Attorney General Curtis Hill today announced a multistate settlement involving 41 states and the District of Columbia requiring Johnson & Johnson and its subsidiary Ethicon Inc. to pay nearly $116.9 million for their deceptive marketing of transvaginal surgical mesh devices.

A multistate investigation found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose risks associated with their use. Indiana will receive more than $4.4 million under the settlement.

“My office will continue to hold accountable companies that cause harm to consumers through improper practices,” said Attorney General Hill. “Women in Indiana and across the country have suffered as a result of the actions of Johnson & Johnson and Ethicon Inc.”

Transvaginal surgical mesh is a synthetic material that is surgically implanted through the vagina to support the pelvic organs of women who suffer from stress urinary incontinence or pelvic organ prolapse.

Evidence shows the companies were aware of the possibility of serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the devices.

Besides the monetary penalties, the settlement also provides injunctive relief, requiring full disclosure of the device’s risks and accurate information on promotional material, in addition to the product’s “information for use” package inserts.

Among the specific requirements, the companies must:

• Refrain from referring to the mesh as “FDA approved” when that is not the case.
• Refrain from representing in promotions that risks associated with mesh can be eliminated with surgical experience or technique alone.
• Ensure that product training provided to medical professionals covers the risks associated with the mesh.
• Omit claims that surgical mesh stretches after implantation, that it remains soft after implantation, that foreign body reactions are transient and that foreign body reactions “may” occur (when in fact they will occur).
• Disclose that mesh risks include: fistula formation, inflammation, as well as mesh extrusion, exposure and erosion into the vagina and other organs.
• Disclose risks of tissue contraction, pain with intercourse, loss of sexual function, urge incontinence, de novo incontinence, infection following transvaginal implantation and vaginal scarring.
• Disclose that risks include that revision surgeries may be necessary to treat complications, that revision surgeries may not resolve complications and that revision surgeries are also associated with a risk of adverse reactions.

U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler announced the appointment of members who will serve on the Science Advisory Board (SAB). Decisions on the SAB’s four standing committees are still pending.

“After an open and transparent public process, EPA has appointed or reappointed experts from a wide range of scientific disciples who reflect the geographic diversity needed to ensure the SAB represents all ten EPA regions,” said EPA Administrator Andrew Wheeler.

Those nominees willing to serve have been vetted for potential conflicts of interest and each has committed to remain financially independent from EPA grants during their tenure.

The Process

The nomination period for the SAB closed on June 26, 2019. The SAB Staff Office identified 33 candidates that have confirmed interest to serve on the board. Each of the candidates has submitted bio-sketches and their curricula vitae. The list of candidates was posted on the SAB website for a 21-day public comment period that closed on Oct. 9, 2019.

The Science Advisory Board

In FY 2019, the SAB had 45 members. Of those, 33 members had terms that do not expire and thus remain on the board. Of the remaining members from FY 2018, four completed their terms of service, one resigned, and seven – appointed during the Obama administration – are timing out of the first term and will be reappointed by Administrator Wheeler to serve for a second three-year term (listed in Table 1 below).

In addition, Administrator Wheeler is reappointing Dr. Peter Wilcoxen, for a one-year extension. Dr. Wilcoxen’s extension will allow him to finish serving as the chair of a recently initiated panel on Computational General Equilibrium. Dr. Wilcoxen will continue to lead an important review currently underway assessing and analyzing an Economic Model used in regulatory analyses. Three new board members (one each from the federal government, a state, and a non-governmental organization) were selected by Administrator Wheeler (listed in Table 2 below). This brings the total SAB membership to 44 for FY 2020. Dr. Michael Honeycutt will remain as the SAB Chairman.

Food Inspection Reports 10-17-19

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