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. Read More

Vaccine Liability in Europe: A New Development

By Alex Stein

Yesterday, the European Court of Justice has issued an important ruling on vaccine manufacturers liability. N.W. et al. v. Sanofi Pasteur MSD, C‑621/15. This ruling triggered a hailstorm of criticism from different media outlets, including CNN. These outlets, however, have largely misreported the ruling and its underlying reasons, partly because of this misleading Press Release issued on behalf of the Court itself. In this post, I analyze the Court’s actual decision and briefly compare it with the American law.

The case at bar was about an adult patient who developed multiple sclerosis shortly after being vaccinated against Hepatitis B. The vaccination he received was manufactured by Sanofi Pasteur. Following the patient’s death from multiple sclerosis, his family filed a products liability suit against the company. The suit was filed in a French court, whose decision on evidentiary matters triggered a series of appeals that brought the case before the European Court of Justice. The Court was asked to determine whether the French evidentiary rule which allows plaintiffs to prove the vaccine’s defect and causation by “serious, specific and consistent evidence” in the absence of medical research in either direction aligns with the European law of products liability. The Court ruled that it does while making a number of clarifications and setting up conditions for such rules being valid under Article 4 of the European Council Directive 85/374/EEC of 25 July 1985. Read More

Reforming the approach to clinical negligence in the National Health Service (NHS)

By John Tingle

The Department of Health in England  have just published a consultation paper on the Governments proposal to introduce a Rapid Resolution and Redress Scheme (RRR) – a voluntary administrative compensation scheme for families affected by severe avoidable birth injury. Action against Medical Accidents (AvMA) the UK charity for patient safety and justice cautiously welcomes the stated intentions of the scheme but state that more thought needs to be given to the proposals. There needs to be more detail of the scheme and  some serious concerns are expressed.

The case for change

There are central three policy objectives behind the (RRR) scheme:

  • Reducing the number of severe avoidable birth injuries by encouraging a learning culture.
  • Improving the experience of families and clinicians when harm has occurred; and
  • Making more effective use of NHS resources.

In the consultation paper, a leading policy justification for the (RRR) scheme is the success of a Swedish initiative called, ‘The Safe Delivery Care Project’ which shows evidence of a reduction of claims for severe neurological birth injury. Read More

Tort Law: Public and Private

By Alex Stein

Readers interested in medical malpractice might be interested in seeing—and commenting on—my new article, The Domain of Torts, forthcoming in 117 Colum. L. Rev. (2017).

This Article advances a novel positive theory of the law of torts that grows out of a careful and extensive reading of the case law. The Article’s core insight is that the benefit from the harm-causing activity determines the form and substance of tort liability. This finding is both surprising and innovative, since tort scholars universally believe that the operation of the doctrines that determine individuals’ liability for accidents—negligence, causation, and damage—is driven by harms, not benefits. The key role of benefits in the operation of our tort system has eluded the searching eye of scholars, even though it is fully consistent with the case law.

Specifically, this Article shows that our tort system operates in two parallel modes—private and public—rather than just one, as conventional accounts erroneously suggest. Furthermore, the system’s mode of operation and the rules allocating liability for accidental harm are dictated by the type of the benefit sought by the alleged tortfeasor. If the benefit sought by the tortfeasor is purely private, she will be held liable for the harm resulting from her actions whenever she exposes her victim to a nonreciprocal risk. The tort system never allows actors to inflict harm on others when the benefit they seek to derive from their activity is purely private, no matter how significant that private benefit is relative to the victim’s harm. The system consequently does not hesitate to discourage the production of private benefits even when they are economically more valuable than the victim’s safety. That is, in cases of private benefit, tort law excludes cost-benefit analysis in favor of the reciprocity and equality principles. When the benefit that accompanies the harm-causing activity is public, by contrast, tort law adopts a strictly utilitarian approach and focuses exclusively on minimizing the cost of accidents and the cost of avoiding accidents as a total sum. Liability in such cases is imposed based on the famous Learned Hand formula (and similar formulations). Accordingly, if the benefit from the harm-causing activity is greater than the expected harm and precautions are too costly, no liability will be imposed. The consequent reduction in the victim’s protection is counterweighted by society’s need not to chill the production of public benefits that the victim enjoys on equal terms with all other members of her community. Read More

