Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
The doctrine of equivalents (DOE), a creation of the Supreme Court in Graver Tank & Mfg. v. Linde Air Products (1950), is balanced by the concept of prosecution history estoppel (PHE), the contours of which were delineated...more
The U.S. Ninth Circuit Court recently revived a medical device lawsuit (Bennett v. C.R. Bard)1 centered on a fact issue regarding the plaintiff’s knowledge of a product defect as the cause of his condition. The case shines...more
A manufacturer produces a medical device for physicians to use to administer a particular type of treatment to their patients. When does that manufacturer have a duty under New York state law to warn a physician of risks...more
From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in 2024 which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
A divided panel of the Federal Circuit affirmed a district court’s grant of summary judgment of noninfringement, holding that importation of two product samples into the U.S. was reasonably related to obtaining FDA approval...more
From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more
A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims. While a treating physician’s failure to read or rely on the manufacturer’s...more
The Federal Circuit recently reversed a lower court’s summary judgment that a medical device design patent was not invalid under the on-sale bar. As a result, the patent owner (Junker) lost the $1.25M infringement damages...more
A series of recent rulings out of the Southern District of Texas in an inferior vena cava (IVC) filter case reflect how well-planned discovery can lead to a successful multipronged summary judgment motion and can effectively...more
The Eleventh Circuit recently reinstated a case alleging a surgical tool caused internal burns during a hysterectomy surgery, holding that the district court erred in disqualifying an expert on the basis that he had never...more
This week, we take a look at the Ninth Circuit’s decisions construing the Biomaterials Access Assurance Act’s immunity for “biomaterials suppliers” and addressing the standard of review when a district court grants summary...more
From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product...more
On December 8, 2020, the Second Circuit Court of Appeals affirmed the Southern District of New York’s granting of summary judgment in favor of Bayer — and resulting closure of all cases against Bayer — in the Mirena...more
Earlier this month, in Plastic Surgery Associates, SC v. Cynosure, Inc., United States District Judge Denise Casper denied plaintiffs’ motion for class certification and allowed Cynosure’s motion for summary judgment on...more
Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more
Frederick (Rick) Fern and the New York City Harris Beach Life Science Practice Group were successful in securing a summary judgment for medical device manufacturers Curlin Medical Inc., Moog Inc., and distributor B. Braun...more
Last week, we covered a summary judgment decision holding that posts on the “Science-Based Medicine” blog were not “commercial speech” under the Lanham Act, and therefore the defendant in that case was not liable for false...more
Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more
In March 2014, Jenna Thurmond sued Bayer in the U.S. District Court for the Northern District of Georgia, alleging that her use of the Mirena contraception system caused her to develop pseudotumor cerebri. Her symptoms...more
Addressing claim construction issues, the US Court of Appeals for the Federal Circuit reiterated the necessity of reading claims in the context of the written description when they are not clear on their face. Howmedica...more
Decision Date: August 7, 2015 - Court: U.S. Court of Appeals for the Federal Circuit - Patent: D661,801; D661,802; D661,803; D661,804 - Holding: Summary judgment of invalidity REVERSED; claim construction...more
Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more