Drama and Fireworks at DePuy ASR Trial

Thomas Schmalzried, M.D. the lead designer of DePuy Orthopaedic, Inc.’s ASR metal-on-metal hip, “was almost shaking with rage, ” over comments made by Birmingham hip inventor Derek McMinn at a British Hip Society meeting. McMinn “implied that the testing of ASR was both incompetent and biased.”

That’s according to an email written by DePuy engineer Graham Isaac in 2008 in one of myriad documents introduced by attorneys for Loren Kransky, the plaintiff in the DePuy ASR hip trial in Los Angeles.

The trial began on January 25, 2013 with opening arguments and the presentation of the evidence by Kranky’s attorneys. The plaintiff has rested and DePuy began presenting its defense on February 20, 2013.

Jurors were shown videotaped depositions of current and former DePuy employees and consultants telling what they knew about the safety and design of the ASR and when they knew it. Kranksy alleges that DePuy knew about safety issues long before making them public and recalling the product in 2010.

The defense argues the device did not have a design flaw, the company did not withdraw the device from the market for safety reasons and that Kransky was so sick from chronic ailments that the failure of his implant was due to his medical condition and improper implantation of the hips by surgeons.

Kransky’s legal strategy will likely be played out in the other 10, 000 cases pending against DePuy—IF they go to trial. Think of this case as determining a “market value” of each side’s legal arguments before serious settlement discussions take place. DePuy has reportedly already offered $200, 000 per case. That was rejected by the patients’ lawyers. If DePuy allows this case to advance to a jury’s decision, and they lose, that settlement offer is likely to go much higher. If DePuy appears to shake Kransky’s case, settlement dollars will likely not move much from the $200, 000, or $2 billion total.

Patients are not the only ones looking for a piece of DePuy’s hide. Payers are getting into the act as Johnson & Johnson (DePuy’s parent) disclosed in a February 22 regulatory filing that the Justice Department has requested documents relating to whether the company may have submitted false claims to federal health care programs over the device.

Even members of the British Parliament have gotten into the act. Bloomberg News reported on February 22, 2013 that if testimony provided by DePuy engineer Magnus Flett is true that the company knew the device had a higher than average failure rate before being recalled in 2010 and didn’t tell anyone, then there should be a criminal inquiry.

The public fallout has not been pretty for DePuy either as a February 10, 2013, New York Times Editorial stated:

[T]here is evidence that [DePuy] was aware of a serious problem with one of its models yet failed to alert patients or doctors and continued to market it aggressively. Court documents now show that DePuy buried the bad news…early as 2008, DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed. That was never disclosed to doctors who were putting the device into patients.

It ain’t over till it’s over and DePuy has yet to present its defense to the jury. For now, based on the daily reporting of Bloomberg, here are some excerpts from the first half of the trial.

Design and Safety Issues

A “higher than expected” failure rate prompted DePuy to recall 93, 000 of the devices in the U.S., Isaac, the previously mentioned DePuy engineer who led the company’s hip-development program, told the jury as a witness for Kransky.

Isaac told jurors that the device was pulled because of safety concerns.

Kransky’s lawyer asked Isaac if the failure rate was a safety issue. Isaac said “yes” and acknowledged that DePuy did not disclose to patients that all hip designs generate ions. Under cross-examination by DePuy’s lawyers, Isaac admitted that the company did more testing on the hip than any other product the company put on the market.

Earlier in the trial, Andrew Ekdahl, DePuy’s current president and senior executive in charge of marketing the device at the time, testified that the company recalled the device because it “did not meet the clinical needs for the product, ” and not because they were unsafe.

James Anderson, a DePuy bioengineer testified that he spent three years studying a redesign of metal-on-metal hip devices because of their failure rate. He said he was disappointment that the work dubbed Project Alpha ended in 2008 with no change to the device.

Earlier in the trial, Kransky’s attorneys referred to a May 2, 2008, email in which Paul Berman, DePuy’s head of U.S. marketing, said, “We will ultimately need a cup redesign but the short term action is to manage perceptions.”

Randall Kilburn, Berman’s boss, testified that he spoke to Berman after Berman sent him an email on March 14, 2010, expressing concern over the safety of the device. Berman said that he had “an obligation as an employee of J&J and DePuy to make it known when I do not feel comfortable.” He also referred to four earlier emails he sent suggesting a possible recall.

