2441 IN RE: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation
District of Minnesota (Hon. Donovan W. Frank)
In November 2014, Stryker Orthopaedics settled approximately 3,000 Rejuvenate Hip Stem and ABG II Modular Hip Stem lawsuits in New Jersey’s Bergen County Superior Court, the 17th Judicial Circuit Court of Florida, the 15th Judicial Circuit Court of Florida, and the MDL. Pursuant to the settlement, Stryker agreed to pay hip implant patients a base award of $300,000 for each revised hip, with additional compensation for patients who had complications during revision surgery to remove the hip implant. Stryker has advised the court that 95% of additional registered eligible patients have enrolled in the 2016 Settlement Program, which means that Stryker will provide compensation to additional eligible U.S. patients who had revision surgery to replace their Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem prior to December 19, 2016.
The hip replacement implant failures at issue relate to the use of metal-on-metal hip implants, or hip implants with increased use of metallic parts intended to withstand greater wear and enhance lifespan profiles. Unfortunately, these implants have actually failed early due to metal blood poisoning, or metallosis (which occurs when high levels of chromium and cobalt ions shed as debris from friction between the components enter the surrounding tissue and bloodstream), inflammation of surrounding tissue, or loosening of components which threatens patients’ stability and mobility.
2768 IN RE: Stryker LFIT V40 Femoral Head Products Liability Litigation
District of Massachusetts (Hon. Indira Talwani)
According to an Amended Case Management Order filed in the U.S. District Court, District of Massachusetts in early March, defendants and plaintiffs were each to have selected nine Stryker hip lawsuits for inclusion in an Initial Bellwether Discovery Pool by February 14th. Cases eligible for selection included those filed before December 12, 2017, in which the plaintiffs have served a substantially completed fact sheet by January 2nd.
Any bellwether pool lawsuit that is dismissed by a plaintiff before October 4, 2018 will be replaced by a case selected by the defendants. Any case settled before October 4, 2018 will be replaced by a case selected by Plaintiffs. The parties are to meet and confer on the procedures for replacing any bellwether pool cases that are dismissed or settled after October 4, 2018.
Per the Court: “On September 4, 2018, each side shall submit a revised proposal to the court as to the number of bellwether cases to include in the Initial Bellwether Trial Pool, and shall address in said proposal whether the goals of the MDL, as set forth at Paragraph 3(b) of MDL Order No. 5 [#11], are better served by proceeding only with cases involving hip implant devices which Plaintiff alleges caused his or her injury, consisting in part of an LFIT V40 head and an Accolade TMZF stem, or whether any case involving an LFIT V40 head should be eligible for the Initial Bellwether Trial Pool.”
The Court has indicated that it will adopt a process for selecting bellwether trial cases no later than October 5, 2018.
Plaintiffs have filed the lawsuit’s Master Complaint. Master Complaints are frequently used in MDLs and other large, centralized proceedings. They are intended to promote judicial efficiency by streamlining the process for filing a lawsuit. The Master Complaint serves as a template and includes all allegations common to all cases. Once a Master Complaint has been filed with a court, new plaintiffs are able to file their lawsuits via a standardized Short Form Complaint.
The Master Complaint for the Stryker hip litigation was filed in October with the U.S. District Court, District of Massachusetts. Among other things, the document sets forth all of the Stryker hip components that can be used in conjunction with the LFIT V40 femoral heads, including:
- The Accolade® TMZF Femoral Stem
- Accolade II® Femoral Stem
- Restoration™ Femoral Hip Stem
- Rejuvenate® Monolithic Stem
- ABG II Monolithic Femoral Stem
- Hipstar® Femoral Stem
- Citation TMZF HA Stem
- Meridian® PA Femoral Stem
- Exeter® V40™ Femoral Stem
- Reliance® PF Femoral Stem
The complaint claims that Stryker’s LFIT femoral heads are defective, causing plaintiffs to suffer one or one or more of the following:
- Release of metal ions and/or metal wear debris followed by pain, disability, destruction of tissue
- Development of fluid collections and pseudotumor
- Necessity of revision surgery (removal and replacement)
Frequent findings during revision surgery include:
- Presence of turbid, milky fluid collection
- Large pseudotumor formation
- Discolored or friable soft tissue and bone
- Bone and soft tissue necrosis
- Detachment or tearing of muscle
Stryker’s LFIT V40 Anatomic CoCr Femoral Heads are made of a cobalt and chromium alloy and were designed to offer surgeons the intra-operative flexibility to better match patient anatomy and restore natural movement to enhance hip stability, minimize dislocation and maximize range of motion. The heads are used in combination with several of modular hip implants, including Accolade TMZF, Accolade 2 Stems, Meridian Stems, and Citation Stems. More than 100,000 LFIT V40 components may have been implanted in patients.
Stryker issued an urgent voluntary medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Heads manufactured prior to 2011. Potential hazards listed in the recall notice included excessive metal debris, disassociation of the head from the stem/failure, trunnion fracture, and corrosion at the femoral head and stem junction.
In April 2017, the United States Judicial Panel on Multidistrict Litigation (JPML) ordered the transfer of 33 pending federal lawsuits from 17 district courts, along with all future claims, asserting injury caused by HowmedicaOsteonics Corp.’s Stryker-branded LFIT Anatomic CoCR V40 femoral heads, a prosthetic hip replacement device, to the United States District Court for the District of Massachusetts. Filed lawsuits alleged that the titanium material of the hip stem did not maintain structural integrity when used with the chromium and cobalt V40 femoral heads, thereby causing disassociation of the head from the hip stem, hip stem fractures, high levels of metallic debris in the bloodstream (metallosis), poor range of motion, loss of implant and/or bone fixation strength, debris from excessive wear, low tissue tension and noise. Accordingly, patients suffered injuries including loss of mobility, pain, inflammation, adverse local tissue reaction, dislocation, joint instability, broken bones, leg length discrepancy, which necessitated painful revision surgeries.
Other Stryker News
In the first quarter of 2018, Stryker’s shares declined 7.6%. Also, Stryker’s Group President of Global Quality and Business Operations, Lonny Carpenter, plans to retire as of March 31, 2019.
#Stryker #hip #implant #recall #lawsuit #productliability
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