The coordinated litigation over Pinnacle metal-on-metal hip implants pending before Judge Kinkeade is also known as MDL No. 2244. The MDL was established in May of 2011. Since then, more than 60 million pages of documents have been produced and nearly 100 depositions have also been completed so far. As of June 30, 2014, more than 6,400 individual lawsuits have been filed in the national multi-district litigation proceedings that are pending before Judge Kinkeade in federal court in Dallas, Texas. There are also a number of cases filed in coordinated proceedings pending in state court in Southern California as well as other state court jurisdictions.
Judge Kinkeade will begin the first jury trial in the country involving a Pinnacle metal-on-metal hip implant on September 1, 2014. The cases of eight plaintiffs were prepared for potential trial settings in the federal court MDL with completion of a number of case-specific depositions of fact and expert witnesses over the past few months. The two cases that are being prepared for the first trial in September both involve plaintiffs from Montana – Mrs. Lay and Mrs. Herlihy-Paoli. Additional MDL bellwether trials are currently scheduled to begin in November of 2014 and January of 2015 before Judge Kinkeade.
Mrs. Lay was implanted with a Pinnacle metal-on-metal hip implant in her right hip in September of 2006. She was implanted with a second Pinnacle metal-on-metal hip device in her other hip in April of 2007. In June of 2010, she was diagnosed with elevated levels of cobalt and chromium in her bloodstream and had other diagnostic tests showing the presence of metallosis. She then underwent a revision surgery on her left hip implant in the summer of 2010, and her surgeon noted the presence of a fluid collection consistent with metallosis as well as significant soft tissue and muscle necrosis. The significant damage to her muscles in her left hip caused by metallosis has nearly eliminated her ability to have a successful revision surgery and have left her with a permanent impairment of her ability to walk normally without assistance. In December of 2010, Mrs. Lay’s right Pinnacle hip implant also prematurely failed. She underwent a right hip arthroplasty revision surgery, and, again, her surgeon noted significant tissue damage and fluid accumulation that was consistent with a metallosis reaction to the defective Pinnacle metal-on-metal hip implant. The surgeon also noted that Mrs. Lay’s Pinnacle implant had corrosion at the Morse taper junction, which is a point where the components of the hip implant are fitted together.
Unfortunately, Mrs. Lay had to undergo a second revision surgery on her left hip in April of 2011, at which time her surgeon noted significant muscle and tissue damage which was impairing the proper function of her new hip implant. Sadly, Mrs. Lay suffered a post-operative infection, a common complication of revision surgery especially in patients who have experienced metallosis, which led to the removal of her hip implant and placement of an antibiotic-laden spacer in June of 2011. Even though nearly a year had passed since her original revision surgery, her surgeon again noted the presence of significant tissue and muscle damage caused by the previous metallosis and corrosion. Long after the June of 2011 revision surgery, Mrs. Lay continued to have issues relating to post-operative infection and underwent several additional medical procedures to treat the infection. She was finally implanted with yet another hip implant in May of 2012.
Mrs. Herlihy-Paoli was first implanted with a DePuy Pinnacle metal-on-metal hip implant in her right hip in October of 2009. Soon thereafter, in December of 2009, she was implanted with the same MOM device in her left hip. A few years later, she developed severe hip pain and evidence of premature failure of the Pinnacle implants. Testing showed that she had cobalt levels of 85-times the normal limit in her bloodstream. An MRI also showed the presence of a sizable pseudotumor growing around her left hip implant. In April of 2011, Mrs. Herlihy-Paoli underwent a total hip revision surgery in her left hip due to premature failure of the Pinnacle device, which was noted to have turned black while inside the patient due to metallosis. The patient underwent a second revision surgery in November of 2011 to remove the other defective Pinnacle hip implant.
On July 18, 2014, Judge Kinkeade issued a 23-page order denying DePuy’s attempt to thwart the plaintiffs from taking the depositions of Dr. Antoni Nargol and Dr. David Langton. Dr. Nargol is an orthopedic surgeon in England, and Dr. Langton served as Dr. Nargol’s research assistant. Drs. Nargol and Langton were featured in a New York Times article in December of 2010 regarding failures of DePuy hip implants in their patients and their futile attempts to convince DePuy to proactively address the safety issues associated with metal-on-metal hip implants for several years prior to the recall of the DePuy ASR metal-on-metal hip implant in August of 2010. Plaintiffs in the MDL are seeking the testimony of these physicians as fact witnesses to support their allegations that DePuy knew of issues with its ASR and Pinnacle metal-on-metal hip implants for years and failed to take appropriate actions to warn surgeons and patients or to stop selling the defective implants.
