Man unsure of the safety of his medicine

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Products Liability Law Daily, November 20, 2013

Manufacturer to pay estimated $2.5 billion to settle claims relating to defective hip implant systems

By Susan Lasser, J.D.

A settlement agreement has been reach between DePuy Orthopaedics, Inc., the manufacturer of a recalled hip implant system and a division of Johnson & Johnson, and patients who were injured by the devices and who required surgery to remove the implants for reasons relating to the recall. Eligibility requirements are available in a settlement program overview. The proposed agreement must be approved by a federal district court in Ohio overseeing the multidistrict litigation against the hip implant manufacturer.

Background. The ASR™ XL Acetabular Hip System and ASR™ Hip Resurfacing System were hip implant systems manufactured by DePuy, and were voluntarily recalled in August 2010 by the manufacturer due to higher than expected revision rates. Data available at the time of the recall indicated that the 5-year revision rate for the ASR™ Hip Resurfacing System was approximately 12 percent and for the ASR™ XL Acetabular System was approximately 13 percent. The rates were across the entire implant size range. Reasons for revision relating to the recall of the metal-on-metal implant systems included component loosening, component malalignment, infection, bone fracture, dislocation, metal sensitivity, and pain. In its 2010 voluntary recall announcement, DePuy stated that it intended “to cover reasonable and customary costs of monitoring and treatment for services, including revisions, associated with the recall of ASR.”

According to a news release issued by Johnson & Johnson, the U.S. settlement is valued at approximately $2.5 billion, based on an estimate of 8,000 patients participating in the program. The company expects that the majority of the payments related to the settlement will occur during 2014 “from currently available cash.”

Judge David Katz of the U.S. District Court of the Northern District of Ohio is presiding over the federal multidistrict litigation.

Proposed settlement agreement. The agreement is intended to compensate eligible ASR patients in the United States who underwent revision surgery to replace their ASR hip implant system (either the ASR XL Acetabular Hip System or the ASR Hip Resurfacing System) on or before August 31, 2013.

Eligible ASR patients are required to meet the following qualifications to participate in the U.S. program: U.S. citizenship or U.S. legal residency; had undergone surgery to implant either ASR implant device (see above) at a U.S. hospital or a U.S. military hospital; had the ASR implant device in place for at least 180 days; and had surgery to remove the ASR device for reasons related to the recall on or before August 31, 2013.

The settlement is structured in two parts for the award amounts. First is the “base award”—qualified patients would receive one maximum base award of $250,000, which would be subject to “potential reductions.” The program lists some factors that could result in reductions to the base award, including: how long the ASR device was implanted; whether the patient smoked at the time of the revision surgery; whether the patient had a hip replacement surgery in the same hip before the ASR device was implanted; whether the patient’s body mass index (BMI) was greater than 35 when the ASR device was implanted; the patient’s age at the time of the ASR implant surgery; and, for cases concerning deceased patients, whether the patient passed away shortly after the ASR revision surgery for reasons unrelated to that surgery.

The second part of the program’s award structure concerns a “supplemental award.” A qualified patient who can show that he or she has “extraordinary injuries” related to his or her ASR device may be able to receive a supplemental award amount which also is subject to potential reductions. For example, a patient could qualify for a supplemental award if that patient: had surgeries on both hips (bilateral surgery); had or will require multiple surgeries following the ASR implant surgery (rerevisions); experienced extraordinary medical events associated with the revision surgery (i.e., heart attack, stroke, pulmonary embolism, deep vein thrombosis, dislocations or foot drop); or experienced “certain extraordinary injuries in a specified time frame in the future.”

Although a patient may qualify for a base award, that patient might not be entitled to a supplemental award. Patients must produce medical records to support claims for supplemental awards. Further, the settlement program specifies that the amounts of the awards will be determined by “experienced professionals” who staff the U.S. program. Qualified patients who disagree with award determinations would have the right to appeal within the program, according to the settlement overview. Patients who participate in the settlement program would agree to abide by the outcome of the claims process and give up their litigation rights as to their revised hip(s).

Eligible patients will have to submit certain documents to the claims processor no later than April 1, 2014, in order to participate in the U.S. program, including: a required enrollment form and a required claims package; medical records showing the patient was implanted with an ASR device, as well as medical records relating to the surgeries implanting and removing the ASR device; and a “Release and Dismissal Stipulation,” signed by the patient. The release form would become operative upon the patient’s receiving an award under the program.

Patients must register their claims by January 6, 2014. At least 94 percent of those patients must enroll in the U.S. program by April 1, 2014, and must qualify to participate in the program for DePuy to be required to fund the U.S. program. Under the proposed agreement, DePuy would be responsible for most healthcare insurance liens for medical costs that are directly associated with the revision surgery.

Further information relating to the U.S. settlement program may be found at: www.USASRHipSettlement.com or www.ASRHipInfo.com.

The case number is MDL 2197.

Companies: Johnson & Johnson; DePuy Orthopaedics, Inc.

MainStory: TopStory SettlementAgreementsNews DamagesNews ClassActLitigationNews MedicalDevicesNews OhioNews

Products Liability Law Daily

Introducing Wolters Kluwer Products Liability Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.


A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.