Category: Depuy Trial

LOS ANGELES — A California Superior Court judge has denied DePuy Orthopaedics’ motions for new trial or judgment notwithstanding the verdict, upholding the $8.26 million judgment that resulted from the state’s first trial of a DePuy ASR hip implant case.

Los Angeles Superior Court Judge J. Stephen Czuleger issued his decision from the bench following a hearing May 24, according to a source, and has scheduled a hearing later this month on plaintiff’ bid for approximately $1.2 million in costs.

There has been no written order and a transcript of the proceedings is not yet available.

DePuy submitted its motion …

The last day of trial consisted of closing arguments from both sides, and instructions on the applicable law.

Brian Panish began with Plaintiff’s closing argument.  He began by thanking the court for running everything so smoothly and efficiently.  He then thanked the jury for their time and commitment.  Mr. Panish quoted Abraham Lincoln saying the greatest act of citizenship one can engage in is sitting on a jury, that together the individuals become the conscience of the community.

Mr. Panish reiterated that companies like DePuy make a profit by providing pain relief to patients, and in this case through orthopedic hip implants.  But that with that profit, manufacturers are responsible, or strictly liable, when they put out a defective product and that product causes harm. He continued by pointing out that the Defendants rather than be held accountable, tried to switch the focus of the case to Mr. Kransky’s medical condition, and failed to explain away any of the incriminating emails, statements, and evidence of their own wrongdoing.

As to DePuy’s overarching goal as a company to profit, Mr. Panish noted that Randy Kilburn himself described the company by saying “[w]e are a competitive company, and hips and knees are a competitive market.  We wanted to be a ruthless competitor.”  Mr.  Panish explained that while a company needs to do business for profit, there was never any talk of patient safety, that once DePuy noticed problems with the ASR and its early failure rates no one stopped to think about the patient.  Instead, the employees only considered what was best for the company.

Most of Mr. Panish’s closing argument on behalf of Plaintiff Bill Kransky consisted of summarizing the causes of action at play in this case and reasoning with the jury that Plaintiff has prevailed on each and every one.  He explained that DePuy is strictly liable for creating a defective product, and also for a failure to warn.  He also explained how DePuy was negligent in their actions with respect to the ASR.

Mr. Panish took the jury through the liability phase of the closing argument, highlighting how defective the ASR was.  He next took them through the causation elements, reasoning how as a result of the defective design of the ASR, Mr. Kransky (and numerous others) were injured.  He reasoned that the ASR caused injuries to Mr. Kransky.  At one point, describing DePuy’s refusal to test the ASR or hire a toxicologist Mr. Panish exclaimed “Did they test about it? Did they get a toxicologist? No.  They just wanted to play Russian roulette and take the risk.  Because they’re getting money.  Who’s taking the risk?  The patient.  Not Mr. Kilburn.  Not Mr. Graham Isaac.  The patients.  And they gambled.”

Mr. Panish also commented on the Defendants’ proffered experts, highlighting the fact that one such expert is considered the “go-to-guy” in the defense industry, the same expert who in a PG&E case regarding bad groundwater, did everything he could to help the industry despite numerous injuries to individuals.  That very expert, Dr. Paustenbach, was paid $5 million to testify in the Kransky case.

Regarding DePuy’s failure to warn, Mr. Panish reiterated that a great deal of internal data existed, showing the ASR was having problems.  DePuy never warned others that internal testing was showing massive wear, nor the fact that they tested the ASR at only one angle.  DePuy instead created a confidential redesign project called ALPHA once the ASR began to have problems.  The project was ultimately discarded as unprofitable.

Mr. Kransky’s own implanting surgeon, Dr. Wendt, testified that had he known these dangers and defective design of the ASR, he would not have used the device. That failure to warn by DePuy caused Mr. Kransky’s injuries.

As to negligence, DePuy’s own employee testified that the performance with respect to design failure modes and effects analyses was inadequate.  They were negligent.  Mr. Panish explained that the standard for DePuy was to roll out a metal-on-metal device that was at least as good or better than others on the market.  The ASR was neither.  Mr. Panish reasoned with the jury that when a company like DePuy has these problems, it should stop and go fix the design.  The fact that DePuy never did so was negligent.  The fact that DePuy encountered numerous red flags with respect to the ASR, but never acted on any of them, constitutes negligence.

