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DePuy Orthopaedics 271 articles

Medical devices need more FDA oversight to protect public from injury

As an orthopedic surgeon specializing in complex hip replacements, Stephen Tower knew enough about the devices to ask his own surgeon specifically for a metal-on-metal hip implant called the ASR XL, made by Johnson & Johnson subsidiary DePuy Orthopaedics, when he was due for hip replacement surgery. The newly approved medical device appeared to be more durable and longer lasting than traditional implants made from other materials. But five years after his surgery, Tower was in so much pain that he underwent revision surgery to remove and replace his device. When his surgeon cut into his hip, he found a ... Read More

Investigators close witness tampering investigation in hip trial

An investigation by federal prosecutors into possible witness tampering in a case involving allegedly defective Johnson & Johnson hip implants and has been put to rest just weeks after the device maker was hit with a $247 million verdict. The U.S. Attorney’s Office for the Northern District of Texas said they didn’t see signs that a Johnson & Johnson unit’s employee tainted the plaintiff’s witness’ testimony in the case. The issue occurred during a bellwether trial involving Johnson & Johnson’s DePuy Orthopedics hip implants The judge presiding over the case asked two FBI agents and a federal prosecutor to investigate ... Read More

J&J Says Hip implant Claims Should Have Never Made It to a Jury

Johnson & Johnson and DePuy Orthopaedics are moving forward with an appeal of last year’s bellwether trial verdict that awarded five plaintiffs $502 million, which was eventually reduced to $150 million. The plaintiffs are a small fraction of the thousands of cases that have surfaced, claiming metal-on-metal hip implants caused them pain, injury and metal poisoning. Most cases required revision surgery to replace the defective hip. The company has wilted in the courtroom, complaining that, during trial, it was subjected to prejudices as well as “outrageously inappropriate evidence and rhetoric.” J&J claims the jury was turned against it with statements saying it was “as evil as ‘big ... Read More

FDA Panel Says Metal-on-Metal Hip Implants are not recommended for Most Patients

The U.S. Food and Drug Administration (FDA) panel of medical device experts convened recently, advising against metal-on-metal hip implants, just short of banning the device altogether. The panel also advised that any patients who have received the devices should be evaluated with an X-ray and blood tests, particularly if they are experiencing pain or other symptoms that might indicate device failure. In particular, blood tests would allow detection of metal in the bloodstream, which could result in metallosis, a dangerous condition of metal poisoning in the blood. The metal-on-metal hip designs, made by a number of medical device manufacturers such as Wright Medical, ... Read More

Johnson & Johnson Plans to Appeal $1 Billion hip implant verdict

It’s been a little over a month since DePuy Orthopaedics and its parent company, Johnson & Johnson, were handed a $1 billion verdict over their metal-on-metal hip implant system that has been known to shed metal debris. The federal jury found J&J responsible for failure to warn about the potential hazards linked to their hip implant products in the third bellwether trial of the multidistrict litigation (MDL). The verdict covers $30 million in damages and $1 billion in punitive damages. J&J and DePuy now plan to appeal the verdict, claiming they were not allowed to “properly and fairly defend against ... Read More

European Medical Device Regulations Tightened Due to Metal-on-Metal Hip Implant Safety Concerns

New medical device regulations (MDR) have been put in place by European Parliament after four years of negotiation. The decision to tighten regulation was spurred by safety concerns over breast implants and metal-on-metal hips. The regulation amendments are expected to begin in early 2017, and medtechs will be allowed three years to comply. If the medical products fail to meet the new regulation standards, the manufacturer will lose their CE rating, which allows legal marketing of the product. The new regulations include stricter rules regarding clinical trials, quality management, and marketing necessities such as product labeling and design. Regulators will now inspect Class ... Read More

Large-Diameter Metal-on-Metal Hips Sparked Study on Metal Allergy

A Missouri orthopedic surgeon and colleagues have initiated a study that identifies the patients who underwent total joint replacement reporting a metal allergy. The study analyzes the effect of voluntary reported metal allergies on the clinical outcomes following the surgery. Dr. Denis Nam, recipient of the Orthopaedic Research and Education/Current Concepts of Joint Replacement (CCJR) Clinical Award Paper, along with other researchers, gathered retrospective data from 589 patients who received total knee arthroplasty (TKA), and 906 patients who received total hip arthroplasty between the years of 2009 and 2011. Before January 2010, the incidence of self-reported metal allergy was 1.7 percent. After January 2010, the incidence was 4 percent. ... Read More

Johnson & Johnson, DePuy Slapped with $1 billion Verdict in Metal-on-Metal Hip Implant Trial

In a two-month trial that ended on November 30th, the jury has found Johnson & Johnson and its subsidiary, DePuy Orthopaedics, liable for more than $1.04 billion due to their hip implant systems that shed metal debris. The six-plaintiff bellwether trial verdict comes mere months after a jury ruled in favor of plaintiffs in a $500 million verdict, which was ultimately reduced to $150 million under a Texas legal punitive damages cap. This time, however, the trial is under California law, not subject to the same cap. Jurors deliberated for less than a day before finding J&J and DePuy liable for negligent design ... Read More

Cobalt Toxicity is a Serious Risk for Metal-on-Metal Hip Patients

When Robert Peters wrote the Daily Mail for advice from Dr. Scurr about concerns with his metal-on-metal hip implants, the response seemed to only confirm his greatest fears – that his hip implants could be poisoning him. Peters’ blood was tested after his surgeon informed him of the recent reports of metal-on-metal hip failures. “Blood tests revealed I have 100 times more than normal the amount of cobalt in my blood,” Peters wrote, “as well as dangerous amounts of chromium.” Dr. Scurr explained that metal-on-metal hips are usually made of a stainless steel alloy containing cobalt and chromium, and were intended to ... Read More

Global Hip Replacement Market is on the Rise

In an industry analysis forecast report, the global hip replacement market has been estimated to expand at a compound annual growth rate of 4.1 percent between now and 2024, which is about $9.1 billion. The number of incidences of arthritis, hip fractures, and hip bone infection, which increase demand for hip replacements, as well as the development of new hip implants using new methods such as 3D printing technology are responsible for the rapid growth of the hip replacement market. Despite the positive growth, however, around 578 hip implant products were recalled from 2002 to 2013, including metal-on-metal hips, per the U.S. Food and Drug Administration ... Read More