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Medtronic Core Valve-Related Recall is Deemed A Class I

Medtronic’s recall of its EnVeo R loading system for the CoreValve Evolut transcather aortic valve device has been designated as Class 1 by the U.S. Food and Drug Administration (FDA). The recall was issued last month due to reports of “particulate being observed in a small number of cases,” Medtronic’s CoreValve was first approved in early 2014 for patients at extreme or high risk of open-heart surgery. The device has also since been approved for “valve-in-valve” (VIV) replacement, where a valve is placed within a failing artificial heart valve.

Medtronic received eight complaints associated with this issue, according to a recall letter posted on the website of Germany’s Federal Institute for Drugs and Medical Devices. The particulate was observed during the valve loading procedure in six cases, and observed in the packaged kits in the other two cases. Medtronic notified customers of the recall in an urgent field safety notice, which stated that a blood clot could arise if particulate matter is mistakenly deployed while the Evolut device is being implanted. More Medtronic Core Valve-Related Recall is Deemed A Class I

Lawsuit Alleges 3M Bair Hugger Surgical Blanket Caused Deep Joint Infection

Lawsuit Alleges 3M Surgical Blanket Caused Infection

Lawsuit Alleges 3M Surgical Blanket Caused Infection


A lawsuit has been filed against Arizant, a 3M subsidiary, alleging that its Bair Hugger forced-air surgical warming blanket caused a deep joint infection. The plaintiff in the case had been undergoing a hip implant revision surgery. Allegedly, the Bair Hugger introduced pathogens from the operating room floor into the surgical site and resulted in Methicillin-resistant Staphylococcus aureus (MRSA) infection. The septic arthritis, or deep joint infection, allegedly caused by the Bair Hugger forced the plaintiff to undergo another six surgeries in less than eleven months. He alleges that he is unable to move freely and continues to suffer physical damages.

The suit alleges although the Bair Hugger is used in 90 percent of major surgeries, it is especially risky in joint replacement and revision procedures. The surgical warming blanket may play a role in the thousands of orthopedic implant infections each year, the suit alleges. Arizant and 3M are accused of hiding the risks of the Bair Hugger. More Lawsuit Alleges 3M Bair Hugger Surgical Blanket Caused Deep Joint Infection

Maquet’s FLOW-i Anesthesia System Recalled Due to Potentially Fatal Ventilation Problem

Maquet's FLOW-i Anesthesia System Recalled

Maquet’s FLOW-i Anesthesia System Recalled


Some of Maquet’s FLOW-i Anesthesia Systems reportedly have a malfunction that could result in potentially fatal ventilation stops, the U.S. Food and Drug Administration (FDA) warned. A July 1st safety alert indicated that the issue “may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.”

The systems are used in hospitals to provide anesthesia and ventilation support in patients who have difficulty breathing. The recall, which affects 1,641 units worldwide including 80 in the United States, was initiated in April. The FDA labeled its as Class 1 in June, which means that there is a reasonable possibility of serious injury or death associated with the issue. More Maquet’s FLOW-i Anesthesia System Recalled Due to Potentially Fatal Ventilation Problem

Hundreds of Women Sue Johnson & Johnson over Use of Talcum Powder

Women Sue Johnson & Johnson over Use of Talcum Powder

Women Sue Johnson & Johnson over Use of Talcum Powder


The litigation against Johnson & Johnson over talcum powder continues to grow, as hundreds of women have filed a lawsuit alleging that the soft powder product caused ovarian cancer. The pharmaceutical giant was allegedly negligent with regards to the risks of their talcum powder products, such include Baby Powder and Shower to Shower. The women allege that J&J should have warned that use of talcum powder in the genital area could increase the risk of ovarian cancer.

FairWarning, a non-profit investigative news organization, reports that a number of studies link talcum powder to an increased risk of ovarian cancer. “Since the early 1980s, a slew of studies had found that women who regularly used talc powder for feminine hygiene had higher than average rates of ovarian cancer.” according to an article posted April 29th. More Hundreds of Women Sue Johnson & Johnson over Use of Talcum Powder

Lawmakers Call on the FDA to ban Amphetamine-like Stimulant Found in Some Dietary Supplements

Lawmakers Call on the FDA to ban Amphetamine-like Stimulant

Lawmakers Call to FDA – ban Amphetamine-like Stimulant


Lawmakers are calling on the U.S. Food and Drug Administration (FDA) to take action against dietary supplement makers who include a potentially dangerous, amphetamine-like stimulant in their products.

