For several years now, the Valsartan MDL has been something of a poster child for the problems with modern serial product liability litigation. It started with questionable data coming out of a questionable lab, leading to publicity and regulatory actions that outpaced reliable evidence of increased risk from an alleged carcinogenic contamination. It snowballed
We have been reporting on third party payer/payor (“TPP”) litigation for a long time. This category covers a range of causes of action and allegations but boils down to boils down to insurance companies or other entities trying to recover amounts they paid for patients to receive medical products because the manufacturers or sellers
Although it is not a drug/device case (if it were, we would have discussed it before now), the recent Supreme Court decision in Gallardo v. Marstiller, 142 S. Ct. 1751 (2022), raises some interesting issues that attorneys defending personal injury action of any sort should consider. Settlement of any personal injury case involving a
This post is from the non-Dechert side of the blog.
Our latest Zantac litigation decision is not from the Florida MDL, but rather a standalone case in Maryland − Mayor & City Council of Baltimore v. GlaxoSmithKline, LLC, 2022 WL 537004 (Md. Cir. Jan. 28, 2022). It’s a split decision, and depending on which
The Xarelto personal injury claims settled in 2019 after six bellwether trials all ended with defense verdicts. What remained, until now, were several third-party payor (health insurers, “TPPs”) actions that have been dormant for almost six years. Despite the passage of time, the motions before the court in 2021 were to dismiss under Rules 12(b)(6)
In this blogger’s family, Monopoly is cutthroat. No freebies. No passes. I own it, you land on it – you pay. Can’t pay, take a mortgage. We play to bankruptcy. Being from New Jersey we are partial to the original based on the streets of Atlantic City. But we’ve also owned the Star Wars edition,
This post comes solely from the Cozen O’Connor side of the blog.
The MDL court in the Testosterone Replacement Therapy (“TRT”) litigation involves more than just individual product liability cases. It includes a class action. In particular, a single named plaintiff, Medical Mutual of Ohio (“MMO”), seeks to represent a class of third-party payers
We have written extensively on the travesty of the Neurontin trilogy (like here and here) and noted how the plaintiffs’ efforts to fit cases based on alleged off-label promotion of the prescription SSRIs Celexa and Lexapro into the same rubric have not been as successful. Today’s case addresses what we understand to be some
We’ve previously written several posts (not recently) on Medicare secondary payer (“MSP”) issues – which we characterized as “boring.” The recent MSP decision, Humana Insurance Co. v. Paris Blank LLP, 2016 WL 2745297, 187 F. Supp.3d 676 (E.D. Va. 2016), is a lot less boring. That’s because of the defendant – a plaintiff-side law firm.
And the law firm lost.
What’s going on? To start with, in addition to the government itself, certain private entities, “Medicare Advantage Organizations” (“MAO”) (abbreviations are ubiquitous in this area) are allowed to bring suits to recover as MSPs (that was what one of our earlier posts was about). The MSP statute is quite broad as to who can be legally liable for not ensuring that Medicare is treated as a secondary payer:
any or all entities that are or were required or responsible (directly, as an insurer or self-insurer, as a third-party administrator, as an employer that sponsors or contributes to a group health plan, or large group health plan, or otherwise) to make payment with respect to the same item or service (or any portion thereof) under a primary plan.
42 U.S.C. §1395y(b)(2)(A)(iii). Recovery in an amount double the actual Medicare outlay is available in litigated cases. Id.
In our neck of the woods (PA & NJ, anyway), a MAO’s ability to sue as if it were the government is already established. In re Avandia Marketing, Sales Practices, & Products Liability Litigation, 685 F.3d 353 (3d Cir. 2012). (We note that our CA blogger would view this issue differently, see Parra v. PacifiCare of Arizona, Inc., 715 F.3d 1146, 1154 (9th Cir. 2013)). So the fact that Humana held that an MAO had standing to sue, 2016 WL 2745297, at *4, would not have resulted in this post.
