Reliance Remains a High Hurdle in Establishing Third-Party Payor Claims

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:

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Alternative Medical Cause Arguments Require Supporting Defense Expert Testimony in Illinois

A recent Appellate Court opinion in a premises liability case alleging back pain has the potential to be a pain in the neck for defense lawyers seeking to argue for possible alternative causes of plaintiff’s injuries in a personal injury cases in Illinois. In Campbell v. Autenreib,  109 N.E.3d 332 (2018), the Fifth District held that testimony about the potential alternative causes of plaintiff’s injuries elicited through cross-examination of the plaintiff’s treating physician was too speculative to be admitted in the absence of any defense expert testimony supporting the alternative causes. This opinion expands on the Illinois Supreme Court’s opinion in Voykin v. Estate of DeBoer, 192 Ill. 2d 49 (2000), which held that in most cases defendants must present expert testimony about the relevance of a prior injury or medical condition in a personal injury case.

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Keeping Summary Judgment Strong

In this age of exorbitant costs and increasingly high stakes in civil litigation, a robust summary judgment mechanism – one capable of terminating cases lacking in merit long before the extraordinary expense of final trial preparation and trial – is simply critical to a properly functioning civil litigation system.

Recently, Division 8 of the Second Appellate District, California Court of Appeal did its part by contributing to several ongoing debates in California law related to the admissibility of expert declarations offered to oppose motions for summary judgment. Fernandez v. Alexander, 2019 WL 336517 (Jan. 28, 2019)(certified for publication). The court weighed in, at least implicitly, on these important issues:

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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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Are You Sure You’ve Got Milk?

Alternatives to traditional food products have increased in availability, number, variety and popularity over the last decade.  So where does this leave consumers and the regulators who are tasked with ensuring food safety?  The Ninth Circuit has held that the reasonable consumer can digest the differences between almonds and cows.

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The Price for Natural Cosmetics

In a world where consumers are more health-conscious and eco-friendly than ever, products containing artificial ingredients have become less attractive. Consumers are looking for natural alternatives, and the cosmetics industry is no exception. The recent boom of all-natural products has coincided with a rise in litigation. Like the food industry, cosmetic companies are learning that marketing products as “natural” comes with a price.

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Direct-to-Consumer Advertising and Promotional Labeling Transparency and Pricing Requirements for Pharmaceutical Manufacturers

Government and regulatory agencies have recently provided guidelines regarding the importance of transparency in Direct-to–Consumer (DTC) advertising through proposed regulation and guidance documents.

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The Early Bird Avoids the Class Action: Recent California Decision Reminds That Winning Summary Judgment Can Be the Ultimate Preemptive Tactic for Beating Class Certification

Defendants faced with putative wide-reaching class action litigation are equipped with a variety of strategies for defeating class certification.  One potential silver bullet, however, expires early, and defendants must deploy it even before a class certification motion is filed in order to wield it effectively.  The United States District Court for the Central District of California’s recent decision granting summary judgment to Unilever United States, Inc. in a would-be class action concerning its St. Ives Apricot facial scrub underscores this strategy for (successfully) defeating class certification: Win the case on summary judgment first.

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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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