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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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Colorado Woman Sues American Medical Systems Over Transvaginal Mesh Injuries

Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a Colorado woman allegedly injured by transvaginal mesh products manufactured by American Medical Systems, Inc. The suit was filed on May 21, 2012 in the U.S. District Court for the Northern District of California (Case No. ...

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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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Actos Bladder Cancer Lawsuit Filed by West Virginia Resident

Actos (pioglitazone) continues to be named in lawsuits alleging long-term use of the type 2 diabetes drug caused patients to develop bladder cancer. Just last week, the national law firm of Parker Waichman LLP filed suit against Takeda Pharmaceuticals on behalf of a West Virginia man who developed bladder cancer ...

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Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.

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Transvaginal Mesh a Nightmare for Thousands of Women

Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim ...

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British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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Parker Waichman Representing Another Louisiana Plaintiff in Actos Bladder Cancer Lawsuit

A Louisiana man has become the latest to claim that his taking the type 2 diabetes drug Actos resulted in developing bladder cancer. He has filed a lawsuit against the Japanese manufacturer of the drug and the marketer of it in the U.S., claiming they failed to warn about this ...

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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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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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Tainted Medical Scopes Allegedly Cause Superbug Infections

Tainted Medical Scopes Allegedly Cause Superbug Infections

The Olympus Corporation, based in Japan, was allegedly aware of superbug outbreaks in three countries as early as 2013 and did not alert American hospitals about possibly deadly infections from contaminated medical scopes known as duodenoscopes. After two-dozen infections were … Continue reading

Posted in Defective Medical Devices, Duodenoscope, Health Concerns | Tagged , , , , , , , |

Following Superbug Outbreaks, FDA Mandates Safety Studies from Scope Manufacturers

FDA Mandates Safety Studies from Scope Manufacturers

The U.S. Food and Drug Administration (FDA) is ordering duodenoscope manufacturers to study how the devices are cleaned. The safety studies are prompted by a series of antibiotic-resistant bacterial infection outbreaks in the United States linked to contaminated scopes. The … Continue reading

Posted in Legal News | Tagged , , , , |

Medical Scope Makers Warned in the Wake of Superbug Outbreaks

Three manufacturers of duodenoscopes—specialized medical scopes—have received Food and Drug Administration (FDA) warning letters because the scopes have been linked to outbreaks of a deadly “superbug.” The FDA says the companies failed to adequately report problems with the devices and, in … Continue reading

Posted in Defective Medical Devices, Health Concerns | Tagged , , , , , |

Outbreak of Legionnaires’ Disease Sickens 46 in the Bronx, Kills 4

Outbreak of Legionnaires’ Disease Sickens 46 in the Bronx

Since July 10th, 46 people have acquired Legionnaires’ disease in the Bronx and four people have died. According WABC, positive samples of the bacteria have been found in air conditioning at a hospital and a complex with a movie theater. … Continue reading

Posted in Legal News, Toxic Substances | Tagged , , , , , |

Indiana HIV Outbreak Connected to Painkiller Abuse

Indiana HIV Outbreak Connected to Painkiller Abuse

The Centers for Disease Control and Prevention (CDC) has warned that the prescription pain pill Opana could be contributing to a rapidly escalating outbreak HIV outbreak in Scott County, Indiana. In 2013, the Food and Drug Administration (FDA) warned Endo … Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals | Tagged , , , |

Tainted Endoscopes also Implicated in Drug-Resistant E. Coli Outbreak

Tainted Endoscopes Implicated in Drug-Resistant Outbreak

Contaminated duodenoscopes, the medical devices recently associated with a series of superbug outbreaks at two Los Angeles hospitals, have also been implicated in an outbreak of drug-resistant Escherichia coli (E. coli) in a Washington state hospital. A study published in … Continue reading

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