What interests us is the holding that a lawyer and his law firm – thankfully, a plaintiff law firm − can be an “entity” “responsible (directly . . . or otherwise)” for making a MSP payment. The allegations in Humana were not kind to the defendants. They represented a plaintiff in an auto accident. Supposedly, they received a one settlement check made out jointly to it and the plaintiff MAO, but “ultimately deposited the check without [the MAO’s] endorsement.” Id. at *2. Allegedly, certain other settlement checks “from several insurance companies” were also received and deposited, without joint the joint payor issue. Id. All told, the settlements totaled $475,600. Id.Continue Reading Medicare Secondary Payer – A Lot Less Boring Now
July in D.C. is hot and sticky. When scorching day follows scorching day, area residents look forward to evening thunderstorms, not just to water otherwise thirsty lawns and gardens but to cool things down. Lightning can be frightening—that the words almost rhyme is no accident—but it seems to always accompany our rain during the swampiest part of our summers.
The decision in Sidney Hillman Health Ctr. v. Abbott Labs., No. 13 C 5865, 2016 U.S. Dist. LEXIS 84662 (N.D. Ill. June 29, 2016), is not as dramatic as a flash of lightning or as stirring as a thunderclap. To us, though, it provides some welcome relief and suggests that a larger storm is coming for cases like this. (Like awkward cocktail party banter, we will keep our discussion of weather brief.) Hillman is one of many third payor cases based on alleged off-label promotion of a prescription drug. It is of the variant where benefit plans principally used RICO as the vehicle to try to get damages for past payments for members’ prescriptions for unapproved indications. We sometimes lump such cases together with those using the False Claims Act or various state fraud statutes to try to recover for amounts paid as a result of allegedly improper marketing, often with large fines or a damages multiplier in the mix. Sometimes these cases are class actions on behalf of lots of payors around the country. Sometimes they are pursued by governmental entities, which occasionally outsource the work to contingency fee lawyers. In their various forms, these TPP cases have caught our attention. We have been particular perturbed by some courts’ blithe acceptance of collective proof of causation in these cases, the point of which is to lump together as many purported actionable claims or implicated payments as possible without having to generate proof as to why each prescription was written or paid. We have also questioned whether statutes like RICO (enacted to combat organized crime) or the False Claims Act (enacted to combat war profiteering) are being stretched beyond their legitimate bounds to accommodate these cases, simply because the defendants are unpopular or the coffers of the governmental or benefit plan plaintiffs need an infusion of cash.
Many of these cases have also been predicated on the idea that promotion of off-label use is inherently wrong. Over the last year or so, largely because of Amarin, the underpinnings of that idea have been eroding fast. The First Amendment’s prohibition on laws “abridging the freedom of speech” applies to commercial speech, including commercial speech by and on behalf of drug companies about uses of their products that are off-label. If truthful statements about unapproved uses of the drug—like those that accurately represent the information on risks and benefits and make clear what the label says—are protected, then civil liability should not be based on them. That would go for cases under the FCA, RICO, or various state laws—with the Fourteenth Amendment making the First Amendment applicable to states. To our eyes, some of the notorious cases imposing massive liability for alleged off-label promotion of prescription drugs seem to have relied in large part on vilifying truthful off-label promotion. (Keep in mind that even pre-Amarin FDA regs allowed drug companies to provide information about off-label uses under certain circumstances without it being considered “promotion.”) So, a First Amendment storm is brewing for these cases, both in terms of the precedential value of decisions in cases that did not differentiate between truthful and false statements about off-label uses and the viability of complaints drafted with the expectation that no such differentiation would be necessary.
This brings us back to Hillman, which had an interesting litigation history of its own. It followed FCA and related actions based on alleged off-label promotion by the manufacturer of a prescription seizure and migraine medication. A large settlement of civil and criminal claims, with attendant press coverage, followed. The Hillman plaintiffs filed a putative class action over a year later, alleging overpayments for off-label prescriptions between 1998 and 2012. The trial court dismissed on statute of limitations and the Seventh Circuit reversed. The plaintiffs amended and the defendants moved to dismiss. Along the way, there have been a number of product liability claims with the same drug, complete with off-label promotion allegations and preemption of some warnings claims. (As an aside, it would be interesting if some of the alleged misrepresentations about safety in the Hillman complaint were about the same issues about which it would have been impossible for the defendants to warn. There is no preemption for RICO claims, because preemption only applies to state law, but it should be hard to misrepresent a drug’s safety by accurately repeating the contents of a label that could not have been changed as to a particular risk.)Continue Reading Another Off-Label Promotion Third Party Payor Case Lacks Causation