Sixty-six year old DePuy ASR hip implant recipient Loren Kransky has smoked since he was 12, served in Vietnam as a U.S. Air Force mechanic, suffers from diabetes, coronary artery disease, high blood pressure, and kidney disease. He’s had two strokes and is dying of kidney cancer.
He had his hip replaced with DePuy Orthopaedic Inc.’s metal-on-metal ASR hip in 2007. In 2012 he required a revision, claiming he was being poisoned by chromium and cobalt released by the device.
Case Goes to Jury
On January 25, 2013, in a Los Angeles County Superior courtroom, Kransky became the first of roughly 10, 000 nationwide patients to get his case in front of a jury. Two previously scheduled trials in Las Vegas and Maryland ended with a settlement and withdrawal of the complaint.
Kransky and his wife Sheryl are suing DePuy, SFG Medical, Inc., Thomas Schmalzried, M.D. and Thomas Vail, M.D. (among others) for failure to warn, negligent recall and manufacturing defects of the device and essentially serve as proxies for cases yet to go to trial.
At issue for this and upcoming trials isn’t exclusively whether Kransky was specifically damaged by the ASR, but what did company officials know about the safety of the device, when did they know it, and what actions did they take with that information?
Opening Statements
In opening statements to the jury, Kransky’s lawyer, Michael Kelly told jurors that DePuy was aware of the defects when the company started selling the device. He introduced documents which allegedly suggest that company executives knew there were serious problems with the ASR because internal testing in 2007 revealed that the device had a critical design flaw. He charged the company with hiding information from doctors complaining about the device.
Alexander Calfo, DePuy’s lawyer told jurors that the evidence will show that the device was not the cause of Kransky’s failed hip and that it was properly designed. He claimed Kransky was exposed to Agent Orange in Vietnam and all his other chronic illnesses were the cause of the hip failure. He also attributed the failure to improper placement of the hip by the surgeon and that the amount of metal shown in Kransky was not high enough to cause his device failure.
“Mr. Kransky did not get worse because of the (implant) and did not get better when it was removed, ” he said. Calfo said that Kransky’s kidney problems compromised his body’s ability to flush chromium and cobalt, which weren’t at high enough levels to cause health problems.
Calfo said that cobalt and chromium from the ASR hips don’t poison patients. “The ASR was thoroughly tested and was researched before it was ever used.”
Before getting to the documented evidence and witnesses after four days of the trial (many testifying via videotaped depositions available to future trials), let’s review the timeline of the device.
DePuy ASR Timeline
The device was introduced in 2004 in Europe and 2005 in the U.S. Eventually over 36, 000 U.S. patients received the hip. Worldwide, over 90, 000 implants were sold.
By 2009, national registries in Australia and elsewhere began reporting high failure rates. Australian national registry data showed that the implant failed at a rate of 22% after five years and 44% after seven years.
In 2009, the FDA rejected DePuy’s request to clear its resurfacing version of the ASR. The agency cited concerns over high concentrations of metal ions.
The company recalled the device in 2010, citing, among other things, poor sales.
In 2012, British experts at the world’s biggest artificial joint registry said doctors should stop using all (not just DePuy’s) metal-on-metal hip replacements after a study found that, after five years, about 6% of people who had the implants needed the device replaced.
Plaintiff: DePuy Knew of Design Flaws
To prove that the company knew of design flaws long before recalling the device in 2010, Kelly called his first witness, Magnus Flett, to tell the jury how DePuy analyzed what might cause the ASR hips to fail. Flett led a design team and oversaw a group conducting a failure mode and effect analysis.
In his opening statement, Kelly had displayed a DePuy document from September. 27, 2007, describing how “massively increased wear” can occur when the cup is “oriented at a steep angle.” The company could “significantly redesign” the ASR to remove a groove, or ridge, that was part of the cup’s design, according to the document.
Kelly said that while DePuy advised doctors ideally to place the cup at a 45 degree angle in the hip, a study showed more than half of implants were placed at wider angles.
“Isn’t it true that DePuy didn’t know in 2008, 2007, 2006, 2005, ’04, all the way down to the design, DePuy had no idea what the acceptable range was for the placement of the ASR?” Kelly asked Flett. “Isn’t that the simple and plain truth?”
“I think the data as we started to get it indicated angles above 55 gave us increased ion results, ” Flett responded.
Who Knew What and When?