Killburn said he made sure all complaints that Berman knew about were investigated internally and handed Berman’s email to David Floyd, DePuy’s president at the time.

Killburn was asked about March 2008 emails from Isaac discussing public ridicule by British orthopedic surgeon, Derek McMinn, of the ASR and its designers. McMinn developed the Birmingham Hip Replacement system in 1997.

Isaac wrote that McMinn gave a speech to the British Hip Society and attacked competitors, while “his main vitriol was reserved for ASR.” This is where Isaac made the reference to Schmalzried’s anger.

Berman wrote to Schmalzried and Thomas Vail, M.D. that is was, “Good to know the Society generally didn’t give credence to what McMinn was saying. I suppose it is somewhat like Brittany Spears…nobody really respects her, but there is a lot of morbid curiosity…I am confident that McMinn will continue to dig his own grave here in the U.S.”

Berman continued that he received 10 calls from surgeons after McMinn’s “little performance.” “We now have some surgeons asking what is wrong with ASR.” He suggested a position statement to Schmalzried, but the surgeon wrote that the ASR design board preferred to avoid publicly rebutting McMinn.

Schmalzried also testified. Kransky’s attorney asked him about an internal DePuy study in 2011 showing 35.8% of the devices failed within 4.57 years, requiring revisions. Schmalzried said of 66 ASR hips he implanted, 11 required revisions.

“If you knew it was going to fail and have to be revised 20% of the time within four years, would you as a designer have recommended this product to be put on the market?” asked Kransky’s attorney.

In what must surely have an impact on the jury, Schmalzried said, “I would not have put the product on the market.”

Kranksy’s Condition

Kranksy, who suffers from medical problems including diabetes, cancer, kidney disease, heart disease and vascular disease, claims that elevated ion levels were responsible for his failed hip. DePuy’s lawyer showed jurors medical records from Tom Trotsky, M.D., Kransky’s personal physician. The records show that when Kransky first complained of pain in his hips in 2008, Trotsky diagnosed it as bursitis.

Peter Wendt, M.D., the Montana surgeon who implanted Kransky’s first hip in 2007, testified he stopped using the device eight months before the company recalled it because he was warned about problems with the implant by a DePuy sales rep named Dan Harrington.

Harrington, he said, told him “there are some problems with this, we are going to pull it. You really shouldn’t be using it anymore.”

He said DePuy never told him about patients who experienced debris from the cobalt and chromium devices and didn’t know that DePuy studied a redesign to try to prevent the problems. Had he known either, he said, he would have stopped using the device.

Jurors also heard testimony from Christopher Hunt, another DePuy bioengineer, about an ASR surgeon design team meeting in September 2005.

The jury was shown his draft minutes of the meeting, which reported that the group discussed adding a toxicologist to “address the perceived risk of cancer due to metal ion release.”

“Although it was agreed that would be a useful study to undertake, concern was raised that the information should be strictly controlled in the event of it showing a negative answer, ” the minutes said. No study was ever done and a toxicologist was never added.

Michael Rhee, a DePuy hip marketing manager, was asked about 2008 emails by San Francisco surgeon, Thomas Sampson, M.D., to Vail. Sampson wrote that he saw an ad on the cover of Orthopedics Today claiming 99.2% survivorship for ASR patients.

“It was difficult to read the ad considering my failure rate is in double digits…and other orthos I have talked with stopped using it all together because of pain and fibrous ingrowth.” Sampson added “I don’t believe the failures are due solely to technique.”

Vail forwarded the e-mail to Schmalzried, who responded, “Using ‘surgical technique’ to explain failures to a surgeon is an uphill fight.”

Jurors also saw an email chain involving Tom Fehring, M.D., a North Carolina surgeon who had advocated studying ASR patients. Berman sent marketing materials to Fehring about another J&J hip, the Pinnacle.

Berman emailed Rhee in January 2009 stating he had “sent all [Pinnacle] design surgeons the new brochure with a letter telling them we plan to continue promoting it. Should make them back off ASR a bit.” Rhee replied, “Why r u getting in my s—?” Berman replied, “Keeping Fehring from recalling your product. You’re welcome.”

The videotaped testimony of depositions from the witnesses is likely to be repeated in the consolidated lawsuits in federal court if no settlement is reached.

DePuy now has the jury’s attention and is making their defense. We’ll report on that when the defense rests. A settlement may still be reached before the jury heads to the jury room.