Number Of Hip Replacement Lawsuits Reaches 6000

So far, there are more than 6,000 lawsuits pending against Johnson & Johnson over its defective DePuy ASR hip replacements, the judge overseeing the consolidated cases said at a May 1 update.

Judge David A. Katz is overseeing the federal multidistrict litigation (MDL) in the U.S. District Court for the Northern District of Ohio, which he said includes about 4,200 suits. The other 2,000 cases are filed in state courts, including California, Nevada, Maryland, Florida, Wisconsin and Utah.

The lawsuits are coming from just a fraction of the 93,000 patients who were implanted with DePuy Orthopaedics hip replacement systems between 2005 and mid-2010, when DePuy issued a global recall. DePuy recalled the faulty medical devices primarily because of early failure rates, but since then, studies have linked an increased risk of cancer to the metal-on-metal artificial hips.

DePuy ASR Hip-Replacement

Lawyers for patients and Johnson & Johnson met with Judge Katz at the status conference in West Palm Beach, Florida, to discuss a bellwether trial. A bellwether trial is the first trial in the MDL and essentially a sample case that can set precedent for the other cases that follow, though the results are not usually legally binding from one case to the next.

In an MDL, lawsuits are consolidated because of similarities and share the pre-trial discovery process. Unlike a class-action lawsuit where the cases are tried as one lawsuit, in an MDL, each case goes to trial separately.

Both sets of lawyers, for a case known as DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, agreed to a bellwether trial and negotiated how to choose the plaintiffs because the results of that trial will help determine the extent of Johnson & Johnson’s responsibility for the defective implants and how much money each case is worth.

The first federal trial could be as soon as March or April 2013, according to Bloomberg News. However, the first DePuy hips case to be tried in state court — and the first case overall — is scheduled for December 3, 2012, in Las Vegas, Nevada. In addition, a second state case has been scheduled for January 2013 in Maryland state court.

Johnson & Johnson said in January that it has spent about $800 million on the recall in the past two years, reports Bloomberg. The company wouldn’t say what it has spent so far defending itself. A Johnson & Johnson attorney did say the company has produced more than 37 million pages of documents in the discovery process.

Another defense attorney said that depositions of company witnesses have taken 22 days so far and they have 32 additional days scheduled.

If you have a DePuy Hip replacement and believe you are affected by the recall, you may be entitled to compensation. Please call us now on  + 353 1 6694696       in strictest confidence for further information. Alternatively email law@petermcdonnell.ie

Faulty DePuy Hip Implant Approved Without Clinical Trials

Hundreds of thousands of people with advanced arthritis get total hip replacements each year, surgically replacing their hip joint with a prosthetic. Typically, implants are made up of a metal head that rotates inside a plastic cup. But in 2005, Johnson & Johnson’s DePuy Orthopaedics introduced a new all-metal design. Maintaining that the new device was substantially equivalent to older models, DePuy got clearance for the hip device without conducting any clinical trials to test how it would perform in patient’s bodies. The company was able to do that through an FDA process called 510(k), which doesn’t require clinical data as long as manufacturers can show that their new device is “substantially equivalent” to one already on the market.

In the case of DePuy’s hip implant, that testing began once the implants went to market.

According to the British Hip Society, the failure rate of the DePuy implant was so high that almost half of all patients who got the implant required surgery within six yearsto fix problems. The metal was eroding, releasing metallic particles into the blood and surrounding tissue of the joint and causing tremendous pain (the New York Times hasan explanatory graphic of this failure.) After thousands of complaints and lawsuits, the device was recalled in 2010, after it had been implanted in almost 100,000 people. DePuy said the company continuously reviewed data about the hip implant while it was on the market, and initiated the recall as soon as new information confirmed a problem.

Last year the Institute of Medicine reviewed the clearance process for medical devices and called for the 510(k) process to be eliminated altogether because it could not guarantee safe devices. They found that from 2005 to 2009, three out of four recalled high-risk devices had not been approved with clinical data, but rather had gone through the 510(k) clearance process or had been exempt from review altogether.

