Potential liability for CT scan manufacturers due to increased risks of cancer
5/14/25
By: Kevin G. Kenneally, James V. Lovett, Eric K. Stryker and Kyle M. Virgin
A new study out of the University of California, San Francisco has linked current CT scanning practices to increased risks and incidences of cancer …
U.S. Supreme Court denies petition regarding on-sale bar for secret processes
5/7/25
By: James V. Lovett
On April 28, 2025, the U.S. Supreme Court declined to hear an appeal in Celanese International Corp. v. International Trade Commission. 111 F.4th 1338, 1340 (Fed. Cir. 2024), cert. denied sub nom. Celanese Int’l Corp. …
EPA announces final National Primary Drinking Water Regulation for PFAS
4/11/24
By: James M. Mathew, David M. Harding, and Kevin M. Ringel
After working for over a year and reviewing 120,000 comments on the proposed rule, the EPA passed its final regulation regarding PFAS in drinking water. The Safe …
12/4/23
By: Kevin G. Kenneally, David Harding and Christina Morgan
“Seldom is so ambitious a case filed on so slight a basis.”
–U.S. Court of Appeals for the Sixth Circuit
On November 27, 2023, the U.S. Court of Appeals for …
8/10/23
By: Kevin G. Kenneally and David M. Harding
The EPA is currently seeking public comment on a proposed rule to expand the hazardous substances designation to certain per- and polyfluoroalkyl substances (PFAS) under the Comprehensive Environmental Response, Compensation, and Liability …
Outbreak!: Why insurance claims professionals should pay attention to Monkeypox
9/22/22
By: Glenn Klinger
Monkeypox was declared a national public health emergency by the U.S. Department of Health and Human Services on August 4, 2022, only the fifth time this has happened since 2009. As of September 20, 2022, the Centers …
DOJ Issues Guidance for Cooperation Credit in False Claim Act Investigations
5/10/19
By: Michael Bruyere
The Provider Self-Disclosure Protocol was created in 1998 to encourage providers to voluntarily disclose self-discovered evidence of potential fraud. According to OIG-HHS, self-disclosure (now commonly referred to as voluntary disclosure) gives providers the opportunity to avoid the …
New Medical Devices and Performance Criteria
2/12/19
By: Koty Newman
The Food and Drug Administration (“FDA”) recently issued final guidance (the “Guidance”), providing a framework for its new Safety and Performance Based Pathway for its updated 510(k) process. Section 510(k) of the Food, Drug and Cosmetic Act …
Office of Inspector General Approves Warranty Program for Medical Device Manufacturer
11/5/18
By: Ali Sabzevari
The Department of Health and Human Services Office of Inspector General recently approved a medical device manufacturer’s proposed warranty program, which provides a refund to the hospital at which a patient underwent joint replacement surgery using the …
PUNITIVE DAMAGES: How Much Is Too Much?
11/1/18
By: Rebecca Smith
On August 10, 2018, in the first Roundup cancer lawsuit to proceed to trial, a jury awarded Dewayne Johnson a total of $289 million dollars. On Monday, October 22, 2018, a San Francisco Superior Court Judge refused …
Leaked DOJ Memo Unearths New Strategy in Qui Tam Cases
2/13/18
By: Samantha L. Skolnick
On January 10, 2018, an internal Department of Justice memorandum (the “Granston Memo”) was leaked to the public, turning heads. The Granston Memo included an in-depth analysis of the DOJ’s position on evaluating dismissals pursuant to …
Eleventh Circuit Rules Florida Strict Liability and Negligence Claims Not Preempted by the MDA
2/12/18
By: Robyn Flegal
A panel of the Eleventh Circuit determined in a February 8, 2018 published decision that a Florida district court erred when it ruled that a husband’s claims, brought against a medical device manufacturer after its Life Vest …