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 …
Advancements in Medical Device Technology Prompts FDA Guidance Document for Manufacturers
9/8/17
By: Michael P. Bruyere and Samantha Skolnick
From operating rooms to a local pediatrician office; we know that medical devices have altered the medical field in a significant way. As technology, has improved; making our homes smarter and allowing our …
The Supreme Court Buys Into Argument that Plaintiffs Should Not Be Permitted to Forum Shop
6/22/17
By: Kristian Smith & Robyn Flegal
The U.S. Supreme Court decided one of the most important mass tort/product liability decisions ever Monday, effectively ending forum shopping or “litigation tourism.” In its 8-1 ruling, the Supreme Court in Bristol-Myers Squibb Co. …
6/9/17
By: Robyn Flegal
In July of 2007, Joshua Martin suffered a brutal gang attack outside of Six Flags Over Georgia and was left with severe brain damage. On June 5, 2017, the Supreme Court of Georgia granted certiorari to decide …
Pharmaceutical Company Held Liable for Lawyer’s Suicide
4/27/17
A federal jury in Illinois recently held GlaxoSmithKline liable for the death of a Reed Smith LLP partner, Stewart Dolin. The jury found that the generic version of GSK’s Paxil caused Mr. Dolin to take his …
Higher Screening Standards Needed to Prevent Fentanyl Misappropriation in Hospitals
11/4/16
By: Robyn Flegal
A disturbing trend is on the rise. Hospital employees are misappropriating drugs intended for patients. The drug of choice is fentanyl, which has been used as a prescription painkiller since the 1960s, but is up to fifty …