was given Children’s Motrin by her mother.

Slip op. at 12 (emphasis added).Continue Reading Sometimes, The Law Doesn’t Matter