Justia Drugs & Biotech Opinion SummariesArticles Posted in U.S. 1st Circuit Court of Appeals
Bartlett v. Mut. Pharm. Co., Inc.
Plaintiff's doctor prescribed, for shoulder pain, sulindac, a non-steroid anti-inflammatory, under the brand-name Clinoril; her pharmacist dispensed generic sulindac. She developed a hypersensitivity reaction, toxic epidermal necrolysis, with which the outer skin layer on a patient's body has deteriorated, been burned off or turned into an open wound. Plaintiff spent 70 days at Massachusetts General Hospital, more than 50 in its burn unit, with 60-65 percent of her skin affected. Her "truly horrific" injuries include permanent near-blindness. Her claims against the manufacturer included breach of warranty, fraud, and negligence, and products liability claims: design defect, failure to warn, and manufacturing defect. By trial, the remaining theory of design defect was narrowed to a claim that sulindac's risks outweighed its benefits making it unreasonably dangerous to consumers, despite the FDA having never withdrawn its statutory "safe and effective" designation. A jury awarded $21.06 million in compensatory damages. The First Circuit affirmed, rejecting claims including that the district court misunderstood New Hampshire law on design defect claims; that such claims as to generic drugs are preempted under federal law; that causation was not proved; and that damages were excessive and required a new trial. .View "Bartlett v. Mut. Pharm. Co., Inc." on Justia Law
Posted in: Drugs & Biotech, Health Law, Injury Law, U.S. 1st Circuit Court of Appeals
Rohn v. Dana Farber/Harvard Cancer Ctr.
Plaintiffs are a dissident group, within a larger class of medical patient consumers in a case alleging fraud in overcharging for the medication Lupron. The patients, along with insurers and private health care providers, obtained a $150 million settlement agreement that was approved by the district court, of which $40 million was allocated to consumers. That agreement provided that if there were unclaimed monies from the $40 million consumer settlement pool after full recovery to consumer plaintiffs, all unclaimed funds would go into a cy pres fund to be distributed at the discretion of the trial judge. Dissident plaintiffs appealed distribution of the $11.4 million cy pres fund to the Dana Farber/Harvard Cancer Center and the Prostate Cancer Foundation for work on the treatment of the diseases for which Lupron is prescribed. They have already recovered more than 100% of their actual damages. The First Circuit affirmed. After expressing concern about distribution of such funds by judges and adding an audit requirement, the court noted the importance of avoiding windfalls for plaintiffs who have already been fully compensated. View "Rohn v. Dana Farber/Harvard Cancer Ctr." on Justia Law
Samaan v. St. Joseph Hosp.
Flying from Cairo to New York, a flight attendant thought plaintiff looked ill and recruited a second-year medical resident to perform an examination. The resident thought that plaintiff was suffering an ischemic stroke or transient ischemic attack. The pilot made an emergency landing and, less than two hours later, plaintiff was treated at a hospital. The hospital did not administer an intravenous shot of tissue plasminogen activator (t-PA), a form of thrombolytic therapy that dissolves clots, but is not appropriate for all patients. His condition deteriorated, then stabilized, and he was transferred for care in New York. The district court held a "Daubert" hearing in plaintiff's malpractice claim and two experts gave vastly different opinions about whether failure to administer t-PA caused plaintiff's injuries. The court held that the standard for causation was "more likely than not" and that Maine had not adopted the "lost chance" doctrine, excluded plaintiff's expert, and granted summary judgment for defendants. The First Circuit affirmed, holding that plaintiff failed to show causation.View "Samaan v. St. Joseph Hosp." on Justia Law
Redondo Waste Sys., Inc.v. Lopez-Freytes
Plaintiff, engaged in treatment and disposal of regulated biomedical waste, had trouble with its shredder and obtained approval from the Puerto Rico Environmental Quality Board to use autoclaves. After a few years, an inspector recommended that plaintiff's facility be shut down and ordered a landfill to stop accepting plaintiff's waste. Unable to resolve the matter with EQB, plaintiff sought a federal court injunction. The injunctions were denied, but plaintiff resumed handling waste. When a second shredder broke, an inspector again ordered the landfill to stop accepting waste and rejected several proposals for dealing with accumulated waste. Plaintiff's suit alleges more favorable treatment of a competitor and other constitutional violations. The district court dismissed for failure to link allegations to any particular defendant. The First Circuit affirmed, finding failure to meet minimal pleading standards. The complaint failed the plausibility test "spectacularly." View "Redondo Waste Sys., Inc.v. Lopez-Freytes" on Justia Law
CQ Int’l Co., Inc. v. Rochem Int’l, Inc., USA
The companies are direct competitors in importing and distributing pharmaceutical ingredients manufactured in China. Plaintiff claimed that defendant intentionally interfered with one of its contracts and sought damages. In court-ordered settlement negotiations, plaintiff demanded $675,000. Defendant made a counter-offer, demanding that plaintiff pay it $444,444.44 in order to settle the case and avoid a motion for sanctions and a suit for malicious prosecution. The court noted that the peculiar amount was due to the fact that the number four is considered an unlucky number in Chinese culture because it is homophonous with the Chinese word for death, but concluded that it was not a death threat and declined to impose sanctions. The court later entered summary judgment for defendant. The First Circuit affirmed the court's refusal to impose sanctions under FRCP 11. Plaintiff's claims were not patently frivolous. View "CQ Int'l Co., Inc. v. Rochem Int'l, Inc., USA" on Justia Law
MS Pub.Emps. Ret. Sys. v. Boston Scientific Corp.
The Mississippi Public Employees' Retirement System filed a class action, claiming that senior management of a publicly traded manufacturer of medical devices in which it invested, withheld material information and made misleading statements about devices for treating coronary artery disease, in violation of the Securities Exchange Act of 1934, 15 U.S.C. 78j(b), 78t(a), and Securities Exchange Commission Rule 10b-5, 17 C.F.R. 240.10b-5. In an earlier opinion, the First Circuit reversed dismissal, finding that the inference of scienter advanced by the plaintiff was at least as cogent and compelling as the contrary inference, satisfying the "strong inference" pleading standard of the Private Securities Litigation Reform Act. After discovery, the district court entered summary judgment in favor of defendants. The First Circuit affirmed, finding that plaintiff did not produce evidence that would support a reasonable inference of scienter. Given the statements and disclosures that defendants did make concerning the devices, they had no obligation to disclose the fact that they were working on an improvement that would reduce the very small number of no-deflate complaints that they received, and of which the market was aware. View "MS Pub.Emps. Ret. Sys. v. Boston Scientific Corp." on Justia Law