Archives: Drug & Device

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Are You Affiliated? The Supreme Court Further Limits Forum Shopping in the Mass Tort Context

Pardon the Jimi Hendrix allusion, but it seemed appropriate given yesterday’s Supreme Court decision in Bristol-Myers Squibb Co. v. Superior Court of California, No. 16-466 (June 19, 2017), in which the California Supreme Court’s finding of specific jurisdiction against a drug manufacturer was reversed as to non-California plaintiffs, who sued alleging personal injuries due to … Continue Reading

Law Lags Science? Not in the Ninth Circuit

In 1996, Judge Posner of the Seventh Circuit burnished his reputation for pithy legalisms by observing that “the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.” Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996). Alas, the truth of that statement appears to … Continue Reading

A Brief Overview of the Case Law Regarding “Failure to Train” Claims – And Its Implications for Medical Device Manufacturers

[The following was originally published in Westlaw Journal Medical Devices.  It is reprinted here with permission © 2014 Thomson Reuters.] In recent years, causes of action for “failure to train,” or allegations predicated on a duty to train, have been on the rise in cases against medical device manufacturers. Historically, however, such claims and allegations have made … Continue Reading

California Supreme Court: Trial Courts Must Act as ‘Gatekeepers’ to Exclude Speculative Expert Testimony

Yesterday, the California Supreme Court issued a unanimous opinion confirming the obligation of California trial judges to act as gatekeepers to insulate jurors from speculative expert testimony.  The Court affirmed a trial court discretionary ruling excluding an expert’s opinion on future lost profits where the opinion lacked any objective factual anchor and applied standards so … Continue Reading

Stengel Preemption on En Banc Review

As we noted here, the Ninth Circuit Court of Appeals’ decision in Stengel v. Medtronic Inc. is making its way through en banc review. Stengel, which involved both Riegel express preemption and Buckman implied preemption of state law claims regarding medical devices, was re-heard by the full Ninth Circuit on September 19, 2012. An audio recording of the … Continue Reading

6th Circuit Paging Ph.D. Jones?: Reliable Physician Causation Testimony Requires More Than Clinical Experience

In Thomas, Melau, and Anderson v. Novartis Pharms. Corp., the Sixth Circuit Court of Appeals recently affirmed a trio of cases prohibiting the testimony of treating physicians as specific causation experts. Though the appellate court’s opinion was not recommended for full-text publication, it nonetheless offers a salient reminder of a Daubert rule well-enunciated in the Sixth Circuit: … Continue Reading

U.S. Supreme Court Rejects Statistical Significance as Requirement to Plead Materiality

Matrixx Initiatives, Inc. v. Siracusano (.pdf) was a securities fraud class action where claimants alleged that Matrixx failed to disclose reports of a potential link between its cold medicine, Zicam, and loss of smell. The district court dismissed the claim because the reports lacked statistical significance and, therefore, could not have formed a “material” omission under … Continue Reading

Justice Kagan and the Future of Generic Drug Preemption

US Supreme Court Will Decide Fate of Preemption Defense for Generic Companies this Term Since the decision of the Supreme Court in Wyeth v. Levine, 129 S.Ct. 1187 (2009), the Eighth Circuit (in Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009)) and the Fifth Circuit (in DeMahy v. Actavis, Inc., 593 F.3d 428 … Continue Reading