DePuy Hip Lawsuit - ASR Recall & Pinnacle Complications
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DePuy Hip Recall Lawsuit

DePuy hip x-rayPlaintiffs who file a DePuy hip personal injury lawsuit typically have complaints about either the DePuy ASR or the DePuy Pinnacle implant. These metal-on-metal devices have been linked to complications like metal contamination, bone loss, premature loosening, and early implant failure. Anyone who has experienced these complications is urged to speak with a DePuy hip lawyer.

The Sanders Firm’s team of product liability lawyers offers free legal consultation to those who received these hip implants and suffered subsequent complications.

Johnson & Johnson, the manufacturer of the devices, implemented a DePuy ASR recall in 2010 in response to the increasing number of complaints, but the Pinnacle continues to be available on the market, despite a growing number of Pinnacle hip lawsuits. Litigation involving both the ASR and Pinnacle hip replacement is ongoing, despite recent settlements proposed by Johnson& Johnson for eligible plaintiffs.

History of complications with the ASR implant

The DePuy ASR was a new hip replacement system approved by the FDA in 2005. DePuy Orthopaedics marketed the device as a stronger, more durable option for total hip replacement, and also as an improved product for younger patients.

Within just a couple years of the product launch, however, the FDA began receiving complaints of problems related to the implant. The design of the device puts a metal femoral ball directly in contact with a metal acetabular cup, which with regular wear and tear over time, can result in metal contamination in the hip joint and surrounding tissue.

DePuy received FDA approval for the ASR and Pinnacle through the fast-track 510(k) approval process, which means they never had to perform clinical trials on the devices to prove its safety. They only had to prove that the components were similar to other hip components already on the market.

Therefore, it was only in post-marketing reports that patients and doctors began to learn that the design of the implant could allegedly cause shedding of small shards of cobalt and chromium into the surrounding hip joint. These free-floating metal pieces could then cause additional complications such as tissue damage, pain, and pockets of swelling (known as “pseudotumors”).

Other problems reported with the Pinnacle and ASR implants include:

  • Immobility
  • Loss of balance
  • Bone loss
  • Premature loosening of the implant
  • Early implant failure

DePuy hip replacement lawsuits

By 2007, over 100 reports of problems regarding the ASR had been sent to DePuy. By the end of 2008, that number had climbed to over 300 reports. Those who have filed DePuy hip replacement lawsuits note that even the surgeon who designed the device, Dr. Thomas Schmalzried, admitted that DePuy had known since 2008 that the ASR cup may have problems.

The New York Times reported in March 2010 that Dr. Schmalzried said in an interview that he and DePuy officials realized within the last two years that the cup might be more of a challenge to implant properly than competing cups. Yet DePuy continued to sell the device, allegedly concealing the known problems from doctors and patients.

Events lead to DePuy ASR recall

In 2009, the FDA sent confidential correspondence to DePuy and parent company Johnson & Johnson stating that the companies had not provided adequate clinical data to demonstrate the safety of the ASR hip resurfacing system, which was already being used in Europe. At the time, the ASR total hip replacement system was widely used in the U.S., but the resurfacing system required clinical trials for FDA approval.

DePuy withdrew the ASR from the Australian market in December 2009, but it wasn’t until March 2010 that they started to disclose some of the damaging information about the ASR to U.S. doctors. That month, they sent a letter warning physicians of an increased failure rate associated with the device, admitting that it suffered from a “higher than expected revision rate.” They also referred to data from the Australian National Joint Replacement Registry which showed that 5.4 percent of all ASR hip implants had to be replaced within three years or less after the initial surgery, and that the expected failure rate could be as high as 10 percent.

On August 26, 2010, the company issued a DePuy ASR recall, confirming that in the first five years after implantation, approximately 12 percent of patients who had received the resurfacing device, and 13 percent of those who received the ASR total hip replacement, required revision surgery. Later data produced by the British Orthopaedic Association showed a much higher failure rate of 21 percent after four years, and 49 percent after six years.

Product liability lawyers can help

Plaintiffs who have been injured by the ASR hip or Pinnacle hip may benefit from a consultation with a DePuy hip lawyer. A successful hip replacement lawsuit can result in substantial compensation to help injured victims pay for medical costs, lost wages, and pain and suffering.

As more and more plaintiffs filed lawsuits, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal ASR lawsuits into one court in the Northern District of Ohio. Some states also centralized cases into one court, including New Jersey and California.

J&J offers settlement for ASR hip lawsuits

In late 2013, Johnson & Johnson agreed to pay $2.5 billion to resolve the majority of ASR hip lawsuits pending in the United States. The accord would settle roughly 8,000 claims filed by patients who had their ASR XL Acetabular system or ASR Resurfacing hip replacement removed and replaced between August 31, 2013 and January 31, 2015.  Under the terms of the agreement, plaintiffs would secure a base payout of approximately $250,000.

The DePuy hip settlement was later augmented in February 2015 to include an additional $420 million, allowing for the inclusion of another 1,400 cases. J&J pushed back the settlement deadline, letting claimants who had hip revision surgery on their ASR implants up through January 31, 2015 to participate in the accord.

Under the terms of the agreement, plaintiffs would receive roughly $300,000, depending on the extenuating circumstances of their particular injuries. The settlement deal includes supplemental compensation earmarked for patients who had bilateral hip surgery, more than one revision surgery, or “extraordinary injuries” linked to their defective ASR hip device and explantation.

Participation in the settlement claims program is not mandatory, as all plaintiffs have the right to a trial.

Pinnacle litigation and trials

As of 2016, more than 8,000 claims involving Pinnacle metal-on-metal hips are pending as part of multidistrict litigation in Texas federal court under the direction of Judge Ed Kinkeade. In the first bellwether trial, J&J won the case after the panel found that improper surgical technique was to blame, not a defective implant.

In the second bellwether Pinnacle trial, which concluded on March 17, jurors found for the plaintiffs and ordered J&J to pay a whopping $502 million. The verdict included $142 million for actual damages and an additional $360 million in punitive damages. Plaintiffs Margaret Aoki, Richard Klusmann, Jay Christopher, Donald Greer and Robert Peterson were forced to endure painful revision surgery for their failed Pinnacle device that caused blood metal poisoning.

Even though J&J says it plans to appeal the decision, the verdict bodes well for other claimants.

The Sanders Firm can help

Johnson & Johnson may be setting aside additional funds for future settlements.  To claim those funds however, eligible parties will benefit from the expertise of a seasoned personal injury lawyer. Call The Sanders Firm and see if you qualify to bring a lawsuit against DePuy and its parent company.

The Sanders Firm has a long record of successful cases involving injuries sustained from defective medical devices. We understand the financial and physical burdens that the injuries imposed by these hip devices inflict, and we can provide you and your family with the legal guidance you need to obtain justice.  Call us today toll-free at 800-FAIR PLAY.