Coverage for unclean hands? Plaintiffs Say Manufacturer Misrepresented Sanitizer’s Effect on Coronavirus
3/25/20
By: Renata Hoddinott and Barry Miller
On March 23 FMG presented the webinar Navigating Coverage Issues Arising from COVID-19. Presenters Marc Shrake, Erin Lamb, and Barry Miller discussed four lawsuits that already have been filed alleging claims related to coronavirus.…
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 …
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 …
11th Circuit Does Not Mesh Around and Upholds $27M Judgment
11/13/17
By Samantha Skolnick
In a recent decision by the U.S. Court of Appeals for the Eleventh Circuit, the Court upheld almost $27 million in judgments against Boston Scientific Corporation (BSC). The consolidated cases stemmed from women who claimed to have …
FDA Continues to Fight the First Amendment But Facteau Deals Another Blow
8/18/16
By: Kristian Smith
Last month, a federal jury in Massachusetts acquitted two executives of medical device company Acclarent, Inc. of 14 felony counts of fraud related to off-label promotion of Acclarent’s “Stratus” device. United States v. Facteau, et al. stemmed …
FDA Approves First Drug Made by 3D Printing
9/1/15
By: Mike Bruyere
Additive manufacturing, or 3D printing, reached a significant milestone this month when the FDA approved the production of an epilepsy medication that will be marketed under the name Spritam. The new drug, developed by Aprecia, controls seizures …
A Rose By Any Other Name: Alabama Supreme Court Denies Creating Tort of Innovator Liability for Brand-Name Drug Manufacturers, But Its Decision Creates A Pathway for Innovator Liability for Brand-Name Drug Manufacturers
8/21/14
By: Michael P. Bruyere and Michael J. Eshman
After the U.S. Supreme Court’s decision in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011) holding that a generic drug manufacturer generally cannot be liable for a failure-to-warn state law …