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.
Continue reading “DOUBLE SNAP! Second Circuit follows Third Circuit to Endorse Snap Removal”
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:
Continue reading “Reliance Remains a High Hurdle in Establishing Third-Party Payor Claims”
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).
Continue reading “The Presumption of Regularity in Prescription Drug Cases”
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.”
Continue reading “Remembering Stengel and Celebrating the Arizona Supreme Court”
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.
Continue reading “California Confronts the High Liability Costs of Scientific Uncertainty”
It is well-established that lawyers seeking to withdraw from representation on the eve of trial face an uphill battle, if not guaranteed defeat. This was recently reaffirmed by the United States District Court for the Eastern District of Missouri in HM Compounding Services, LLC, et al. v. Express Scripts, Inc. Plaintiffs’ counsel filed a motion to withdraw citing “irreconcilable differences” two weeks before the breach of contract matter was set for trial, and not surprisingly, the court required counsel to proceed with the representation.
