Tag Archives: Off-Label

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Crash on N.State Pkwy Kills Port Jefferson Station Man

Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man

A Port Jefferson Station man was killed on Wednesday due to a single-vehicle crash on the Northern State Parkway in Dix Hills. Police are investigating the accident, Newsday reports. According to Newsday, the 81-year-old man was driving a Nissan Altima west in the right lane, west of Exit 42. He ...

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Tennessee Resident Files Pradaxa Bleeding Lawsuit Following Cerebral Hemorrhage

A man from Tennessee has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage. The complaint alleges Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause Serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects ...

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Dozens Receive Nonsterile Simulated Saline Solution

Dozens-Receive-Nonsterile-Simulated-Saline-Solution

The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.

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Bleeding Side Effects of Pradaxa, Xarelto Have Some Doctors Concerned

Some heart doctors are raising concerns about a new class of heart drugs that include Pradaxa. Recently, a number of doctors interviewed by Reuters said they were hesitant to prescribe Pradaxa, as well as another blood thinner called Xarelto, because of concerns regarding the risk of stroke, serious bleeding ...

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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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Louisiana Whistleblower Lawsuit Revived

Louisiana Whistleblower Lawsuit Revived

A state appeals court in Louisiana has ruled that a former employee of Rapides Parish Coliseum can proceed with a whistleblower lawsuit against the Coliseum Authority.

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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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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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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

Posted in Pharmaceuticals | Tagged , , , , |

Federal Judge Denies Motion to Dismiss Claims in Zofran Birth Defect Cases

zofran-baby

A federal judge in Massachusetts has denied a motion by drug maker GlaxoSmithKline to dismiss cases alleging that the drug Zofran (ondansetron) caused birth defects on the grounds that federal law preempts state failure-to-warn claims. Federal law is the “supreme” … Continue reading

Posted in Birth Defects, Defective Products, Health Concerns, Legal News, Pharmaceuticals | Tagged , , , , |

New Study Warns of Side Effect Risk in “Off-label” Drug Prescribing

Side Effect Risk in “Off-label” Drug Prescribing

When a doctor prescribes a drug for a use not approved by the Food and Drug Administration—“off-label” prescribing—the patient can be at risk for serious side effects, a new study finds. In a review of off-label prescribing, a Canadian-U.S. research … Continue reading

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

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