Growing Pains: The Story Behind Florida’s Daubert Arc – Part 2

You can find the first part of this story here.

The Aftermath of Marsh

When the Marsh case was decided in 2007 its broad interpretation of the “pure opinion exception” and narrow vision of the role of Frye took Florida expert evidence admissibility law well out of the mainstream. Florida law was starkly at odds with the reliability concerns addressed by Daubert and its progeny and counterparts.

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Growing Pains: The Story Behind Florida’s Daubert Arc – Part 1

The steady but sometimes slow adoption by the states of the Daubert standard for expert admissibility, and the accompanying recession of the Frye standard, is something of a coming of age for the national jurisprudence. Frye has become outmoded and anachronistic in an era of dizzying technological and scientific advancement ─ and riddled with exceptions. Daubert’s focus on reliability and fit incorporates the necessary flexibility, rigor, and judicial engagement to warily allow the expert wheat while turning away the chaff. The transition has played a pivotal role in fine-tuning the tort system in search of well-founded fact-finding and more rational adjudications.

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Does Pennsylvania Recognize Strict Liability Claims Against Medical Device Manufacturers? A Pennsylvania federal court calls the question.

For at least two decades, Pennsylvania law has recognized an exemption from strict liability for prescription drug manufacturers based on the state Supreme Court’s interpretation of the Restatement (Second) of Torts Sec. 402A cmt. k.  Comment k carves out an exception to traditional strict product liability claims for “unavoidably unsafe products,” or those which bear inherent risks—such as medicines which must be prescribed by a doctor.  A less settled question is whether that exemption extends to manufacturers of prescription medical devices, specifically regarding manufacturing defect claims.  On June 25, 2019, Judge Robreno of the U.S.D.C. Eastern District of Pennsylvania asked the Third Circuit to answer it.

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Final Drug Pricing DTC Advertising Rule to Take Effect July 9 – But Faces Challenges from Pharmaceutical Companies

This winter we discussed new regulatory guidelines intended to increase transparency in Direct-to-Consumer (DTC) advertising including a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would require pharmaceutical manufacturers to list prices in DTC advertising for drugs costing $35 for a 30-day supply.

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Worth the Wait? Some Semi-Mature Thoughts on Albrecht

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.

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District of Delaware Grants Motions for Summary Judgment in Three Risperdal Gynecomastia Cases

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.]

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