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Wright Medical 2015 Wrap Up

Defective Medical Devices

At this time, pending in the federal court MDL proceedings in Georgia and 700 cases pending in the California state court consolidated proceedings.  There are also more than 800 individual cases pending on a tolling agreement with Wright Medical, which is a contract that suspends the statute of limitations period for a case so as to avoid the necessity of filing suit.

Courtesy of WikiCommons and EraSoft24On November 24, 2015, a jury in federal court in Atlanta rendered a verdict in favor of Plaintiff Robyn Christiansen, who was the first patient to proceed to trial against Wright Medical in the national, coordinated MDL proceedings.  This case was chosen by the Plaintiffs for the first MDL trial from the ten cases that were part of the original bellwether trial pool and had completed case-specific discovery and failed settlement conferences more than a year ago.  The case was originally scheduled for trial in March of 2015, but was delayed for a few months to permit Judge Duffey to rule on various legal motions that had been filed by Wright Medical.

Ms. Christiansen is 74 years old and resides in Utah.  She has been a ski instructor for 47 years, and leads an extremely active lifestyle that includes lots of skiing and mountain hiking.

Ms. Christiansen underwent a right hip implant surgery in April of 2006 and was implanted at that time with a Wright Medical Conserve Total Hip Device, a metal-on-metal hip implant. Her implanting surgeon was Dr. Lynn Rasmussen, who is based in Salt Lake City and had been a consultant and Key Opinion Leader for Wright Medical.  This metal-on-metal hip implant failed approximately six years following implantation, and Ms. Christiansen underwent a revision surgery in 2012.  At that time, her orthopedic surgeon noted the presence of abnormal fluid, tissue necrosis, inflammatory synovium, and evidence of metallosis, which required the removal of additional soft tissue in addition to revision of the defective Wright Medical Conserve MOM hip implant prosthesis.  She also had elevated levels of cobalt and chromium in her bloodstream and other signs and symptoms consistent with metallosis.  Ms. Christiansen has reportedly had a decent recovery from the revision surgery.

She had previously been implanted with a total hip implant on her left side following a water skiing accident in 1984 and underwent a revision surgery for that hip in 1995.  The implant placed in 1995 was a ceramic-on-polyethylene design and is still performing well.  She had also underwent two total knee replacements, back surgery, and surgery on both of her wrists.

During the course of the trial, Wright Medical’s attorneys claimed that her surgeon did not implant the hip implant as precisely as he should have, and that this malposition of the implant, coupled with her overuse of the device due to her active lifestyle, led to the metallosis and the need for the revision surgery.  The Plaintiff’s revision surgeon and the Plaintiff’s experts testified that the device was not improperly positioned and that the device was defective.

In this particular case, the Plaintiff had not read any of Wright Medical’s advertising materials prior to the original implantation surgery, so a lot of good evidence that has been developed in the national litigation with regard to alleged fraud and misrepresentations to surgeons and patients was not admissible at trial.

At the trial, the Plaintiff presented testimony from the treating orthopedic surgeon; a friend of the Plaintiff who was a fellow ski instructor; Dr. John Waldrop (an orthopedic surgery expert); Dr. John Jarrell (a biomechanical expert); Dr. Elizabeth Laposata (a pathologist); and Dr. Jason Snibbe (another orthopedic surgeon expert). The Plaintiff also presented testimony from Wright Medical’s head of research and development as well as Wright’s former Head of Clinical, Marketing and Post-Market Surveillance.  The Defendant presented testimony from several of its employees as well as a few experts in the fields of tribology, biomaterials, and orthopedic surgery.

