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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

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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Parker Waichman Representing Another Louisiana Plaintiff in Actos Bladder Cancer Lawsuit

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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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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Canadian Study Confirms Actos Bladder Cancer Risk

Canadian Study Confirms Actos Bladder Cancer Risk

A new study conducted by Canadian researchers has found that users of the type 2 diabetes drug, Actos (pioglitazone), may face a higher risk of developing bladder cancer than first thought. The study, published in the British Medical Journal, found that taking Actos for two years doubles the likelihood ...

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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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Colorado Woman Sues American Medical Systems Over Transvaginal Mesh Injuries

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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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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

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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Newly-Filed Plavix Lawsuits Claim Drug Caused Gastrointestinal Bleeds, Cerebral Hemorrhage, and TTP

Newly-Filed Plavix Lawsuits Claim Drug Caused Gastrointestinal Bleeds, Cerebral Hemorrhage, and TTP

The manufacturer of Plavix continues to be named in lawsuits alleging the blood thinner caused some patients to suffer from serious bleeding side effects. Most recently, the national law firm of Parker Waichman LLP filed nine Plavix bleeding lawsuits in state court in New York.

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Child Dies from Liquid Nicotine Poisoning

Police report that a one-year-old child died in Fort Plain, New York, after ingesting liquid nicotine, used in e-cigarettes.

The child was found unresponsive and rushed to a hospital where he was later pronounced dead, ABC News reports. A statement from Fort Plain police called the death a “tragic accident.” Continue reading

Posted in Health Concerns |

Jeep Grand Cherokee Owner Concerned about Interior Power Failure

One Jeep Grand Cherokee owner is afraid due to an interior power failure issue that leaves her driving in the dark. The Morning Call reports that Sandy Busedu experiences this issue about once a week; the interior power failure turns off the dashboard instruments and interior dome lights, radio and heater. Ms. Busedu is unable to see how fast she is driving when this happens. Furthermore, it appears that she is not the only one to experience this issue.

“Now it’s occurring more often and I’m afraid to go on a long-distance drive,” she said to The Morning Call. Continue reading

Posted in Legal News |

FDA Warns of Potentially Life-Threatening Skin Condition with Antipsychotic Drug Geodon

In a safety announcement last week, the Food and Drug Administration (FDA) warned that the antipsychotic drug Geodon (ziprasidone) is associated with a rare but serious skin reaction that can progress to affect other parts of the body.

The FDA is requiring the manufacturer to add a new warning to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Patients taking Geodon who develop a fever with a rash and/or swollen lymph glands should seek immediate medical attention, the agency advises. Ziprasidone should immediately be stopped if DRESS is suspected. Continue reading

Posted in Health Concerns, Pharmaceuticals |

Sutphen Firetrucks Recalled due to Faulty Ladder

Sutphen has recalled its firetrucks to repair a cable failure that could cause the aerial ladders to collapse while being used, “increasing the risk of injury to a user”, the National Highway Traffic Safety Administration (NHTSA) announced. According to Associated Press, the recall began in November and affects trucks from the 2000 to 2014 model years.

Last November, Sutphen recalled 156 aerial platform trucks from model years 2000 through 2011 because the ladder could retract unexpectedly. The company issued another recall in July. Hours before the recall was issued, one of the ladders being used in Hall County, Ga. retracted more than 20 feet and jammed, injuring three firefighters. Three firefighters were also injured a month earlier in Erie, Pa when their aerial platform rapidly descended.

The NHTSA announced it was investigating the issue in August to determine whether the repair for the 2013 recall was adequate. Trucks from the 2000 to 2012 model years are affected by the investigation. Drew Sutphen, company president, stated on the website that fire departments should not use the ladders until further notice. The statement said the company has “voluntarily removed all 5-Section Aerial Devices (SPH 100, SP 110, SPI 112, and SAI 110) from service” and is undertaking a thorough review of the equipment and the 2013 remedy.

In the 2013 recall, the company said that ball bears could seize and cause the cables running over them to chafe and fail. The July 2014 and November 2013 recalls both involved the SPH100, SPI112 and SAI110.

