Demands higher standards to set manufacturing limits on prescription painkillers

LITTLE ROCK — Arkansas Attorney General Leslie Rutledge joined seven states in pushing federal regulators to consider more information as they set manufacturing limits on prescription painkillers in hopes a more thorough review will lead to fewer overdose deaths.

“Opioid distributors and manufacturers have flooded Arkansas with millions of pills - 62 opioid pills for every man, woman and child in the State,” said Attorney General Rutledge. “Limiting the excessive manufacturing and distribution of opioids is an important proactive step that will help combat this epidemic and save lives.”

Along with this effort, Rutledge has led the country with a multifaceted approach of education, prevention and litigation. In April 2018, Rutledge filed a lawsuit against opioid manufacturers, Purdue Pharma, Johnson & Johnson and Endo for creating and fueling the epidemic that has devastated so many in the State. In April 2019, Rutledge then filed suit against distributors McKesson, AmeriSource Bergen and Cardinal, for allowing millions of opioid pills annually to be diverted to people who do not have a medical need for the drugs. Rutledge launched the Prescription for Life program, a free educational digital platform on which more than 15,000 high school students have participated throughout the State.

The U.S. Drug Enforcement Administration (DEA) is required to account for illegal drug diversion by setting quotas, but the states question whether the methodology used to set next year’s manufacturing limit is enough.

The letter filed by Rutledge and colleagues late Tuesday argues DEA officials must adopt a uniform methodology for all controlled substances, do more to account for overprescribing and expand its universe of information sources.

The current data sets make accounting for diversion difficult, but argues such complexity cannot hinder progress. For instance, the letter suggests that the DEA take into greater account data from its Drug Take Back Day as evidence of overprescribing.

The states also suggest DEA officials should consider best practices developed by the medical community and State regulators, in addition to improving the usability of its reporting system and its suspicious orders database.

The DEA’s proposed limits for 2020 slash hydrocodone manufacturing by 19 percent and oxycodone by 8.8 percent in one year.

Arkansas joined the West Virginia-led filing along with attorneys general in Florida, Idaho, Louisiana and Nebraska and the governor of Kentucky.

To sign up for the Prescription Drug Abuse Summit on Nov. 14, or for more on how Attorney General Rutledge is combating this opioid epidemic, visit ArkansasAG.gov.

Read the filing at http://bit.ly/2MPGcOt.

Arkansas to receive $1.86 million

LITTLE ROCK — Arkansas Attorney General Leslie Rutledge today announced a multistate settlement requiring Johnson & Johnson and its subsidiary Ethicon, Inc. to pay nearly $117 million for their deceptive marketing of the transvaginal surgical mesh device. An investigation of the company found violations of state consumer protection laws by misrepresenting the safety and effectiveness of the device and failing to sufficiently disclose risks associated with its use. Arkansas will receive $1,855,302.53 under the settlement.

“Arkansas moms, sisters and daughters have been deceived by false claims of Johnson & Johnson, and now they must endure irrevocable damage to their bodies,” Arkansas Attorney General Rutledge said. “This settlement confirms these victims have been heard, and I will remain diligent to protect Arkansans from companies not following the law.”

The multistate investigation found the companies misrepresented or failed to adequately disclose the product’s possible side effects, including the risk of chronic pain and inflammation, mesh erosion, incontinence developing after surgery and other complications related to the implantation of the device. Evidence shows the companies were aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the device.

Under the settlement, Johnson & Johnson has agreed to pay $116.86 million to the 41 participating states and District of Columbia. 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

Joining Arkansas in this multistate settlement are Alabama, Alaska, Arizona, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, and Wisconsin.

For Arkansans who have a consumer complaint or questions please contact the office at (800) 482-8982 or visit ArkansasAG.gov.

Says, ‘he should never hold another public office’

LITTLE ROCK – Arkansas Attorney General Leslie Rutledge released the following statement on the decision by the Arkansas House of Representatives to remove Mickey Gates as a member of the General Assembly.

“The House of Representatives rightfully removed Gates today because he selfishly chose to put his colleagues and Arkansans through this costly spectacle instead of immediately resigning,” said Attorney General Leslie Rutledge. “Gates lived on the taxpayers’ dime and violated their trust by not properly paying taxes, and therefore, he should never hold another public office.”

Says, ‘It is unacceptable for retailers to exploit our youth’

LITTLE ROCK – Arkansas Attorney General Leslie Rutledge today is taking legal action against three online e-cigarette retailers for violating State laws. By selling and shipping nicotine products and devices, including e-cigarettes, to Arkansas children without age verification, the companies are in violation of the Arkansas Deceptive Trade Practices Act (ADTPA).

“These out-of-state retailers are illegally selling vaping products online that are dangerous to Arkansas children, and it’s time to take a strong stance to stop this practice in our state,” said Attorney General Rutledge. “It is unacceptable for retailers to exploit our youth by selling vaping products to them illegally.”

