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Rutledge Reaches Settlement Over Illegal Promotion of Hip Implants

Rutledge Reaches Settlement Over Illegal Promotion of Hip Implants

Tue, Jan 22, 2019

Arkansas to receive $1.7 million

LITTLE ROCK – Arkansas Attorney General Leslie Rutledge today announced she has joined 45 attorneys general to reach a $120 million settlement with Johnson & Johnson and its wholly-owned subsidiary DePuy Orthopaedics, Inc. to settle allegations that DePuy unlawfully promoted its metal-on-metal hip implant devices. Arkansas will receive $1.7 million in the settlement.

“Today’s settlement helps to ensure that doctors and patients have necessary and accurate information when considering implant options,” said Attorney General Rutledge. “Surgeons who implant devices like these metal-on-metal hip replacement systems need to have the most up-to-date information concerning patient outcomes.”

The Attorneys General allege that DePuy engaged in deceptive practices in its promotion of the ASR XL and Pinnacle Ultamet hip implant devices by making misleading claims as to the longevity, also known as survivorship, of metal-on-metal hip implants. DePuy advertised that the ASR XL hip implant had a survivorship of 99.2% at three years when the National Joint Registry of England and Wales reported a 7% revision rate at three years. Similarly, DePuy promoted the Pinnacle Ultamet as having a survivorship of 99.8% and 99.9% survivorship at five years when the National Joint Registry of England and Wales reported a 2.2% three year revision rate in 2009 increasing to a 4.28% five year revision rate in 2012.

Some patients who required hip implant revision surgery to replace a failed implant experienced persistent groin pain, allergic reactions, tissue necrosis, as well as a build-up of metal ions in the blood. The ASR XL was recalled from the market in 2010. DePuy discontinued its sale of the Pinnacle Ultamet in 2013.

As part of the settlement, DePuy has agreed to reform how it markets and promotes its hip implants, including:

  • Advertised claims of survivorship, stability or dislocations will be based on scientific information and the most recent dataset available from a registry for any DePuy hip implant device.
  • Maintain a post market surveillance program and complaint handling program.
  • Update and maintain internal product complaint handling operating procedures including training of complaint reviewers.
  • Update and maintain processes and procedures to track and analyze product complaints that do not meet the definition of medical device reportable events.
  • Maintain a quality assurance program that includes an audit procedure for tracking complaints regarding DePuy products that do not rise to the level of a medical device reportable event but that may indicate a device-related serious injury or malfunction.
  • Perform quarterly reviews of complaints and if a subgroup of patients is identified that has a higher incidence of adverse events than the full patient population, determine the cause and alter promotional practices as appropriate.

Arkansas was joined in the settlement, which was led by South Carolina and Texas, by Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, Washington, and Wisconsin.

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Rutledge Honors Dr. Martin Luther King Jr.

Rutledge Honors Dr. Martin Luther King Jr.

Mon, Jan 21, 2019

LITTLE ROCK – Arkansas Attorney General Leslie Rutledge released a statement today in observance of the Dr. Martin Luther King Jr. day of service.

“Dr. Martin Luther King Jr. Day is a time for all Americans to reflect on the work of a man who was tireless in his dedication to freedom and justice for all,” said Attorney General Rutledge. “Communities around Arkansas will pause today to reflect and celebrate Dr. King and his dream of equality for citizens across the country. But today is not only a day of remembrance; it is also a day to honor his memory by giving back and serving our communities where it is needed most.”

Rutledge attended the Arkansas Dr. Martin Luther King, Jr. Commission’s Interfaith Prayer Breakfast at the Saint Mark Baptist Church in Little Rock.

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Rutledge Reaches Settlement for Illegal Diesel Emissions

Rutledge Reaches Settlement for Illegal Diesel Emissions

Thu, Jan 17, 2019

Arkansas to receive more than $1.5 million in settlements with Fiat Chrysler and Bosch

LITTLE ROCK – Arkansas Attorney General Leslie Rutledge has reached two settlements in the form of consent judgments requiring Fiat Chrysler and auto supplier Bosch to pay a total of $171.2 million nationwide for their roles in selling and leasing diesel vehicles equipped with illegal and undisclosed defeat device software.

“Fiat Chrysler is being held accountable for cheating on emissions testing, and Bosch is answering for its role in providing the software,” said Attorney General Rutledge. “I will continue to hold automobile makers and their suppliers accountable for wrongful and deceptive conduct.”

