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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Thursday, February 4, 2021

FDA reg doesn't preempt state medical device liability, but plaintiff must plead 'plausible' theory, Court says

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Medical-device liability claims in state courts are not preempted by federal law, the Massachusetts Supreme Judicial Court confirmed Friday, but the plaintiff before the Court failed to meet the pleading standard.

Seeking relief from the pain of osteoarthritis, Plaintiff Dunn received in her knees two injections of "Synvisc-One," a product of defendant Genzyme Corp. and an FDA-approved "Class III medical device," the Court retold.  Subsequently, she "experienced severe side effects, including 'pain and swelling in her knees, difficulty walking, hip bursitis and systemic pseudoseptic acute arthritis," resulting in falls and injuries, including a torn meniscus and broken neck.

The plaintiff sued Genzyme in negligence and product liability and under Massachusetts consumer protection law.  Commonly called "93A," after its codification, the latter theory of unfair or deceptive practices is favored by plaintiffs' lawyers for its allowance of punitive damages upon an up-to-treble multiplier.  Massachusetts allows punitive damages only upon statutory authorization, and 93A is generous, tracking tort liability theories, including product liability, that would not be thought of as statutory consumer protection in other states.

The U.S. Supreme Court ruled in 2008 that state law claims are not necessarily preempted by regulatory approval under the 1976 Medical Device Regulation Act (MDA).  To survive preemption, a plaintiff's claim must parallel, and not exceed, federal regulatory requirements.

Justice Gaziano
Applying the Supreme Court standard, the SJC determined that the plaintiff's claims met the standard.  Specifically, "negligent failure to warn, breach of warranty, negligent manufacture, products liability, and violations of [chapter] 93A—all can be interpreted as coextensive with the comprehensive Federal requirements."

Contrary to implication by the defense, the SJC held that a plaintiff asserting medical-device liability in parallel with the MDA is not required to plead with the high level of particularity (Rule 9(b)) required in fraud.  Rather, the requisite pleading standard is "plausibility": "plaintiffs asserting parallel State-law claims based upon a violation of FDA regulations must articulate only "factual allegations plausibly suggesting (not merely consistent with) an entitlement to relief" (quoting SJC precedent).

Nevertheless, the plaintiff failed to meet that standard.  The complaint alleged foreseeability of "significant dangers," known or reasonably knowable "dangerous propensities," and, as an alternative theory, adulteration or defect of the product.  But the plaintiff alleged no factual support for causation linking the injection to the injury other than "temporal proximity."  Evidence of other complaints about the product would have helped, the Court suggested.  But deficiency of pleading does not entitle a plaintiff to discovery.

Accordingly, the Court reversed the trial court's denial of the defense motion to dismiss.

The case is Dunn v. Genzyme Corp., No. SJC-12904 (Mass. Jan. 29, 2021).  Justice Frank M. Gaziano authored the opinion of the unanimous Court.

Monday, July 15, 2019

'Genetically modified humans are among us'

An alum of my constitutional law class, Paul EnrĂ­quez, J.D., LL.M., Ph.D.—Structural and Molecular Biochemistry, is doing some stellar academic work at the cutting edge of genetic science and law and policy.  He privileged me with a sneak peak at his latest contribution to the legal literature, now available on SSRN, Editing Humanity: On the Precise Manipulation of DNA in Human Embryos, forthcoming in 97 N.C. L. Rev. Here is the abstract:

Genetically modified humans are among us. Emerging technologies for genome editing have launched humanity into the uncharted territory of modifying the human germline—namely, the reproductive cells and embryos that carry our genetic ancestry. Reports of the first live births of humans with edited genomes in China recently confirmed that the power to manipulate our genes at an embryonic stage is no longer theoretical. In the wake of enormous scientific progress, questions regarding how the law will treat this technological breakthrough abound.