Posted in Legal News |

Judge Urges C.R. Bard to Settle Thousands of Vaginal Mesh Lawsuits

In a rare move, a federal judge has urged device maker, C.R. Bard, to settle thousands of lawsuits brought over its vaginal mesh implants. According to Bloomberg.com, the move was made as juries are expected to potentially award billions of dollars in damages in the cases.

“I can’t imagine a corporation facing potentially billions of dollars in verdicts wouldn’t find it advisable to try to achieve a settlement for a much lesser sum,” U.S. District Judge Joseph Goodwin in Charleston, West Virginia, said at a December 9 hearing, according to a transcript. “I base that billions of dollars of business on some of the rather large verdicts that we’ve had,” the judge added, according to Bloomberg.com. The judge noted that the many multi-million-dollar verdicts that have been reached against a number of implant device makers, including C.R. Bard, should provide incentive for the device maker to, by 2015, resolve the more than 12,000 cases it faces. Continue reading

Posted in Defective Medical Devices, Transvaginal mesh |

Health Canada Warns About Risk that Uterine Surgery Tool May Spread Cancer

In a Notice to Hospitals, Canada’s national health regulatory agency, has warned about the use of laparoscopic morcellators during hysterectomies and surgeries for uterine fibroids.

The notice warns that the use of a morcellator during minimally invasive hysterectomy or fibroid surgery may result in the spread and “upstaging” of an undetected uterine cancer.  These cancers cannot “reliably” be detected preoperatively, according to Health Canada. The frequency of such unsuspected uterine cancer is estimated to be about 1-in-350, a higher rate than previously reported. Continue reading

Posted in Defective Medical Devices |

12-year-old Valley Stream Boy Dies after being Hit by Driver with Suspended License

On Thursday, a 12-year-old boy in Valley Stream was struck and killed by a car on his way to school, Newsday reports. Nassau police say the driver had a suspended license.

According to Newsday, the boy was standing on the southeast corner of South Franklin Avenue and West Merrick Road and started crossing west onto South Franklin. He was hit by a 29-year-old man of Seaford driving a GMC Yukon. He was pronounced dead at Long Island Jewish Medical Center in New Hyde Park.
“I can’t believe this is happening. I keep telling myself he’s with his father now.” said the boy’s grandmother to Newsday; in 2006, the boy’s father died of pneumonia. His grandmother described him as “a very happy boy, very smart”. He participated in Boy Scouts and Little League teams. Continue reading

Posted in Legal News |

Retaliation Against Corporate Whistleblowers at All-Time High

Retaliation against corporate whistleblowers is at an all-time high, according to Stephen Kohn of the National Whistleblowers Center.

In addition, Kohn said, the U.S. Chamber of Commerce has mounted an aggressive lobbying campaign against the False Claims Act, one of the country’s most effective whistleblower laws. Continue reading

Posted in Whistleblower |

Woman Crossing Brooklyn Street Struck and Killed

A 71-year-old woman died this week, after being hit by a car while she was crossing a Brooklyn street. The driver who hit her was taken into police custody. Police say he was driving with a revoked license.

Joan Hale was crossing Foster Avenue in East Flatbush around 5 p.m. on Dec. 9 when she was struck by a Subaru Outback, NY1 reports. Hale was later pronounced dead at Kings County Hospital. The Outback was driven by a 75-year-old man, whose name has not been released. Continue reading

Posted in Accident |

FDA Classifies Reusable Menstrual Pads as Medical Devices; Retailers Must Pay Fee to Stock Them

Menstrual cups and reusable menstrual pads have been labeled as “medical devices” by the Food and Drug Administration  (FDA) for a number of years, but a growing number of small businesses report receiving demands to pay a “premarket notification fee” to continue the sale of these products, according to Medical Daily.

Reusable pads are made from absorbent fabric, such as cotton, and can be washed and reused. Menstrual cups fit inside the vagina and catch the flow. Many women use these products as an environmentally friendly alternative to disposable pads, Medical Daily reports. The fees are due before Dec. 31, 2014 and many small business owners are struggling to get cash together. Continue reading

Posted in Defective Medical Devices |

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