A number of motions have been filed by DePuy seeking to dismiss or delay the first bellwether trial. DePuy sought a dismissal on the basis that it alleged that the Texas court did not have personal jurisdiction over the parties, as the plaintiffs resided in Montana and DePuy contended that some of the DePuy-related entities that have been sued (such as Johnson & Jonson, Johnson & Jonson International, Johnson & Johnson Services Inc. and DePuy Synthes, Inc.) did not have sufficient legal contacts with either Montana or Texas. Judge Kinkeade issued an order denying DePuy’s jurisdictional challenge and noted that there was sufficient evidence provided by the plaintiffs to show that DePuy and the various Johnson & Johnson entities engaged in a nationwide campaign promoting the Pinnacle metal-on-metal hip implants, which would be sufficient to establish personal jurisdiction over those companies in the states of Montana and Texas as well as the rest of the nation.
The judge also denied Johnson & Johnson’s attempt to dismiss the lawsuit based upon its contention that it was not involved in the marketing, manufacture or sale of Pinnacle hip implants, and noted that Johnson & Johnson’s name is featured on the packaging for the products along with DePuy’s name. The court found that there were fact issues that a jury would need to decide in light of evidence relating to Johnson & Johnson’s and DePuy’s joint marketing and promotion of the Pinnacle product and knowledge of potential harm to patients, and thus denied the Defendants efforts to have a number of legal claims dismissed prior to trial.
Judge Kinkeade also denied the defense request for summary judgment on the sufficiency of the allegations of plaintiffs as to misrepresentations made to the plaintiffs who are part of the first bellwether trial pool. The order issued by Judge Kinkeade also upheld the plaintiffs’ rights to seek medical monitoring as an element of future damages in their cases under Montana law, and made the legal finding that cobalt and chromium that is used to manufacture metal-on-metal hip implants has the potential to be toxic in patients. Judge Kinkeade also upheld the plaintiffs’ rights to seek recovery against DePuy for intentional infliction of emotional distress in light of the aggressive marketing efforts aimed at younger patients; this is a legal claim that is often dismissed prior to trial as the evidentiary standards are quite high.
Ultimately, the jury in the first MDL bellwether trial will be asked to determine whether the plaintiffs have provided sufficient evidence to meet the legal standards with regard to their claims of product defect, fraud, misrepresentation, and infliction of emotional distress.
On July 18, 2014, Judge Kinkeade also issued a 32-page opinion denying DePuy’s efforts to strike expert witness testimony in the upcoming bellwether trial cases. Here is a summary of the plaintiffs’ expert witness testimony and supporting reports that DePuy sought to exclude the jury from hearing in the upcoming September 1, 2014, trial:
Dr. John Abramson (physician and marketing expert) – Dr. Abramson’s testimony which DePuy sought to exclude focuses on his opinion that several marketing statements made by Defendants were false and misleading. These would include DePuy falsely claiming that 99.9% of its Pinnacle implants were implanted and functioning well more than five years after implantation and that the Pinnacle metal-on-metal hip implants produced the lowest published levels of cobalt and chromium ions of any MOM implants on the market. DePuy also sought to keep Dr. Abramson from testifying that DePuy minimized the clinical importance of taper corrosion in its communications with surgeons, patients, and regulatory authorities and that DePuy paid physician consultants millions of dollars to provide their input into the design and marketing of Pinnacle metal-on-metal hip prostheses. Judge Kinkeade denied DePuy’s motion as to this expert as well as with regard to Nicholas Jewell, Ph.D., a plaintiffs’ biostatistics expert, whose testimony relates to DePuy’s own data which, he will testify, fails to substantiate the manufacturer’s 99.9% marketing claim.
Scott Bayley, CPA (financial testimony relevant to punitive damages claims) – DePuy sought to exclude testimony from Mr. Bayley that attempts to calculate the net worth of the Defendant and its ability to pay punitive damages. Judge Kinkeade denied DePuy’s motion and found that the testimony was appropriate. Testimony with regard to financial issues is appropriate in a civil case once a jury has found that there is sufficient proof that the Defendant met the legal thresholds required in order to award punitive damages (which essentially requires the jury to find that the Defendant acted with a level of reckless indifference with regard to the safety of patients, such as the plaintiffs, as to meet the standards for manslaughter).
