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

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. Continue reading

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. Continue reading

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. Continue reading

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. Continue reading

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.

Continue reading

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. Continue reading

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. Continue reading

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. Continue reading

“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.  Continue reading

Lost Chances to Recover: An Elaboration

By Alex Stein

An important development of the lost-chance doctrine recently took place in Rash v. Providence Health & Services, — P.3d —- (Wash.App.Div.3 2014).

An 82-year old patient with a critical heart condition was hospitalized to undergo surgery. The patient’s heart condition made her death inevitable, but she managed to prolong her life with the help of medications. The hospital negligently failed to give the patient blood pressure medications. As a result, the patient suffered a series of strokes from which she died. The hospital’s negligence thus accelerated the patient’s demise.

The patient’s heirs sued the hospital for medical malpractice. The patient’s preexisting condition doomed the plaintiffs’ claim that the hospital’s negligence was the but-for cause of her death. The plaintiffs consequently demanded compensation for the lost chance of  better outcome, pursuant to Herskovits v. Grp. Health Coop. of Puget Sound, 664 P.2d 474 (Wash. 1983); and Mohr, 262 P.3d 490 (Wash. 2011). Continue reading

Evidential Damage: Liability for Uncertainty in Medical Malpractice Suits

By Alex Stein

As I wrote in my book with Ariel Porat, Tort Liability Under Uncertainty, our torts system must develop systematic remedy for wrongful inflictions of evidentiary harm.

The Florida Supreme Court’s recent decision, Saunders v. Dickens, — So.3d —- (Fla. 2014), is a case in point. Continue reading

The Law of Breast Cancer

By Alex Stein

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.

Can the patient successfully sue the negligent radiologist? Continue reading

Mental Therapist’s Duty to Prevent Patient’s Crime

By Alex Stein

A clinical social worker hears from his patient about the patient’s interest in child pornography, but does nothing to solve the problem. Later on, the police raids the patient’s house to find evidence that he illegally downloaded, viewed and possessed child pornography. The patient now faces criminal charges.

Can he sue the social worker for malpractice? Would a similar suit be available against a psychiatrist? Continue reading

Medical Malpractice Causation Revisited

By Alex Stein

Evidence law requires the plaintiff to prove every element of her suit by a preponderance of the evidence.  Under this requirement, an aggrieved patient will not succeed in her suit against the doctor unless she adduces persuasive evidence of causation. This evidence must demonstrate that it is more probable than not that the doctor’s malpractice caused the patient’s damage. Satisfying this requirement is difficult because doctors can virtually always blame the patient’s damage on her preexisting medical condition. This factor makes causation in a medical malpractice case an extremely complex issue. In the absence of special legal rules, this issue could present an insurmountable evidentiary obstacle for many wronged patients. Courts responded to this problem by relaxing the causation requirements for medical malpractice suits. They have developed what I call the “relaxed causation” doctrine: see Toward a Theory of Medical Malpractice, 97 Iowa L. Rev. 1201, 1216-26 (2012). The doctrine’s idea is to close the exit from liability for negligent doctors: these doctors should not go scot free because of the patient’s preexisting condition that complicates the causation issue.

This doctrine was at play in a recent case Klein v. Aronchick, — A.3d —-, 2014 WL 46648 (Pa. Super. 2014). Continue reading

Anti-Abortion Practices at Catholic Hospitals as Medical Malpractice

By Alex Stein

The New York Times has recently reported about a suit filed by ACLU against the United States Conference of Catholic Bishops for requiring Catholic hospitals to avoid abortion “even when doing so places a woman’s health or life at risk.” The suit unfolds a disturbing story about an 18-week pregnant woman who rushed to the Mercy Health Partners in Muskegon, Michigan – the only one in her county – after breaking water. According to the suit, the plaintiff’s pregnancy was not viable but posed significant risks to her health. Instead of inducing labor or surgically removing the fetus to reduce the plaintiff’s chances of infection, the doctors at Mercy Health sent her home. The doctors also did not tell the plaintiff that her pregnancy is not viable and that it poses risk to her health. The plaintiff returned to the hospital next morning and was sent home again (!!) despite her bleeding and pain. On her third visit to the hospital – with severe pain and fever – the plaintiff miscarried and her fetus died shortly thereafter.

