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Infuse Should not be Used in Patients Under age 18, the FDA Warns

In a Safety Communication issued today, the U.S. Food and Drug Administration (FDA) warned that Infuse and other bone graft substitutes containing recombinant proteins or synthetic peptides are not safe for use in patients under age 18.

Infuse and other bone graft substitutes containing recombinant proteins or synthetic peptides are considered high-risk (Class III) medical devices by the FDA. Medtronic and the manufacturers of similar products must submit a premarket approval application (PMA) to the agency that includes clinical data supporting safety and effectiveness, the FDA explained in the Safety Communication. These devices have not been approved for use in people under age 18 and have not been reviewed by federal regulators. More Infuse Should not be Used in Patients Under age 18, the FDA Warns

Many People are Losing Faith in the Safety of E-Cigarettes, but Teens are Vaping Even More

Many People are Losing Faith in the Safety of E-Cigarettes

Many People are Losing Faith in the Safety of
E-Cigarettes


Last year, the American Journal of Preventative Medicine issued a report showing that 65 percent of smokers said they believed that e-cigarettes are safer than smoking regular cigarettes in 2013, down from 85 percent in 2010.

In high schools across America, however, vaping is on the rise. This past December, the National Institute on Drug Abuse (NIDA) reported that 17 percent of high school seniors said they’d vaped at least once a month, compared with 14 percent who admitted smoking traditional cigarettes. Sixteen percent of 10th graders said they had vaped, which was more than twice the number of students who said they had smoked regular cigarettes. More Many People are Losing Faith in the Safety of E-Cigarettes, but Teens are Vaping Even More

Researchers say the Liquid Found in E-Cigarettes is Dangerous Even if it Doesn’t Contain Nicotine

Researchers say Liquid Found in E-Cigarettes is Dangerous.

Researchers say Liquid in E-Cigarettes Dangerous


According to a new study from National Jewish Health in Denver, the liquid found in e-cigarettes significantly increases the risk for viral infections in users, whether it contains nicotine or not.

By taking cells from the airways of young, healthy non-smokers and exposing them to the liquid or vapors from e-cigarettes, researchers were able to determine that inhaling the vapor can damage epithelial cells and increase the risk of infections. The scientists discovered that when they exposed the cells to the liquid or vapors in the lab, it only took 10 minutes for a reaction to occur, according to the National Jewish Health (NJH) website. More Researchers say the Liquid Found in E-Cigarettes is Dangerous Even if it Doesn’t Contain Nicotine

Suit Alleging Talcum Powder Caused Woman’s Ovarian Cancer will Proceed

Suit Alleging Talcum Powder Caused Ovarian Cancer Proceeds

Suit Alleging Talcum Powder Caused Cancer Proceeds


A motion by Johnson & Johnson (J&J) and Imerys Talc America to dismiss a lawsuit filed against them by the husband of a woman who died of ovarian cancer allegedly caused by her use of talcum powder in her genital area has been dismissed by a U.S. District Court judge.

The husband claims his wife developed and subsequently died from ovarian cancer as a result of using J&J Baby Powder and Shower to Shower (containing talc mined and sold by Imerys) in the genital area. Women often use talc as a feminine hygiene product because of its ability to absorb moisture and prevent chafing. More Suit Alleging Talcum Powder Caused Woman’s Ovarian Cancer will Proceed

Judge Won’t Toss Proposed Class-Action Over Recalled Toddler Seats

A federal judge in California will not toss out a proposed class-action lawsuit filed by a consumer who purchased a defective front-facing toddler seat from Graco Children’s Products Inc.

In March 2013, the Plaintiff sued Graco over the recalled seats. Graco officially recalled the products in February after the U.S. National Highway Transportation Safety Administration (NHTSA) put pressure on the company. The agency said it had received complaints from consumers that food and liquid spills made the buckles difficult to open. One complaint filed with the agency said it took a consumer 45 minutes to unbuckle her child – so long that she considered first cutting the child out of the seat, and then calling 911, according to The Detroit News. More Judge Won’t Toss Proposed Class-Action Over Recalled Toddler Seats

Months after Recall Many GM Cars Still Have not Been Repaired

Almost nine months after General Motors began recalling millions of its cars for an ignition switch defect, nearly half of the vehicles still have not been repaired.

GM recently said it has taken steps to improve outreach to owners who have not yet scheduled repairs, including the use of social media and a new call center with a staff of 72. But many owners who requested repairs months ago are still waiting for the work to be done, The New York Times reports. Some owners have contacted federal regulators to ask why it is taking so long and they have raised safety concerns about the long waits. Thirty deaths have been linked to the defective ignition switch and a recent crash death may also be linked to the switch. On October 9th, 25-year-old Brittany Alfarone was killed in a crash in her 2006 Chevrolet Cobalt, one of the recalled models. Deirdre Betancourt said her daughter had twice tried to have the car repaired but had been turned away by two dealers. More Months after Recall Many GM Cars Still Have not Been Repaired

Tobacco Companies Try to Win Consumers’ and Regulators’ Trust by Placing Lengthy Warnings on E-Cigarettes

Bigger, direr health warnings are appearing on e-cigarette labels these days.

The warnings on electronic cigarettes (e-cigarettes) are getting longer and more serious compared to the warnings on packages of traditional tobacco cigarettes, The New York Times (The Times) recently pointed out. Per the U.S. Food and Drug Administration (FDA), tobacco cigarettes are only required to have short warnings. A 2009 push by federal regulators to require tobacco companies to create bigger, graphic warnings failed after a successful court challenge from several Big Tobacco companies, according to The Washington Post (The Post). More Tobacco Companies Try to Win Consumers’ and Regulators’ Trust by Placing Lengthy Warnings on E-Cigarettes

Defective Saline Sheaths Prompt Recall of Atherectomy Systems

The U.S. Food and Drug Administration (FDA) announced that Cardiovascular Systems is recalling certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems because they contain defective saline sheaths that could fracture during use.

The Diamondback 360 Peripheral Orbital Atherectomy System is a high-speed cutting tool inserted through a catheter into a patient’s blood vessel. The system is intended to reestablish blood flow in narrowed arteries or arterio-venous dialysis shunts. More Defective Saline Sheaths Prompt Recall of Atherectomy Systems

Woman who took Supplement Containing DMMA Experienced Liver Failure

A healthy woman who took three Saba Appetite Control and Energy (ACE) weight loss pills within two days developed liver failure and needed a liver transplant, researchers said.

Two weeks after the 35-year-old woman took the pills she developed jaundice, a yellowish pigmentation of the skin, according to the report from researchers at the University of Kentucky in Lexington, who treated the woman. More Woman who took Supplement Containing DMMA Experienced Liver Failure

Acne Medications can Cause Serious Skin Reactions

The U.S. Food and Drug Administration (FDA) is warning the public that many over-the-counter acne treatments can cause serious and even life-threatening skin reactions.

The FDA released a statement warning that use of certain acne products containing the active ingredients benzoyl peroxide or salicylic acid can cause rare but serious allergic reactions or severe irritation. More Acne Medications can Cause Serious Skin Reactions