Kelly referred to a May 2, 2008, email in which Paul Berman, DePuy’s head of U.S. marketing, wrote, “We will ultimately need a cup redesign but the short term action is to manage perceptions.”
Kelly also referred to a Berman email of July 2, 2008, about sales representatives “telling surgeons DePuy is making an emergency change to the ASR cup. We must keep the ASR 2 project under total wrap, particularly in the U.S. where we will not make the change immediately. As expected, the competition will use this information against us.”
Andrew Ekdahl, the current president of DePuy and in charge of the 2005 introduction of the device in the U.S., was also told by a company consultant that the ASR was flawed, according to another document.
“The issue seen with the ASR today, over five years post-launch, are most likely linked to the inherent design of the product and that is something we should recognize, ” company executive, Raphael Pascaud reportedly wrote in March 2009.
DePuy Pulls Device off Market
Flett said DePuy scrapped efforts to redesign the ASR cup because of financial and business reasons. He said that DePuy never told surgeons that the ASR failed and required revisions at a rate that was eight times that of another company hip device, the Pinnacle.
He said DePuy stopped selling the ASR in late 2009. “We didn’t see the sales of the product continuing the way we wanted, so we took it off the market, ” Flett said.
A memo from Berman to the company sales force read, “This global rationalization is consistent with DePuy’s strategy to streamline its portfolio, reduce cost and reallocate resources to high growth brands and technologies that best meet the current and future needs of surgeons and patients.”
According to Kransky’s lawyers, DePuy “has consistently claimed it recalled the ASR for purely ‘financial reasons.’” They claim DePuy then “attempted to pivot off that position, claiming the real reason it recalled the ASR was for a ‘remedial or precautionary measure.’”
They argue that DePuy sought to deem the recall a “remedial measure” so that it could exclude certain evidence from the trial.
Ekdahl Testimony
Then it was time for the jury to hear from Ekdahl himself via videotaped deposition taken in December 2012.
Ekdahl testified the company recalled the 93, 000 implants because they “did not meet the clinical needs for the product, ” not because they were unsafe. In answering Kelly’s questions about the recall, Ekdahl said that the ASR didn’t have an acceptable revision rate.
“What was the acceptable revision rate?” Kelly asked.
“I don’t think we put a revision rate on paper and said this is a revision rate that was acceptable, ” responded Ekdahl. Kelly asked how many revisions DePuy forecasts for the U.S. “We’re not forecasting a revision rate, ” Ekdahl said.
Kelly asked why the U.S. rate of revision wouldn’t reach 40%, as in Australia. Ekdahl said he doesn’t know what the rate will be. About 32, 000 patients had ASR devices implanted in the U.S., said Ekdahl, and that “somewhere in the neighborhood of 15 to 20%” of those hips had failed.
Handling of Safety Concerns
Kelly questioned Ekdahl about DePuy’s handling of safety complaints that surgeons filed with the company about the device. Kelly noted that one surgeon, William Griffin, emailed Ekdahl and others on December 18, 2008, to say he had “concerns about the design and have started to see failures consistent with my concerns.”
Ekdahl acknowledged, “I believe this was reported to our clinical team. I just don’t recall who did it. We should have done it. I’m assuming that we did it. I don’t recall.” Ekdahl said that in response to the email, he spoke to people on the marketing team.
Kelly asked about DePuy discussions in 2008 to redesign the ASR cup. A company engineer, Graham Isaac, emailed Ekdahl on April 30, 2008, to say the ASR is “susceptible to extreme metal ion levels, ” which a competitor product didn’t face.
“We need to discuss that at the earliest possible opportunity as I believe it means that we need to start any ASR upgrade sooner than our previous plans had suggested, ” Isaac wrote.
At a September 2009 meeting of the company’s U.S. board overseeing joint devices, officials said the revision rate of the ASR device was two or three times that of another DePuy implant, the Pinnacle. It said that the impending publication of Australian registry data would be “very damaging to the ASR.”
Thomas Vail, M.D., testified that the device was not defective. He also told the jury he received almost $2 million in royalty payments. During the recall, he said he did not experience any safety issues with his patients.
Settlement Rumored
So concluded the fourth day of the biggest trial in orthopedics in decades.
Legal experts have said they are certain that ultimately there will be some sort of global settlement after some of the cases are litigated. DePuy can fight each case said one expert. News reports have said that DePuy has offered to settle the cases for $200, 000 per case or about $2 billion. The plaintiff lawyers have turned that down.
The trial continues in Los Angeles.
