Bloomberg News

J&J’s Marketer E-Mailed Hip Safety Concerns Before Recall

February 12, 2013

A top marketing executive at Johnson & Johnson (JNJ:US)’s DePuy unit said the company should consider a recall of a hip implant almost a year before 93,000 of the devices were recalled, according to an internal e-mail shown to jurors.

Paul Berman, DePuy’s director of hip marketing, wrote Sept. 18, 2009, that he wanted to “reiterate my concern” over safety of the ASR device, given mounting failures. Jurors, at the first of 10,000 lawsuits to go to trial, saw several e-mails yesterday from marketers before the recall on Aug. 24, 2010.

Berman discussed a recommendation to “discontinue the product from all but 10 surgeons because of failure rates with the broader universe,” according to the e-mail shown to state court jurors in Los Angeles.

“If the company feels the safety profile of the platform is not acceptable among the majority of surgeons it seems we should consider recalling it altogether,” Berman wrote.

Jurors are weighing the lawsuit of Loren Kransky, 65, a retired prison guard who claims that DePuy defectively designed the device. Kransky’s lawyers claim that surgeons who implanted the ASR complained for years before the recall about device failures, and DePuy failed to warn properly of the risks.

Health Problems

J&J, the world’s largest (JNJ:US) seller of health-care products, denies it defectively designed the device or that it contributed to Kransky’s health problems. J&J is based in New Brunswick, New Jersey. In an opening statement on Jan. 25, J&J lawyer Alexander Calfo said Kransky’s lawyers took e-mails out of context to “paint a picture about a company that simply isn’t true.”

In a videotaped deposition shown yesterday of Michael Rhee, a hip marketing manager, Kransky’s lawyers asked about e-mails starting in 2008. A San Francisco surgeon, Thomas Sampson, e- mailed Thomas Vail, a surgeon who helped design the ASR.

Sampson wrote that he saw an ad on the cover of Orthopedics Today claiming 99.2 percent survivorship for ASR patients.

“It was difficult to read the ad considering my failure rate is in double digits,” Sampson wrote on July 28, 2008. He said another doctor’s “are worse 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 another surgeon who also helped design the ASR, Thomas Schmalzried, who responded, “Using ‘surgical technique’ to explain failures to a surgeon is an uphill fight.”

ASR Study

Jurors also saw an e-mail chain involving Tom Fehring, a North Carolina surgeon who had advocated studying ASR patients. Berman sent marketing materials to Fehring about another J&J hip, the Pinnacle, according to an e-mail. Fehring complimented Berman on the materials.

Berman e-mailed Rhee in January 2009 stating he had “sent all Pinn design surgeons the new Pinn 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 wrote, “Keeping fehring from recalling your product. You’re welcome.”

On March 14, 2010, Berman wrote an e-mail to a colleague, according to testimony.

“I want to reiterate my concerns with the safety of the ASR platform,” he wrote. “With growing chatter in the market and commentary” from a British surgeon and others, “I still remain concerned with the safety of this product,” he said.

‘An Obligation’

“As a marketing professional, I do not make product safety decisions, but I do have an obligation as an employee of J&J and DePuy to make it known when I do not feel comfortable,” he wrote.

He referred to four earlier e-mails he sent, including the one in September 2009 suggesting a possible recall.

Kransky’s hip was implanted in December 2007 and removed in February 2012 through a so-called revision surgery. His lawyers said that he suffered from high levels of chromium and cobalt released from the ASR device. Kransky also suffers from diabetes, coronary artery disease, high blood pressure, kidney cancer, and other health problems.

His physician, Thomas Trotsky, said he was concerned that Kransky wouldn’t be healthy enough to survive the revision.

“What was driving this was everyone’s conviction that unless the hip was replaced, Bill was dying,” Trotsky said in videotaped testimony shown yesterday. “We felt we were dealing with a man who was slowly dying from being poisoned.”

“I was convinced that Mr. Kransky would die from toxicity if the hip weren’t removed,” he said. “Mr. Kransky was convinced it was his last and only chance to survive.”

Cobalt Measurement

In his opening statement, Calfo said “the evidence will show the amount of cobalt measured in Mr. Kransky was not enough to cause any adverse systemic health effects.”

Asked by J&J attorney Michael Zellers what caused him to conclude that Kransky was threatened with metal toxicity, Trotsky said: “There’s no research evidence that would cause me to come to that conclusion.”

Kransky’s daughter, Jennifer Flynn, wept as she testified yesterday about her father’s suffering before his revision surgery. She said her father fell several times, including once when he came out of the shower and landed with his head in the cat litter box.

“He’s a prideful man and to have your daughter pick you up because your head is in the catbox is not the way it’s supposed to be,” she said.

The case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).

To contact the reporters on this story: Maurice Possley in Los Angeles Superior Court at mauricepossley@gmail.com; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.


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