Malpractice, Terminal Patients, and Cause in Fact

By Alex Stein

Any person interested in medical malpractice or torts in general must read the Missouri Supreme Court’s recent decision, Mickels v. Danrad, 486 S.W.3d 327 (Mo. 2016). This decision involved a physician who negligently failed to diagnose the presence of a malignant brain tumor, from which the patient was doomed to die. The patient first saw the physician when he experienced numbness, blurred vision, and headaches. The physician sent the patient to an MRI scan, which he subsequently reviewed but made no diagnosis. Eleven weeks later, the patient arrived at a hospital in an altered mental state and underwent a CT scan of his brain, which showed a malignant and incurable tumor. Four months later, the patient died of that tumor. According to patient’s oncologist – who testified as a witness in a subsequent malpractice trial – the tumor was incurable when the patient first saw the physician. The plaintiffs offered no evidence controverting that testimony. Read More

Understanding “Lost Chances to Recover” (and Looney v. Moore)

By Alex Stein

My colleague, Professor Tony Sebok, drew my attention to an important recent decision, Looney v. Moore, 2015 WL 4773747 (N.Dist.Ala. 2015, by Chief United States District Judge Karon O. Bowdre). This decision adjudicated a textbook lost-chance case that involved the effects of oxygen saturation levels (SpO2) in premature infants with extremely low birth weights (ELBW). For any such infant, high SpO2 levels involved (among other complications) the risk of blindness caused by retinopathy of prematurity (ROP). On the other hand, low levels of SpO2 could lead to life-threatening neurodevelopmental impairments (NDI). The neonatologists’ customary practice was to maintain SpO2 levels in ELBWs between 85% and 95%. The effects of variations within that nationally accepted range were hitherto unknown.

To find out what those effects are, the defendants conducted a clinical trial. They divided the nationally accepted range of SpO2 levels into a high range (90%- 95%) and a low range (85%-90%). Infants whose parents agreed to participate in that trial—all having an extremely low birth weight—were randomly placed in either of the two groups. By making that division, the defendants tracked the infants’ rates of NDI, on one side, and ROP, on the other side.

Read More

Proving Decision-Causation

By Alex Stein

Proving decision-causation in a suit for informed-consent violation is never easy. Things get even worse when a trial judge misinterprets the criteria for determining – counterfactually – whether the patient would have agreed to the chosen treatment if she were to receive full information about its benefits, risks, and alternatives. The recent Tennessee Supreme Court decision, White v. Beeks, — S.W.3d —- 2015 WL 2375458 (Tenn. 2015), is a case in point. Read More

The Timeline Approach to Medical Malpractice Defenses

By Alex Stein

California’s Court of Appeal has recently delivered a first-impression decision on the conditions under which a patient’s own negligence can be asserted as a defense against medical malpractice allegations. Harb v. City of Bakersfield, — Cal.Rptr.3d —- (Cal.App. 5th Dist. 2015) 2015 WL 302291.  Among the materials cited by this decision was my article, Toward a Theory of Medical Malpractice, 97 Iowa Law Review 1201 (2012). The court used my “timeline approach” to separate the patient’s pre-treatment negligence, upon which providers of substandard medical care cannot rely, from self-injurious behaviors that occur during and after treatment and that can properly mitigate – and in extreme cases, even eliminate – the legal consequences of medical malpractice. Read More

Organ Transplant Malpractice and the “Proximate Cause”

By Alex Stein

Everyone interested in that area must read Shierts v. University of Minnesota Physicians, — N.W.2d — (Minn.App.2014), 2014 WL 7344014.

This important – yet, unreported – decision deals with a medical-malpractice action arising out of the patient’s death from cancer contracted from a donated pancreas. The trial court dismissed the action summarily based on the “proximate cause” doctrine, and the plaintiff appealed against that dismissal. Read More

“Proximate Cause” and the Patient Suicide Problem

By Alex Stein

This difficult problem and the underlying human tragedy have recently been adjudicated by the Supreme Court of Mississippi in Truddle v. Baptist Memorial Hosp.-Desoto, Inc., — So.3d —- (Miss. 2014).

A hospital patient suffering from a number of illnesses became agitated and aggressive. He took the IV out of his arm and attempted to leave the hospital. When nurses stopped him and forced him back to his room, he hallucinated that someone was trying to rape him. Despite these psychiatric symptoms, the patient was discharged and treated as an outpatient. During his outpatient treatment, he complained to his doctor that the medications he was taking “make him crazy.” Six days after his release from the hospital and two days after his last outpatient appointment, the patient barricaded himself in his bedroom and committed suicide.  Read More