General Rutledge filed lawsuits today against Utah-based BuyVapor.com, Arizona-based The Vape Co. and Minnesota-based Mystic Juice USA, LLC. While all three companies sold and shipped vape products to customers in Arkansas and failed to confirm the consumers’ ages, which are violations of state law, Mystic Juice also utilized eBay.com to avoid the legal-minimum-age-to-purchase requirements and used deception to bypass eBay’s own policy of not selling tobacco products on its platform. Rutledge sent a letter to eBay earlier this week demanding the removal of all electronic nicotine devices and products from its website.

Earlier this week, Rutledge issued an Enforcement Advisory to 100 online e-cigarette retailers, warning these retailers that it is illegal to sell or ship any tobacco products, including e-cigarettes and e-liquids, to consumers in Arkansas. The advisory warns legal action if businesses are found selling to minors over the internet.

Each ADTPA violation is subject to a fine up to $10,000 per occurrence. To report online retailers in violation of ADTPA or learn more about the dangers of youth vaping, visit ArkansasAG.gov.

Focused on practical solutions for positive change

LITTLE ROCK – Arkansas Attorney General Leslie Rutledge today hosted the Youth Vaping Summit at Bentonville High School, welcoming more than 150 educators, physicians and parents. By partnering with Arkansas Children’s and University of Arkansas Medical Sciences (UAMS), participates received first-hand information on the health risks and long term dangers e-cigarettes and nicotine can have on children and teens.

“I often hear the misconception that vaping is safer than cigarettes for children and teens. That’s simply not true,” Attorney General Rutledge said. “I am grateful we could hear the scientific facts directly from the medical leaders in our State who see the negative impact nicotine has on our impressionable children and their future.”

Participants heard from a panel of physicians who spoke on the dangers of vaping and who have experience with the impacts of vaping on youth. They specifically addressed the damage caused to children’s lungs and overall health concerns triggered by e-cigarettes.

E-liquids are under regulated and can be cut with other dangerous products that consumers are unaware of, such as toxic THC. Dr. Joe Thompson, the former Arkansas Surgeon General, spoke on the popular yet poisonous trend of using vape pods and e-cigarette devices to consume marijuana-based products.

Rutledge moderated a panel that included a lawmaker, consumer protection expert and school leaders who also discussed what can be done at the State level to help educate Arkansans on the risks of vaping, enforce the law and find solutions to better serve communities.

Earlier this week in Little Rock, General Rutledge hosted the first Youth Vaping Summit in the State. She announced a new initiative calling on e-commerce retailers including eBay, to be aware that selling tobacco products and devices to Arkansans is against the law and can subject them to fines up to $10,000 per violation. There are additional penalties for products sold to children.

For more information on the dangers of vaping in children and to view Rutledge’s new public service announcement, please visit ArkansasAG.gov.

Focused on dangers and identifying solutions to the epidemic

LITTLE ROCK – Arkansas Attorney General Leslie Rutledge today hosted the first Youth Vaping Summit in the State, welcoming over 200 to Children’s Hall at Arkansas Children’s Hospital Monday. By partnering with Arkansas Children’s and University of Arkansas for Medical Sciences (UAMS), participants received first-hand information on the health risks and long term dangers e-cigarettes and nicotine can have on children and teens.

“I often hear the misconception that vaping is safer than cigarettes for children and teens. That’s simply not true,” Attorney General Rutledge said. “I am grateful we could hear the scientific facts directly from the medical leaders in our State who see the negative impact nicotine has on our impressionable children and their future.”

Participants heard from a panel of physicians who spoke on the dangers of vaping and who have experience with the impacts of vaping on youth. They specifically addressed the damage caused to children’s lungs and overall health concerns triggered by e-cigarettes.

E-liquids are under regulated and can be cut with other dangerous products that consumers are unaware of, such as toxic THC. State Drug Director Kirk Lane spoke on the popular yet poisonous trend of using vape pods and e-cigarette devices to consume marijuana-based products.

Rutledge moderated a panel that included a lawmaker, consumer protection experts and school leaders who also discussed what can be done at the State level to help educate Arkansans on the risks of vaping, enforce the law and find solutions to better serve communities.

Prior to the Summit, General Rutledge announced a new initiative calling on e-commerce retailers including eBay, to be aware that selling tobacco products to Arkansans is against the law and can subject them to fines up to $10,000 per violation. There are additional penalties for products sold to children.

Rutledge will host the second Youth Vaping Summit at 2 p.m. on Wednesday, October 9 at Bentonville High School in northwest Arkansas. Seats are limited, but registration for the free event is available at ArkansasAG.gov/vape.

For more information about the dangers of vaping in children, please view Rutledge’s new public service announcement at ArkansasAG.gov.