Category Archives: Whistleblower

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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also ...

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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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FDA Warning for Bone Graft Products in Patients Under 18

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.

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Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...

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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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Metal-on-Metal Hip Replacement Concerns Grow in Canada

Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...

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British Health Agency Strengthens Warnings about Valproate

British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

Statement issued urging healthcare professionals to give women information on birth defects when Depakote and other valproate medicines are used during pregnancy.

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Exploding Tanks Kill Jeep Drivers 18 months after Recall

Exploding Gas Tanks Continue to Kill Jeep Drivers 18 months after Recall

Chrysler recalled Jeeps with exploding gas tanks more than 18 months ago, but 1 million+ of these vehicles have not been fixed as the death toll continues to rise.

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Halyard Health Allegedly Provided Defective Surgical Gowns during Ebola Crisis

Surgical gowns are worn for the purpose of protecting health care workers from dangerous pathogens, so they must be impermeable to blood or any substances that may transmit disease. Halyard Health sells approximately 13 million MICROCOOL surgical gowns worldwide every … Continue reading

Posted in Defective Products, Health Concerns, Whistleblower |

New Jersey Supreme Court Ruling Extends State Whistleblower Protections to Watchdog Employees

A recent ruling by the New Jersey Supreme Court has extended the state’s whistleblower protections to employees whose jobs entail identifying health and safety risks. The court ruled unanimously to affirm an appeals court ruling that said whistleblower protections included … Continue reading

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AstraZeneca to Pay $46.5 Million to Settle Whistleblower Lawsuit

AstraZeneca to Pay $46.5M for Whistleblower Lawsuit

Drug maker AstraZeneca has agreed to pay $46.5 million plus interest to settle claims that it underpaid rebates it owed under Medicaid. The company will pay $26.7 million to the U.S. government, and $19.8 million will be split among 24 … Continue reading

Posted in Health Concerns, Legal News, Whistleblower | Tagged , , , , |

SEC Chief Praises Agency’s Strong Whistleblower Program

SEC Chief Praises Agency’s Strong Whistleblower Program

The whistleblower program included in the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 owes its success in large part to the support of the Securities and Exchange Commission (SEC). Payments totaling more than $50 million have been … Continue reading

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Federal Agent Exposes Security Concerns in Controversial Visa Program

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Testifying last week at a Senate hearing, a special agent for U.S. Immigration and Customs Enforcement exposed serious national security concerns in a controversial immigration program that provides a route to Green Cards for wealthy foreigners. Senior Special Agent Taylor … Continue reading

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Food Vendor to Pay $19 Million to Settle Whistleblower Lawsuit with Washington DC Schools

Food-Vendor

The largest food vendor for the Washington DC public schools has agreed to a $19 million settlement in a lawsuit alleging the company overcharged the city and mismanaged the school meals programs. A whistleblower lawsuit was filed by a former director … Continue reading

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$495 Million Settlement Announced in DaVita HealthCare Whistleblower Lawsuit

$495M Settlement Announced in DaVita HealthCare Lawsuit

DaVita HealthCare Partners, based in Denver, Colorado, has announced that it will pay $495 million to settle a whistleblower lawsuit. The company is accused of defrauding the federal Medicare and Medicaid programs of millions of dollars. The Denver Post reports … Continue reading

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Jury in Washington State Awards $1 Million to Plaintiff “Perceived” as Whistleblower

Jury in Washington State Awards $1M to Plaintiff

On March 26, 2015 a Washington state jury awarded a supervisor for the state’s ferry system $1 million, concluding that his employer had demoted him as an act of retaliation for perceived whistle blowing, though the plaintiff had not in … Continue reading

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Justice Department Settles False Claims Case with Medtronic for $4.4 Million

Justice Department Settles False Claims w/Medtronic

In an announcement last week, the U.S. Department of Justice said it had reached an agreement with medical device maker Medtronic for violations of the False Claims Act. The announced settlement is $4.4 million. The Justice Department brought action against … Continue reading

Posted in Defective Medical Devices, Defective Products, Legal News, Whistleblower | Tagged , , , , |

Former JCPenney Employee Files Whistleblower Lawsuit

Former JCPenney Employee Files Whistleblower Lawsuit

A former part-time JCPenney employee has filed a lawsuit claiming retaliation after he reported the retailer was overcharging customers. The fired employee has filed a claim against the company under Florida’s Private Whistleblower Act, Fortune reports. Former CEO Ron Johnson … Continue reading

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