If you have a DePuy Hip replacement and believe you are affected by the recall, you may be entitled to compensation. Please call us now on  + 353 1 6694696       in strictest confidence for further information. Alternatively email law@petermcdonnell.ie

Patients advised to retain faulty hips after surgery

From the Munster Express Newspaper, 6th April 2012:

Patients who received faulty DePuy hips have been advised by solicitors, Peter McDonnell & Associates, to keep their faulty hips after surgery. The firm, which is leading the DePuy Hip Action Group, is advising patients who are due to have their DePuy hip removed to inform the hospital team that they wish to keep the removed prosthesis as evidence for their own medical and legal experts. The action group’s medical team recommends that patients who received a DePuy hip should get blood tests and MRI scans every six months to monitor the levels of metallic debris that may shed from the faulty implant into the bloodstream, leading to raised levels of chromium and cobalt in patients.

According to an FDA letter reviewed by the New York Times, Johnson & Johnson executives decided to phase out hip implant devices in 2009 shortly after receiving a request from the Food and Drug Administration for safety data about an artificial hip. The Food and Drug Administration’s statements were contained in a so-called ‘non-approvable’ letter in which the agency confidentially notified DePuy in 2009 that it was turning down the company’s application to sell the device in the United States.

The bulk of the letter focused on problems that agency reviewers found with study data submitted by DePuy to support its claim that the artificial hip was safe and effective.At the same time, the agency told the company that blood tests of some patients who got the all-metal hip showed a ‘high concentration of metal ions’ that it found ‘concerning’.It was not until August 2010 that DePuy recalled the device at issue or a companion model that was used in the USA. “is took a year after it got the administration’s letter.

But just weeks after the letter arrived in September 2009, company executives started a strategy to phase out the devices while selling their remaining stocks for use in patients both here and abroad, according to company records.Officials also wrote that reports from countries where the implant was then being used showed it was performing ‘somewhat more poorly’ than data submitted by the company’s DePuy Orthopedics unit indicated. ”ere is data from Australia in mid-2009 that showcases the device failing at high rates a few years after implantation, rather than lasting 15 years as expected.During the eight years the DePuy prosthesis was on the market in Ireland, it was used in an estimated 93,000 people worldwide, 3,282 of those was used in Irish men and women.

Peter McDonnell and the DePuy Hip Action Group in the Waterford Today newspaper

From Waterford Today, 7th March 2012 http://www.waterford-today.ie/waterford-today-news/15847-johnson-and-johnson-15847.html

“Top Johnson & Johnson executives knew of DePuy Hip Failure a year before recall

A year before recalling the DePuy hip implant, an executive at DePuy’s parent company Johnson & Johnson, reported in an internal email that the F.D.A. had refused to approve the device after reviewing the company studies that showed it had failed prematurely in “significant” cases, requiring repeat surgeries for patients.

The statements in that email, which was reported by The New York Times on February 21st, contrast greatly with those made by the company in recent years about the all-metal hip prosthesis. Johnson & Johnson, before recalling the device amid rising failure rates in 2010, insisted it was safe and continued to maintain that its internal studies refuted complaints by surgeons and regulators that the hip prosthesis was flawed. The device turned down by the United States’ F.D.A. was sold overseas instead of in the US.

The email, which was written in August 2009 by vice president of Johnson & Johnson’s DePuy Orthopaedics subsidiary, Ms. Pamela Plouhar, reported that the device had not met F.D.A. approval standards and that a major concern was its high rate of early failure during clinical trials.

DePuy has blamed orthopedic surgeons for the prosthetic hips failures, saying that doctors were not positioning a component properly. But the clinical findings that were rejected by the F.D.A. came from A.S.R. studies run by surgeons selected by DePuy, including some who had developed the implant and received royalties or consulting fees in connection with it.

DePuy does not appear to have violated any laws by not publicly releasing the F.D.A. ruling, but its decision not to publicise the agency’s findings to doctors, patients and others while continuing to market the prosthesis may undercut its defense in current and pending legal proceedings. During the eight years the prosthesis was on the market, it was used in an estimated 93,000 people worldwide, 3,282 of those was used in Irish men and women.

Dublin solicitor Peter McDonnell who is leading the DePuy Hip Action Group is advising every patient who received a DePuy hip to get blood tests and MRI scans taken every 6 months, to monitor the levels of metallic debris that may shed from the faulty implant into the bloodstream, leading to raised levels of chromium and cobalt in patients. Mr. McDonnell also strongly advises patients who are due to have their DePuy hip removed to keep the faulty hip after surgery, as this maybe removed from the patient by the hospital and sent to DePuy. The patient must request to retain the prosthesis, for evidence for his or her own medical and legal team.”

