DePuy ASR Patient Wins $8.3 Million

After a five week trial and five days of deliberation, the jury in the DePuy Orthopaedic, Inc. ASR hip trial returned a mixed verdict on March 8, 2013, and awarded Loren Kransky $8, 338, 000 in compensatory damages.

In a mixed verdict, the jury found that the metal-on-metal device was designed badly, but also determined that DePuy properly warned surgeons and patients of the risks.

DePuy issued an immediate statement saying the company believes the device was properly designed and its actions were “appropriate and responsible.”

Lorie Gawreluk, a spokeswoman for DePuy said the company is planning to appeal the jury’s decision on design defect pending the outcome of post-trial motions. “We believe we have a number of valid grounds for appeal, notably that the court didn’t let the company tell the jury about the Food and Drug Administration’s review and clearance of the device.”

Before being sequestered in the jury’s chambers, jurors heard final arguments from both side.

DePuy has no soul and is more concerned about negative publicity than protecting patients, said Brian Panish, a lawyer for plaintiff Loren Kransky during closing arguments in Los Angeles on February 28, 2013.

Panish asked jurors for $338, 000 in economic damages, $5 million in economic damages for pain and suffering, and up to $179 million in punitive damages.

“Kransky’s lawyers have tried to make you angry at DePuy, ” Michael Zellers, DePuy’s attorney then told the jury. “They have tried to convince you that DePuy acted maliciously. DePuy set out to make the very best hip device they could make. DePuy is a good company. It has a superb reputation. DePuy is an open and honest company.”

Zellers said Kransky’s revision came after his hip grew infected, not because of problems with the hip. “Mr. Kransky had an infected hip, ” Zellers said. “That caused him pain. That pain caused the revision.”

He said the evidence showed that Kransky’s hip was implanted at an angle greater than 55 degrees. “If you are going to put a cup in at that angle, you are going to get more wear, ” he said.

“This was the mostly extensively tested device in DePuy history at the time, ” continued Zellers. “They worked hard to develop a product that had low wear and would last a long time.” He denied that DePuy hid its testing data. “DePuy shared its information with everyone, ” he said. “This was not something DePuy hid and kept in its laboratory.”

In the Jury’s Hands

And so after a trial that lasted 33 days and left the jury visibly weary, according to published reports, the decision rested in juror’s hands.

DePuy rested its defense on February 27, 2013. Kransky’s lawyers produced compelling evidence that DePuy engineers and hip surgeons warned company executives of higher than normal failure rates long before the company recalled the product.

The evidence that Kransky’s specific hip failed because of cobalt and chromium being released into his body was not as compelling.

The fact that the jury took so long may mean DePuy was successful in planting a seed of doubt of whether or not the company was guilty of covering up unfavorable data.

For the Defense – Patient Infection

The defense called expert witnesses who testified that there was no conclusive proof that Kransky’s hip failed because of cobalt and chromium levels in his body. Bruce Spinowitz, M.D., an internist and nephrologist testified that cobalt and chromium mostly exit the body through the kidney and discussed Kransky’s various risk factors that are believed to lead to chronic kidney disease. Dr. Spinowitz concluded that the ASR had no impact on Kransky’s chronic kidney disease.

Kransky’s lawyers reminded Dr. Spinowitz that Kransky’s own nephrologist and internist recommended that the hip be removed and commented that following the revision surgery, Kransky was doing surprisingly well.

Gonzalo Ballon-Landa, M.D., an infectious diseases doctor, testified on February 26 that Kransky had revision surgery because of an infection that spanned several years. “The infection caused him pain, and the pain is why Mr. Kransky had revision surgery.” He said the kind of infection Kransky had was “the most common cause of artificial joint infections.”

“It is impossible to completely cure an infected hip, ” he said.

He also testified that Kransky developed a staph infection through the port used to administer chemotherapy drugs for his kidney cancer.

On cross-examination, Dr. Ballon-Landa said none of the five physicians who examined Kransky from December 2007 until his revision found an infection. “There’s no indication that they thought he had an infection.”

Design and Testing

Another defense witness, John Cuckler, M.D., a retired orthopedic surgeon and a developer of Biomet Inc.’s metal-on-metal hip also testified that Kransky’s hip was infected. He was paid $500, 000 by DePuy to analyze the ASR.

Dr. Cuckler has performed about 5, 000 total hip surgeries, including 2, 400 revisions. He said the ASR wasn’t defective. He also said Kransky’s buildup of metal debris around his hip was caused by an infection and the steep angle at which his surgeon implanted his device.

