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Appeals Court Revives Medtronic Infuse Lawsuit

A special appeals court found Monday that off-label promotion claims related to a Medtronic-related lawsuit are not preempted, thus reviving a man’s lawsuit filed over Medtronic’s Infuse bone growth product.

The man alleges he suffered serious injuries after his surgeon inserted the Infuse device in an off-label manner during 2007 surgery to treat back pain. The U.S. Food and Drug Administration (FDA) approved Infuse to be inserted in an anterior approach, but the patient claims his surgeon inserted the device in a posterior approach at the urging of Medtronic, the product’s manufacturer, Law360 reported. More Appeals Court Revives Medtronic Infuse Lawsuit

New Jersey Man Alleges Eli Lilly Testosterone Replacement Product Caused Him a Heart Attack

Drug maker Eli Lilly is facing a lawsuit filed by a New Jersey man in federal court in Newark over the company’s testosterone replacement drug Axiron.

According to the lawsuit, the patient stated that he began taking Axiron at age 54 in September 2012 and suffered a heart attack on October 3, 2012. Had the patient known that Axiron could increase users’ risk for heart attack, he would not have started taking it, the suit states. More New Jersey Man Alleges Eli Lilly Testosterone Replacement Product Caused Him a Heart Attack

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

FDA to Doctors: Beware of Counterfeit Prescription Drugs

The U.S. Food and Drug Administration (FDA) has warned doctors to be vigilant when purchasing medications as the number of rogue wholesale distributors selling unapproved prescription drugs continues to grow.

The agency issued a statement that said the problem is so widespread that it has started a program to educate physicians and other healthcare providers and administrators about how to properly purchase medications to ensure their quality and safety. The program is intended to shield patients from taking potentially harmful counterfeit drugs, according to WSFA.com. More FDA to Doctors: Beware of Counterfeit Prescription Drugs

FDA Says E-cigarette Makers Don’t Have Enough Data to Claim Their Products are Healthier than Tobacco Cigarettes

The makers of e-cigarettes want consumers to believe the nicotine delivery systems are healthier than regular cigarettes, but the U.S. Food and Drug Administration (FDA) says there is not enough information to make those claims.

“While e-cigarette aerosol may contain fewer toxicants than cigarette smoke, studies evaluating whether e-cigarettes are less harmful than cigarettes are inconclusive,” according to a FDA report obtained by Daily News Journal (DNJ). More FDA Says E-cigarette Makers Don’t Have Enough Data to Claim Their Products are Healthier than Tobacco Cigarettes

Settlement Approved in Lenovo IdeaPad U Class Action

The U.S. District Court for the Central District of California, Southern Division, has approved a preliminary settlement agreement in a class action lawsuit against Lenovo, Inc., The national law firm Parker Waichman LLP announced.
The settlement approval was signed by U.S. District Judge Cormac J. Carney on September 4, with a final approval hearing scheduled for December 8. More Settlement Approved in Lenovo IdeaPad U Class Action

Parker Waichman Files Class Action against Protein Manufacturer

Parker Waichman LLP has filed a class action lawsuit on behalf of consumers alleging  the protein supplement product Body Fortress Super Advanced Whey Protein has less protein than the label claims.
The lawsuit was filed on last week in the U.S. District Court for the Eastern District of New York. More Parker Waichman Files Class Action against Protein Manufacturer

CDC Manipulated Study Data to Negate a Link Between Autism and Immunizations in African-American Boys

A whistleblower says federal health officials have been manipulating data that shows a link between the MMR (measles, mumps, rubella) vaccination and autism in a certain population.

According to a study by the Focus Autism Foundation, a top scientists working for the U.S. Centers for Disease Control and Prevention (CDC) helped Dr. Brian Hooker of the Focus Autism Foundation uncover data manipulated by the CDC that revealed a higher rate of autism among African-American boys, according to Organic Lifestyle Magazine. More CDC Manipulated Study Data to Negate a Link Between Autism and Immunizations in African-American Boys

DePuy Must Pay Oregon $4 Million to Settle Allegations Related to its Marketing of ASR XL Hips

DePuy Orthopaedics Inc. has been ordered to pay $4 million to settle allegations by the Oregon Department of Justice (ODOJ) that the medical device maker knowingly marketed faulty ASR XL metal-on-metal (MoM) hips.

The ASR XL all-metal hip device was intended to last 15 years, but studies showed the devices failed much sooner than expected. Data collected from the National Joint Registry of England in 2010 revealed that one in every eight patients (12 percent to 13 percent) had to undergo revision surgery within five years of receiving it.The hips have caused thousands of patients to experience pain, swelling, bone and muscle damage, and difficulty walking. More DePuy Must Pay Oregon $4 Million to Settle Allegations Related to its Marketing of ASR XL Hips

An Increasing Number of Potentially Illegal Nondisclosure Agreements are Being Forced on Employees

Companies are asking employees to sign overly restrictive nondisclosure agreements in growing numbers, many of which violate federal whistleblower laws, creating tense and threatening workplace environments.

Donna Busch, the former manager of environmental and nuclear safety at the Hanford nuclear processing plant in Washington State, is just one example of someone who found themselves jobless after speaking out against their employer, according to WashingtonPost.com. More An Increasing Number of Potentially Illegal Nondisclosure Agreements are Being Forced on Employees