Stryker Hip Replacement Lawsuits, Settlements and Information for Consumers

Stryker Voluntary Recall

On July 6, 2012, Stryker voluntarily recalled its popular Rejuvenate and ABG II modular-neck stems, according to its own press release, which was distributed by the FDA. The recall was unusual for several reasons: for one, unlike Stryker’s infamously defective Trident line of hip replacements (also the subject of ongoing mass tort litigation), the recall was fully voluntary, and not spurred by FDA investigation of wrongdoing. The product itself also makes it an unusual recall: most defective hip replacements feature problems only with the ball-and-socket joint, leading to discomfort as the surfaces of joint wear. The Stryker Rejuvenate and ABG II products, however, are modular-neck stems meant to implant into and follow the contours of the femur to provide a stable full-hip replacement.

Bone Remodeling Less Effective Than Promised

The bone remodeling, however, was less effective than promised, resulting in instability and bone regrowth problems. Worse, implanted stems were vulnerable to corrosion: Stryker’s proprietary metal alloy failed quickly for many patients, resulting in rapid loss of mobility. The corrosion also resulted in pain, swelling, inflammation, and disconcerting grinding noises in the area of the implant.

Patients with the corrosive stems were also vulnerable to metallosis, which occurs when the corroding metal grinds free of the replacement joint. Once the metal particles have ground free of the hip replacement, the alloyed metals can enter the bloodstream, or nearby soft tissues. Once the metal has corroded and spread in this way, the patient may experience surging levels of metallic ions in the bloodstream. Metallosis can result in infection, severe pain, and death. Further release of metal ions may also result in necrosis of the surrounding tissue or bone.[1]

20,000 Devices Implanted in U.S.

Roughly 20,000 of the devices were implanted in US patients[2], and lawsuits alleging injuries related to Rejuvenate and ABG II design defectsmanufacturing defects, breaches of warranty, and failures to warn, multiplied quickly following the June 2012 recall. As district courts began to struggle under the weight of federal claims, the US Judicial Panel on Multidistrict Litigation issued a transfer order effective June 6, 2013 for centralized pretrial proceedings in the District of Minnesota. The Panel ceded control of the MDL docket to Judge Donovan Frank. In addition to establishing the transferee court and pretrial Judge, the Panel’s transfer order also rejected Stryker’s motion that the MDL contain only the Rejuvenate cases, which far outnumber the ABG II cases. The transfer order also denied Stryker’s request that its name be dropped from the suit. The Panel decided that although the products were sold and marketed through Stryker’s parent Howmedica (also a named defendant), Stryker itself issued the recall notice under its own name. The Panel decided that naming Stryker in the MDL was therefore appropriate. [3]

MDL in Minnesota

The resulting MDL in Minnesota originally encompassed 41 actions pending in sixteen districts, though the Panel noted 110 additional actions likely to be transferred. Cases continued to trickle in after the consolidation, however, leaving the current number of pending cases under the MDL at around 660. So far, pretrial discovery has progressed regarding product design defects and a handful of other issues universal to plaintiffs’ claims. After meeting with Defense and Plaintiffs’ lead counsels for a status conference on March 20, Judge Frank issued an amended pretrial order regarding scheduling of bellwether cases on March 25, 2014. The pretrial order required both sides’ counsel to meet and agree on between three and five bellwether categories no later than May 1, 2014. Should counsel fail to propose a plan by that date, the Court will then issue an order describing the number and definition of the bellwether cases. The Court requires counsel to confer and to agree upon the lead cases for each category by June 12, 2014.

The pretrial order anticipates a detailed scheduling order for the bellwether by the time of the August, 2014 status conference. The pretrial order also describes a plan to ready those 3-5 cases for trial during the summer of 2015.[4]

Litigation in NJ

In addition to the Federal MDL in Minnesota, Stryker also faces centralized litigation of Rejuvenate and ABG II in New Jersey state court—Stryker’s parent company, Howmedica, is based in Mahwah, NJ, where it enjoys general jurisdiction–under Judge Brian Martinotti. The New Jersey cases number around 650, according to a joint status report filed in March 2014.

Unlike the ongoing federal MDL litigation, however, the New Jersey multi-county litigation successfully pressured both sides to enter mediation as of April 2013, although there have been few settlements so far. This may be because New Jersey aggregation pursued a bellwether mediation process, in which early mediations were scheduled in order to indicate benchmarks for future settlements. Of the ten proposed cases for bellwether mediation, four remain to be mediated, though details of those mediations remain to be disclosed.

Cases are stilled being filed in the federal MDL, and separately around the country, making settlement predictions difficult. Stryker, however, released a statement in October, 2013 indicating that they anticipated litigation costs of $1.1 billion for injuries related to the Rejuvenate and ABG II models. Stryker claimed it intended to compensate patients for reasonable and customary costs of medical testing and treatment, including necessary revision surgeries to failing stem implants.

[1] Stryker Orthopaedics Field Safety Notice RA2012-067

[2] http://online.wsj.com/article/BT-CO-20131023-714444.html; corroborated by http://www.lawyersandsettlements.com/articles/stryker-orthopedics-rejuvenate-modular-hip-system/interview-stryker-orthopedics-rejuvenate-modular-hip-7-18507.html#.U1GVgq1dXVQ

[3] US Judicial Panel on Multidistrict Litigation, In Re: Stryker Rejuvenate and ABG Implant Products Liability Litigation, MDL No. 2441, Transfer Order, Document 170, Filed 06/12/13

[4] http://www.mnd.uscourts.gov/MDL-Stryker/Orders/2014/2014-0325-Amended-PTO12-13md2441.pdf

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