Category Archives: Medtronic Infuse

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Cancer Groups Call for E-cigarettes Regulation/Research

Two-Leading-Cancer-Groups-Issue-Call-for-Regulation-of-E-cigarettes-and-Research-on-Health-Risks

The American Society of Clinical Oncology & the American Association for Cancer Research called for government regulation & research of e-cigarettes on health effects.

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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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FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today

The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.

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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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Cancer Groups Call for E-cigarettes Regulation/Research

Two Leading Cancer Groups Issue Call for Regulation of E-cigarettes and Research on Health Risks

In a joint statement, the American Society of Clinical Oncology and the American Association for Cancer Research have called on the federal government to move quickly to regulate e-cigarettes and increase research on their health effects. These leading research and treatment organizations asked the Food and Drug Administration (FDA) to make ...

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Birth Control Shot Depo-Provera may Increase HIV Risk

Birth Control Shot Depo-Provera may Increase HIV Risk, Study Suggests

A new study has linked the use of Depo-Provera (medroxyprogesterone acetate), an injectable type of birth control, to an increased risk of HIV infection.

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FDA Questions Device Makers about Duodenoscope Cleaning Procedures

Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures

In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...

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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 Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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Medtronic Uses Preemption in Medtronic Infuse Case, Again

Medtronic Uses Preemption in Medtronic Infuse Case, Again

The denial of review by the United States Supreme Court today in the case of Caplinger v. Medtronic, Inc., Docket No. 15-321, though it might appear to be a victory for medical device manufacturer, Medtronic, Inc., it was not. While … Continue reading

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

European Medicines Agency Seeks Market Suspension of Medtronic InductOs

Euro Medicines Agency Seeks Suspension of Medtronic InductOs

The European Union’s medical device regulator has recommended suspension of the marketing authorization for Medtronic’s InductOs bone growth device until issues at a U.S. plant that makes a component of the device are resolved. The European Medicines Agency (EMA) launched … Continue reading

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

Medtronic Claims InFuse Injury Suits Preempted by Federal Law

Medtronic Claims InFuse Injury Suits Preempted by Federal Law

In an effort to avert lawsuits filed over injuries attributed to its InFuse bone growth device, device maker, Medtronic Inc., has tried to convince courts that the federal preemption clause of the federal Food, Drug and Cosmetic Act preempts the … Continue reading

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Class Action Lawsuit over Infuse Could Complicate Medtronic Acquisition of Covidien

A class action lawsuit over Medtronic’s bone growth product Infuse could complicate the company’s planned acquisition of Dublin-based device maker Covidien. U.S. District Judge John Tunheim will allow lawyers for Medtronic investors to explore an alleged coverup of Infuse’s side … Continue reading

Posted in Class Action Lawsuits, Defective Medical Devices, Legal News, Medtronic Infuse |

Medtronic Fourth-Quarter Reported Profits Drop 54 Percent, InFuse Litigation Cited

Medtronic, Inc. just announced a massive drop in its net earnings for fourth-quarter ended April 25th. The announced drop of 54 percent involved fourth-quarter net earnings of $448 million—$.44 per share—over the prior year’s $969 million and $.95 per share. … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse |

Medtronic Could Pay Up to $140 Million in Lawsuits Over Infuse Bone-Growth Product

Medical device maker Medtronic Inc. announced on Tuesday that it would include in its fourth-quarter results a charge between $120 and $140 million to settle hundreds of lawsuits over its InFuse bone-growth product. The charge will account for 1,200 claims … Continue reading

Posted in Defective Medical Devices, Health Concerns, Legal News, Medtronic Infuse |

Five Infuse Patients Bring Lawsuit Over Bone Graft Injuries

Infuse-patients-bring-lawsuits-over-bone-graft

Five Infuse patients have brought a lawsuit against Medtronic Inc. over its controversial bone graft product. The recent litigation was recently filed in California Superior Court. Allegations all involve that the patients were implanted with Infuse off-label and have, as … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse |

Medtronic Denied Preemption in Another Device Injury Lawsuit

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An Indiana appeals court just ruled that Medtronic cannot use so-called “preemption” to get out of a negligence lawsuit filed over a failed Transvene defibrillator lead. Preemption is legal concept that a number of medical device makers have used in … Continue reading

Posted in Defective Medical Devices, Medtonic Infuse, Medtronic Defibrillators, Medtronic Infuse |

Merck Cutting Staff Over Research Unit Re-Structure Plans

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Drug giant, Merck, has announced plans to cut 8,500 employees as part of a restructuring meant to increase marketplace competitiveness. Over the next two years, in addition to the massive layoffs, Merck also announced that it would be implementing significant … Continue reading

Posted in Defective Medical Devices, Fosamax, Medtronic Infuse, Pharmaceuticals |

Stryker, Medtronic Lose Preemption Bid in Lawsuit Involving Alleged Off-Label Bone Product Use

stryker_medtronic_court_lose

A preemption bid made by device makers Medtronic and Stryker to dismiss a lawsuit filed over their bone protein products has been rejected. A California state court ruled that federal law does not preempt the case from proceeding, according to … Continue reading

Posted in Defective Medical Devices, Defective Products, Medtronic Infuse |

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