Map of United States made up of pills.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of January. The selections feature topics ranging from an analysis of recent regulatory and legal developments in drug-pricing transparency, to an argument for the extent to which political actors should have influence over the FDA, to a descriptive analysis of state-level drug product selection laws. A full posting of abstracts/summaries of these articles may be found on our website.

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Another Blow to Tort Reform in Florida: Statute Allowing Defendants in Medical Malpractice Suits to Hold Ex Parte Interviews with the Aggrieved Patient’s Care Providers Declared Unconstitutional

By Alex Stein

STEIN on Medical Malpractice has recently published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, Weaver v. Myers, 229 So.3d 1118 (Fla. 2017), that voided Florida statute allowing defendants in medical malpractice suits to hold ex parte interviews with the aggrieved patient’s care providers.

The case at bar involved a medical malpractice suit filed in connection with the patient’s allegedly wrongful death. The defendants attempted to take advantage of Florida’s pre-suit discovery statute, Fla. Stat. Ann. §§ 766.106, 766.1065. This statute authorized defense attorneys to hold secret ex parte interviews with all doctors and organizations that have ever provided treatment to the deceased patient.

The Florida Supreme Court decided that this statute violates the broad constitutional right to privacy under Fla. Const. art. 1, § 23. The Court reasoned that “The ex parte secret interview provisions of sections 766.106 and 766.1065 fail to protect Florida citizens from even accidental disclosures of confidential medical information that falls outside the scope of the claim because there would be no one present on the claimant’s behalf to ensure that the potential defendant, his insurers, his attorneys, or his experts do not ask for disclosure of information from a former treating health care provider that is totally irrelevant to the claim.” The Court also clarified that “the right to privacy in the Florida Constitution attaches during the life of a citizen and is not retroactively destroyed by death. Here, the constitutional protection operates in the specific context of shielding irrelevant, protected medical history and other private information from the medical malpractice litigation process. Furthermore, in the wrongful death context, standing in the position of the decedent, the administrator of the decedent’s estate has standing to assert the decedent’s privacy rights. Finally, the Legislature unconstitutionally conditioned a plaintiff’s right of access to courts for redress of injuries caused by medical malpractice, whether in the wrongful death or personal injury context, on the claimant’s waiver of the constitutional right to privacy.”

Florida Caps on Noneconomic Damages Held Unconstitutional

By Alex Stein

STEIN on Medical Malpractice has published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, North Broward Hospital District v. Kalitan, 219 So.3d 49 (Fla. 2017), that voided Florida’s cap on medical malpractice victims’ noneconomic damages, Fla. Stat. Ann. §§ 766.118(2), 766.118(3).

Section 766.118(2) provides that in a cause of action for personal injury arising from the medical negligence of practitioners, the noneconomic damages award shall not exceed $500,000 per claimant; however, if the negligence resulted in a permanent vegetative state or death, or if the negligence caused a catastrophic injury and a manifest injustice would occur unless increased damages are awarded, then damages may be awarded in an amount up to $1 million. Section 766.118(3) similarly limits damages to $750,000 and $1.5 million, respectively, when the injury results from the negligence of non-practitioners.

Based on the precedent laid down in McCall v. United States, 134 So.3d 894 (Fla. 2014), and discussed here, (holding Florida’s cap on wrongful-death noneconomic damages unconstitutional), the Florida Supreme Court held that Section 766.118 violates the Equal Protection Clause of the Florida Constitution. Art. I, § 2, Fla. Const. The Court reasoned that Section 766.118 arbitrarily reduces the damages that may be awarded to the most drastically injured victims and that this arbitrary reduction is “not rationally related to alleviating the purported medical malpractice crisis…”

Undisclosed Arbitration Clause in the Doctor-Patient Agreement Held Unenforceable

By Alex Stein

STEIN on Medical Malpractice has published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, King v. Bryant, 795 S.E.2d 340 (N.C. 2017), that examines the validity of a doctor-patient agreement to arbitrate disputes over medical malpractice.

A front desk employee at a surgeon’s practice provided the patient with several intake forms to complete and sign while he waited to meet the surgeon. The forms included an agreement to arbitrate medical malpractice disputes, which the patient signed without reading (together with other documents) because he believed it to be “just a formality.” After an unsuccessful surgical procedure, the patient sued the surgeon in court for medical malpractice. The surgeon filed a motion to stay the action and enforce the arbitration agreement. The trial court denied the motion after finding the arbitration agreement unconscionable. The Court of Appeals affirmed that decision and the surgeon appealed to the North Carolina Supreme Court. Read More

Reproductive Negligence under Maine Law

By Alex Stein

STEIN on Medical Malpractice has published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, Doherty v. Merck & Co., Inc., 154 A.3d 1202 (Me. 2017), featuring reproductive negligence.

