Tag Archives: FDA

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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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Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Lawsuits filed by alleged victims of DePuy Orthopaedics’ recalled ASR hip replacement devices continue to pile up in the multidistrict litigation currently underway in U.S. District Court, Northern District of Ohio. Most recently, a woman from Pryor, Oklahoma, filed suit alleging complications caused by a DePuy ASR hip implant ...

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Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer AG reported yesterday that it continues to settle Yaz and Yasmin birth control pill lawsuits. According to a report from Bloomberg News, the company said in its latest Stockholder Newsletter that it has settled 651 Yaz and Yasmin blood clot lawsuits for a total of $147 million. The average ...

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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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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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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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Western Pennsylvania Familes File Suit Over Alleged Fracking Pollution

Three families in western Pennsylvania believe a leading hydraulic fracturing (fracking) company and two water testing labs are conspiring to produce false results that show natural gas drilling is not contaminating their private water wells.

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MTA Bus Crash and Two Cars Injures 23 at Utica Ave. & Clarendon Rd

Crash Involving MTA Bus and Two Cars Injures 23

Police are investigating an accident in Brooklyn on Wednesday afternoon that injured 23 people, 3 of them critically, when a car was knocked into the path of an MTA bus.

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Medtronic Settles Charges Over Kickbacks To Doctors

Medical device giant, Medtronic Inc., is settling charges over kickbacks to doctors. The firms just agreed to pay $23.5 million to settle claims it paid physicians kickbacks in exchange for their use of its pacemakers and defibrillators, according to a U.S. Justice Department announcement yesterday. The company was accused of seeking ...

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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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Risperdal Litigation is Second Largest Mass Tort in Philadelphia

Risperdal Litigation is Second Largest Mass Tort in PA

Mass Tort Contains Risperdal Gynecomastia Lawsuits Lawsuits alleging the antipsychotic drug Risperdal caused gynecomastia continue to mount against Johnson & Johnson’s Janssen unit. In fact, Risperdal litigation accounts for most of the mass tort growth in Philadelphia’s Complex Litigation Center. … Continue reading

Posted in Pharmaceuticals | Tagged , , , , |

Catheter Recalls due to Serious Complications and Injuries

Catheter Recalls due to Serious Complications and Injuries

The benefits and usefulness of catheters are not in question, when the broad scope of applications and indications for which the devices are used are examined. Catheters are used for administering medications, injecting contrast dye for angiogram procedures, and removing … Continue reading

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

IVC Filter Medical Device Risks May Outweigh Benefits

IVC Filter Medical Device Risks May Outweigh Benefits

An inferior vena cava (IVC) filter is a small cage-like device designed to catch and dissolve blood clots. These devices are implanted in patients who have a higher risk of blood clots but for various reasons, cannot take anticoagulants. An … Continue reading

Posted in Bard IVC Filter Injuries, Defective Medical Devices | Tagged , , , , |

Invega Linked to Serious Side Effects Such As Gynecomastia

Invega Linked to Serious Side Effects Such As Gynecomastia

Invega is a popular antipsychotic medication increasingly associated with serious side effects such as gynecomastia, or male breast growth. Invega, known also by its generic name, paliperidone, is manufactured and distributed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson … Continue reading

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Depakote Anti-Epilepsy Medication Linked to Birth Defects

Depakote Anti-Epilepsy Medication Linked to Birth Defects

The family of a 12-year-old child has filed a lawsuit on behalf of the young girl who underwent an extremely difficult operation, along with her mother, while she was still in the womb. The highly complicated open fetal surgery took … Continue reading

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Sorin 3T Heater-Cooler System Linked to Lung Infections

Sorin 3T Heater-Cooler System Linked to Lung Infections

A woman whose husband was exposed to non-tuberculous mycobacteria during cardiac surgery has filed a lawsuit against LivaNova and Sorin Group alleging the Sorin 3T Heater-Cooler System used during her husband’s surgery ultimately led to his death. The plaintiff’s husband … Continue reading

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

Controversial Diabetes Drug Actos Still on the Market

Controversial Diabetes Drug Actos Still on the Market

Though research has shown an association between the type 2 diabetes drug Actos and serious side effects including bladder cancer, heart failure, liver failure, and bone fractures, the Food and Drug Administration (FDA) has stopped short of recalling Actos. Actos … Continue reading

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Clash Over Regulation of “Off-Label” Promotion of Drugs and Devices

Clash Over “Off-Label” Promotion of Drugs and Devices

A 2012 decision from the U.S. Court of Appeals for the Second Circuit that reversed the conviction of Alfred Caronia, a drug representative accused of conspiring to promote the drug Xyrem for unapproved uses set up a clash between the … Continue reading

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DePuy Recalls Battery Adaptors Over Potential Explosion Risk

DePuy Recalls Battery Adaptors Over Potential Explosion Risk

A Class 1 recall for the DePuy Synthes’ Small Battery Drive and the Small Battery Drive II adaptor and light adaptor has been announced by the U.S. Food and Drug Administration (FDA). The adaptors potentially produce extreme internal pressure that … Continue reading

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Antidepressant Viibryd to Carry Warning for Acute Pancreatitis, Sleep Paralysis

Viibryd Now Warns for Acute Pancreatitis, Sleep Paralysis

Viibryd (Vilazodone) Safety Label to Include Sleep Paralysis, Acute Pancreatitis Viibryd (vilazodone) is a selective serotonin reuptake inhibitor (SSRI) manufactured by Forest Laboratories. According to a recent letter from the U.S. Food and Drug Administration (FDA), the warning label on … Continue reading

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