One of the largest orthopedic companies in the world, Stryker marketed hip replacements with metal components as being more durable than those made with other materials. Its Rejuvenate and ABG II hip replacement stems were implanted in more than 20,000 patients, but some patients claim the devices were flawed.
Patients who filed lawsuits against Stryker claimed they suffered injuries including:
- Bone and other tissue death
- Bone fractures
- Medical expenses and lost wages
- Metallosis and elevated metal ion levels in the body
- Physical and mental pain
- Revision surgeries to repair or replace the devices
- Tumor-like swelling
The neck of the hip implant was made of metals that corroded and fretted when they rubbed against titanium coating that was on the implant’s stem. The fretting caused metal particles to enter patients’ bodies and cause a number of complications, including pain, implant loosening and a type of metal poisoning called metallosis.
Stryker recalled the hip replacements in 2012, but thousands of patients were already harmed by the devices. They filed lawsuits against the company to seek compensation for medical expenses, pain and suffering, loss of consortium and other damages.
Instead of fighting the cases in court, Stryker settled the majority of cases in an agreement expected to total more than $1.4 billion. The company reached a new agreement in December 2016 that extended the number of plaintiffs covered under the initial settlement.
In addition to the Rejuvenate and ABG II, plaintiffs can file lawsuits against Stryker for other devices that contain TMZF femoral stems, including the Accolade, Citation and Meridian implants. The LFIT cobalt-chromium V40 femoral head may also cause complications that were mentioned in the Rejuvenate and ABG II lawsuits.
Consolidation of Lawsuits in Minnesota and New Jersey
Less than a year after Stryker recalled the Rejuvenate and the ABG II, enough lawsuits were filed across the country for the federal government to consider consolidating them into a multidistrict litigation (MDL) court. Consolidating similar cases against the same defendant helps courts operate more efficiently.
So many cases were filed in New Jersey that the state’s Supreme Court consolidated the cases in Multicounty Litigation in the New Jersey Superior Court under Judge Brian Martinotti. Weitz & Luxenberg’s Ellen Relkin filed the first hip implant lawsuit in New Jersey in August 2012.
When Martinotti moved to the U.S. District Court for the District of New Jersey in July 2016, the cases were reassigned to New Jersey Superior Court Judge Rachelle L. Harz.
In June 2013, about five months after the New Jersey cases were consolidated, the federal Judicial Panel on Multidistrict Litigation consolidated thousands of additional cases involving the Rejuvenate and ABG II hip replacements to an MDL in the United States District Court for the District of Minnesota. Judge Donocan W. Frank and Magistrate Judge Franklin L. Noel have presided over that litigation.
More than 1,100 cases involving the ABG II implant had been filed in the New Jersey multicounty litigation as of May 2017. As of August 2017, more than 3,400 cases had been filed in the Minnesota MDL, and 1,836 were still pending.
Why People Filed Hip Implant Lawsuits against Stryker
Stryker’s faulty hip implants disrupted the lives of thousands of people who thought their lives would improve after getting a hip replacement. People who brought lawsuits against Stryker over its hip implants leveled several allegations in their claims including:
- Stryker knew or should have known it had manufactured, marketed, distributed and sold defective devices
- Defects in the implants’ designs led to loosening, infection and metallosis in people implanted with the devices
- Stryker failed to take reasonable care for the safety and well-being of patients implanted with faulty implants
- Stryker failed to adequately test the devices
- The company made “false and misleading” representations about the safety of the devices
According to court documents, individuals from across the country experienced similar complications from Stryker’s ABG II, Rejuvenate, Accolade TMZF and LFIT Anatomic V40 Femoral Head implants.
Branko Obradovic filed a lawsuit after he required revision surgery less than two years after receiving a Stryker hip replacement. He told the Palm Beach Post that he couldn’t sit for long periods of time and getting out of a car was an ordeal. “I’m very angry about the whole thing,” Obradovic said in 2013. “They should know what they are putting in someone’s body.”
The newspaper also reported Obradovic’s surgeon had been a consultant for Stryker around the time of Obradovic’s hip replacement, paid between $225,000 and $300,000 in 2011 by the company. Obradovic said he was unaware of the relationship and sought a different surgeon to perform his revision surgery.
In 2007, Stryker had been among five hip implant manufacturers the U.S. Department of Justice (DOJ) cited for setting up improper consulting arrangements with surgeons to encourage use of its products. It had been cleared in 2009 after taking part in a DOJ monitoring program of its consulting relationships.
Dianne Pingel of Boca Raton, Florida, filed the first lawsuit in the U.S. over Stryker’s Rejuvenate implants. She received two faulty hip implants in 2011, but by early 2013, she had undergone three revision surgeries to correct problems.
