Posts Tagged ‘Endo Pharmaceuticals’

Endo Pharma Faces Suit for Opioid False Claims

TN Attorney General sues opioid maker Endo Pharmaceuticals (photo courtesy Times News)

Endo Pharmaceuticals, the same company which was at the center of a $193 million settlement with one of James Hoyer’s whistleblower clients, is now facing another major legal battle. The Tennessee Attorney General is suing Endo for making unlawful and false claims about the safety and benefits of its opioid products.

The AG’s office says Endo violated the Tennessee Consumer Protection Act and contributed to a devastating health crisis in Tennessee. Here are details from the news release by Attorney General Herbert Slatery’s office:

Attorney General Herbert H. Slatery III today sued Endo Pharmaceuticals and Endo Health Solutions Inc. (Endo) for making unlawful and false claims about the safety and benefits of its opioid products.

The State’s lawsuit, filed in Knoxville, alleges Endo violated the Tennessee Consumer Protection Act and contributed to a devastating public health crisis in Tennessee.

“Our Office has conducted an extensive investigation into Endo’s unlawful marketing practices which included targeting vulnerable populations like the elderly,” said Tennessee Attorney General Herbert H. Slatery III. “Endo has repeatedly refused to take responsibility for its unconscionable conduct, which is why we are taking this action.”

The allegations in the State’s 180-page complaint detail how Endo deceptively marketed its opioid products as being less addictive and more effective than others on the market. It did this despite evidence to the contrary, including the FDA’s explicit rejection of Endo’s claim that Opana ER was resistant to abuse as well as overwhelming evidence that Opana ER was being abused throughout Tennessee.

The Complaint alleges that Endo also knew the dangers of its opioid products, including increased risks of respiratory depression and death in elderly patients, and failed to clearly disclose those risks while it specifically targeted patients in that age group.

The State also has reason to believe Endo used the recommendations and educational materials of third-party groups like the American Pain Foundation without disclosing that Endo was by far the biggest donor to the Foundation and provided more than half of its total funding. Endo provided significant funding to other third-party groups and subsequently relied on material generated by those groups without disclosing the financial relationship.

The Attorney General requested the complaint be filed under a temporary seal because Endo claims the information produced during the State’s investigation is confidential. The order sealed by the judge allows the seal to expire in 10 days unless Endo acts to extend it.

The Attorney General believes the complaint should be made available to the public in its entirety and efforts to keep it confidential will only prolong and diminish Endo’s accountability for its conduct.

 

Truth in Media Investigates Big Pharma

Judy pic - Truth in MediaThe online news website Truth in Media just finished a series of reports on Big Pharma. It’s a fascinating look at how the pharmaceutical industry has manipulated the system to increase sales and profits.

Part 4 of the series highlights the case of Endo pharmaceuticals and its orphan drug Lidoderm.  The James Hoyer Law Firm represented whistleblower Peggy Ryan in the case against Endo.  The False Claims Act suit ended with Endo paying $193-million to the government in a settlement for off-label marketing.

James Hoyer founding partner and former federal prosecutor Judy Hoyer was interviewed for the report.  Watch it below.

 

James Hoyer Law Firm Named Whistleblower Lawyers of the Year

TAF Award Group Picture

The James Hoyer team at the TAF Awards Dinner

James Hoyer is honored to have been named Whistleblower Lawyers of the Year by the Taxpayers Against Fraud or “TAF.”  TAF is a national, nonprofit organization dedicated to combating fraud against the government and protecting public resources headquartered in Washington, D.C.

James Hoyer client Peggy Ryan, whistleblower in the off-label marketing case against Endo Pharmaceuticals, was also named Whistleblower of the Year. The Endo case resulted in a $192.7 million settlement for both criminal and civil charges that the company illegally marketed a pain treatment patch called Lidoderm.

“Together, Ryan and her legal team were instrumental in bringing a $193 million dollar case against Endo Pharmaceuticals to resolution, while notching an important victory in the battle for full, fair and justified whistleblower awards,” TAF wrote in its announcement of the award. (Click here to read details on the announcement on TAF’s website.)

Hoyer Accepting Award

Chris Hoyer Accepting Award

“This is an honor we are very proud to accept as advocates fighting to hold companies accountable when they commit fraud against the government,” said Chris Hoyer, founding partner of the James Hoyer law firm. “Too often, American citizens pay the price when companies try to game the system for profit. The False Claims Act gives whistleblowers the power to fight back on behalf of all taxpayers.”

Peggy Ryan was an Endo sales representative hired to sell Lidoderm, a pain patch approved to treat a shingles complication. She became concerned when the company pressured her to sell the drug off-label. Ryan took her concerns to the government in 2005 and assisted the investigation by turning over hundreds of documents and internal voicemails. She also agreed to wear a wire for the FBI, providing government investigators and prosecutors with more than 200 hours of recorded conversations, including incriminating statements by Endo management.

Ms. Ryan was humbled to receive this award. “It’s not an easy decision to become a whistleblower, but it’s even harder to look away when you know wrongs are being committed. Ten years was a long time to see this through, but it was important to do the right thing,” Ms. Ryan said.

“Peggy Ryan was a tireless advocate for the taxpayer,” Hoyer said. “The courage it takes for an

Adam, Chris & Jesse Hoyer

Adam, Chris & Jesse Hoyer

employee to come forward and risk her career to do the right thing is rare and something we all should celebrate.”

In announcing this year’s award, TAF also pointed to the decision by Judge Robert Kelly to award Ms. Ryan close to the maximum reward for her contributions. She received 24% of the civil portion of the settlement, which amounted to $33.6 million. The judge sent a message with his decision as to how important the role of a whistleblower can be in stopping fraud and returning money to the taxpayers. The judge noted the contributions of Ms. Ryan and her legal team in the Endo case were “nothing short of extraordinary.”

