Posts Tagged 'johnson and johnson'

FDA Addresses Cancer Risk of Morcellation Devices

A panel of Food and Drug Administration experts says that it is unlikely that power morcellation can be used to remove fibroids from women without the risk of spreading undetected cancers to other parts of the body. The FDA takes into consideration the opinions of its health advisors on these panels when making regulatory decisions about medical devices.

Power morcellators are used in the removal of fibroids and in some hysterectomies. Fibroids can cause severe pain, heavy ...

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Johnson & Johnson Asks Doctors to Return Its Ethicon Power Morcellator Devices

Johnson and Johnson requests voluntary recall of Ethicon power morcellatorsThe FDA previously advised doctors to stop all use of power morcellators while the devices’ propensity to spread cancer was reviewed. Now J&J is pursuing a global, voluntary return of its power morcellator devices. An article in Reuters reports that this move comes as a result of concerns that the surgical device potentially spreads cancerous uterine growths in women.

Uterine growths, called fibroids, are divided into ...

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Johnson & Johnson Alerted to Morcellator Cancer Risk in 2006

report indicates Johnson and Johnson knew of morcellator risk in 2006A report published in the Pittsburgh Business Times indicates that the Johnson & Johnson subsidiary responsible for manufacturing power morcellators was warned eight years ago that their device could increase the risk of spreading cancer. The news is based on a series of communications between the company and a Pennsylvania pathologist, Dr. Robert Lamparter, who requested that Johnson & Johnson reconsider the risk posed by ...

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Laparoscopic Uterine Power Morcellation Linked to Increased Cancer Risk

A Pennsylvania man is suing the manufacturer of a device used to remove large masses of tissue during minimally invasive surgeries. The man is alleging that the device caused the spread of cancerous tissue during his wife’s hysterectomy, ultimately resulting in her death. The device at issue is known as a morcellator, which operates by breaking up tissue into smaller fragments, allowing a surgeon to remove the tissue through a smaller incision than would be required in standard laparoscopic surgery.

On ...

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Johnson & Johnson Settles $23 Million Lawsuit and Looks to Reestablish OTC Business

A story on Pharmalot reports a settlement of $23 million dollars against Johnson & Johnson for issues caused by their Fort Washington, Pennsylvania plant and its over-the-counter business as a whole. After practices at the Fort Washington plant resulted in numerous product recalls and a variety of quality control issues, shareholders filed a class action lawsuit over J&J’s poor managerial performance. The lawsuit alleged that management caused a decline in market share, congressional probes, and a loss of consumer confidence ...

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Johnson & Johnson Guilty Plea Helps Risperdal Lawsuits

After a ten-year long criminal investigation, Johnson & Johnson has entered a guilty plea and will pay $2.2 billion in damages. The U.S. Department of Justice charged the company with promoting the drugs Risperdal and Invega for off-label uses (uses that were not approved by the FDA). These drugs were approved solely for the treatment of schizophrenia, but Johnson & Johnson was promoting them for non-schizophrenic patients—including children, ...

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