Medical Device MDL & Recall Status: DePuy / Johnson & Johnson

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The following is the status of pending multidistrict litigation (MDL) and defective product recalls involving major orthopedic medical device manufacturer, DePuy, a subsidiary of Johnson & Johnson:

MDLs

2197 IN RE: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation
Northern District of Ohio (Hon. Jeffrey J. Helmick)

The MDL is still pending notwithstanding settlement whereby DePuy agreed to pay $2.5 billion to settle approximately 8,000 lawsuits by United States patients who had hip revision surgery as of August 31, 2013. The ASR Settlement has been extended to cover people implanted with the Depuy ASR hip who received a revision surgery between January 31, 2015 and February 15, 2017. The deadline to enroll is now June 19, 2017.

DePuy recalled all ASR hip implant systems sold since 2003 in August 2010. DePuy said the recall was due to unpublished National Joint Registry data showing a 12% revision rate for resurfacing at five years and an ASR XL revision rate of 13%. All hip prostheses fail in some patients, but the normal anticipated rate is about 1% per year. Further, metal debris from wear of the implant led to reactions in many patients that destroyed the soft tissues surrounding their joints, leaving some patients with long-term disability. Ions of cobalt and chromium — the metals from which the hip implant was made — were also released into the blood and cerebral spinal fluid in some patients.

2244 IN RE: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation
Northern District of Texas (Hon. James Edgar Kinkeade)

On December 1, 2016, in the third set of bellwether trials, a Texas federal jury awarded $40 million in compensatory damages and more than $1 billion in punitive damages to six plaintiffs who alleged that DePuy Orthopaedics Inc.’s Pinnacle metal-on-metal hip implants were defectively designed and that the company failed to warn doctors and consumers about complications possible from the device, which included pain and subsequent revision surgeries.

Johnson & Johnson prevailed in the first bellwether trial in 2014, and the second bellwether trial in March 2016 yielded a $500 million jury award to five plaintiffs. The court ordered that $140 million would be applied to collective compensatory damages with $360 million being awarded in punitive damages. After the trial, Judge Kinkeade reduced the $360,000,000 punitive damages award to $9,646,256 pursuant to a Texas statute capping punitive damages. DePuy Orthopaedics and Johnson & Johnson appealed the decision and the plaintiffs filed their brief in response.

Defendants also recently filed a reply brief supporting their motion for a protective order, maintaining that the plaintiffs are seeking a deposition that is not proportional to the needs of the lawsuits. Plaintiffs and defendants have now completed briefing before the Fifth Circuit on defendants’ appeal of the $498 million verdict in the second bellwether trial of the Pinnacle hip implant MDL. Next comes oral argument and then the Fifth Circuit’s decision. A fourth bellwether trial, which will involve 10 patients, is scheduled for September 2017.

A recent study presented on May 31st at the 18th EFORT Annual Congress in Vienna found a 27% failure rate at 10 years for Pinnacle metal-on-metal implants based upon 569 patients that had total hip replacement (arthrolpasty) with the Pinnacle prosthesis manufactured by DePuy Synthes with a 36-mm cobalt chrome head and an uncemented Depuy Synthes Corail stem. “This large cohort study of Pinnacle metal-on-metal (MoM) [total hip replacements] THRs has confirmed a high failure rate at 10 years with this device, but it is especially seen if the Pinnacle was put in from 2006 onwards and in bilateral MoM hip patients. This supports the recent and serious concerns about potential manufacturing differences in more recent years,” said study presenter, Gulraj S. Matharu, BSc (Hons), MBChB, MRCS, of Oxford, United Kingdom.

Recall

DePuy Synthes Radial Head Prosthesis System

In December 2016, DePuy Synthes, a division of Johnson & Johnson, issued an “Urgent Notice: Medical Device Field Safety Notification” to inform patients that the Synthes Radial Head Prosthesis System was being voluntarily removed from the worldwide market given that the radial stem (the component that anchors the implant in the arm’s radius bone) could loosen at the stem-bone interface following implantation. The DePuy elbow implant recall involved 50,311 units distributed throughout the United States.

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