Subject: Failure to Warn Standards

The Presumption of Regularity in Prescription Drug Cases

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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

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

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

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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 Reverses Course on Bare Metals Defense

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The New Jersey Appellate Division recently published an opinion significantly affecting asbestos litigation and defenses available to certain product manufacturers. In Whelan v. Armstrong International Inc., No. A-3520-13T4 (Aug. 6, 2018) the court changed the landscape related to the “bare metal defense,” breaking from prior law regarding the scope of a manufacturer’s liability for injuries caused by exposure to asbestos-containing components or replacement parts in their products supplied by third parties.

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