Health Canada Issues Serious Complication Risk Warning on IVC Filters

Health Canada Issues Serious Complication Risk Warning on IVC Filters

Health Canada recently issued a warning of “Serious Risks of Complication” arising from the surgical use of Inferior Vena Cava (IVC) filters. The warning targeted a wide range of healthcare professionals, including radiologists, cardiologists, vascular surgeons, thrombosis specialists, internists, emergency physicians, bariatric surgeons, orthopaedic surgeons, and primary care physicians — any physicians who request or implant IVC filters as well as clinicians responsible for follow-up care. [Read more…]

Upcoming FDA Public Hearing on Off-Label Drug and Device Use

Upcoming FDA Public Hearing on Off-Label Drug and Device Use

The U.S. Food and Drug Administration (FDA) has announced a public hearing forum to take place on November 9-10, 2016 with regard to the enforcement of rules relating to off-label drug and medical product use in the public health industry. The registration deadline to present at the hearing is October 19, 2016, and the deadline for written commentary after the hearing is January 9, 2017. [Read more…]

Texas Law Leads to Reduction of $496 Million Hip Defect Judgment Against DePuy

Texas Law Forces Huge Cut in $496 Million Hip Defect Judgment Against DePuy

As reported by Law360 (subscription), U.S. District Court Judge Ed Kinkeade has reduced a $496 million judgment against Johnson & Johnson’s DePuy Orthopaedics in five combined Pinnacle implant hip injury bellwether trials to keep the amount in line with the Texas punitive damages cap. Attorneys in the case indicate the new overall amount assessed against DePuy for its allegedly defective and dangerous Pinnacle hip implants will be closer to $150 million. A jury in the consolidated trial in Dallas had found the companies liable for serious health problems, including bone erosion and metal poisoning, that plaintiffs claimed were directly related to the metal-on-metal hip implants. Judge Kinkeade lowered the $360 million punitive damages award by $350 million in the face of Texas’ statutory $10 million limit on punitive damages. [Read more…]

Second J&J DePuy Pinnacle Bellwether Trial Receives Nearly $500 Million Verdict

Second J&J DePuy Pinnacle Bellwether Trial Receives Nearly $500 Million Verdict

In the second multidistrict bellwether trial over allegedly defective DePuy Pinnacle hip implants, a Texas jury awarded a $497.6 million in a verdict against Johnson & Johnson. The five plaintiffs in the aggregate trial who sued over health problems from the metal hip implant devices received $360 million in punitive damages. [Read more…]

Seven Bellwether Cases Selected for DePuy Hip Implant Trial Against Johnson & Johnson

Seven Bellwether Cases Selected for DePuy Hip Implant Trial Against Johnson & Johnson

U.S. District Judge Ed Kinkeade has selected seven DePuy hip injury bellwether cases to proceed to trial in the multidistrict injury litigation against Johnson & Johnson’s DePuy Orthopaedics Inc. unit. J&J had asked Judge Kinkeade to stay (pause) the cases pending J&J’s appeal of a previous $497.6 million injury-related verdict against the company, but he refused, slating the 7 bellwether cases to begin trials starting September 6, 2016. The other 8,800 cases in the MDL will be put on hold until all of the bellwether trials take place. [Read more…]

New Jersey Court Upholds $11 Million Judgment for Plaintiff in Vaginal Mesh Product Injury Case

New Jersey Court Upholds $11 Million Judgment for Plaintiff in Vaginal Mesh Product Injury Case

A New Jersey state appeals court has awarded plaintiff Linda Gross $11.1 million on claims that health care giant Johnson & Johnson’s vaginal mesh product caused serious injuries after use in surgery and that the companies failed to disclose these product risks to physicians and the general public. [Read more…]

Endoscope Manufacturer Olympus Drastically Increased Price of Medical Scopes During Superbug Outbreak

Medical Scope Superbugs

During the deadly “Superbug” CRE infection outbreak from contaminated medical scopes, three UCLA patients died and five more fell ill to the lethal bacterial spread. When doctors at UCLA’s Ronald Reagan Medical Center inquired about replacing the tainted medical scopes, medical device maker Olympus Corp. offered to sell the hospital 35 new scopes for $1.2 million — a 28% increase in price for the defective products, compared to the pricing just months earlier. [Read more…]

Laparoscopic Power Morcellator Injury Lawsuits Expected to Increase in Number as Morcellator Injury Awareness Increases

Laparoscopic Power Morcellator Injury Lawsuits Expected to Increase

Each year, around 650,000 women in the United States undergo hysterectomies. The U.S. Food and Drug Administration (FDA) estimates that one in 350 women are potentially at risk for the spread of undiagnosed cancers while undergoing a hysterectomy or other type of uterine surgery using a laparoscopic power morcellator tool. It is estimated that the 300 lawsuits that have been filed will only increase in number as more women become aware of the reported connections between morcellator use and the internal spread of undiagnosed uterine cancer.