This Article examines the legality of human genome editing, specifically germline genome editing (“GGE”), from administrative and constitutional law perspectives. It argues that the Food and Drug Administration’s (“FDA” or “Agency”) forbearance in claiming jurisdiction over GGE is creating a perilous void for an emerging field of law. At the same time, the contemporary de facto legislative ban on GGE clinical applications, which categorically prohibits the Agency from evaluating the safety and efficacy of any investigational new drug or biological product application derived from the technology, is unnecessary and creates more societal costs than benefits. On a broad scale, the ban embodies poor public policy because it prevents the FDA from exercising jurisdiction over matters that constitute extensions of the Agency’s traditional regulatory scope. An analysis of the law reveals salient regulatory gaps that could be viewed as rendering some types of GGE beyond the FDA’s regulatory reach. Notwithstanding those gaps, this Article argues that the FDA can work within the existing statutory framework to cure regulatory deficits and promulgate rules to regulate the technology and, thus, urges the FDA to exercise that jurisdiction. This Article ultimately demonstrates how law and policy converge into a proposed new regulatory paradigm for human GGE that flows from the D.C. Circuit’s ruling in United States v. Regenerative Sciences, LLC, which held that specific stem cell mixtures can be regulated as drugs or biological products within the meaning of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

This Article further contends that efforts to ban GGE technologies cannot withstand constitutional scrutiny in the long run because they impinge on a cognizable fundamental right that protects select uses of GGE. This fundamental right flows from jurisprudence in the areas of procreative, parental, and—to some extent—privacy rights, but it is not absolute. The Article presents an interpretive model for this body of jurisprudence in the GGE context, which promotes extrapolation of applicable legal principles that can guide and promote coherent public policy. Launching from this jurisprudential departing point, this Article introduces a novel legal- and science-based normative framework to delineate primary limits for a right to perform GGE based upon four distinct categories: (1) therapeutic uses to remedy disease; (2) prophylactic purposes, which may or may not be therapeutic; (3) cosmetic or enhancement purposes; and (4) uses involving modification of traits that raise concerns of discrimination already prohibited by the law. This conceptual and structural approach outlines a legal blueprint for GGE clinical interventions, but more importantly it circumvents problems that dominate the existing literature, which arise from the conventional tendency to group GGE applications into therapeutic uses on one hand, and enhancements on the other.

Sunday, March 25, 2018

Mass. high court allows generic-drug consumer to sue Big Pharma for reckless labeling


Just more than a week ago, the Massachusetts Supreme Judicial Court (SJC) issued an adroit and important decision on drug manufacturer liability.  In a decision worthy of other states’ attention, the SJC allowed a common law recklessness claim for failure to warn, unobstructed by federal preemption.  The case is Rafferty v. Merck & Co., No. SJC-12347 (Mar. 16, 2018) (PDF), per Chief Justice Ralph Gants.

It was in the last season of Boston Legal in 2008 (s5e02) that Alan Shore (James Spader), maybe my favorite TV lawyer, took on Big Pharma, right on the heels of victory over Big Tobacco.  In real life, Big Pharma has long been about the business of avoiding tort liability.  When labeling defects have been alleged, the Big Pharma defense has found traction in federal preemption, owing to the FDA’s close supervision of labeling under the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq.

One thread of this debate involves the relative responsibilities of brand-name and generic manufacturers.  In 2011, in PLIVA, Inc. v. Mensing, 564 U.S. 604, the U.S. Supreme Court, 5-4, rejected liability for a generic drug maker accused of failure to warn of side effects when the label matched that of the brand-name equivalent.

In the SJC last week, the plaintiff also was injured taking a generic drug, but sought to hold the brand-name maker accountable in negligence and consumer protection, accusing the maker of failure to warn on the label that the generic provider copied.  The plaintiff took the generic drug finasteride, in lieu of defendant Merck’s brand-name drug Proscar, to treat an enlarged prostate.  The label warned of sexual dysfunction as a temporary side effect, but the plaintiff experienced persistent dysfunction.  The plaintiff alleged that Merck was aware of the risk from several studies and had changed the warning label accordingly in some foreign markets, including Italy, Sweden, and the United Kingdom.

Significantly, then, the plaintiff admittedly complained against a defendant whose drug he did not take.  But the plaintiff traced causation to Merck, because FDA regulation of generic drugs compelled the generic maker to copy the Merck label, and PLIVA precluded liability for the generic maker.  The trial court dismissed, holding that brand-name-maker liability to a patient who did not take the maker’s drug also would “disturb the balance struck” by statute and regulation for the approval of generic drugs.

