Johnson & Johnson Marketing Exec Emailed Concerns Over ASR Device

exec-email-over-ASR-recallIn the first of some 10,000 lawsuits against Johnson & Johnson over its recalled DePuy Orthopaedics’ ASR metal-on-metal hip implant, jurors heard more testimony from a key DePuy executive regarding the failed medical device.

Jurors were shown an email in which key marketing executive, Paul Berman, wrote that DePuy should consider recalling the ASR; this, one year before 93,000 ASR devices were globally recalled in 2010, said Bloomberg News. Berman is DePuy’s director of hip marketing.

In the email dated September 18, 2009—over one year before the device was recalled—Berman wrote that he wanted to “reiterate my concern” over the ASR’s safety, given mounting reports of the ASR’s failures, said Bloomberg News. In the email, Berman discussed a recommendation to “discontinue the product from all but 10 surgeons because of failure rates with the broader universe.” Berman added, “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.”

The lawsuit was brought by Loren Kransky, 65, a retired prison guard from Montana who alleges that DePuy defectively designed the metal-on-metal ASR. Kransky’s lawyers claim that surgeons who implanted the ASR had complained for years prior to the recall over device failures, but that DePuy never appropriately issued warnings about the ASR’s risks, said Bloomberg News.

In other videotaped testimony, DePuy hip marketing manager Michael Rhee, was asked about emails written in 2008 from surgeon, Thomas Sampson, to surgeon Thomas Vail. Sampson is a San Francisco-based surgeon and Vail helped design the ASR, said Bloomberg News. In Sampson’s email he indicated that he saw an ad on the cover of Orthopedics Today touting a 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, adding that another doctor’s “are worse and other orthos I have talked with stopped using it all together because of pain and fibrous ingrowth…. I don’t believe the failures are due solely to technique,” he added, according to Bloomberg News. Vail sent the email to another surgeon who helped in the ASR design, Thomas Schmalzried, who responded, “Using ‘surgical technique’ to explain failures to a surgeon is an uphill fight.”

Another email shown to jurors involved Tom Fehring, a North Carolina surgeon who suggested that ASR patients be studied. Berman sent some marketing materials to Fehring about Johnson & Johnson’s Pinnacle hip device, the email said. Fehring complimented Berman on the Pinnacle materials, said Bloomberg News. Berman then sent an email to Rhee to January 2009 stating he “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 responded, “Keeping fehring from recalling your product. You’re welcome.”

According to testimony, Berman emailed a colleague on March 14, 2010 writing, “I want to reiterate my concerns with the safety of the ASR platform….  With growing chatter in the market and commentary” from a British surgeon and others, “I still remain concerned with the safety of this product,” according to Bloomberg News. “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,” Berman added. Berman discussed three prior emails he sent in addition to the September 2009 email suggesting a possible recall, said Bloomberg News.

Kransky received his ASR in December 2007 and underwent surgery to have the device removed in February 2012. His lawyers assert Kransky suffered from high levels of chromium and cobalt released by the ASR, said Bloomberg News. Kransky’s physician, Thomas Trotsky, said he was worried that his patient would not be well enough to survive the revision surgery. “What was driving this was everyone’s conviction that unless the hip was replaced, Bill was dying,” Trotsky said in videotaped testimony. “We felt we were dealing with a man who was slowly dying from being poisoned.” Trotsky, added, “I was convinced that Mr. Kransky would die from toxicity if the hip weren’t removed…. Mr. Kransky was convinced it was his last and only chance to survive.”

Johnson & Johnson denies that it defectively designed the ASR or that the device contributed to Kransky’s health issues. A lawyer for the drug maker said in opening statements that Kransky’s attorneys took the emails out of context so that they could “paint a picture about a company that simply isn’t true.”

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