A lawsuit involving Johnson & Johnson's pelvic mesh device reveals that relationships between doctors and device makers will be deeply scrutinized in product liability cases. A recent Wall Street Journal article honed in on the actions of Johnson & Johnson's physician-consultant who reportedly influenced language in a research paper that evaluated the Johnson & Johnson's device procedure.
The Wall Street Journal notes that while payments that constitute kickbacks from companies have sparked the most regulatory and legal action, discovery documents in the J&J lawsuit "suggest that potential influence over medical practice also can be more subtle."
Johnson & Johnson's transvaginal mesh device was designed as an alternative to more invasive surgery procedures to treat pelvic organ prolapse. In 2012, the device was removed from the market due to reports of pain associated with the product. During 2007-2012, however, thousands of women used the device
In 2007, the American College of Obstetricians and Gynecologists (ACOG) published an initial report, which said that the mesh procedures "should be considered experimental" and that "patients should consent to surgery with that understanding."
Johnson & Johnson sought input from one of its physician-consultants, Vincent Lucente, a well-known urogynecologist and advocate of the procedure. According to emails uncovered by the Wall Street Journal, Dr. Lucente advised J&J executives that the guidelines' characterization of the product as "experimental" needed to be changed because the devices had been cleared by the FDA and the language would scare off patients, he explained later in an interview. Furthermore, procedures deemed "experimental" have trouble receiving reimbursement from insurance companies.
Shortly after the initial report, members of ACOG began objecting to the use of the word "experimental." Johnson & Johnson denies that it was involved in any of these efforts, but within 7 months, ACOG had changed its guidelines. "Note, no further use of the word experimental!" wrote Dr. Lucente in an email to Ethicon's (a J&J unit) marketing director. "Well, this is one I'm taking credit for. I led the charge on this and never thought we would get a complete replacement of the earlier bulletin."
ACOG stated that it wouldn't have known about Dr. Lucente's relationship with the industry because it requires financial disclosures only when members serve in leadership roles, which Dr. Lucente did not in 2007.
Wall Street Journal notes in the article that, in fact, financial relationships between the medical community and device manufacturers are both legal and commonplace. Johnson & Johnson told the Journal: "Ethicon's relationships with the medical community concerning our pelvic mesh products have been appropriate and responsible." They went on to say that "[a]s part of our efforts to advance the standard of care for women's health, it is customary for us to have discussions with leading physicians and researchers."
Dr. Lucente was paid about $800,000 by Ethicon as a consultant over a 10-year period to educate other doctors. J&J said he was paid to tell doctors about the safety and efficacy of Ethicon medical devices.
The Wall Street Journal stated that the Physician Payments Sunshine Act has been implemented to encourage transparency about such relationships.
"Companies also may exert influence in the medical community through research papers," the article noted. The Wall Street Journal examined this second potential conflict of interest regarding a clinical trial of the mesh procedure conducted by Swedish researcher Daniel Altman, a professor at the Karolinska Institute. J&J gave $750,000 to the university, along with grants from the Swedish government, to support research that Dr. Altman initiated. Dr. Altman reportedly stated that he fought from the beginning to conduct the trial independently from the company. The original contract stipulated that J&J would own the data and could stop the trial whenever they wanted, so Dr. Altman said he refused to sign it. Ultimately, the contract gave Dr. Altman full control over the trial.
"As is customary for independent, investigator-initiated research studies that receive funding from a manufacturer, Ethicon provided commentary on a draft of the Altman study after Dr. Altman asked for our comments," said J&J in a statement. "Ethicon did not inappropriately seek to influence the study results or the author's conclusions. We did not know what, if any, changes Dr. Altman would make until we saw the final paper."
Companies and doctors have stated that their relationships are important to improve medical education and inform doctors about the creation of new or improved devices. Complex devices often require thorough training, and who best to talk about an innovative product than leaders in a specific medical field? Device representatives are considered helpful, even at times essential, in training physicians to use important products that can improve patients' quality of life. While many news outlets seem to forget this, teachers, especially highly educated and respected doctors, do not work for free.
This case makes obvious, however, the need to separate a doctors' research and medical beliefs from efforts to improperly promote products. The critical mistake in the fact pattern appears to be that emails appeared to be too friendly between Johnson and Johnson and Dr. Lucente. The WSG points to Dr. Lucente's email to J&J about ACOG removing the "experimental" definition as a "smoking gun" of sorts. As noted above, the email stated: "Well, this is one I'm taking credit for. I led the charge on this and never thought we would get a complete replacement of the earlier bulletin."
Objectively, Dr. Lucente seems to be touting his own business negotiation skills, rather than his medical beliefs about the products efficacy. This is despite the fact that J&J hired Dr. Lucente as a consultant because he genuinely believed in the value of the particular medical device for patient well-being.
It will be interesting to see whether this case marks a change of more litigation in the device field, and if industry reacts by redefining the boundaries with their physician-consultants.