For some long-awaited events, a little time and distance can add a measure of clarity. Not always – many still are processing the Game of Thrones finale, with no end in sight. But over the past few weeks pharmaceutical products liability lawyers have had the opportunity to acquire some Zen and enlightenment about the Supreme Court’s highly anticipated preemption decision in Merck Sharp & Dohme, Inc. v. Albrecht, 2019 WL 2166393 (U.S. May 20, 2019). An initial description of the decision is here.
In a trio of recent decisions arising out of cases alleging that an antipsychotic medication, Risperdal, and its generic, risperidone, had caused gynecomastia (breast tissue growth) in men, the United States District Court for the District of Delaware granted motions for summary judgment for defendant Janssen Pharmaceuticals, Inc. The three opinions clarify that Delaware law would not impose innovator liability on a branded drug manufacturer when the plaintiff had used only a generic drug, and addressed “but-for” warnings causation and proximate cause in prescription drug products liability cases. [Disclosure: Drinker Biddle & Reath. LLP attorneys were co-counsel of record in these cases for Janssen.]
Third-party litigation funding has received increased scrutiny over the past several years, particularly in the context of mass torts, class actions, and multidistrict litigation. Most of this scrutiny has focused on pre-litigation or pre-resolution commercial loans to fund the litigation, and particularly whether parties are required to disclose such funding during the course of the litigation.
A judge, and not the jury, is the better-positioned and appropriate decisionmaker to determine whether a failure-to-warn claim is federally preempted, the U.S. Supreme Court held today.
The Court also clarified the “clear evidence” standard governing an impossibility preemption defense to failure-to-warn claims.
On April 11, 2019, the Texas Senate passed by a vote of 20-10 bipartisan Senate Bill 1189 regulating attorney advertising relating to prescription medication and medical device litigation.
The bill prohibits certain advertisements for legal services that use the phrases “medical alert,” “drug alert,” “public service announcement,” or other language to suggest that “the advertisement is offering professional, medical, or government agency advice about medications or medical devices rather than legal services.”
Last fall we wrote about the Third Circuit’s opinion endorsing the snap removals, making it the first circuit opinion in the country to approve such practice. This week, the United States Court of Appeals for the Second Circuit followed the Third Circuit’s lead and affirmed snap removals.
Third-party payor (TPP) claims against pharmaceutical companies are nothing new. The arguments are common – TPP insurers claim financial injury arising out of payments made for alleged medically unnecessary prescriptions written for numerous insureds/ beneficiaries. In some instances, the TPP plaintiffs point to evidence or allegations of off-label promotional activity to support the claims of lack of medical necessity; and sometimes the TPP plaintiffs attempt to bolster their allegations of “medically unnecessary” prescriptions by advancing a variation of the garden variety failure-to-warn narrative:
In products liability cases involving prescription medicines, defendants sometimes rely on a preemption defense that FDA would not have approved – or in some cases, already rejected – the warnings that plaintiffs argue were required by state law. Where the evidence shows FDA considered and rejected plaintiffs’ proposed warnings, plaintiffs often argue that the Agency would have approved their proposed warnings were it not for some technical issue. For example, that FDA rejected the warning because the manufacturer asked to put it in the wrong section of the label or FDA would have approved it had the manufacturer asked rather than some third party in a Citizen’s Petition. In rejecting such arguments courts often point, explicitly or implicitly, to the presumption of regularity, which “presumes” government agencies have “properly discharged their official duties” unless “clear evidence” shows otherwise. See United States v. Chem. Found., Inc., 272 U.S. 1, 14-15 (1926); see also Nat’l Archives & Recs Admin. v. Favish, 541 U.S. 157, 174 (2004) (requiring “meaningful evidentiary showing” to rebut presumption of regularity).
Those familiar with his legend know that Hall of famer Casey Stengel managed the New York Yankees in their mid-century heyday and, for a short time at their inception, the New York Mets. But he also is remembered as one of baseball’s great characters.
One story about Stengel was told by the great broadcaster Curt Gowdy. He was having a beer with Stengel at a bar in Cleveland. Stengel received his beer and quickly downed it in one long gulp, leading Gowdy to ask why he drank it so fast. Stengel said he drank beer that way ever since “the accident.”
Much has been said about the eye-popping verdict and the post-trial rulings in the Roundup case tried in San Francisco earlier this year. Johnson v. Monsanto Co., 2018 WL 5246323 (S.F. Super. Ct. Oct. 22, 2018). The court sustained the jury’s award of ~$39 million in compensatory damages, including $37 million in non-economic damages, and its finding that Monsanto was liable for punitive damages. The court reduced the punitive award on due process grounds to a one-to-one ratio, slashing it from $250 million to approximately $39 million. Monsanto recently filed its notice of appeal, and as we await the briefing and argument, a few issues and takeaways merit further discussion, particularly several disturbing issues surrounding the award of punitive damages. We will save for another day (or post) other significant liability and damages issues.