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We love being right. We especially love telling the plaintiffs’ bar that we told ya so. Now can we finally drive a stake through these off-label marketing RICO cases brought by third-party payors (TPP)? (probably not, but we can keep hoping).

The latest crash-and-burn RICO TPP class action comes courtesy of the Southern District of…

The title pretty much says it all, but it is rare that you have a state supreme court weighing in on whether revocation of a pro hac is an appropriate sanction for plaintiffs’ lawyer shenanigans, so we call it to your attention. Recently, a North Carolina judge revoked the pro hac vice status of two (non-resident) plaintiffs’ lawyers in a case involving powdered Similac. See Sisk v. Transylvania Comm. Hosp., __ S.E.2d __, 2010 WL 2403438 (N.C. June 17, 2010). The facts alleged in the complaint are tragic – baby takes powdered Similac instead of sterile liquid Similac, baby is a neonate with a compromised immune system, baby develops meningitis. The plaintiffs sued the hospital – and we’ll refrain from making tired Transylvania jokes – and Abbott, the maker of Similac.
But the facts of the case and the legal claims asserted aren’t what caught our attention. Nope, it’s the way the trial court slammed the two non-Tarheel plaintiffs’ lawyers when the court learned that those lawyers had been in contact with Abbott’s consulting expert. It turns out that these plaintiffs (and Abbott) were no strangers to Similac litigation. In fact, these same lawyers had been involved in Similac litigation in Kentucky, in a case called Hill. After the Hill case settled, but before an order of dismissal was entered, the plaintiffs’ lawyers contacted and retained Abbott’s consulting expert with respect to another Similac case, called Froman. At the time of the contact, Abbott was not yet a party in the Froman case, but it was added later, leading to the disqualification of Abbott’s consulting expert in Froman. Abbott was understandably upset, and moved to disqualify plaintiffs’ counsel for their tactics. The Kentucky court refused to disqualify or sanction the lawyers, finding that they did not knowingly violate the Kentucky Rules of Professional Conduct.Continue Reading Plaintiffs’ Counsel Kiss Their Pro Hacs Goodbye After Messing With Defense Expert

We love being the bearers of glad tidings, especially when those glad tidings are cases rejecting the whacky theory espoused by Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008) — i.e., that a brand-name manufacturer is possibly liable even where the manufacturer did not make the (generic) version of the product…

Ah, pomegranates. In ancient times, the Greeks believed pomegranates were responsible for the seasons. Demeter’s daughter Persephone couldn’t resist the urge to eat a few pomegranate seeds while visiting the Underworld, condemning her to marry Hades and spend six months in hell. During those months, Demeter was so upset that she ignored the harvest. Hence, fall and winter.
In modern times, some researchers believe that pomegranates may unlock the secret to better health. It turns out that pomegranates are high in antioxidants, which may have cardiovascular benefits. Team up pomegranate juice with other juices like blueberry, and you have a potent cocktail of health claims.
This has been an emerging area of focus, both in grocery stores and with the FDA. It turns out that the world of juices is both highly competitive and increasingly the target of FDA scrutiny. In February of this year, the FDA issued a warning letter to POM Wonderful, LLC (one guess what they make). The FDA took the position that POM, by making health claims in its label and advertising, converted its 100% pomegranate juice into an unapproved new drug. Just to be clear, we think this is bogus paternalism – we don’t think pomegranate juice is a drug. Meanwhile, POM faced simultaneous pressure from a competitive source – Coca-Cola, who manufactures an enhanced (juiced up?) blend of juices with the catchy title, “Minute Maid ® Enhanced Pomegranate Blueberry Flavored 100% Juice Blend.” Coca-Cola marketed this blended juice as containing a host of benefits that contribute to brain development.
So what did POM do when faced with this competitive challenge from Big Juice? It sued, of course (POM also sued Welch’s, Ocean Spray, and Tropicana on similar grounds). And recently, a federal court in California, having examined POM’s claims, split the baby and let some claims proceed while tossing other core claims. See POM Wonderful LLC v. The Coca Cola Company, 2010 U.S. Dist. LEXIS 55400 (C.D. Cal. May 5, 2010). Importantly, POM did not contest the scientific accuracy of the claims made by Coca-Cola. Id. at *5. Rather, POM was annoyed because the blended juice contained predominantly apple and grape juice – standby, sweet juices that we all remember and love from our childhood – but marketed the pomegranate and blueberry aspects of the blend. In fact, POM alleged that the blended juice contained only 0.3% pomegranate juice and 0.2% blueberry juice. Id. at *14. This, POM claimed, was deceptive to consumers (and, incidentally, competitively harmful to POM), so POM sued under the Lanham Act and a collection of California consumer/unfair trade statutes.Continue Reading Pomegranate Turf Wars Implicate FDA Regulatory Scheme

Posted in FDA

First the Digitek MDL gave us a new weapon – the “Digitek Order” – to ensure plaintiffs’ counsel comply with their Rule 11 obligations to actually investigate their clients’ claims before filing thousands of cases. Novel concept, right? And now we have another helpful opinion – a new decision out of the MDL…

Plaintiffs love lobbing civil conspiracy claims into drug and device cases. Maybe it’s because there’s a deep pocket on the sidelines. Maybe plaintiffs hope to use a bogus “conspiracy” allegation to argue for the broad admissibility of conduct evidence or “co-conspirator statements.” Or, more likely, maybe the plaintiff just can’t figure out who to blame (so blame everyone!).
A federal court recently wielded our good friend TwIqbal and blew out civil conspiracy claims in a pair of pain pump cases. The cases are virtually identical: both plaintiffs alleged a civil conspiracy between the pain pump manufacturer and a distributor, claiming that the defendants conspired to promote pain pumps for an off-label use in violation of FDA regulations. See Dean v. DJO, LLC, 2010 WL 1999295 (D. Or. May 17, 2010); Flint v. DJO, LLC, 2010 WL 1999302 (D. Or. May 17, 2010). The off-label use in both cases was the implantation of pain pumps into the shoulder joint after arthroscopic surgery. In one case, DJO was alleged to be a co-conspirator who participated in the design, manufacture, marketing, or distribution of the pain pump at issue (the Flint case). In the other case (Dean), the plaintiff did not allege that DJO had anything to do with the specific pain pump at issue, but rather was liable for conspiring to promote pain pumps (generally) off-label. Shades of Bone Screw!Continue Reading TwIqbal Quashes Quazy Conspiracy Claims

Those pesky state AGs, usually aided by the plaintiffs’ bar, are an increasingly important player in coordinated drug and device litigation. And there always seems to be something vaguely unfair about a state filing a parens patriae action in its backyard state court, and then waving the (state) flag about how the AG is simply…

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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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