[Read more…]

Injured Plaintiffs Win $498 Million Verdict in Second DePuy Pinnacle Hip Implant Bellwether Trial

Injured Plaintiffs Win $498 Million Verdict in Second DePuy Pinnacle Hip Implant Bellwether Trial

As reported today by Law360 (subscription), the jury in the second bellwether trial multidistrict litigation over allegedly defective Pinnacle hip prosthetics manufactured by Johnson & Johnson’s DePuy Orthopaedics Inc. unit reached a verdict of $497.6 million on a judgment for the plaintiffs in consolidated claims relating to five separate hip implant patients.

[Read more…]

Johnson & Johnson Pays $120 Million Settlement in Surgical Mesh Lawsuit

Johnson & Johnson $120 Million Settlement in Surgical Mesh Lawsuit

Medical device manufacturer Johnson & Johnson (J&J) has agreed to pay a $120 million settlement to the 2-3,000 women who filed injury lawsuits claiming to have suffered organ damage and constant pain from allegedly dangerous and defective surgical mesh. As reported by Bloomberg, these “settlements mark the first time J&J and its Ethicon unit have agreed to resolve a significant number of mesh cases.” [Read more…]

Defective Surgical Mesh Injury Case Verdict Affirmed by U.S. Court of Appeals

Surgical Mesh Injury Case

As reported by The Legal Examiner, the U.S. Court of Appeals for the Fourth Circuit upheld the first injury trial jury verdict against transvaginal surgical mesh manufacturer C.R. Bard, a jury award of $2 million in a decision that could affect many thousands of American women allegedly harmed by this medical device known variously as transvaginal mesh (TVM), pelvic mesh, or bladder sling mesh.

[Read more…]

Olympus Voluntarily Recalls Defective Medical Scope that Led to Deadly Patient Infections

Olympus Voluntarily Recalls Defective Medical Scope

Olympus, the manufacturer of some allegedly defective medical scopes that have been linked to deadly superbug CRE infections worldwide, announced that it will voluntarily recall and redesign its affected medical scope products. Japan-based Olympus Corporation holds 70% of the share of gastrointestinal endoscopes on the global market.

[Read more…]

U.S. Senate Superbug Medical Scope Investigation Shows Alarming Results

US Senate Superbug Medical Scope Investigation

Contaminated medical scopes may have sickened more Americans than federal investigators had originally determined, according to the results of a U.S. Senate investigation released today. The Seattle Times reports the Senate investigation indicates that from 2012 to 2015, antibiotic-resistant illnesses linked to specialized duodenoscopes sickened at least 250 people – most at U.S. hospitals. That number is nearly double the statistic previously identified by the U.S. Food and Drug Administration (FDA) for cases since 2010. [Read more…]

FDA Classifies Transvaginal Mesh as High-Risk due to Serious Complications from Surgery

FDA Classifies Transvaginal Mesh As High Risk

The U.S. Food and Drug Administration (FDA) has reclassified the surgical mesh device utilized for transvaginal repair of pelvic organ prolapse (“POP”) and other conditions in women as a high-risk (class III) product. Previously, the agency classified the product as moderate-risk (class II). [Read more…]

Olympus Kept U.S. Hospitals in the Dark About Deadly Infections

Deadly superbug CRE bacteria

The Los Angeles Times has published a scathing report on failures by medical device company Olympus to respond to warnings from its own researchers about contamination dangers in certain medical examination scopes, failures that led to the deaths of 21 people and severe injury to dozens more. The US FDA identified at least 7 separate infection outbreaks relating to the Olympus scopes over the last three years in Pittsburgh, Seattle, and Los Angeles. [Read more…]

IVC Filter Product Liability Lawsuit Announced

ivc filter lawsuit

Lawsuit charges negligence and other wrongs by medical device manufacturers C.R. Bard and Bard Peripheral Vascular arising from the implantation of an allegedly defective Bard-branded blood filter marketed as the Bard G2 IVC Filter.

December 14, 2015, New York, NY — Wendy R. Fleishman of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Gary Leigh Piazza has filed a personal injury product liability lawsuit against C.R. Bard and Bard Peripheral Vascular, Inc. (“Bard”) for injuries she allegedly sustained as a result of surgical implantation of the Bard G2 IVC Filter. [Read more…]

$11 Million Jury Verdict Against Wright Medical Over Defective Metal Hip Implant

Wright Hip Implant Jury Verdict

In the first bellwether trial in multidistrict litigation over alleged defective hip implants, plaintiffs won an $11 million jury verdict against Wright Medical Technology, Inc. The verdict included $1 million in compensatory damages and $10 million in punitive damages. [Read more…]