This decision could benefit from Dov Fox’s excellent article, Reproductive Negligence, 117 Colum. L. Rev. 149 (2017).

The plaintiff, Kayla Doherty, visited a federally-supported health care center in Maine to inquire about birth control options. Her physician recommended an implantable drug manufactured by the defendant, the Merck company. The drug consisted of a single, four-centimeter-long rod inserted under the skin of the inner side of the patient’s upper arm with a syringe-like applicator. The drug works by inhibiting ovulation and is designed to be effective for at least three years unless the rod is removed sooner by a physician. The drug’s applicator, however, occasionally malfunctioned: it had a history of failed insertion attempts that occurred when the rod would remain stuck in the applicator following the procedure (unbeknownst to the treating physician and the patient).

Doherty was a victim of this malfunction. Read More

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

Psychiatrists’ Liability for Patient’s Violence Against Other People: Washington Supreme Court Abolishes the Inpatient-Outpatient Distinction

By Alex Stein

In a recent decision, Volk v. DeMeerleer, 386 P.3d 254 (Wash. 2016), the Washington Supreme Court relaxed the “control” prerequisite for psychiatrists’ duty to protect third parties against violent patients.

The Court made this decision in a case involving a psychiatric patient who murdered his girlfriend and her nine-year old son and then committed suicide (after attempting to kill the girlfriend’s older son as well). For nine years leading up to that tragedy, the patient received outpatient care from the defendant psychiatrist, during which he expressed suicidal and homicidal ideations (without naming the potential victims).

The Court held that the psychiatrist had a “special relationship” with the victims because he was able to control the patient. Correspondingly, the psychiatrist had a duty to exercise “reasonable care to act consistent with the standards of the mental health profession, in order to protect the foreseeable victims of his or her patient.” The Court reasoned in this connection that some ability to control the patient’s conduct is sufficient for the “special relationship” and the consequent duty of care to exist. For that reason, psychiatrists should assume responsibility not only for an inpatient’s actions, but also in connection with an outpatient’s violence against third parties. Read More

CAVEAT HOSPITIA: Suits Alleging Negligent Credentialing Against Hospitals Get Exemption from Tort Reform

By Alex Stein

Policymakers and scholars interested in medical malpractice and torts generally should read Billeaudeau v. Opelousas General Hospital Authority, — So.3d —-, 2016 WL 6123862 (La. 2016). In this recent and important decision, the Louisiana Supreme Court ruled that suits alleging negligent credentialing against a hospital sound in regular negligence, rather than medical malpractice, and consequently fall outside the purview of the state’s Medical Malpractice Act (MMA) and its limitations on liability. The Court made this decision in connection with the state’s cap on damages recoverable in medical malpractice actions, La. Rev. Stat. § 40:1231.2(B)(1), which limits the total amount that courts can award the victim to $500,000, plus interest and cost, on top of the victim’s future expenditures on medical care and support. For many victims of medical malpractice and their families this cap amount is meager, but the Court nonetheless upheld its constitutionality back in 1992. See Butler v. Flint Goodrich Hosp., 607 So.2d 517 (La. 1992).

The Court has now decided that suits alleging negligent credentialing against hospitals are not subject to this cap and that successful plaintiffs consequently will recover full compensation for any proven damage. Read More

President Trump’s Tort Reform

By Alex Stein

President Trump’s budget for Fiscal Year 2018 proposes a thoroughgoing reform of our medical malpractice system [Executive Office of the President of the United States, Major Savings and Reforms, Budget of the U.S. Government, Fiscal Year 2018, at 114 (2017) (hereinafter, the “Budget”)]. The reform’s stated goals are “[to] reduce defensive medicine … limit liability, reduce provider burden, promote evidence-based practices, and strengthen the physician-patient relationship.”

To achieve these goals, the reform will introduce the following measures:

  • a cap on non-economic damage awards of $250,000 (adjustable to inflation);
  • a three-year statute of limitations;
  • allowing courts to modify attorney’s fee arrangements;
  • abolition of the “collateral source” rule (to allow judges and jurors to hear evidence of the plaintiff’s income from other sources such as workers’ compensation and insurance);
  • creating a safe harbor for clinicians who follow evidence-based clinical-practice guidelines.

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