Posts Tagged 'early failure'

FDA weighs in on dangerous hip implants

The U.S. Food and Drug Administration says patients who received Johnson & Johnson’s all-metal hip replacements need more frequent testing, according to Bloomberg.

In light of almost 16,800 reports of problems with all-metal hip implants since 2000, federal regulators hope that precaution will help prevent risky replacement surgery for some recipients. The FDA recommendation was part of a report advising members ...

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FDA panel won’t ban all-metal hip implants

A U.S. Food and Drug Administration panel holding a two-day forum about metal-on-metal hip implants will discuss widely reported problems with the devices, but will not make a decision on whether or not to ban them.

A report in U.S. News and World Report about the panel quotes an FDA spokeswoman as saying: “During the panel meeting, FDA will discuss failure rates and modes for these devices, as well as any ...

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Flawed FDA approval process results in deaths

A recent report in Scientific American takes a look at a faulty heart device that’s been responsible for at least 20 deaths.

According to the article, implantable defibrillator leads are wires that connect defibrillators – devices similar to pacemakers – to the heart. “Over the past decade, the $10 billion heart device industry has seen several high profile cases of malfunctioning products that posed severe risks to patients,” the article states.

The ...

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FDA holds hearing into metal hip implants

On Wednesday, the U.S. Food and Drug Administration will begin a two-day hearing into all-metal hip implants, examining reports that the devices are causing debilitating health problems for a large proportion of the patients who receive them.

A report on Boston.com says the all-metal implants – in which both the ball and sockets are coated with metal – were originally introduced ...

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J&J hopes to avoid felony charge

According to a Wall Street Journal report, Johnson & Johnson and the U.S. Justice Department are close to settling a lengthy investigation into allegations that the company used illegal tactics in marketing its antipsychotic drug Risperdal.

The report cites unnamed sources who said the settlement would be one of the highest ever in a drug marketing case.

Federal law says drug makers can market medicines only for uses approved by the U.S. ...

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Writer says J&J missteps worry investors

In a recent article, The Motley Fool writer Catherine Baab-Muguira addresses a number of recent management errors and product recalls at Johnson & Johnson.

She writes that they’ve “had investors scratching their heads and asking: Is Johnson & Johnson broken?”

The Department of Justice filed a civil False Claims Act against Johnson & Johnson in 2010, alleging that the company had illegally paid kickbacks to nursing-home pharmaceutical supplier Omnicare to induce Omnicare ...

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