BMPEA is an amphetamine-like stimulant first synthesized in the 1930s as a replacement for amphetamine. The chemical has never been tested in humans and is not an authorized dietary supplement ingredient under federal law. Supplement makers have been hiding BMPEA in their products under the name “acacia rigidula,” which is an exotic shrub native to Mexico and southern Texas. Canadian health authorities pulled a popular supplement from store shelves and forced a recall of the product in December, according to The New York Times (The Times.) More Lawmakers Call on the FDA to ban Amphetamine-like Stimulant Found in Some Dietary Supplements

Contaminated Duodenoscopes also Linked to Drug-Resistant E. Coli Outbreak

Contaminated Duodenoscopes also Linked to E. Coli Outbreak

Contaminated Duodenoscopes also Linked to E. Coli Outbreak

Tainted duodenoscopes, which have come under scrutiny in light of a series of superbug outbreaks, are also associated with an outbreak of drug-resistant Escherichia coli (E. coli) in a Washington state hospital. According to a study published in Infection Control & Hospital Epidemiology, patients can still be infected even when following manufacturers’ cleaning instructions.

An investigation revealed that between November 2012 and August 2013,32 patients were infected with an antibiotic-resistant strain of E. coli at Seattle Virginia Mason Medical Center. The hospital had followed the manufacturer’s cleaning protocol, but these procedures were apparently insufficient.

Recent evidence suggests that manufacturers’ cleaning instructions alone are not enough to sterilize duodenoscopes, a specialized type of endoscope. Recently, the devices were implicated in recent outbreaks of Carbapenem-resistant Enterobacteriaceae (CRE) at two Los Angeles Hospitals: UCLA’s Ronald Reagan Medical Center and Cedars-Sinai hospital. A total of 11 patients were infected with CRE at the two hospitals and 246 more were potentially exposed.
More Contaminated Duodenoscopes also Linked to Drug-Resistant E. Coli Outbreak

Flooring Company Facing Class Action Over Allegations That it Sells Defective Products Containing High Levels of Formaldehyde

Company Facing Class Action Over Selling Defective Products

Company Facing Class Action Over Selling Defective Products


The first amended class action complaint has been filed against Lumber Liquidators alleging that some of the company’s flooring products fail prematurely, contain defects and have been associated with very high levels of the cancer-causing agent, formaldehyde.

Plaintiffs in the class action lawsuit allege that their Lumber Liquidators flooring is defective and prone to premature cracking, splitting, warping and shrinking sooner than claimed in the product’s warranty. According to the suit, consumers have also complained that Lumber Liquidator’s flooring contains significantly high levels of formaldehyde, a known carcinogen. More Flooring Company Facing Class Action Over Allegations That it Sells Defective Products Containing High Levels of Formaldehyde

OxyElite Pro Found to Contain Prozac

OxyElite Pro Found to Contain Prozac

OxyElite Pro Found to Contain Prozac


The U.S. Food and Drug Administration (FDA) told consumers on February 28 to be extra vigilant when purchasing weight loss supplements, specifically mentioning OxyElite Pro, which was found to contain a powerful antidepressant drug.

OxyElite Pro is a thermogenic supplement. It is designed to boost metabolism and burn fat, but it increases the body’s internal temperature. More OxyElite Pro Found to Contain Prozac

Measure that Offers Financial Incentives to Auto Industry Whistleblowers to Reach the Senate Floor

Financial Incentives to Whistleblowers to Reach the Senate

Financial Incentives to Whistleblowers to Reach the Senate

A United States Senate panel unanimously voted in support of a measure that would offer financial incentives for auto industry employees who reveal safety defects.

Thirteen Republican and Democratic members of the Senate, Science and Transportation Committee voted to send the legislation to the floor of the Senate. The measure would allow whistleblowers to share in auto company penalty payments. The legislation was prompted by recalls of millions of vehicles by General Motors (GM) over faulty ignition switches and Takata Corp airbag inflators, according to Reuters. More Measure that Offers Financial Incentives to Auto Industry Whistleblowers to Reach the Senate Floor

Heart Monitor App Crashes, Prompting Recall

AliveCor has recalled one of its heart monitor apps due to the app crashing upon use.

More than 5,000 active iOS users are affected by the recall, the U.S. Food and Drug Administration (FDA) said in a recall notice. The AliveECG app works in tandem with the AliveCor Heart Monitor to record electrocardiograms and detect the presence of atrial fibrillation and normal sinus rhythm when prescribed by or under the guidance of a physician. The FDA has designated this as a Class III recall, according to HITConsultant.net More Heart Monitor App Crashes, Prompting Recall