Attorney General Bob Cooper And 44 Attorneys General Reach $105 Million Settlement With GlaxoSmithKline Concerning Asthma Drug Advair

Wednesday, June 04, 2014

Attorney General Bob Cooper announced a settlement that signals a major change in the way pharmaceutical sales teams are motivated and paid for the ultimate benefit of consumers.  The 45 Attorneys General led by a bipartisan leadership committee have reached a $105 million settlement with GlaxoSmithKline, LLC to resolve allegations that GlaxoSmithKline unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin. Tennessee will receive $3 million for the Attorney General’s work on the leadership committee of this multistate consumer protection investigation.

The complaint and agreed final judgment filed today in Davidson County Circuit Court alleges that GlaxoSmithKline violated state consumer protection laws by misrepresenting the uses and qualities of these drugs. In particular, the complaint alleges that GSK used false and misleading representations to promote Advair as a first line treatment for all asthma patients, including mild asthma patients who only occasionally needed a rescue inhaler. Furthermore, GSK allegedly provided financial incentives to GSK sales representatives to deceptively promote Advair for mild asthma patients.

“We appreciate the cooperative work of all the states participating in this consumer protection investigation,” Attorney General Cooper said. “My office remains vigilant in its efforts to stop deceptive marketing practices by some drug companies which may lead to unnecessary, expensive drugs and risk the health of Tennesseans.”

The agreed final judgment also requires GlaxoSmithKline to reform its marketing and promotional practices. Specifically, GSK shall not:

·         Make, or cause to be made, any written or oral claim that is false, misleading, or deceptive about any GSK product;

·         Make promotional claims, not approved or permitted by the FDA that a GSK product is better, more effective, safer, or has less serious side effects or contraindications than has been demonstrated by substantial evidence or substantial clinical experience;

·         Present favorable information or conclusions from  a study that is inadequate in design, scope  or conduct to furnish significant support for such information or conclusions, when presenting information about a clinical study regarding GSK products in any promotional materials;

·         Provide samples of GSK products to those health care professionals who are not expected to prescribe the sampled GSK products for an approved use, but who would be expected to prescribe the sampled products for an off-label use; or

·         Disseminate information describing any off-label use of a GSK product, unless such information and materials are consistent with applicable FDA regulations and FDA Guidances for Industry. 

The agreed final judgment also requires GSK to continue its Patient First Program at least through March 2019. The Patient First Program reduces financial incentives for sales representatives to engage in deceptive marketing. In addition, the judgment requires scientifically-trained personnel to be ultimately responsible for developing and approving responses to health care provider questions and for these responses to be unbiased and non-promotional.

The State’s Complaint and Agreed Final Judgment may be viewed by going online to www.tn.gov/attorneygeneral and clicking on “Filings of Interest.”

Consumers may file complaints regarding prescription drug advertisements or any other deceptive conduct by going online to www.tn.gov/consumer or calling the TDCI Division of Consumer Affairs at (615) 741-4737 or toll-free in Tennessee at 1-800-342-8385.




Attorneys Batts And Taylor Elected To Lead State Drug Court Association

The Tennessee Association of Drug Court Professionals has elected attorneys Kevin Batts and Richard Taylor to leadership positions in the statewide group. Mr. Batts will serve as president and Mr. Taylor will serve as vice president of the association in 2015. Mr. Batts is director of the Drug Court in the 23rd Judicial District, serving five counties of Middle Tennessee. He ... (click for more)

Karen Tindell And Kelly Still Join Southern Community Bank

Robert Stahl, Chattanooga city president of Southern Community Bank, announced Karen Tindell and Kelly Still have joined the Chattanooga branch. “Karen joins the staff as assistant vice president and Kelly joins the staff as a commercial lender,” said Mr. Stahl.  “Together Karen and Kelly collectively have over 50 years’ experience in the financial industry with regional ... (click for more)

2 Suspects Sought In Armed Robbery At Highway 153 Long John Silver's

Police are searching for two suspects in an armed robbery that happened Friday morning. At approximately  8:10  a.m. the Chattanooga Police Department responded to 5317 Highway 153 for a robbery at the Long John Silver's.  Officers discovered that two black men, wearing hoodies and masks, entered the Long John Silver's and forced the assistant manager ... (click for more)

Pair Charged With Beating Man With Stick, Taking His Wallet

Two men are charged with beating a man with a large stick while he slept on the steps of a downtown church, then taking his wallet. Jerry Quincy Allen, 45, and James Leo Boas, 40, both of 727 E. 11th St., are charged with aggravated robbery. In the incident on Wednesday, Bradley Casehart said he and a friend were asleep at Tompkin Chapel Church on Palmetto Street. He ... (click for more)

Please Don't Close The Piccadilly Cafeteria At Hamilton Place - And Response

Oh, no. The Piccadilly Cafeteria at Hamilton Place is closing.  Its last day is Christmas Eve.  I will miss the great food they have there but most of all I will miss their servers, cashiers and waitresses.  They are all so friendly and accommodating.  They make it like it’s a home-style restaurant. I sure wish there was some way that Hamilton Place and ... (click for more)

Roy Exum: ‘Scrooge’ Of The Year

As we move into the last weekend before Christmas, the “Scrooge of the Year” has just appeared in Aurora, Ill. Actually Connie Ley has just died. She passed away on Nov. 25, but in her wake left the worst will many around the country have ever heard – her last wishes included that her nine-year-old dog should be put to death, cremated, and buried with her. Bela, a beautiful German ... (click for more)