News & Analysis as of

Manufacturing Defects Medical Devices

Epstein Becker & Green

Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program

At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to...more

Searcy Denney Scarola Barnhart & Shipley

The Exactech Recall: A Quick Synopsis and Update on What You Need to Know

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

Searcy Denney Scarola Barnhart & Shipley

The Most Common Exactech Shoulder Issues and How to Identify Them

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

Stark & Stark

A Definitive Guide to ParaGard Lawsuits

Stark & Stark on

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

Searcy Denney Scarola Barnhart & Shipley

C.R. Bard, Inc. Faces First Bellwether Trial Over Hernia Mesh Injuries – Hernia Mesh Lawyer Explains

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

White and Williams LLP

Medical Device Update: Third Circuit Certifies Questions Concerning Device Manufacturers’ Liability Under Pennsylvania Law

White and Williams LLP on

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

Kohn, Kohn & Colapinto LLP

Manufacturer of Defective Heart Devices Settles False Claims Act Case for $27 Million

St. Jude Medical Inc. (“St. Jude”), which was acquired by Abbott Laboratories in 2017, entered into a settlement last week with the United States Department of Justice (“DOJ”) for $27 million to resolve allegations it had...more

Foley Hoag LLP

Product Liability Update: October 2020

Foley Hoag LLP on

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

Faegre Drinker Biddle & Reath LLP

Indiana State and Federal Courts Rule That Manufacturing Defect Claims May Survive Preemption in PMA Context

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

Haug Partners LLP

Clarifying the Scope of the Parallel Claim Exception to Federal Regulatory Preemption of Medical Devices

Haug Partners LLP on

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

Holland & Hart - Your Trial Message

Know What Drives Juror Perceptions of Medical Device Liability

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

Faegre Drinker Biddle & Reath LLP

Does Pennsylvania Recognize Strict Liability Claims Against Medical Device Manufacturers? A Pennsylvania federal court calls the...

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

Searcy Denney Scarola Barnhart & Shipley

Smith and Nephew SMF and Redapt Modular Hip Implant Recall

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

Hogan Lovells

CDRH's Voluntary Malfunction Summary Reporting Program

Hogan Lovells on

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 Scarola Barnhart & Shipley

Smith & Nephew SMF Hip System and REDAPT Recall Lawyers

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

Harris Beach PLLC

Circumstantial Evidence Ruled Not Enough in Case Against Medical Device Manufacturer

Harris Beach PLLC on

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

Cozen O'Connor

Proposed Legislation to Relax Rules on Medical Device Reporting Passes U.S. House

Cozen O'Connor on

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

Cozen O'Connor

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure

Cozen O'Connor on

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

Snell & Wilmer

Product Liability Verdicts in Arizona

Snell & Wilmer on

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

Foley Hoag LLP

Product Liability Update - July 2015

Foley Hoag LLP on

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

Searcy Denney Scarola Barnhart & Shipley

The Boston Mesh Litigation

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

Bennett Jones LLP

Ontario Court Certifies Class Action Relating to Allegedly Faulty Hip Implants

Bennett Jones LLP on

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

Nexsen Pruet, PLLC

The Exclusion of Other Incident Evidence in Product Liability Litigation

Nexsen Pruet, PLLC on

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

23 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide