Pharmaceutical

Emails presented in DePuy trial show marketer’s concerns over ASR hip implant safety

DePuy ASR hip recall 435x369 Emails presented in DePuy trial show marketers concerns over ASR hip implant safetyInternal communications among DePuy executives discussing how to handle metal-on-metal ASR hip problems were presented to jurors hearing the first of several thousand personal-injury lawsuits involving the faulty devices to go to trial. DePuy is a subsidiary of Johnson & Johnson.

According to the records presented, on September 18, 2009, Paul Berman, DePuy’s director of hip marketing, sent one of many emails to company officials warning that the metal-on-metal hip devices should be recalled given the alarming number of reports that the devices were failing.

Mr. Berman wrote that he wanted to “reiterate my concerns” about the safety of the ASR hip devices, and recommended discontinuing production of the hip implants considering mounting reports of premature failure. Mr. Berman added that the devices should be recalled altogether if DePuy felt the majority of surgeons found their “safety profile” to be unacceptable.

DePuy started phasing out production of the ASR implants in November 2009 but did not recall them until August 2010. The implants, which include a metal ball fitted into a metal cup, were implanted in about 37,000 Americans and 56,000 others worldwide before DePuy recalled them.

One of those patients, Loren Kransky, a 65-year-old retired prison warden from North Dakota, sued DePuy after the ASR hip implant he received in 2007 failed, leaving him with pain, swelling, difficulty walking, and other symptoms. Mr. Kransky’s lawsuit against DePuy Orthopedics was selected to be the first case to go to trial in California Superior Court in Los Angeles reportedly because the plaintiff is a cancer patient and may not have much longer to live.

Jurors also saw another thread of emails between Mr. Berman and a Tom Fehring, a North Carolina surgeon who advocated studying patients with ASR hip implants. Mr. Berman sent Dr. Fehring information about another of DePuy’s all-metal hip implants to which the doctor responded favorably.

The response prompted Mr. Berman to email another DePuy marketing manager, Michael Rhee, in 2009, telling him he had “sent all [the other device] design surgeons the new brochure with a letter telling them we plan to continue promoting it. Should make them back off asr a bit.”

Mr. Rhee replied, “Why r u getting in my s**t.”

“Keeping fehring from recalling your product. You’re welcome,” Mr. Berman replied.

In March 2010, Mr. Berman again emailed colleagues to express his concerns over the safety of the ASR devices, especially in light of “growing chatter in the market and commentary” by a number of medical professionals about the ASR devices.

“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,” Mr. Berman wrote, referring back to earlier emails he sent out, including the one he wrote in September 2009.

Source:

Bloomberg