The jury trial on Plaintiff’s claims for strict products liability, negligence, fraudulent misrepresentation, negligent misrepresentation, and fraudulent concealment lasted for two weeks in federal court in Georgia.  The Plaintiff claimed that Wright Medical knew or should have known long before Ms. Christiansen was first implanted that their devices, over time, would generate metal debris and metal ions which presented a substantial risk to patients of developing metallosis, inflammatory tissue reactions, non-infectious (or aseptic) loosening of the hip implant, tissue death, and premature failure of the device necessitating revision surgery.  Some of the Plaintiff’s strongest evidence in this case focused on Wright Medical’s marketing campaign to “de-criminalize” metal ions in patients which led to surgeons and patients failing to fully understand and appreciate the risks presented by metallic debris and metal ions that are cast off of the metal-on-metal hip implants over time.  Obviously, if this critical safety information had been shared with surgeons and patients, many would have chosen to undergo implantation of hip implants that did not include a metal-on-metal articulating surface, such as the older metal-on-polyethylene and ceramic-on-polyethylene hip implant configurations that have a long history of safe implantation in patients.

After several days of difficult deliberations (including the dismissal of one juror who refused to engage in the deliberation process), the jury awarded compensatory damages in the amount of $550,000 for the design defect claim, $450,000 for negligent misrepresentation, and $10 million in punitive damages.  Compensatory damages are awarded to compensate the Plaintiff for pain and suffering, inconvenience, disability, disfigurement, lost wages, medical expenses, and other damages personal to the patient.  Punitive damages, on the other hand, are awarded to punish the Defendant when the jury has found that they have acted with a willful and wantonness towards the safety of the Plaintiff and other patients, essentially meeting the same level of recklessness as is required for a conviction for criminal manslaughter.

In the coming weeks, the MDL judge will be asked to consider a number of post-trial motions.  It is anticipated that Wright Medical will appeal this verdict, which would first go to the Eleventh Circuit Court of Appeals and then, perhaps, to the United States Supreme Court.  No money will be paid to Ms. Christiansen until all of the appeals are resolved.  We anticipate that Judge Duffey will likely schedule the next trial in the MDL proceedings in the near future, and that case will be one that was already prepared for trial as a part of the initial ten-case bellwether trial pool.

Elsewhere in the national litigation, the parties are preparing for a jury trial against Wright Medical, which is scheduled to begin in March of 2016 in Los Angeles.  This individual trial involves the claims of Barbara Trucker, and will be the first bellwether trial in the Wright Medical state court proceedings, which have been pending in the California consolidated action (known as the “JCCP”) for several years.  The JCCP cases are coordinated with the lawsuits that are pending in the federal MDL based in Georgia, but the JCCP action involves a larger number of Wright Medical metal-on-metal hip implant products than those hip implant designs covered by the federal MDL. This next trial in Los Angeles should include different evidence than was admitted in the recently-completed federal court MDL trial, as Ms. Tucker was provided with Wright Medical marketing materials relating to Jimmy Connors. The accuracy of the representations made in the Jimmy Connors advertising campaign will certainly be the focus of this upcoming trial.  Depositions and other trial preparation are currently underway, and we anticipate that the judge will be considering a number of legal motions and requests to limit evidence in the coming weeks.  There is a second trial, which was selected by the Defendant, which is currently being worked up for trial as well.  That jury trial is likely to begin in September of 2016 in state court in California.

Unfortunately, we are still facing a tremendous problem in the national litigation with a lack of sufficient liability insurance coverage.  There is ongoing litigation over the amount of coverage that is available.  These issues have been further complicated by Wright Medical’s sale of its hip division to a Chinese manufacturer and merger with a Belgian company.  These new companies are not responsible for Wright Medical’s products prior to the asset sales and mergers. One of the practical problems is that many of the employees of Wright Medical who were involved in the design and marketing of the metal-on-metal hip implant products now work for the Chinese company or have moved on to other employers.

As indicated in previous letters, the verdict plus all of the costs associated with the defense of the Wright Medical cases are depleting the insurance coverage that is available. Previous settlement discussions in conjunction with the preparation for the first MDL trial were unsuccessful, even with the involvement of a retired judge serving as a mediator, primarily due to the pending insurance coverage dispute.

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