Medical device maker Stryker paid $2 billion to settle lawsuits over two models of its hip implants in 2014. But the company faces a new round of lawsuits over problems with yet another Stryker hip implant
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More than 3,400 people sued Stryker after problems with its Rejuvenate and AGB II hip led the company to pull the implants off the market. The company settled lawsuits over the devices in 2014. Less than two years later, the company recalled 42,000 other implants, triggering a new wave of lawsuits against the company.
Stryker has paid nearly $2 billion to settle thousands of lawsuits over its Rejuvenate and AGB II hip implants. The deadline to file a lawsuit under the settlement was March 2017. Stryker expected all settlement payments to be delivered by the end of 2017. As of November 2017, more than 1,800 lawsuits were still pending in a Minnesota federal court.
Meanwhile, lawsuits over the company’s LFIT V40 femoral head hip components are still being filed. Those cases are still in the early stages and hundreds more lawsuits over the devices could be filed before the first trial expected in late 2019.
As of November 2017, at least 83 lawsuits over the LFIT V40 had been combined in New Jersey state courts as a multicounty litigation (MCL). Another 131 lawsuits from across the U.S. had been combined in a Minnesota federal court as a multidistrict litigation (MDL). MDLs and MCLs allow several similar lawsuits to be consolidated to pool resources, reduce duplication and move cases more quickly through the courts.
People who sued Stryker over faulty hip implants claimed their devices caused severe pain and other complications that required additional surgery to repair.
“[Stryker] failed to adequately design and manufacture the device to insure that it would not fret, corrode, erode, deteriorate and induce severe metal toxicity in patients,”
- Mern Direnzo’s complaint filed in her lawsuit against Stryker, May 20, 2014
Stryker’s faulty hip implants disrupted the lives of thousands of people who thought their lives would improve after getting a hip replacement.
“[C]onduct of [Stryker] is attended by circumstances of fraud, malice, or willful and wanton conduct, and constitutes a flagrant disregard for human life so as to warrant the imposition of exemplary damages.”
- Tracy Sponer’s complaint filed in her lawsuit against Stryker, November 7, 2012
Court documents show that people from across the country experienced similar complications from several types of Stryker hip replacements. At least six models of Stryker hip implants or their components have been named in lawsuits.
In 2014, Stryker agreed to pay $1.43 billion to settle thousands of lawsuits over its Rejuvenate and AGB II hip implants. It extended the settlement to more patients in 2016, raising the total settlement amount to somewhere between $2 billion and $2.2 billion. The average amount paid for each problematic hip implant was $600,000.
Stryker issues a market withdrawal of all Rejuvenate and ABG II hip implants worldwide after the company alerts doctors to potential health complications from the hips
First Stryker lawsuit over Rejuvenate and AGB II filed in New Jersey state courts
U.S. Judicial Panel on Multidistrict Litigation combines federal Stryker lawsuits into Minnesota federal court
First trial over Rejuvenate and AGB II lawsuits canceled as Stryker offers to settle
Stryker offers $1.4 billion settlement in Rejuvenate and AGB II lawsuits
Stryker recalls more than 40,000 LFIT Anatomic CoCr V40 (LFIT V40) Femoral Heads for taper lock failure
Stryker extends Rejuvenate and AGB II settlement
Deadline to apply for Rejuvenate and AGB II settlement; Stryker promises to have all settlement payments sent out by end of year
JPML combines first LFIT V40 lawsuits into an MDL in Massachusetts federal court
New Jersey courts combine all state court LFIT V40 lawsuits into a multicounty litigation in Bergen County
131 lawsuits over LFIT V40 femoral heads were pending in the Massachusetts MDL
1,861 Rejuvenate and ABG II hip lawsuits remain pending in Minnesota MDL
First LFIT V40 lawsuit scheduled for trial in Massachusetts
There are currently no class-action lawsuits over Stryker hip implants. The lawsuits over the LFIT V40 implants are primarily in either the multicounty litigation in New Jersey or the multidistrict litigation in Massachusetts.
MCLs and MDLs provide some of the same benefits as class-action lawsuits such as allowing people to pool their resources in court. But there are significant differences.
|Class Action Lawsuits||Multidistrict Litigation (MDL)|
|A single lawsuit filed by an individual or small group on behalf of a large group of people||Made up of several (even thousands) of individual lawsuits originally filed in multiple courts around the U.S.|
|Lawsuit undergoes “class certification” in which a court rules whether the case can be a class action||A federal panel determines whether lawsuits can be combined in a single multidistrict litigation|
|Filed in either state or federal court||Can only be filed federal courts (Some states allow MCLs or similar consolidation in state courts)|
|People taking part must have suffered the same injuries||Injuries may be similar but do not have to be exactly the same|
|Can be filed for damages so small they would not be worth pursuing in individual lawsuits||Individual awards or settlements can be quite large, hundreds of thousands of dollars in some cases|
|All parties receive a proportionate share of any award or settlement||Awards and settlements can be tailored to each individual’s particular injuries|
In July 2012, Stryker issued an Urgent Field Safety Notice about problems with its Rejuvenate and AGB II hip implants. The company warned that “fretting and/or corrosion” could lead to “metallosis, necrosis, and/or pain” for people implanted with the devices.
The company immediately withdrew both products from the market.
Stryker issued another notice for certain LFIT V40 Femoral Heads in August 2016, citing taper lock failure. The notice listed “potential hazards” that could occur with the recalled devices. These included “excessive metallic debris,” which has been associated with metallosis in other hip implants.
In another notice seven months later, the company repeated that doctors did not need to change their follow-up procedures, but suggested they be alert for possible symptoms that could mean serious complications resulting from LFIT V40 implants.
“Complaints of new or continued pain, stiffness, instability or swelling in the hip, groin, buttock or thigh warrant further investigation.”
- Stryker Urgent Field Safety Notice for LFIT V40 Femoral Heads, March 13, 2017
Stryker advised doctors to consider lab tests for patients already implanted with the recalled devices if they showed symptoms of possible complications.
Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.
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