Ultimately, Mr. Panish asked on behalf of Mr. Kransky, for economic damages (medical expenses) and non-economic damages for pain and suffering.  Mr. Kransky’s medical expenses totaled $338,136.12.  As to Mr. Kransky’s non-economics, Mr. Panish described the unrelenting pain he endured, unable to do anything for himself including take a shower or dress, falling in the middle of the street,and the loss of his independence generally.  Mr. Panish asked the jury to award $5 million to Mr. Kransky’s for his pain and suffering.

Mr. Panish then discussed a very important element in this case, punitive damages.  Punitive damages, or exemplary damages, are intended to punish for certain behavior and set an example.  The fact that DePuy acted with conscious and intentional disregard of the dangers of the ASR would call for a punitive damages award.  Mr. Kilburn himself admitted that if a company ignores numerous red flags, as was the case with the ASR, then the company is acting in conscious disregard for the safety of others.

Mr. Panish discussed the fact that not once throughout the trial did someone from the DePuy camp apologize for what happened with the ASR.  Mr. Ekdahl, the worldwide president, refused to show up for the trial.  In reasoning with the jury, Mr. Panish commented that the punitives should be something that catches the attention of these people, that DePuy needs a sound solid message sent to them.  He also brought up the fact that even when DePuy finally determined the ASR to be defective and knew it was failing, rather than stop selling, the company “rationalized,” meaning they made a business decision to sell off the remaining implants.  DePuy continued selling the defective ASR to be placed in numerous patients’ body, all while knowing that it was dangerous.

On the issue of numbers, Mr. Panish reasoned with the jury to choose a number that Mr. Ekdahl would notice, one that would make him take a second look and think about his shareholders, his stock options, that something needs to be done. A number that would deter DePuy and warn others against similar acts.  The company is valued at 3.575 billion.  This means that just one percent of the company is $36 million dollars.  Mr. Panish then explained that one percent would not get anyone’s attention and that DePuy sold off an extra $24 million in the defective ASR product earlier.  Only 2% of the company is $72 million.  Mr. Panish said maybe DePuy would not do it a second time if they were to owe this much.  But only 5% of the company amounts to $179 millions.  A number that high would likely register with DePuy, or possibly 10% at $357 million.  Ultimately, Mr. Panish told the jury he believed that between 2 and 5 percent would be the proper amount for punitive damages against DePuy.

 

Next, Mr. Zellers gave the closing argument for Defendants.  He thanked the jury and court for their time.  He began by  telling the jury that until the time of the recall, late 2010, the reported complaints to DePuy were “very low.”

Mr. Zellers claimed that DePuy is not strictly liable in the first cause of action because the ASR’s design was not defective. He also raised the defense that Mr. Kransky’s revision was not caused by the ASR, but by infection.  Mr. Zellers again raised the defense that Mr. Kransky’s ASR was implanted at a bad angle and subluxation occurred.

Mr. Zellers argued that the hip did not worsen Mr. Kransky’s overall medical condition and health.  He argued that DePuy had actually performed extensive testing and development of the  ASR.  For these reasons, he argued that DePuy was neither strictly liable with  respect to design and warnings, nor to negligence as a result of the company’s behavior.

The jury will now begin deliberations.

February 27th marked the last day of the Kransky trial before closing arguments were given and the jury began deliberation.  Mr. Kelly, for Plaintiff, continued the cross-examination of defense expert Dr. Cuckler.  Mr. Kelly asked Dr. Cuckler why he, rather than those doctors who designed the ASR (Dr. Schmalzried and Dr. Vail), was hired to testify regarding the ASR.  Dr. Cuckler agreed that Dr. Vail and Dr. Schmalzried would be in a better position to explain what was going on in the mind of the DePuy executives about safety and efficacy to the extent they had contact with those executives during the design process.  Dr. Cuckler also agreed that in the case of a device like the ASR, clinical tests would be the ultimate tests in determining how this device works in the patient.

Mr. Kelly remarked on Dr. Cuckler’s comment that an “astounding” amount of simulator labratory testing had been performed on the ASR.  He asked Dr. Cuckler whether this testing predicted that the device would be recalled, whether it predicted the 44% failure rate in the Australian registry, the 8,000 premature revisions that occurred, Dr. Schmalzried’s 23% minimum revision rate at five years, pseudotumors, metallosis, cup loosening, adverse tissue reactions and so on.  Dr. Cuckler conceded that the simulator testing performed on the ASR failed to predict any of those things.

Mr. Kelly asked Dr. Cuckler whether patients and doctors had a right to rely on DePuy that the company would sell a product which performed consistent with what it’s “design history of performance” would require, and that it would be at least as good if not better than those devices already on the market when it was launched in the U.S. in 2005.  Dr. Cuckler agreed that doctors and patients had the right to both.

