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
Defective medical devices present serious risks for patients. Just how big—and how severe—is the problem? Consider this from the U.S. Food and Drug Administration (FDA): “Each year, the FDA receives over two million medical...more
At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to...more
Exactech is a medical device company that manufactures implantable joint replacements. It is also a company that has faced numerous lawsuits related to its products in recent years. In many cases, Exactech has acknowledged...more
Getting a shoulder replacement is supposed to improve your quality of life. It is supposed to eliminate your pain, restore your mobility and allow you to do most of the things you were able to do before you started to have...more
What Is ParaGard And Why Are There ParaGard Lawsuits? ParaGard is one of many intrauterine medical devices (IUDs) on the market that are implanted in women as a birth control device. Like all IUDs, ParaGard is meant to...more
C.R. Bard, Inc. is one of many medical device companies involved in large nationwide litigation concerning defective hernia mesh products. C.R. Bard, Inc. faces more than 25,000 lawsuits in state and federal courts, with the...more
The United States Court of Appeals for the Third Circuit has asked the Pennsylvania Supreme Court to clarify Pennsylvania’s medical device liability law. On June 24, 2021 in Ebert v. C.R. Bard, Inc., No. 20-2139, 2021 U.S....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
Indiana courts have recently addressed preemption issues in matters involving devices approved by the Food and Drug Administration (FDA) through the premarket approval (PMA) process. First, the Indiana Court of Appeals...more
Medical device manufacturers who seek to dispose of meritless claims at the initial pleading stage have long relied upon the doctrine of federal regulatory preemption. This doctrine is embodied by 21 U.S.C. § 360k(a), the...more
Medical practitioners know that, for all its wonders, modern medicine is still a matter of chances not guarantees. In other words, in practice, medical interventions are often a matter of improving the patient’s chances at...more
For at least two decades, Pennsylvania law has recognized an exemption from strict liability for prescription drug manufacturers based on the state Supreme Court’s interpretation of the Restatement (Second) of Torts Sec. 402A...more
In what has become an alarming trend in drug and medical device manufacturing, Smith and Nephew felt compelled to copycat other hip implant manufacturers and market a pair of dual modular hip stems. This trend is alarming...more
On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part of the Medical Device User Fee...more
Searcy Denney is representing clients who have been implanted with the Short Modular Femoral Hip System and Modular REDAPT from Smith & Nephew in lawsuits alleging that the manufacturer failed to warn them of the risks...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
On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug...more
Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more
Product liability cases show a strong defense trend in Arizona. Since 2011, Arizona juries have given twelve defense verdicts and three plaintiff’s verdicts. Here are all of the Arizona product liability verdicts over the...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
Mesh products have been regularly used to repair abdominal hernias since the 1950s. In the 1970s, gynecologists used surgical mesh products designed for abdominal hernia repair to repair prolapsed organs....more
In a decision released on August 27, 2013, Justice Belobaba of the Ontario Superior Court of Justice certified a class action against DePuy Orthopaedics Inc. on behalf of persons who were surgically implanted with any one of...more
A crucial issue in the successful defense of a product liability case is the exclusion of other incidents and accidents involving products of the manufacturer. In old school parlance, prior incidents were often referred to...more