The Presumption of Regularity in Prescription Drug Cases

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).

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Remembering Stengel and Celebrating the Arizona Supreme Court

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.”

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California Confronts the High Liability Costs of Scientific Uncertainty

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.

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Think Through Representation in MDLs: Plaintiff’s Failure to Opt-In to Settlement Not Grounds for Plaintiff Counsel’s Withdrawal From Representation

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.

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Hallmarks of an Efficient Defendant Fact Sheet Process

Parties involved in coordinated proceedings featuring thousands of plaintiffs and a tight discovery schedule are expected to negotiate an efficient process for production of baseline data.  The Plaintiff Fact Sheet (PFS)/Defendant Fact Sheet (DFS) process provides an orderly procedure for discovery specific to plaintiffs and their prescribing/treating physicians.

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Supreme Court Hears Arguments on Bare Metal Defense in Asbestos Maritime Case

On October 10th, the United States Supreme Court heard arguments in Air & Liquid Systems Corp., et al. v. Devries, et al., No. 17-1104, over  whether the manufacturer of a bare metal product, in this case engines on a Navy ship, may be held liable for injuries suffered from later-added asbestos-containing materials. Under maritime law, the Third Circuit said yes, if the facts show the manufacturer reasonably could have known that asbestos is hazardous and its product will be used with an asbestos-containing part, because (a) the product was originally equipped with the asbestos part, which needs to be replaced, (b) the manufacturer specifically directed that the product be used with the asbestos-containing part, or (c) the product required the asbestos-containing part to properly function.

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FDA Warns Against Sales Representative’s “False and Misleading” Oral Statements Regarding Prescription Medicine

The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Eisai Inc. on October 11, 2018, based on a sales representative’s “false and misleading” oral statements during a lunch presentation about the safety of the antiepileptic medication Fycompa®, downplaying warnings, and engaging in off-label promotion of the product.

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NJ Top Court Tosses More Than 500 Suits Against Acne Medication Maker

On October 3, 2018, the New Jersey Supreme Court dismissed 532 cases against Hoffmann-La Roche Inc. and Roche Laboratories Inc., the manufacturer of the prescription acne medication Accutane, holding that the laws of New Jersey – the location of Roche’s principal place of business– and not the respective laws of plaintiffs’ home states governed the adequacy of the warnings underlying plaintiffs’ failure to warn claims.  The Court held that because the medication’s warnings were FDA-approved, “they enjoy a ‘rebuttable presumption’ of adequacy under New Jersey’s Products Liability Act ([NJ]PLA).”

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New Jersey MCL Update: Three New Consolidated Litigations in New Jersey

August was a busy month for multi-county litigation (MCL) in New Jersey: the Supreme Court of New Jersey designated three new MCLs and terminated one in a matter of just three days. Newly added to the MCL docket are the Physiomesh Flexible Composite Mesh litigation, Zostavax litigation, and Taxotere litigation. Meanwhile, the Pompton Lakes Environmental Contamination litigation has been terminated. Here is a brief update on these four litigations.

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