Based on his review of the ASR design file, Dr. Cuckler said, “I think this is a safe design which is not defective in any way, ” and the testing performed by the company was absolutely “spot-on.”

“We can never fully recreate the demands placed on the human body with a machine, ” Dr. Cuckler told the jury. “There is no simulator test that has ever fully approximated the performance of a device in a human being.”

Surgeon Error

Drexel University’s School of Biomedical Engineering professor, Avram Edidin, Ph.D., also testified that the hip failed because of the angle of implantation. Kransky’s cup “was implanted at a high inclination angle, ” said Edidin. Higher angles are “associated with higher wear. If you put any component in that position you are going to see the kind of wear that you see on Mr. Kransky’s component.”

On cross-examination, Kransky lawyer Michael Kelly showed the jury the X-ray on which Edidin had drawn the angle. Kelly superimposed a protractor on the image and showed the actual angle was 57.5 degrees, not the 63 to 65 degrees calculated by Edidin.

“You are aware you can find a protractor at Walgreens, are you not?” Kelly asked.

“I am, ” said Edidin.

He offered no explanation of the discrepancy. On redirect, Edidin said he reviewed several images of Kransky’s ASR before the revision surgery; re- measured the angle and determined it was 63 degrees.

Kelly showed Edidin a DePuy document from the Health Hazard/Risk Evaluation Executive Review Board at the time of the recall. Under “market action strategy” were three possible explanations for the recall. The company checked Class A for “defective product that would affect product performance and/or could cause health problems.”

Among those who signed the document was DePuy’s former president, David Floyd.

Closing Arguments – Plaintiff

In asking for money damages and penalties, Panish, Kransky’s lawyer, told jurors that “compensation should not be reduced simply because the plaintiff was more susceptible to injury than a normally healthy person.” Panish asked jurors to award Kransky 2% to 5% of the company’s value.

“This is a company that needs a solid message sent to them, ” Panish said. “Nobody has ever accepted responsibility from DePuy. For a company in today’s world to do this to patients—unfortunately, it happens because the money corrupts. They don’t have a soul.”

He described DePuy as a company that only cared about “profits, balance sheets and business, ” accused it of playing “Russian roulette” with patient safety, and treating the trial as little more than a “game.”

DePuy executives would be “flipping the champagne glasses” if jurors failed to deliver adequate damages, Panish said.

“You have a chance in this case to make difference for product safety, ” Panish told the jury. “The money needs to be enough that you get their attention and they put a stop to this.”

Closing Arguments – Defense

But DePuy attorney Zellers retorted that Kransky’s injuries were not caused by the hip or the company’s conduct. He said Kransky was already in poor health from diabetes and other ailments when the hip was removed.

He claimed that Kransky and his attorney influenced doctors to use language suggesting metal poisoning, though his injuries were actually caused by an infection.

He reminded jurors that the device had shed metal because of the high inclination angle at which it had been implanted. “There was no evidence that the result would have been different if surgeons had used a different device.”

DePuy’s sales literature warned surgeons that wear could result if an artificial hip were placed at greater than a 45-degree angle, Zellers said, and Kransky’s was implanted at greater than a 60-degree angle.

“Ultimately, the product did not perform as DePuy expected it to perform, ” Zellers said. But he said DePuy had acted “responsibly” and is a “good company.” He said DePuy had done “the right thing” in recalling the hip because it did not live up to the company’s own standards. “It did that because it put patients over money, ” Zellers said.

“This case is about what caused Mr. Kransky’s injuries, ” Zellers said. “The evidence is clear that Mr. Kransky’s injuries were not caused by a defect in the ASR hip. It’s not a case about a recall. It’s not about revision rates of the ASR today.”

Zellers denied claims that the tissue around Kransky’s hip was damaged because the device. “There is no scientific support that Mr. Kransky’s metal ions were toxic, ” Zellers said. “The evidence in this case was that Mr. Kransky was not being poisoned and that the cobalt and chromium levels in his system were not toxic.”

The jury’s decision may set a precedent for the remaining 10, 000 plus lawsuits still pending against DePuy. At $8 million per case, that amounts to a stunning $80 billion. Having the jury return a verdict on product design as opposed to company behavior, DePuy’s appeal on FDA clearance grounds may rest on the legal theory of “federal preemption.” The Supreme Court has ruled that companies are immune from product safety lawsuits in state courts if the FDA properly allowed the device on the market.