Insights

In Brown v. GlaxoSmithKline, LLC and Providence Health System – Oregon, 323 Or. App. 214 (Ct. App. Or. 2022), the Oregon Court of Appeals recently found that a hospital could be a “seller” of pharmaceutical drugs under Oregon law, subjecting it to strict products liability for alleged drug defects.  This decision contravenes—and thus threatens to upset—the overwhelming consensus among U.S. courts that hospitals are not strictly liable for allegedly defective drugs or medical devices used in the course of providing medical care to patients. 

On January 26, 2016, the U.S. Food and Drug Administration (FDA) released draft Guidance on interoperable medical devices. This provides important direction for medical device manufacturers to consider in the design of their products. Comments on the draft Guidance will be accepted by FDA for 60 days. 

On October 2, 2014, the FDA released a set of guidelines designed to improve the cybersecurity of medical devices and to combat increasing vulnerability to cyber-attacks. Compliance with the guidelines, although not mandatory, is strongly recommended to protect not only patients, but also manufacturers, facilities, and providers. In drafting the guidelines, the FDA was careful to consider the particular sensitivities involved in the regulation of instruments designed for health care. Overly strict regulations may run the risk of inhibiting a device's functional capabilities – a distinct concern in the case of devices intended for emergency response. Conversely, if regulations are not strict enough, there is an increased risk of potential cyber incidents that could result in patient harm such as illness, injury, or even death.

According to nearly simultaneous statements made by three senior Justice Department officials on November 12, 2009, the Justice Department is planning to focus more criminal enforcement against the pharmaceutical and medical device industry's interaction with foreign officials.

This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm's Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups.  Cases in this issue:

This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm's Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups.  Cases in this issue:

This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm's Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups. Cases in this issue:

This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm's Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups.  Cases in this issue:

This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm's Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups. Cases in this issue:

This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm’s Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups. Cases in this issue:

On March 5, 2009, House Energy and Commerce Health Subcommittee Chairman Frank Pallone, Jr. (D-NJ) and House Energy and Commerce Chairman Henry Waxman (D-CA) introduced the Medical Device Safety Act of 2009 (H.R. 1346) ("MDSA"). If passed, the MDSA would authorize state product liability lawsuits for medical devices, effectively overturning the U.S. Supreme Court's 2008 decision in Riegel v. Medtronic.

This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm’s Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups. Cases in this issue:

This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm’s Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups. Cases in this issue:

This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm’s Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups.  Cases in this issue:

This summary of key lawsuits affecting medical device companies is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm’s Torts, Antitrust, Commercial Litigation, and Intellectual Property Groups.  Cases in this issue:

Yesterday the U.S. Supreme Court decided that federal medical device law prohibits state tort claims against manufacturers whose products pass the Food and Drug Administration’s ("FDA's") pre-market approval ("PMA") process.

This summary of key lawsuits affecting medical devices is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm’s Torts, Antitrust and Intellectual Property Law Groups. Cases in this issue:

This summary of key lawsuits affecting medical devices is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm’s Torts, Antitrust and Intellectual Property Law Groups. Cases in this issue:

This summary of key lawsuits affecting medical devices is provided by the Health Care Law Group of Crowell & Moring LLP, in collaboration with the firm’s Torts, Antitrust and Intellectual Property Law Groups. Cases in this issue:

Federal enforcement authorities are focusing on key fraud and abuse issues in the medical device industry -- safety-related reporting and fraud risks, kickbacks, device alteration and off-label marketing. A May 24th presentation at a BNA audioconference by Virginia Gibson, chief of the Civil Division of the U.S. Attorney's Office for the Eastern District of Pennsylvania, outlined these risk areas.