Mr. Kelly then discussed the “unanticipated” failure rates which ultimately led DePuy to recall the ASR.  No one from DePuy, as part of their analysis as to why the complaints and vigilance department didn’t foresee this high failure coming, went to Dr. Cuckler for assistance.  No one within DePuy asked Dr. Cuckler to help determine why their internal data did not lead to the true revision rate. Dr. Cuckler agreed that it was DePuy’s obligation from the moment that a product is put on the market in the United States until the moment it is taken off the market, to be proactive and aggressive in following up on information about complaints, revisions, and unanticipated problems.

Mr. Zellers then conducted a redirect of Dr. Cuckler.

Next, Mr. Calfo for the Defendants called to the stand Dr. Bruce Spinowitz, an internist and a nephrologist.  He testified that cobalt and chromium mostly exits the body through the kidney.  Dr. Spinoqitz discussed Mr. Kransky’s various risk factors that are believed to lead to chronic kidney disease.

Mr. John Gomez from Gomez Iagmin cross-examined Dr. Spinowitz.  Mr. Gomez questioned Dr. Spinowitz’s testimony as to the reasons why Mr. Kransky was admitted to the nursing home in late 2011.  He also asked Dr. Spinowitz if the doctor had any conversations with anyone at DePuy about the ASR device in order to reach his conclusion that the device had no impact on Mr. Kransky’s chronic kidney disease.  Dr. Spinowitz had not spoken to anyone from DePuy about the ASR device.

Mr. Gomez questioned Dr. Spinowitz’s conclusion that the ASR did not impact his chronic kidney disease, and asked if he was aware that all of the doctors who saw and treated Mr. Kransky for one reason or another recommended the hip be removed.  Dr. Kransky’s own nephrologist and internist, Dr. Shannon, recommended Mr. Kransky’s hip be removed and commented that following the revision surgery, he was doing surprisingly well.

The Kransky trial continued on February 26, 2013 with the resumed testimony of the Defendants’ infectious disease expert, Dr. Ballon-Landa.  Mr. Calfo continued the direct examination and Mr. Kelly cross-examined the doctor.

On cross-examination, Mr. Kelly dissected Dr. Ballon-Landa’s testimony that Mr. Kransky’s hip was infected, which caused the pain and was the reason why it was ultimately removed.  Mr. Kelly asked the doctor if the statement “A hematoma can be infected when the hip itself is not,” was a true and accurate statement.  Dr. Ballon-Landa agreed it was.  He also admitted that Dr. Hansen in fact believed Mr. Kransky’s hematoma, not hip, was infected.

Dr. Ballon-Landa then admitted that while its extremely important to note any significant findings in medical records, none of Mr. Kransky’s medical records ever stated he had an infected prosthesis.  None of Mr. Kransky’s doctors noted that they believed his hip was infected.

Mr. Kelly then walked Dr. Ballon-Landa through the testimony of Dr. Hansen.  Dr. Hansen performed the process of differential diagnosis where the doctor looks at the patient and essentially goes through a mental checklist based on education, skill, and experience to form a medical opinion.  Dr. Ballon-Landa admitted that he believed Dr. Hansen to be both caring and competent, and that Dr. Ballon-Landa himself was never called into an operating room to assist in diagnosing an infection in hips.

Dr. Ballon-Landa also  conceded that Mr. Kransky’s portacath was more likely to become infected than his artificial hip, and that the portacath in fact never became infected.

Mr. Kelly discussed the fact that in November of 2012 there were case studies of individuals with metal hip implants and these findings stated “the clinical picture seen with metal hypersensitivity is not dissimilar to that of a hip infection.”  This means that in some patients who have had a reaction to the metals in the hip implant, such as cobalt and chromium, their reactions can mimic that of an infected hip.

Defendants next called to the stand Dr. John Cuckler, an orthopedic surgeon who specializes in hip and knee replacement. Dr. Cuckler was involved in the design of another large head metal-on-metal device and testified that all metal devices release metal ions.  He further testified that at this time there is no data indicating adverse systemic effects from exposure to metal ions.

Dr. Cuckler also testified regarding the wear testing DePuy performed with respect to the ASR.  He believed it was reasonable and that the device itself is not defective.

Cross-examination of Dr. Cuckler by Plaintiff’s attorney is to take place tomorrow.  Closing arguments by both sides are expected to begin on Thursday.