A Summary of the Stryker Hip Recall
The Stryker Rejuvenate and ABGII metal hip implants obtained FDA approval in 2008 and 2009, but were not aggressively marketed until early 2010. The company claimed the devices were geared specifically toward younger, more active patients, and were both long-lasting and safe. Just months after the devices were released, adverse event reports began coming in to the FDA, regarding symptoms of metallosis and metal poisoning as well as failure of the implants which required Stryker hip revision surgery. By April, 2012, Stryker issued an Urgent Field Safety Notification to surgeons and hospitals regarding the unusually high failure rate of the hip implants as well as the likelihood of fretting and corrosion, leading to the release of tiny metal ions into the bloodstream and surrounding tissues. The recall was issued months later in July, 2012.
Problems Associated With the Stryker ABGII and Rejuvenate
When the safety notification was released, Stryker maintained the Rejuvenate and ABGII hip implant devices had only a one percent risk of failure. That figure was later placed at between 12% and 65%, depending on the research. Stryker also attempted to lay the blame for patients’ adverse health issues on the patients themselves as well as the surgeons who implanted the devices. When cobalt and chromium ions shear away and implant into the hip tissues, symptoms of metallosis can develop such as chronic pain, inflammation, deterioration of bone and tissue and the necessity for hip revision surgery. Some of the more serious health issues associated with metal poisoning, resulting from cobalt and chromium ions in the bloodstream, include: loss of vision and hearing and neurological, cardiovascular, renal and thyroid disorders.
Litigation Resulting From the Stryker Hip Recall
Since the time of the recall, more than 4,000 lawsuits were filed against Stryker by those who suffered injury and harm from the defective hip devices. As many as 20,000 devices were sold by Stryker between the release of the devices and the recall. Many of these lawsuits claimed Stryker was aware of design defects which could cause harm to consumers, but continued to sell the implants. In late 2013, during the first phase of mediation in the Stryker cases, eight Stryker lawsuits were settled for an undisclosed amount. In early 2014, another nine cases were settled through mediation. Bellwether trials would have been the next step in the Stryker litigation, however Stryker deemed it more advantageous to offer a settlement to at least a part of the litigants.
Stryker Hip Settlement Eligibility for the Proposed Stryker Master Settlement Agreement
Under the proposed Stryker hip settlement, those who will potentially benefit are persons implanted with a Rejuvenate or ABGII modular hip stem who have undergone a qualified revision surgery of the hip stem and neck. Stryker is unwilling at this time to negotiate with claimants unless and until their recalled hip device fails, and revision surgery becomes necessary. Plaintiffs who have not undergone revision surgery have other options, detailed further in to the Stryker Master Settlement Agreement. Patients who have upcoming revision surgery scheduled after November 2, 2014, may be able to ask for a deadline extension. Settlement eligibility includes removal of both the femoral stem and neck, more than 180 days following initial implantation but prior to November 3, 2014. The patient must have undergone revision surgery in the United State or in a U.S. military hospital, and the revision surgery must be the result of elevated cobalt levels or an abnormal diagnostic scan or findings of tissue damage. Revision may not be caused solely by trauma, recurrent dislocation or infection and the device must not have been removed because it broke.
Base Award and Potential Reductions for the Stryker Master Settlement Agreement
The Stryker hip settlement monetary compensation in the form of a proposed base award for the Stryker hip settlement is $300,000, with certain reductions, including the following:
· If the patient had a pre-existing hip implant device prior to receiving a Rejuvenate or ABGII, there will be a 15% reduction in the base award.
· There is a reduction in the base award according to age: if the patient is seventy or older, there will be a 5% reduction in the base award. A patient who is seventy-five or older will have a 10% reduction in the base award, a patient who is eighty years old or older will see a 15% reduction in the base award, and for those eighty-five or older, a 20% reduction in the base award will occur.
· Unlike many other hip implant settlements, patients will experience no reduction in base award for being obese, for smoking or for having certain other factors such as diabetes or a prior infection.
· A patient who underwent a qualified revision surgery but pass away from causes unrelated to the revision surgery prior to the enrollment date of January 16, 2015, will have their base award reduced by 30%.
· Claimants who were advised they should have their Stryker implant removed, but were medically unable to do so are entitled to a one-time payment of $75,000. No further payments will be made, even if the plaintiff later undergoes revision surgery.
Stryker Hip Settlement Enhancements and Caps
There are a significant number of enhancements available to claimants who qualify. These enhancements are subject to caps, regardless of the number of complications suffered by the patient. For patients who do not undergo infection-related treatment, the enhancement cap is $450,000, and for patients who do undergo infection-related treatment, the enhancement cap is $550,000. These amounts are doubled for patients with bilateral qualifying revision. Patients who suffer specific complications after enrolling in the Stryker Master Settlement Agreement are entitled to additional compensations for up to two years.
Stryker Hip Settlement Information for Unrevised Claimants
Patients who have not undergone revision surgery and for whom revision surgery is not yet indicated will have their case dismissed without prejudice on November 3, 2015. After this time, any applicable statutes of limitations will be tolled until five years from the date of the original implant surgery or until June 30, 2017, whichever comes first. Claimants who need revision surgery but are not medically able to undergo the surgery, are entitled to a one-time payment of $75,000. Claimants with upcoming revision surgery scheduled may be able to have their deadline extended.
Miscellaneous Issues Associated With the Stryker Master Settlement Agreement
The spouses of those injured by a recalled Stryker Rejuvenate or ABGII who have a current lawsuit against Stryker are entitled to a one-time payment of $1,500. The spouse must grant a release in return. The Broadspire program remains in force; claims filed prior to November 3, 2014 will be paid, and there will be no corresponding deduction if the patient receives an award under the Master Settlement Agreement. Broadspire claims filed after November 3, 2014 will have the payments deducted from an award garnered from the Stryker Master Settlement Agreement. Patients who owe money to public or private insurance companies for medical expenses related to revision surgery must settle these liens with proceeds of the settlement. The plaintiff’s award will be reduced by a pro-rata share for attorney’s fees and costs. If the 95% participation rate is reached, Stryker is expected to begin funding base award settlements by the end of June, 2015, and enhanced award payments by the last quarter of 2015 and the first quarter of 2016.
How Injured Stryker Patients Can Receive the Help They Need
Whether you have received a revision surgery and believe you qualify for an award under the Stryker Master Settlement Agreement or have not yet undergone revision surgery, it can be helpful to speak to an experienced, knowledgeable Stryker hip attorney regarding your options.