Depuy Hip Replacements

New J&J CEO involved in previous recall

A Newark Star-Ledger profile of Alex Gorsky, the new CEO of Johnson & Johnson, describes him as “the go-to man” during the company’s 1998 recall of Hismanal, an antihistamine that proved to have dangerous cardiovascular side effects.

Gorsky has succeeded previous chief executive officer William Weldon, who stepped down after a disastrous series of recalls. But the Star-Ledger mentions that some industry observers are questioning whether Gorsky played a part in marketing a hip implant that has generated thousands of lawsuits ...

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Surgeon: hip implant concern only for metal-on-metal devices

A British surgeon who specializes in hip surgery writes that he’s heard from many patients who have received hip replacements, and are concerned about recent reports dealing with the hazards of metal-on-metal hip implants.

In a piece for “This is Nottingham,” Dr. Andrew Manktelow of Queen’s Medical Centre writes that most hip replacement patients have no need for concern.

“Most patients will have had either a metal or ceramic ball on a plastic liner or a ceramic on ceramic bearing. If you ...

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Radiological devices had FDA whistle-blowers concerned

Six U.S. Food and Drug Administration doctors and scientists who claim the agency retaliated against them said they were trying to raise valid concerns about medical devices of unproven effectiveness, The Washington Post has reported.

The doctors and scientists, who worked in the office charged with reviewing medical devices, have filed suit in federal court alleging that the FDA monitored their personal e-mail accounts, and used information obtained that way to harass and improperly dismiss them.

According to The Washington Post, they ...

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FDA looks to get devices on market more quickly

The U.S. Food and Drug Administration has announced a plan to get medical devices through the federal approval process and on the market more quickly.

According to the Wall Street Journal, the plan is an expansion of the FDA’s Innovation Pathway program.

The report says the plan will weigh factors such as how much risk patients are willing to accept with new devices. It quotes an agency spokesman as saying patients dealing with terminal illness are generally willing to accept a higher ...

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Lawsuit accuses Johnson & Johnson of deception

A lawyer representing the state of Arkansas claims that Janssen, a unit of Johnson & Johnson, misled thousands of doctors in the state about the risks accompanying the anti-psychotic drug Risperdal, Bloomberg reports.

Arkansas is seeking more than $1.25 billion in penalties for alleged violations of the state’s deceptive-trade practices law.

Lawyers representing Arkansas argue that the company hid Risperdal’s diabetes risks, defrauded the state’s Medicaid program by failing to properly disclose those risks on the warning label, deceptively marketed the drug ...

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Consumer Reports says tracking for implants needed

According to Consumer Reports, a major problem with medical devices in the United States is a lack of any systematic way to keep track of them.

The May issue of the magazine contains an investigation titled “Dangerous Medical Devices,” which examines the flawed federal approval process that allows potentially hazardous devices to go onto the market.

Some of those problematic devices are surgically implanted in patients’ bodies. They include metal-on-metal joint replacements for hips, and transvaginal mesh implants to treat patients suffering ...

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