Stryker Hip Accolade and Rejuvenate Settlement Extended

Some Additional Plaintiffs Are Now Included in the Revised Stryker Settlement Agreement

Patients implanted with specific Stryker hip replacements who were ineligible for the initial 2014 Stryker hip settlement may now be eligible for the expanded settlement agreement.

Specifically, patients implanted with the Stryker ABG II Modular Neck Hip Stem and the Stryker Rejuvenate Modular Neck Hip Stem who were implanted from 2014 to December 19, 2016, are now eligible to take part in the 2014 settlement. In the initial program, over 95 percent of eligible patients enrolled, according to OrthoSpineNews.com. Under the new agreement, additional patients are now eligible to participate and apply for compensation.

Law360 notes that the settlement involves both Stryker Corporation and its subsidiary, Howmedica Osteonics Corporation. The compensation for additional plaintiffs arose from the multidistrict litigation (MDL) that led to the $1 billion settlement. The MDL is In re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation, MDL number 2441 that is centralized in Minnesota federal court. A multicounty litigation has also been organized in New Jersey state court. The deal was struck between the Stryker entities and court-appointed committees of attorneys who were representing plaintiffs in the federal MDL and the New Jersey multicounty litigation.

Litigation was incited when Stryker recalled the modular-neck stems in June 2012, indicating the device components could fret or corrode, damage body tissue, and lead to pain or swelling. Some 95 percent of eligible patients enrolled in the 2014 settlement, according to Law360.

Thousands of plaintiffs were involved in the initial settlement; however, eligibility for inclusion in the settlement was contingent upon the plaintiffs having had undergone the implant surgery and having also undergone the revision surgery prior to November 3, 2014, which was the date of the initial settlement. This meant that patients who had been implanted with the Stryker devices but who had not yet undergone the revision surgery were excluded from the settlement fund.

The extension to the original settlement now enables patients who underwent both the initial and revision surgeries by December 19, 2016 eligibility in the settlement fund. Those patients who already took part in the 2014 settlement or who have otherwise resolved their Stryker claims are not eligible to be part of the revised, extended settlement. Individuals who were eligible for the 2014 settlement but did not enroll in the initial settlement program are again eligible to do so; however, they must enroll by January 9, 2017. Settlement values begin at approximately $300,000; however, greater amounts may be given to individuals who suffered complications that called for additional medical treatment.

Also, the $300,000 base award is for each revised hip and is subject to certain applicable reductions and limitations, the agreement indicates, according to Law360. Unrepresented claimants are eligible for 71 percent of the base award, which is $213,000. Reductions will be applicable for obesity, smoking, and age, the agreement also states.

Stryker has been faced with numerous complaints concerning a variety of its hip replacement devices, including the Rejuvenate and the Accolade. Concerns about Accolade have been seen more recently; however, like the Rejuvenate device, complaints are of premature hip failure and severe pain. When patients experience premature hip failure, they must typically undergo revision surgery to remove and replace the defective implant. Stryker Accolade complaints site catastrophic dislocation of the implant.

While this announcement does not impact individuals with lawsuits involving the Stryker Accolade TMZF, the settlements being seen in lawsuits on other hip replacement devices could indicate that Stryker may be in a more willing position to settle Accolade claims, as well.

The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing a metal-on-metal lawsuit.

Stryker reached a settlement of about $1 billion in 2014 over its Rejuvenate Modular Hip and ABG II Modular hip stems to resolve thousands of claims. Plaintiffs alleged that the devices had an increased risk of premature failure. Also, since the Rejuvenate hips were constructed of metal-on-metal, patients were at increased risk for metallosis (metal poisoning), which occurs when the metal components rub against one another and metallic debris is loosened from the implant and released into the patient’s body. This may lead to a serious array of dangerous injuries.

Stryker believes most payments under the newly expanded settlement agreement will be made by the close of 2017. The agreement is also expected to close “significant” litigation activity; however, some lawsuits will remain open, according to a statement issued by Stryker. “The final outcome of this matter is dependent on many variables that are difficult to predict. The ultimate cost to entirely resolve this matter may be materially different than the amount of the current estimate,” the statement also indicated, Law360 reported. About 20,000 people in the United States were implanted with Stryker Rejuvenate and ABG II hip products, attorneys said.

Metal-on-Metal Hip Devices

Metal-on-metal hip implants are made of all-metal surfaces. When these devices were first released to market, they were promoted as being a more durable, as well as a better choice for younger, more active patients. Metal-on-metal hip implant safety has, instead, been the focus of growing controversy and concerns, especially that metal hip implants release metal debris when the device surfaces rub together during normal activities, including walking.

Meanwhile, not all medical devices are tested for safety prior to their release to market. This is a long-debated, well-known issue that has increased controversy, especially concerning specific metal devices such as metal-on-metal hips. In fact, many of the metal-on-metal hip devices that were released and are on the market today were approved via the 510(k) route, a more rapid method of clearing medical devices in the United States. Many consumer advocates consider this a sloppy way in which to release a device to market. The 510(k) is a regulatory route that allows device manufacturers to receive U.S. Food and Drug Administration (FDA) clearance for the devices without undergoing the requirement of clinical testing if the manufacturer is able to prove that their device is substantially equivalent to a previously approved device. Under the 510(k), device makers need only file paperwork with, and pay a fee to, the federal regulators.

Because of the quickened route, many lawsuits allege that metal-on-metal hips were never clinically tested before they were approved. Meanwhile, in August 2015, the agency sought to change the rapid clearance process, mandating devices makers to follow a stricter process when seeking approval to release metal-on-metal hip devices. In fact, Johnson & Johnson ceased sales of its metal-on-metal version of the Pinnacle device when this decision was announced.

Some of the complications associated with metal-on-metal devices include:

  • Difficulty ambulating, rising, standing, and balancing; limited mobility
  • Hip replacement failure: Loosening, dislocation, loosening, or fracture of the joint
  • Elevated blood levels of cobalt and chromium ions; metallosis (metal poisoning)
  • Fluid collection, pseudotumors
  • Necrosis (death of tissue) or soft tissue damage
  • Osteolysis, or damage/death to the bone cells
  • Popping sounds and other noise emanating from the joint
  • Revision surgery (additional surgery or surgeries) needed to correct or replace the implant
  • Pain: Severe pain that spreads to the groin and/or back; unexplained hip pain

Filing a Metal-on-Metal Hip Implant Lawsuit

If you or someone you know suffered injuries related to the use of a metal-on-metal hip implant device, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).

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