Doctors found abnormally high cobalt levels in her blood. She also had pockets of fluid and dying tissue and bone surrounding her hip. The metal debris caused her bone to die, and her femur was fractured during one of the revision surgeries.
“The injury suffered by the plaintiff was so extensive and the surgery required to repair the damage so challenging that the second revision surgery was performed by an orthopedic surgeon who specializes in orthopedic trauma surgery,” Pingel’s complaint said.
Her lawsuit accused Stryker of producing and selling a defectively designed implant and failing to warn people of the device’s dangers among other allegations.
Tracy Sponer of North Little Rock, Ark., had her Stryker Rejuvenate hip implanted on Sept. 6, 2011. A year later, she was forced to have revision surgery after the hip failed.
In her lawsuit, Sponer claimed the failure and revision surgery caused her ongoing mental and physical pain and that Stryker should have known about and warned people of the risk the device posed.
Her complaint accused Stryker of “fraud, malice, or willful and wanton conduct” and sought punitive damages to punish the company.
Mern Direnzo had the Accolade TMZF and LFIT Anatomic V40 Femoral Head implanted in October 2009. Blood tests showed high levels of metal ions in her blood and urine. She underwent a revision surgery to remove the device.
Her lawsuit claimed Stryker designed a faulty product, failed to test it properly and failed to warn patients about potential risks.
“Defendant 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,” her complaint said.
History of Stryker Hip Implant Settlements
Claims against Stryker include that the company misrepresented the safety of the hip implants, used deceptive marketing practices and falsely claimed that the devices were “safe alternative(s) to metal-on-metal bearing devices.”
Models involved in the lawsuits include:
- ABG II
- Accolade TMZF
- Citation TMZF
- Meridian TMZF
- LFIT Anatomic CoCr V40 femoral head
The first group of cases involving the Rejuvenate and ABG II were scheduled to go to trial in December of 2013, but the plaintiffs settled the cases with Stryker for an undisclosed amount.
Initial $1.4 Billion Settlement
In November 2014, Stryker agreed to settle several thousand claims for $1.43 billion. The amount was not capped, and attorneys expected the final payout to exceed that amount. The settlement encompassed cases in the New Jersey MCL and the Minnesota MDL. Depending on the nature of the injuries, plaintiffs could have received as much as $600,000.
The settlement included claimants who had revision surgery before Nov. 3, 2014. The first payouts were scheduled to begin in the summer of 2015 and continue through 2016. Claimants had until March 2, 2015 to be eligible for the initial settlement.
Terms of the Agreement
Only people who had implantation and revision in the U.S. or a U.S. military hospital qualified.
The revision surgery had to be for one of the following reasons:
- High cobalt blood test
- Abnormal diagnostic scan
- Findings of tissue damage
Revision surgeries caused by trauma, such as a fall, were not eligible. Each claimant was entitled to a $300,000 base award. Claimants with two hip implants could get a base award of $600,000. The base awards could decrease or increase depending on the circumstances of the revision surgery.
Items that decreased the award included:
- Claimants who were 70 years old had a 5 percent reduction. The reduction went up 5 percent for each 5-year increment in age until 85. For example, claimants older than or equal to 85 years of age had a 20 percent reduction in base settlement.
- Claimants who died before the enrollment date got a 30 percent reduction to the base award and would receive $210,000.
- Claimants who were advised to get revision surgery but could not because of health reasons would receive $75,000.
Items that increased the award included:
- Femur fracture with cabling or prosthetics: $100,000
- Hairline fracture: $40,000
- Muscle repair: $75,000
- Dislocations: $25,000 to $75,000
- Heart attack during hospitalization: $66,000 to $360,000
- Stroke during hospitalization: $85,000 to $516,000
- Death during hospitalization: $100,000 to $600,000
If claimants had infections and required surgery and care, they could also get additional award amounts totaling between $30,000 and $175,000. The maximum award for lost wages was $200,000.
Stryker Extended Settlement Coverage
In December 2016, Stryker announced that it would extend compensation to individuals who received an ABH II or Rejuvenate hip stem and had to have revision surgery before December 19, 2016. Patients could enroll in the settlement between Jan. 17 and March 1, 2017.
The new settlement extended the terms of the first settlement by two years, but 95 percent of eligible plaintiffs had to agree to the settlement for it to go into effect.
In May 2017, Stryker announced the 95 percent threshold had been met and the company expected most claimants to receive payments before 2018.
Chris Elkins is a writer and researcher for Drugwatch.com. He’s worked for various newspapers and has writing experience in sports, health communication and public relations fields. He graduated from the University of West Florida with a master’s degree in Strategic Communication and Leadership, a graduate-level certificate in Health Communication Leadership and a bachelor’s degree in Journalism.