Following a nearly two-year investigation, Rutledge, with 51 jurisdictions nationwide, filed suit against Fiat Chrysler and its subsidiaries, for having installed unlawful defeat device software and undisclosed auxiliary emissions control devices in several models of its diesel vehicles. The attorneys general found that Fiat Chrysler cheated on federal and state emissions tests by calibrating the software to conceal that vehicles emitted higher than permitted levels of harmful nitrogen oxides in real-world driving conditions, and misled consumers by falsely claiming some vehicles were environmentally friendly.

After a separate but related investigation, Rutledge, along with 49 other jurisdictions, filed suit against Bosch which is the engineering company that supplies Fiat Chrysler and other automobile manufacturers with electronic control units housing the complex software that controls nearly all aspects of an engine’s performance, including emissions systems. The investigation concluded that Bosch facilitated the implementation of the defeat device software in more than 600,000 Volkswagen and Fiat Chrysler vehicles over a period of more than 10 years.

Under the terms of the two settlements, Fiat Chrysler will pay a total of $72.5 million to the litigating jurisdictions for consumer and environmental violations, with Arkansas receiving $763,750. Bosch will pay $98.7 million, with $737,100 for Arkansas.

The settlement requires Fiat Chrysler to eliminate the defeat device features through a software “flash fix”; provide eligible owners and lessors extended warranties; and, together with co-defendant Bosch, pay eligible owners who take their vehicle to an authorized dealer for the software repair an average restitution payment of approximately $2,908 and lessees and former owners who do so restitution of $990. Fiat Chrysler is also prohibited from engaging in future unfair or deceptive acts and practices in connection to its dealings with consumers.

Bosch has also agreed to injunctive terms and to maintain robust processes to monitor compliance and must refuse to accommodate requests for software development and programming that could result in the installation of defeat device software.

Rutledge reached a settlement with Volkswagen in 2016 on similar allegations.

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Rutledge Announces Pulaski County Man Sentenced for Possessing Child Pornography
Rutledge Takes Oath of Office for Second Term as Attorney General

Rutledge Takes Oath of Office for Second Term as Attorney General

Tue, Jan 15, 2019

Says, ‘true honor to pursue justice, good and right’

LITTLE ROCK – Arkansas Attorney General Leslie Rutledge issued a statement following having been sworn in for her second term as Attorney General today.

“Serving the people of Arkansas as Attorney General has been a true honor to pursue justice, good and right,” said Attorney General Rutledge. “As we begin the next four years, I remain committed to increasing economic and educational opportunities for our families and keeping our most vulnerable children and seniors safe from predators. I will continue making the State more efficient and effective by expanding services and accessibility while decreasing the budget. On behalf of Boyce, Julianna and me, thank you, Arkansas families, for trusting me with these great responsibilities.”

Rutledge took the oath of office in the Chamber of the Arkansas State Capitol House of Representatives while her parents Keith and Nancy Rutledge, her brother Alan Rutledge and niece Kylie Rutledge as well as several other family members and friends observed from the House Gallery. She was escorted onto the House floor by her husband, Boyce Johnson who held their five-month old daughter Julianna and the family Bible.

In December 2015, Rutledge announced her marriage to Johnson and in July 2018, Rutledge announced the birth of their daughter, Julianna. Rutledge is the first constitutional officer of Arkansas to give birth while holding office, and also the first female and first Republican elected to the Office of Attorney General in Arkansas.

Rutledge joined Governor Asa Hutchinson, Lieutenant Governor Tim Griffin, Secretary of State John Thurston, Auditor of State Andrea Lea, Treasurer of State Dennis Milligan and Commissioner of State Lands Tommy Land at today’s inaugural ceremonies.

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Rutledge Joins President Trump for Roundtable Discussion on Border Security and Safe Communities

Rutledge Joins President Trump for Roundtable Discussion on Border Security and Safe Communities

Fri, Jan 11, 2019

WASHINGTON, D.C. – Arkansas Attorney General Leslie Rutledge participated today in a roundtable discussion with President Donald J. Trump on border security, illegal immigration and the dangers facing our communities nationwide that have been created at our southern border.

“President Trump understands that our Nation's security must be a top priority and that Congress must provide funding to protect our borders,” said Attorney General Rutledge. “It is imperative for the United States to restore security and the integrity of our immigration system. Every Arkansan and American is less safe following decades of failed policies, and it is time for Congress to fund not only the border wall, but also new technology and reinforcement for our border patrol agents.”

Rutledge’s top priority as attorney general is keeping Arkansans safe. The southern border is overwhelmed with illegal immigration, gang violence, crime, drugs and human trafficking, which disperse across the United States and into Arkansas. Rural America is particularly impacted because the border crisis has empowered cartels and drug trafficking. Rutledge has worked alongside Arkansas law enforcement leadership to combat the opioid crisis and identify ways to better serve those providing an essential service.

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