Product News and Recalls

FDA looks to get devices on market more quickly

Posted April 10, 2012 in Depuy Hip Replacements | Drug and Medical Device Lawsuits | Product Liability | Product News and Recalls | Transvaginal Mesh Lawsuit

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 ...

Categories: Depuy Hip Replacements, Drug and Medical Device Lawsuits, Product Liability, Product News and Recalls, Transvaginal Mesh Lawsuit

Tags: debris, DePuy, early failure, hip implants, lawsuits, metal-on-metal, transvaginal mesh

Lawsuit: FDA whistle-blowers faced retaliation

Posted April 10, 2012 in Drug and Medical Device Lawsuits | Legal Issues | Product Liability | Product News and Recalls | Transvaginal Mesh Lawsuit

A group of six doctors and scientists who worked for the U.S. Food and Drug Administration have sued the agency, claiming their personal e-mail was monitored after they warned Congress that the FDA was approving faulty medical devices, The Washington Post has reported.

All of the doctors and scientists who filed suit in federal court had worked in the office responsible for reviewing medical devices. They claim information gathered from the surveillance was used to harass and dismiss them, and their ...

Categories: Drug and Medical Device Lawsuits, Legal Issues, Product Liability, Product News and Recalls, Transvaginal Mesh Lawsuit

Tags: debris, DePuy, early failure, hip implants, lawsuits, metal-on-metal, transvaginal mesh

New study shows doubling of cancer risk with Depo-Provera

Posted April 9, 2012 in Product News and Recalls | Yaz

The Fred Hutchinson Cancer Research reports a study that found a link between the injectable contraceptive Depo-Provera and breast cancer in young women.

The study involved women between the ages of 20 and 44 — 1,028 of whom had been diagnosed with breast cancer, and 919 of whom had not.

The women who received injections of Depo-Provera within the previous five years were 2.2 times more likely to have been diagnosed with breast cancer than those who never used the contraceptive.

According to ...

Categories: Product News and Recalls, Yaz

Tags: Bayer, Beyaz, blood clots, drospirenone, lawsuit, Ocella, pulmonary embolism, Yasmin, Yaz

Blood Clot Risk Assessment Lists Birth Control as Risk Factor

Posted April 9, 2012 in Product News and Recalls | Yaz

The Coalition to Prevent Deep Vein Thrombosis provides a “DVT Risk Assessor” on the organization’s Website to help people gauge their susceptibility to developing these blood clots, which occur when blood clots form in the body’s deeper veins (usually in the legs).

The Risk Assessor asks about factors that have been known to play a role in the formation of blood clots, such as recent surgery, birth control pills, or a family history of blood-clotting disorders.

According to the tool, if a ...

Categories: Product News and Recalls, Yaz

Tags: Bayer, Beyaz, blood clots, drospirenone, lawsuit, Ocella, pulmonary embolism, Yasmin, Yaz

Lawsuit accuses Johnson & Johnson of deception

Posted April 6, 2012 in Depuy Hip Replacements | Drug and Medical Device Lawsuits | Product Liability | Product News and Recalls | Transvaginal Mesh Lawsuit

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 ...

Categories: Depuy Hip Replacements, Drug and Medical Device Lawsuits, Product Liability, Product News and Recalls, Transvaginal Mesh Lawsuit

Tags: debris, DePuy, early failure, hip implants, joint replacement, lawsuits, metal-on-metal, transvaginal mesh

Consumer Reports says tracking for implants needed

Posted April 5, 2012 in Depuy Hip Replacements | Drug and Medical Device Lawsuits | Health | Product News and Recalls | Transvaginal Mesh Lawsuit

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 ...

Categories: Depuy Hip Replacements, Drug and Medical Device Lawsuits, Health, Product News and Recalls, Transvaginal Mesh Lawsuit

Tags: debris, DePuy, early failure, hip implants, joint replacement, lawsuits, metal-on-metal, transvaginal mesh

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Product News and Recalls

FDA looks to get devices on market more quickly

Lawsuit: FDA whistle-blowers faced retaliation

New study shows doubling of cancer risk with Depo-Provera

Blood Clot Risk Assessment Lists Birth Control as Risk Factor

Lawsuit accuses Johnson & Johnson of deception

Consumer Reports says tracking for implants needed

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