Tagged Articles

hip-recall-lawyer.com 164 articles

FDA increases fees in hopes of improving medical device approval process

Medical device manufacturers will have to double the fees they pay to the Food and Drug Administration (FDA) in order to have their products reviewed over the next five years as part of a plan to provide faster, more thorough evaluations. The increase would allow the FDA to hire 200 new full-time employees within five years to assist with medical device evaluations. As part of the approval process, evaluators would be required to meet with device applicants midway through the review process in order to address concerns. Medical device makers are in favor of a plan that would allow for ... Read More

Will DePuy settle artificial hip lawsuits soon?

Analysts are predicting that Johnson & Johnson is preparing to offer some settlements for patients who received defective artificial hips from its subsidiary DePuy Orthopaedics. They say they were tipped off when the medical and consumer health products giant recently reported $3 billion in quarterly charges largely related to the recall of its DePuy hip implant and gave a 2012 earnings forecast below analysts estimates. “The hip recalls worry me because their eventual costs are unknown,” Gabelli & Co. analyst Jeff Jonas told Reuters. DePuy’s ASR XL hip replacement and resurfacing systems were recalled in 2010 after reports that the ... Read More

FDA monitored emails of staff who questioned medical device safety

A group of former and current Food and Drug Administration (FDA) officials have filed a lawsuit against the agency alleging the FDA secretly monitored their private email after they questioned the approval of certain medical devices which they felt put the public’s health and safety at risk. The group of nine doctors and scientists told members of Congress and the incoming Obama administration in 2008 that they were shocked to find medical devices they had researched had been approved by the FDA. In 2009, after Obama was elected but before he took office, the plaintiffs sent Obama’s transition team a ... Read More

All-metal hip implant makers will likely pay billions in settlement fees

Makers of all-metal hip replacement systems, including Johnson & Johnson and Zimmer Holdings, will likely shell out millions, possibly billions, in settlement fees to patients who have suffered after they received the hip implants, according to Forbes. Artificial hips are traditionally made with plastic or ceramic parts, but many newer versions on the market are made with all metal parts. The idea behind the new composition was that they would hold up better over time. But the design, surgeons have discovered, is flawed. When the metal ball rubs against the metal socket, tiny bits of metal debris may fall into ... Read More

All-metal hip implant settlements could cost manufacturers $5 billion, analyst says

An economic analyst and Forbes contributor estimates all-metal hip devices will ultimately cost Johnson & Johnson subsidiary DePuy Orthopaedics and other manufacturers about $5 billion in legal fees and settlement costs. Orthopedic hip device manufacturers developed metal-on-metal hip replacements about 10 years ago as a stronger, longer-lived alternative to traditional hip implants, which incorporate plastic or ceramic components in addition to metal. But now it appears these metal-on-metal implants are hurting the patients who receive them as well the companies that make them. All artificial hip systems more or less release particles of the components they are made of into ... Read More

Motrin recall latest in string of J&J woes including recalled hip replacement parts

The latest recall from Johnson & Johnson, this time for slow-working caplets of the over-the-counter painkiller Motrin, has brought the consumer health company’s shortcomings back into the forefront. The company’s Motrin recall is the sixth for this drug in the past two years. More than 12 million bottles manufactured at the company’s troubled McNeil consumer health-care division were recalled from retails in the United States, Puerto Rico, the Bahamas, Fiji, Belize, St. Lucia, and Jamaica. But the OTC drug recalls, which have drawn reports of mostly minor side effects, pale in comparison to some of J&J’s medical device recalls, which ... Read More

UK surgeon warns public about dangers of all-metal hip implants, especially for women

Some surgeons in Great Britain are so alarmed over the failure rate of all-metal hip resurfacing devices that they no longer offer them as a regular option to women, according to a report in the Daily Mail. Tony Nargol, one of the orthopedic surgeons in the U.K. steering women away from all-metal hip implants, told the Daily Mail that women are particularly vulnerable to the dangers of hip implants featuring all-metal components, but nobody knows for certain why this is the case. Some studies suggest that women are more likely than men to suffer problems with their artificial hips because ... Read More

NZ man never knew his hip implant could be poisoning him

New Zealand farmer Billy Heads figured aches and pains were common with hip replacements. For five years he suffered through occasional bouts where, he says, he walked like “an old cripple.” It wasn’t until he went for a routine five-year follow up doctor’s visit that he learned his hip implant had been recalled. And those “common” aches and pains he was suffering from were actually clues that his artificial hip was failing. In August 2010, DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a recall on its ASR XL Acetabulator hip replacement and resurfacing systems, a move that affected ... Read More

Attorneys investigating injuries associated with recalled DePuy hip implants

Thousands of patients with artificial hips could receive hundreds of thousands of dollars in compensation after a popular hip replacement system was found to be defective. DePuy ASR metal-on-metal hip implants have been marketed in the United States since the early 2000s. But last year, the system was recalled after the devices began failing at a higher than expected rate. These failures were allegedly causing pain, limited mobility, inflammation, loss of feeling in the legs, and a clicking sensation in the joint. Doctors were also finding that the metal device could leak high levels of cobalt and chromium into the ... Read More

DePuy artificial hip patients may be victim of faulty design

Stephen Ellis, 57, of the United Kingdom, was furious when he learned that black liquid drained from his right hip joint during revision surgery to replace his two-year-old metal hip implant which had started poisoning his blood. Ellis suffers from rheumatoid arthritis, and is among thousands of Liverpudlians who have had to undergo revision surgery to replace their faulty hip implant. All told, about 93,000 people worldwide, including in the United States, are affected by a recall of one brand of metal-on-metal hip implant, the ASR made by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. While the medical device ... Read More