Described by the NYT as opening “a new front in the clash over religious rights and medical care,” the suit was filed in federal court in Michigan. Continue reading

Compensation for a Patient’s Lost Chances to Recover from Illness: A Redux

By Alex Stein

Three days ago, Washington’s Court of Appeals issued a decision explaining the state’s Supreme Court precedents that entitle patients wronged by their doctors to recover compensation for their lost chances to recover from illness: Herskovits v. Group Health Cooperative of Puget Sound, 664 P.2d 474 (Wash. 1983), and Mohr v. Grantham, 262 P.3d 490 (Wash. 2011). The Court of Appeals ruled that this compensation entitlement is limited to cases in which the injured patient cannot prove causation by a preponderance of the evidence due to her preexisting condition. The Court explained that when a doctor’s malpractice reduces the patient’s chances to recover by more than 50%, the patient would be able to satisfy the preponderance requirement and recover full compensation. The Estate of Ruth M. Dormaier v. Columbia Basin Anesthesia, P.L.L.C., — P.3d —-, 2013 WL 6037098 (Wash.App. Div. 3 2013).

This decision also has continued the prevalent, but mistaken, “arithmetical approach” to lost chances. Under this approach, when a doctor’s malpractice reduces his patient’s chances to recover from illness from 75% to 25%, and the patient ultimately does not recover, the doctor must pay the patient 50% (75%-25%) of her damage.

This approach is mistaken for the following reasons: Continue reading

Daubert as a Problem for Psychiatrists

By Alex Stein

Most psychiatrists don’t know about it, but the switch from Frye to Daubert in the admission of expert testimony matters for them a lot. Psychiatrists treat patients with second-generation antipsychotics: Zyprexa, Risperdal, Clozaril, Seroquel, and similar drugs. A reputable, but still controversial, body of research links those drugs to tardive dyskinesia: a serious neurological disorder involving uncontrollable facial grimacing, repetitive tongue thrusting, and other untoward bodily movements. Under Frye, expert evidence can only be admitted upon showing that it received “standing and scientific recognition” from the relevant community of experts. Absence of a solid consensus disqualifies the evidence. Expert testimony linking tardive dyskinesia to antipsychotic drugs consequently would not be admissible under Frye. Under Daubert, however, it would go into evidence because its underlying research is grounded in scientific method and procedure that can be replicated, examined, and properly explained to the jury.

This is exactly what happened in a recent case decided by the United States District Court for the District of Columbia: Patteson v. Maloney— F.Supp.2d —-, 2013 WL 5133495 (D.D.C. 2013). Continue reading

Proximate Cause in Georgia

By Alex Stein

Two days ago, Georgia’s Court of Appeals decided Georgia Clinic v. Stout, — S.E.2d —-, 2013 WL 3497703 (Ga. App. 2013).

This tragic case features an elderly patient with an arthritic knee. Her doctors injected that knee with medication drawn from a multi-dose vial. They did so at their clinic under non-sterile conditions that included poor infection controls, failure to maintain sterile field, and poor hand-washing facilities (the clinic had no sinks and alcohol hand cleaners in the examination rooms). As a result, the patient’s knee was infected with methicillin-sensitive staphylococcus aureus (“MSSA”). Four other patients of the same clinic were also infected with MSSA from the same multi-dose vial.

The patient developed excruciating pain in her knee and became depressed. The doctors treated her for the pain in the knee but neglected the depression. They failed to refer the patient to a psychiatrist. After a short period of time, the patient committed suicide by jumping from the window of her 14th floor apartment. She left behind a suicide note saying that she can’t take her pain anymore and prefers to die. Continue reading