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DePuy Orthopaedics 271 articles

Johnson and Johnson settles metal hip lawsuit

Robert Ottman was ready for his day in court against consumer health care products giant Johnson & Johnson. Ottman underwent total hip replacement surgery in 2008 during which he was implanted with Johnson & Johnson’s DePuy ASR metal-on-metal artificial hip system. Ottman claims the device caused him so much pain and disability that in 2011 he was forced to undergo invasive revision surgery to remove and replace the defective device. In 2010, Johnson & Johnson pulled the hip implants due to an alarmingly high number of premature failures. Ottman’s lawsuit claims that Johnson & Johnson and its subsidiary DePuy Orthopaedics ... Read More

European Parliament considers stronger medical device oversight to better ensure patient safety

Europen Parliament is considering adopting a proposal that would give European drug and medical device regulators more control over medical devices, and require high-risk devices to undergo an approval process before they reach the market. In both Europe and the United States, most medical devices are cleared swiftly for marketing if they can prove they are similar to products already on the market. This has raised safety concerns in the past in both countries, especially after high-profile recalls and safety advisories including the worldwide recall of Johnson & Johnson’s DePuy Orthopaedic ASR metal-on-metal hip replacement system. The devices were granted ... Read More

FDA launches tracking, monitoring program for high-risk medical devices

The Food and Drug Administration (FDA) is launching a new program that requires manufacturers of medical devices to put codes on their products so that the agency can track the devices, monitor their safety, and issue recalls when problems arise. The codes, known as unique device identifier, or UDI codes, placed on each medical device from defibrillators to artificial joints, will be entered into a public, searchable database. The UDI codes must also be noted in medical device records. The first devices to receive the UDI codes will be higher risk devices, including heart pumps and artificial hips. Many low-risk ... Read More

Lawyers ask FDA to investigate DePuy after alleged wrongdoing surfaces in ASR hip trials

Lawyers representing patients allegedly harmed by metal-on-metal hip implants have called upon the U.S. Food and Drug Administration (FDA) to investigate allegations of wrongdoing in DePuy Orthopedics, a division of Johnson & Johnson that manufactured and sold and subsequently recalled tens of thousands of defective metal ASR hips. The lawyers say new evidence emerged in testimony given during the first two bellwether personal-injury trials indicating DePuy broke federal laws when it concealed information that could have spared thousands of patients from injuries allegedly brought about by its ASR metal hip implants. That evidence had been sealed by court order until ... Read More

Johnson and Johnson considers $3 billion settlement for defective metal hip implant

Johnson & Johnson is considering shelling out more than $3 billion to settle lawsuits related to a faulty all-metal hip replacement system. The payout is about 50 percent higher than the company proposed in previous discussions, and would resolve as many as 11,500 lawsuits in the United States, at more than $300,000 per case. If accepted, the settlement would be the largest involving artificial hips. The lawsuits allege that the metal-on-metal ASR hip replacement system, made by Johnson & Johnson subsidiary DePuy Orthopaedics, was defectively designed, which caused the devices to fail at a higher than expected rate. Thousands of patients ... Read More

Judge denies metal hip maker’s request to dismiss lawsuit in multidistrict litigation

A lawsuit in a multidistrict litigation (MDL) will move forward against Biomet Inc. over its allegedly defective metal-on-metal hip implant after an Indiana federal judge declined the company’s request for dismissal. Biomet argued that the claim against the company was preempted by federal law because the device was approved for use as part of a clinical investigation to determine safety and efficacy. The lawsuit was filed by Leslie Caccia who claimed he received a defective M2A-Magnum hip replacement system, made by Biomet. The complaint states the device damaged bone and tissue surrounding Caccia’s implant and he required multiple revision surgeries ... Read More

Canadian report reinforces dangers of metal-on-metal hip implants

Hip-replacement patients fitted with all-metal large-diameter modular implants, such as DePuy’s ASR hip devices, are more than three times likely to need to need their devices replace prematurely, according to a new report by the Canadian Institute for Health information (CIHI). While the Canadian report doesn’t shed new light on the risks many metal-on-metal hip devices pose, it echoes the findings of many previous studies and reports that have found certain types of all-metal hip implants are, by design, prone to fail early and injure the patient. The CIHI based its conclusions on voluntary data for 56,942 hip-replacement surgeries performed ... Read More

DePuy recalls defective femur bone implant

DePuy Othopaedices, a subsidiary of Johnson & Johnson, is recalling an implant used to replace part or all of the femur bone. The device could fracture when exposed to normal weight loads while walking, which can cause pain, infection, loss of limb, neurovascular injury or the need for revision surgery. Patients heavier than 200 pounds and those who are highly active are at greater risk for fracture. DePuy has notified doctors and hospitals of the defect with the LPS Lower Extremity Dovetail Intercalary component. The medical device company is also providing surgeons with a patient letter template for notifying their ... Read More

Lady Gaga reveals she was close to needing a full hip replacement

Lady Gaga was possibly one performance away from needing a full hip replacement after an injury forced her to postpone, then cancel, the remaining 22 gigs on her Born This Way Ball tour, the artist revealed in a recent interview. In February, Gaga’s tour company announced that she suffered from a “labral tear of the right hip,” which is essentially a tear of the cartilage that forms the outside socket of the hip joint. A labral tear is usually painful and immobilizing, but Gaga’s case turned out to be exceptionally severe, she told Women’s Wear Daily. “My injury was actually ... Read More

Many more revision surgeries occur in patients with all-metal hip implants

Nearly 75 percent of revision surgeries to remove and replace a hip replacement within five years of initial implantation occur in patients who received a metal-on-metal device, according to a Canadian study. Researchers pored through data involving 60,000 hip replacements performed across Canada between 2003 and 2011. They found that the need for revision surgery was greater in patients who had large-diameter modular metal-on-metal implants compared to patients who had more common plastic devices. Traditional hip replacement systems are made with ceramic or plastic parts, and can last 20 years or more before needing to be replaced. In the past ... Read More