More on the ECJ Vaccine Liability Decision

By Alex Stein

My friend and mentor, the former Israeli Chief Justice Aharon Barak, used to say that when neither side likes the court’s decision, chances are that the court was right. This is likely to be the case with the European Court of Justice (ECJ) decision on vaccine manufacturers’ liability, N.W. et al. v. Sanofi Pasteur MSD, C‑621/15. Popular press reacted to this decision with sharp criticism that included unsubstantiated assertions about the European law of products liability, about what the Court did and did not say, and about the economics of vaccines. My short blog-post, which appeared here, offered a more positive (and hopefully more informative) assessment of this decision and its implications. I argued that the decision was balanced and well grounded in the principles of evidence and products liability. The follow-ups and subsequent analyses that appeared in Nature, Science and Hipertextual (in Spanish) have largely vindicated the decision (while citing some of its critics alongside the decision’s supporters such as myself).

To remove any remaining confusion about the implications of the ECJ decision, I thought I should clarify the Court’s statement that a vaccine liability suit can only succeed when the plaintiff proves that the vaccine complained against was “defective” within the meaning of Article 6(1) of the European Council Directive on products liability (85/374/EEC) (the Directive). Critics of the Court’s decision have uniformly missed this important proviso. Continue reading

Hospitals’ Exposure to Products Liability Suits

By Alex Stein

The United States District Court for the District of Connecticut has recently delivered an important decision that opens up new possibilities for suing hospitals and clinics. This decision allowed a patient alleging that hospital employees injected her with a contaminated medication to sue the hospital in products liability. Gallinari v. Kloth, — F.Supp.3d —- (U.S.D.C. D.Conn. 2015), 2015 WL 7758835. Continue reading

Products Liability or Medical Malpractice? The Definition of a “Healthcare Provider”

By Alex Stein

Every defendant in a suit for medically inflicted injuries wants to be a “healthcare provider.” This status entitles the defendant to categorize the suit as “medical malpractice” and become eligible to special litigation advantages, which include shortened limitations and repose periods, dismissal of suits not verified by experts, and statutory caps on damages.

In Verticor, Ltd. v. Wood, — S.W.3d —- 2015 WL 7166024 (Tex.App.–Austin 2015), the manufacturer of Eclipse Shield – a spinal implant for fusion – claimed to be a “healthcare provider” for purposes of the Texas Medical Liability Act (TMLA). The purpose of this claim was to recharacterize the products liability action filed against Verticor into a “healthcare liability claim” that can proceed to court only upon showing of medical malpractice verified by an expert. To establish this claim, Verticor argued that it provides the Eclipse Shield “for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement” under its “device manufacturer” license. This service, explained Verticor, makes it a “healthcare provider.” Continue reading