Tag Archives: Boston Scientific

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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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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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Federal DePuy ASR Hip Implant Trials Likely to Start This Year

It looks as though the first trials in the DePuy ASR hip implant multidistrict litigation could begin sometime later this year. According to a report from Bloomberg News, during a status conference held yesterday in Florida, attorneys for both plaintiffs and the defense told U.S. District Judge David Katz that ...

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West Virginia Man Claims Metal-on-Metal DePuy Pinnacle Hip Replacement Led to Pain, Elevated Cobalt Levels

A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...

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Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...

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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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Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...

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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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Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.

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Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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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 , , , , |

Boston Scientific Plaintiff Wins Appeal, Gets New Trial

Boston Scientific Plaintiff Wins Appeal, Gets New Trial

A woman who lost her case in the Boston Scientific transvaginal mesh litigation more than two years ago is getting another opportunity in court. Previously, she filed a lawsuit alleging that she suffered injuries caused by the Pinnacle Pelvic Floor … Continue reading

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

Boston Scientific Accused of Using Counterfeit Plastic in Transvaginal Mesh

Boston-Scientific

A federal lawsuit filed under the Racketeering and Corrupt Organizations Act (RICO) alleges Boston Scientific conspired to use counterfeit plastic in their transvaginal mesh implant products. Transvaginal mesh is used to treat pelvic organ prolapse and stress urinary incontinence. It … Continue reading

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Boston Scientific Recalls Chariot Guiding Sheaths Due to Risk of Shaft Separation

Boston-Scientific

Medical device maker Boston Scientific has voluntarily recalled the Chariot Guiding Sheath worldwide because of the risk of shaft separation, which could cause permanent injury or death. The recall, which was initiated on November 19, 2015, affects all lot numbers … Continue reading

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Jury Awards $100 Million in Boston Scientific Transvaginal Mesh Case

Jury Awards $100M in Boston Scientific Mesh Case

Late last week a Delaware jury ordered medical device maker Boston Scientific to pay $100 million to a woman who said she was injured by a transvaginal mesh device. The jury award contained $25 million in compensatory damages and an … Continue reading

Posted in Defective Medical Devices, Health Concerns, Legal News, Transvaginal mesh | Tagged , , , |

Boston Scientific Loses Bid to Remove Punitive Damages Claim in Pelvic Mesh Case

Boston Scientific Loses Bid to Remove Punitive Damages Claim

Boston Scientific failed in its bid to remove punitive damages claims in a pelvic mesh lawsuit this month, Mass Device reports. This case is one out of 15,000 product liability lawsuits filed over the devices, which are used to treat … Continue reading

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Justice Department Fines Medical Device Makers over $110 Million

Justice Department Fines Medical Device Makers

The U.S. Department of Justice and U.S. Department of Health and Human Services released their joint annual report on health care fraud and abuse control on March 19th. According to the report, the federal government won or negotiated roughly $3.3 … Continue reading

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