Hip-makers sold faulty units a year after finding flaws

From the Irish Examiner, March 2nd 2012 http://www.irishexaminer.com/ireland/health/hip-makers-sold-faulty-units-a-year-after-finding-flaws-185768.html#ixzz1thqxsXFq

“Patients given faulty hip replacements may have received a boost to their case for compensation following the revelation that the manufacturers continued to sell the defective devices a year after discovering their flaws.

In Ireland, 3,282 people were fitted with the faulty hip implants made by the DePuy company which is part of the international Johnson and Johnson conglomerate. Several hundred have already been told they need surgery to replace the implants while many others need regular tests to check if their implants are deteriorating.

While the hospitals and DePuy are taking care of medical costs for affected patients, a growing number are considering suing the company for pain, distress and inconvenience.

Solicitor Peter McDonnell who is dealing with almost 150 patients said yesterday their case for a class action against DePuy and/or Johnson and Johnson was strengthening all the time.

The New York Times published an email sent from one executive at the conglomerate to three others in Aug 2009 in which she informed them that the Food and Drug Administration, the US equivalent of the Irish Medicines Board, had refused approval for use of the implants in the US because records showed a high failure rate with them.

Regardless of that knowledge, the implants continued to be marketed and sold in Europe for another year before they were withdrawn amid growing concerns by medical practictioners using them and the failure rate.

DePuy has disputed the significance of the email, saying it was part of the process of reviewing the implant over time which eventually led to the decision to withdraw it.

However, Mr McDonnell said it undermined any defence the company would seek to make in legal proceedings taken against it here or in other jurisdictions. Preparations for class actions are under way in the US, the UK, and Australia.

“Medical negligence cases are always difficult and every case has to be won on its merits but the point about this case is that a hip op is a massive surgery that leaves a huge scar, usually shortens the bone and leaves people with a limp and requires a lengthy period of rehabilitation afterwards. To have to go through that twice because of a faulty implant is an ordeal nobody should have had to face.”

Mr McDonnell is so confident of success that he has already begun paying for the collection and specialist storage of removed implants in laboratory conditions in the UK.

The HSE is advising patients to allow hospitals to send on their old implants to the London Implant Retrieval Centre which has been commissioned by DePuy to investigate why the devices failed but Mr McDonnell said patients would have more confidence in an arrangement that was not paid for by DePuy.

“Really the HSE should be arranging independently for the storage and examination of the implants.” He said he would be contacting the HSE shortly to request a meeting to discuss this issue and other concerns relating to the speed at which patients were being assessed and how thoroughly they were being examined”

FDA Plans Hip Replacement Implant Review

The U.S. Food and Drug Administration will be asking an advisory panel of experts to take a closer look at metal-on-metal hip implants, according to a news release. Though the FDA metal hip implant investigation is nothing new, it signals that the agency may be ready to subject the devices to stricter scrutiny.

The investigation originally made the news in August of 2010, when DePuy, a division of Johnson & Johnson, recalled 93,000 XL Acetabular metal-on-metal hips. The device was experiencing a 13% failure rate.

Following up on that recall, the FDA ordered manufacturers to collect more post-implant safety data, according to the agency press release. Since then, the FDA has been investigating the safety of metal-on-metal hip implants and trying to decide if they should undergo more rigorous testing and premarket review.

Evidence suggests that such review may be necessary. A recent study from the National Joint Registry of English and Wales found that 6% of people with the implants needed additional surgery, reports Reuters. This is high when compared to the 1.7 to 2.4% rate found in individuals with ceramic or plastic hips.

As the FDA’s metal hip investigation continues, a number of defective product lawsuits have already been filed, but expert opinion and more data can make those suits stronger. Such individuals may therefore want to keep an eye on the FDA metal hip investigation.

If you have a DePuy Hip replacement and believe you are affected by the recall, you may be entitled to compensation. Please call us now on + 353 1 6694696 in strictest confidence for further information. Alternatively email law@petermcdonnell.ie

 

Coverage of Peter McDonnell’s involvement in ongoing DePuy Case – Irish Examiner 2nd March

Peter McDonnell Solicitors in the Irish Examiner, 2nd of March