An internal documentary produced by the James Hoyer law firm on the Endo case was instrumental in moving the case forward.  Watch the video below to see a video clip from the documentary.

More pictures from the awards dinner are below:

TAF Linclon

Al Scudieri & Elaine Stromgren

Al Scudieri & Elaine Stromgren

Chris Hoyer & Jillian Estes

Chris Hoyer & Jillian Estes

Chris Hoyer, Angie Moreschi, Jesse Hoyer, Jillian Estes & Adam Hoyer

Chris Hoyer, Angie Moreschi, Jesse Hoyer, Jillian Estes & Adam Hoyer

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James Hoyer Partner Speaks at Big Pharma Compliance Conference

Jillian Estes-Speaking at Pharma Congress 10-22-15-CROPPED

James Hoyer Partner Jillian Estes – speaking at 16th Annual Pharma Congress, Washington D.C.

James Hoyer Partner Jillian Estes joined other experts in qui tam litigation for a discussion of whistleblower cases against Big Pharma, at the 16th Pharmaceutical Compliance Congress and Best Practices Forum.

This summer, James Hoyer client Peggy Ryan was awarded close to the maximum percentage that a whistleblower can receive in a False Claims Act case against Endo Pharmaceuticals.  Ryan is a former sales rep for Endo and blew the whistle on the company for off-label sales of its Lidoderm pain patch.  Her award was a 24-percent share of the federal government’s civil settlement with Endo, amounting to a $33.6 million reward.

The Endo case was among the cases discussed by Estes at the Pharma Congress held in Washington D.C., the week of October 21st.  Her panel also discussed what a whistleblower law firm looks for when vetting a case– including what attributes make a person the strongest relator.  Other topics included: what factors are considered when deciding to proceed with a case if the government declines to intervene and a shift in the government’s focus from holding companies accountable to holding individuals accountable for their conduct.

The annual conference brings together top drug companies, regulators and watch dogs to discuss and improve best practices for compliance.  It featured presentations by leading government regulators, company compliance professionals, in-house counsel, prominent industry consultants, and whistleblower attorneys, like Estes.

Pharma Congress is sponsored by the Pharmaceutical Compliance Forum, a coalition of industry compliance professionals and legal counsel from more than 50 of the largest research based drug companies.

 

$33.6 Million Whistleblower Award for James Hoyer Client

RyanPic3-MS_at_Lake_2012

Peggy Ryan

In a striking decision, Endo Pharmaceuticals former employee Peggy Ryan was granted a whistleblower award close to the maximum percentage that a whistleblower can receive in a False Claims Act case. United States District Court Judge Robert Kelly in the Eastern District of Pennsylvania ruled that Ryan is entitled to a 24-percent share of the federal government’s portion of a settlement reached in 2014. The whistleblower reward amounts to $33.6 million for Ryan, a client of the James Hoyer law firm.

For her efforts, the Taxpayers Against Fraud Education Fund named Peggy Ryan Whistleblower of the Year in 2015.  Click here to read the announcement on TAF’s website.  James Hoyer was also named Whistleblower Lawyers of the Year.

Decision Marks Strong Stand for Whistleblowers

“Judge Kelly’s decision is not only a testament to Peggy’s commitment in this decade-long case, but also reaffirms the value of all whistleblowers and the False Claims Act as the government’s most powerful tool in fighting fraud,” said James Hoyer law firm managing partner Chris Casper.

The Court called Ryan’s efforts “nothing short of extraordinary” in explaining his decision. “Without the assistance of Ryan, the probability of the Government recovering any funds for the FCA violations would have been slim at best.”

The government disputed that Ryan should be entitled to 24 percent, instead arguing she should receive only 19 percent of the federal recovery. Judge Kelly sharply disagreed and indicated the government’s attempt to minimize Ryan’s significant contribution was misguided. “In light of the nature and abundance of her contributions, it is clear that Ryan was indispensable to the investigation.”

Extraordinary Contribution

The case was first filed by Ryan, a pharmaceutical rep for Endo, in 2005, after she felt the company unduly pressured her to sell the Lidoderm patch off-label for unapproved uses. She showed remarkable strength and commitment over the past 10 years, helping the government make its case.

Ryan provided insider testimony, crucial documents and analysis, and even wore a wire for the FBI. “Throughout the nine-year period from her first qui tam complaint in 2005 to the settlement in 2014, Ryan continually provided access behind the corporate walls of Endo. Ryan’s insider status, conferred by her employment with Endo, enabled the government investigatory team to recover evidence which would have otherwise been unobtainable,” Judge Kelly explained.

In addition to “hours of incriminating evidence” recorded by Ryan and a bounty of invaluable documents, Judge Kelly also cited an 18-minute documentary produced by the James Hoyer law firm, which summarized the evidence in the Endo case, as a unique tool that helped to drive the case when it began to lag in 2010.

“An examination of the record exhibits that Ryan provided not only the spark for the investigation, but that she nurtured the flame at the darkest times when the possibility of a favorable outcome seemed most remote,” Judge Kelly wrote.

The Court’s decision on Ryan’s whistleblower award came exactly 10 years and 10 days after she first filed the case. “It has been a long and sometimes difficult road, but we are gratified that Peggy’s efforts to do the right thing are being recognized in such an extraordinary way,” said attorney Casper. “We are hopeful this decision will encourage other insiders with information regarding fraud against the government to come forward on behalf of American taxpayers. “It’s not easy to be a whistleblower,” he added, “but this decision shows their efforts are valued.”

Read more on the whistleblower award and the Court’s decision from ReutersCorporate Crime Reporter, The Legal Intelligencer, and USDC – Memorandum by Judge Robert F. Kelly, Sr.