Rudolph Buchheit, Ph.D. (metal corrosion expert) – DePuy sought to prevent this materials expert from testifying as to the impropriety of DePuy’s choice of cobalt-chromium and titanium alloys in the design of its Pinnacle metal-on-metal hip implant, which led to premature failure of the devices, metallosis, corrosion, and injuries to patients. The Defendants’ challenge to the expert’s testimony included the mechanism by which corrosion occurs (including crevice effects, galvanic action, and fretting) due to problems with the design of the implant as well as the materials selected by the manufacturer. Dr. Buchheit’s testimony also focuses on the consequences of medical device corrosion inside the body, including volume loss and the generation of wear debris, as well as the evidence gathered in this litigation involving the significant incidence of corrosion noted on Pinnacle metal-on-metal hip implants that have been explanted from patients. DePuy’s attack on Dr. Buchheit’s testimony focused, in part, on the type of testing that was chosen by the expert to document his opinions, including his examination for corrosion (primarily at the taper junction) and improper wear of more than 200 Pinnacle metal-on-metal hip implants that had been removed from patients, including some of the explants of our clients that are currently being stored at the Steelgate facility in Bradenton, Florida. Judge Kinkeade’s opinion noted that the methodologies that underlie Dr. Buchheit’s scientific opinions were reliable under federal court legal standards, which require that the methods be tested, subject to peer review and publication, and follow industry standards, and, as such, the motion to strike his testimony was also denied.
Vicki Colvin, Ph.D. (toxicology) – DePuy challenged the admissibility of Dr. Colvin’s testimony with regard to the generation of metal ions by Pinnacle hip implants and the fact that nanoparticles of cobalt can cause cell death and physical injury. For a myriad of reasons, the plaintiffs are not seeking to introduce evidence in the upcoming trial regarding the potential long-term health risks associated with cobalt and chromium toxicity. Rather, they are offering Dr. Colvin’s testimony only with regard to the fact that wear debris, including cobalt nanoparticles, have been associated with cell death and physical injury. DePuy challenged this testimony on the basis that it contends that Dr. Colvin cannot prove that the wear debris generated from a Pinnacle metal-on-metal hip implant does in fact contain cobalt, even though the product is manufactured from cobalt and chromium and the plaintiffs have had blood tests showing elevated levels of cobalt ions. Judge Kinkeade determined that DePuy may cross-examine Dr. Colvin with regard to her opinions and reliance on underlying scientific papers and studies with regard to cobalt ions, but that excluding her testimony would be inappropriate as the expert opinions meet the federal standards for reliability and admissibility. The MDL judge also rejected DePuy’s arguments that the expert’s opinions should be excluded since she cannot quantify the amount of cobalt that is necessary to cause harm to patients or the amount of cobalt that might have been generated in individual plaintiffs due to defects in the Pinnacle hip implants. The judge’s opinion indicates that he will also permit Dr. Colvin to testify with regard to her “Trojan Horse” theory on the mechanism of action, whereby nanoparticles of cobalt are released in the metallic wear debris generated by the defects in the Pinnacle hip implant and are then dissolved into white blood cells (which attempt to attack the cobalt particles as foreign bodies). Once the cobalt ions are within the white blood cells, they release a “toxic cargo that destroys white blood cells before the nanoparticles are completely broken down,” and this process repeats itself over and over again and causes cell death.
John Ziegert, Ph.D. (mechanical engineering and metrology expert) – Dr. Ziegert seeks to testify as to the quantity of wear debris that has been generated from the plaintiffs’ defective Pinnacle hip implants. DePuy claimed that there is no scientifically-reliable method for anyone to quantify the wear debris from a metal-on-metal hip implant, and also contended that Dr. Ziegert could not testify since he is not an expert in friction and wear. Judge Kinkeade concluded that Dr. Ziegert was a properly-qualified expert in the science of measurement of the amount of wear, and that his general expertise in this area was sufficient to allow him to offer opinions as to the amount of material that had been worn away from the Pinnacle metal-on-metal hip implants that were removed from the plaintiffs who are part of the first bellwether trial.
Judge Kinkeade’s order, which denied all of DePuy’s requests for the striking of expert witness testimony, noted: “DePuy has made no credible argument that any of the Plaintiffs’ expert testimony is being offered by unqualified experts or is unreliable or irrelevant.” The Special Master who works with Judge Kinkeade will hold another hearing on August 18th to address any remaining issues prior to commencement of the trial on September 1, 2014.