The following is the latest news regarding major orthopedic medical device manufacturer, Stryker/ HowmedicaOsteonics Corp.:
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 governing the bellwether selection and trial process, the parties must submit a revised proposal as to the number of bellwether cases to include in the initial bellwether trial pool by September 4th.
In a prior Scheduling Order dated October 25, 2017, the court outlined the process for the completion case questionnaires and disclosures; master and short-form pleadings; fact depositions; initial disclosures; and written discovery, among others. Fact discovery is slated to be completed by October 4, 2018, and all expert discovery completed by February 15, 2019. The court has designated the June 2019 case management conference as the initial “pretrial conference,” where the parties will provide an estimate for how long they think each trial will last. A final pretrial conference is scheduled for September 9, 2019, and the first bellwether trial is expected to begin on September 16, 2019.
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
Stryker recently reported that full year net sales were up 9.9% to $12.4 billion. Orthopedics sales grew 6.6 percent to $4.7 billion, with knee sales increasing 7% to $1.6 billion, while hip sales showed 1.6% growth. Reported net earnings were down 148.9% in the fourth quarter, and Stryker reported a $249 million net loss; for the full year, the net loss reached $1 billion with reported earnings decreasing 38.1%.
#Stryker #hip #implant #recall #lawsuit #productliability
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