Stryker Rejuvenate Litigation Update

February 24, 2013, 12:30PM. By Jane Mundy

Bergen County, NJBecause so many people have complained about their Stryker Rejuvenate hip implant, attorney Ben Stewart says that the judge in charge of all Stryker hip cases formed a multi-district litigation (MDL) last week, which is more practical than trying all cases on an individual basis.

An MDL makes more sense for plaintiffs and the judicial system alike. “Now we are conducting a unified general discovery - a discovery into the general allegations common amongst all plaintiffs,” says Stewart. “One of our partners has been named as chair of the plaintiffs’ steering committee. Within 30 days, the judge is going to provide us with a timeline regarding how he wants the discovery stage to progress.”

Stewart adds that his team has their experts lined up. “We had a meeting three weeks ago with a metallurgist as well as orthopedic experts,” he explains. “All our experts have reviewed the claims and they are advising us as to the mechanism of injury. Along with Stryker hip recipients alleging injuries were caused by the Rejuvenate or ABG II Modular stems fretting and corroding, leading to a buildup of metallic debris in the nearby tissue, we are now seeing victims with soft tissue degradation.” (Doctors and attorneys’ experts are saying metallosis occurs as a result of the systems’ metallic components rubbing against one another, releasing dangerous levels of cobalt and chromium into the body.)

The Stryker Rejuvenate is yet another metal-on-metal hip replacement device that has been recalled. When the Rejuvenate and ABG II systems were approved by the FDA in 2008 and hit the market in late 2009, Stryker sold its products by marketing them as having less stress on the bone, joints and surrounding tissue.

In July 2012, The Stryker Orthopedics Rejuvenate Modular Hip System was recalled because of corrosion. At least 20,000 Stryker’s Rejuvenate and ABG II modular hip joints were implanted over almost three years in the US alone. Since that time, thousands of Stryker hip recipients have complained of pain and swelling - the complaints are increasing and more Stryker recall lawsuits are expected.

(In August 2010, DePuy Orthopaedics (a division of Johnson & Johnson) recalled two of its hip-replacement units: theDePuy ASR XL Acetabular System and the ASR Hip Resurfacing System. More than 90,000 patients worldwide had one of these two products implanted, according to DePuy.)

In September 2012, a petition was filed to coordinate 10 plaintiffs seeking Stryker hip settlements or jury awards into MDL. On January 24, Judge Martinotti was assigned to preside over the MDL, and the 10 consolidated cases (those numbers are expected to drastically increase as more Stryker hip lawsuits are filed) will be heard at Bergen County Superior Court.

Attorney Calvin Warriner, who works with Stewart and is chair of the plaintiffs’ steering committee, blames the Stryker hip recall on two factors:
• The FDA approval process that allows medical devices into the market with minimal testing if they claim to be improvements on already approved devices.
• The government’s lack of an independent and transparent system for tracking medical devices. A national joint registry could enable doctors to know with certainty they were matching the right type of prosthesis to the appropriate patient because they could sort data based on patient characteristics. (The national joint replacement registry is already in place, and successful, in Australia). They could then assess product life and revision rates for their type of patient. Regulatory agencies (i.e., the FDA) could act quickly when problems arose.

Currently the FDA relies on companies to track their products and report back. Because of a lengthy lag time, the failure rate is not determined, mainly because the data doesn’t include the total number sold.

Stryker was one of five companies cited by the U.S. Department of Justice for having improper consulting arrangements with physicians in 2007. Stryker agreed to a monitoring program, and it was deemed compliant in 2009.

Dr. Art Sedrakyan, director of the Comparative Effectiveness Research Program at Weill Cornell Medical College’s Public Health Department in New York, served on the FDA panel that reviewed metal-on-metal joints. “We really need that large data capture system that goes back to regulatory agencies,” Sedrakyan said. “Without information, we cannot inform patients.”

Now getting the information to the regulatory agencies and the public is up to the attorneys. Stay tuned for Stryker Rejuvenate litigation updates.