All articles by Matthew S. Trokenheim
Massachusetts Supreme Judicial Court Expands Liability for Branded Drug Companies to Consumers of Generics
On March 16, 2018, the Supreme Judicial Court of Massachusetts, the state’s highest appellate court, issued a decision of importance for branded drug companies. In Rafferty v. Merck & Co.
, the Massachusetts high court held that a brand-name drug company can be liable to a consumer of a generic drug for injuries arising from the failure to update the brand-name drug’s label that results from a “reckless disregard of an unreasonable risk of death or grave bodily injury.”
The background for this decision is…
Federal Law Preempts State Law Product Liability Claims Involving “Hybrid” Medical Devices
On an issue of first impression in the federal Circuit Courts of Appeals, the Third Circuit held that federal law preempts state law claims involving hybrid medical devices where any part of the device requires FDA pre-approval of the device’s safety and effectiveness.
The 1976 Medical Device Amendments to the Food, Drug and Cosmetics Act brought medical devices under the regulatory authority of the Food and Drug Administration. The Amendments established a system whereby certain types of devices, termed Class 3 devices, require approval by…
Increased Enforcement and Litigation Risk for Data Breaches Involving Personal Health Information
HIPAA and HITECH have long been high priority concerns for health care and life sciences organizations. But recent developments in HIPAA enforcement and data breach litigation raises the threat level for all companies dealing with personal health information (PHI).
On the enforcement front, on February 1, 2018, HHS’s Office of Civil Rights — which enforces HIPAA privacy, security, and breach notification rules — announced a $3.5 million settlement with Fresenius Medical Care North America to resolve several potential HIPAA violations. In 2013, Fresenius filed five…
Sixth Circuit Discourages False Claims Act Claims Based On Off-Label Promotion
On October 27, 2017, in U.S. ex rel. Ibanez v. Bristol-Myers Squibb Co.
, 874 F.3d 905 (6th
Cir. 2017) (Ibanez
), the Sixth Circuit Court of Appeals affirmed the dismissal of a qui tam
action under the False Claims Act (FCA) alleging that Bristol-Myers Squibb engaged in a nationwide scheme to promote off-label uses of its anti-psychotic drug Abilify. In its decision, the Sixth Circuit highlights the challenges for a relator asserting FCA claims based on off-label promotion in a manner that…
Seventh Circuit Bars RICO Claims by Third-Party Payors Against Drug Companies Based on Off-Label Promotion
On October 12, 2017, in Sidney Hillman Health Center of Rochester v. Abbott Laboratories
, —F.3d —-, 2017 WL 4544834 (7th
Cir. 2017), the Seventh Circuit affirmed the dismissal of a civil RICO class action by third-party payors against drug manufacturer Abbott Laboratories. The decision appears to completely foreclose payors’ suits against drug companies for off-label promotion under the Racketeer Influenced and Corrupt Organizations Act (RICO) and potentially signals a bar against tort claims of any kind by payors against drug companies for off-label…
The FTC has its Eyes on Biotech for Antitrust Enforcement
On July 27, 2017, representatives of the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) gave coordinated testimony to Congress that ought to raise alarm bells for pharmaceutical companies. Scott Gottlieb, Commissioner of the FDA, and Markus Meier, Acting Director of the Bureau of Competition at the FTC, both testified before the House Judiciary Committee’s Subcommittee on Regulatory Reform Commercial and Antitrust Law. Their statements announced a renewed coordination between the respective agencies with a goal to increase competition in the pharmaceuticals market…
Federal Court Denies Qui Tam Action Against Medical Device Manufacturer Rejecting Novel Theory that Free Product Support Services Create Liability Under Anti-Kickback Statute
Medical device manufacturers operate in a competitive market. To differentiate themselves from their competitors, manufacturers may offer above-and-beyond customer service. And if you were to understand from right here
on how they generate such good customer leads, you’d understand that they have solid foolproof tactics in their arsenal. A recent federal qui tam action alleged that too much customer service constitutes an illegal kickback under the federal Anti-Kickback Statute. The court rejected the claim, and its reasoning supplies some comfort and some questions for medical…
Third Circuit Adopts Heightened Materiality Standard under False Claims Act
On May 1, 2017, the Third Circuit issued a decision in United States ex rel. Petratos v. Genentech Inc.
, 855 F.3d 481 (3d Cir. 2017) narrowing the ability of qui tam relators to show materiality under the False Claims Act (FCA). In essence, the court held that to be material, a misrepresentation or omission by a drug company must relate to the United States’ decision to pay a claim, not a doctor’s decision to prescribe a drug that would lead to a reimbursement claim…