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 →
During an annual mammogram screening for breast cancer, the radiologist detects a nodule in the patient’s breast. The nodule is large enough to require a biopsy, but the radiologist prefers to schedule a follow-up appointment with the patient for six months later. This appointment reveals that the nodule had grown and the radiologist refers the patient to a biopsy. The biopsy is carried out four days later by a surgeon. The surgeon determines that the nodule was malignant and diagnoses the patient with breast cancer. The patient consults two breast cancer specialists who unanimously recommend mastectomy and chemotherapy. These procedures and the ancillary treatments prove successful. They make the patient cancer free in one year. The chemotherapy caused the patient to experience hair loss, pain, nausea, headaches and fatigue, but all these symptoms are now gone as well.
The patient is happy with the result but is still upset. She believes that a timely discovery of her cancer would have given her a far less painful and less disfiguring treatment option: lumpectomy followed by radiation therapy.