The SJC regarded the problem as one of duty.  Typically, the court explained, a manufacturer owes a duty of care only to consumers of the manufacturer’s own products.  The First Circuit upheld that logic in a 1983 case under Massachusetts law, Carrier v. Riddell, Inc., 721 F.2d 867.  The court, per then-Circuit Judge Stephen Breyer, denied recovery to a high school football player who blamed a helmet defect for his severe spinal injury.  He had not used the defendant-manufacturer’s helmet, but teammates had.  He alleged that had the defendant properly labeled its helmets, he would have been informed properly about his own.  The SJC further analogized the problem to the effort to hold responsible for a shooting an earlier-in-time actor accused of failing to secure the firearm.  The key to this duty analysis, the court explained, is the foreseeability of a plaintiff-victim—reminiscent of Judge Cardozo’s classic “orbit of duty” analysis in Palsgraf.

Duty in the drug liability problem, the SJC reasoned, is not the same as the product liability analysis in Carrier.  Rather, consistently with the federal regulatory scheme, Merck knows that generic manufacturers will be compelled to rely on its labeling.  Merck therefore has control over the generic label, and duty follows control.  One might say that the consumers of the generic drug are therefore foreseeable victims, for duty purposes, or that the chain of proximate causation runs intact through the intermediary generic maker, because the intermediary lacks control over the label.  Like Palsgraf itself, the case demonstrates the fluid interchangeability of duty and causation.

However, the court further reasoned, negligence, like strict liability, might be too low a liability threshold.  Shifting the liability of generic consumers on to brand-name makers adds to the cost of drug research and development in a way that might interfere with the legislative-regulatory scheme.  Under PLIVA, the brand-name maker could not share joint liability with the generic maker.  At the same time, allowing the brand-name maker wholly to escape liability would allow an injured plaintiff no recovery under any circumstances.  A balance may be struck, the court concluded, when the plaintiff can prove recklessness, or more, intent, on the part of the brand-name maker.

The court wrote: “We have nevertheless consistently recognized that there is a certain core duty—a certain irreducible minimum duty of care, owed to all persons—that as a matter of public policy cannot be abrogated: that is, the duty not to intentionally or recklessly cause harm to others.”  The court analogized to the duty of care owed by defendants in other exceptional areas of Massachusetts tort law: landowner to trespasser, defamation defendant to public figure, bailee to bailor, and athletes and coaches to competitors.

Otherwise put, the court maintained the essential balance of tort law upon its four fundamental elements, duty, breach, proximate cause, and injury.  The extension of liability to a defendant-manufacturer who did not actually make the injurious product depressed the thresholds for duty and causation.  To maintain balance, the requisite standard of breach is amplified to recklessness or intent.  Physical injury remains constant. 

Chief Justice Gants’s opinion in Rafferty is insightful and masterful.  It takes account of the greater endeavor of tort law to define civil wrongs, while balancing the corrective role of the judiciary with the policy-making role of the legislative and executive branches, and also striking a balance in federalism between tort accountability in the states and market regulation under the Commerce Clause.  At the same time, the decision recognizes how these balances are struck across the body of tort law in areas that usually seem only distantly related, from premises liability to reputational harm to sports.  This would be one for the casebooks, if casebooks were still a thing.

Tuesday, August 22, 2017

Abstract: Arthur on vaccination and consumer protection

Donald C. Arthur, M.D., J.D. UMass Law '17, has published Commercial Deception by Anti-Vaccine Homeopathic Websites: A Consumer Protection Approach, 10 Biotechnology & Pharmaceutical L. Rev. 1, 27 (2017).  Here is the abstract.

Abstract
Some internet marketers offer for sale “vaccination substitutes” that can purportedly replace actual scientifically-tested and federally-approved vaccinations. Deceptive internet advertising for vaccine substitutes has dissuaded parents from vaccinating their children, resulting in a resurgence of vaccine-preventable childhood diseases. The Food and Drug Administration and Federal Trade Commission have the authority to address dangerously deceptive product claims, including those for homeopathic preparations that have thus far avoided safety and efficacy testing. This article presents the issues involved in deceptive advertising and proposes regulatory solutions.
The article is available to Westlaw Next subscribers here.  The Review is published at North Carolina Central University School of Law.

Claiming Don as an alumnus is decidedly my privilege.  Dr. Arthur is an emergency medicine and preventive medicine physician.  He served 33 years in the U.S. Navy, culminating his career as Navy surgeon general and retiring at the rank of vice admiral. He served as chief executive officer of three hospitals, including the National Naval Medical Center in Bethesda, Maryland.