Posts Tagged ‘Endo Pharmaceuticals’

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.

 

James Hoyer Client Named Sole Whistleblower in $193M Settlement

A federal judge has ruled former Endo Pharmaceuticals Sales Representative Peggy Ryan is the sole whistleblower eligible for a portion of the company’s $193 million off-label marketing settlement, announced in February by the U.S. Justice Department.   Ryan is represented by the James Hoyer Law Firm.

The order was issued by Senior Judge Robert Kelly of the U.S. District Court for the Eastern District of Pennsylvania.  Judge Kelly granted Ryan’s motion for Relator’s Share and denied the requests of two other later-filed Relators, Max Weathersby and Gursheel Dhillon.

“Ryan supplied the Government with the initial notification of Defendants’ fraudulent activities and then proceeded to go to extraordinary lengths to provide further information to aid the Government in prosecuting the FCA (False Claims Act) action.  In light of this contribution and legal justifications presented by Ryan, it is our holding that Ryan is the sole Relator eligible to receive the settlement award.” Judge Kelly wrote.

Judge Kelly said his decision was based upon “the extensive role Ryan played” and serves to “promote the intent of the FCA” which is “to provide incentives to relators to ‘promptly alert the government to the essential facts of a fraudulent scheme.’”  He went on to say, “In the context of this objective, it is apparent that allowing multiple relators to share in the recovery for the same claim would drastically decrease the incentive for a ‘whistleblower’ to promptly bring a qui tam action.”

“In addition to filing the first Complaint in this matter, Ryan also provided extensive assistance in the investigation of Defendants’ fraudulent activities by serving as a confidential source in the Government’s covert criminal investigation of Defendants over a several year period beginning in 2005,” Judge Kelly also wrote in the Order.

He cited a statement submitted on Ryan’s behalf by the retired FBI agent with whom Ryan and the James Hoyer Law Firm worked closely throughout the investigation. “During the course of the investigation, Ryan provided the FBI with Defendants’ off-label sales and training materials, and with over two hundred (200) hours of recorded conversations with employees of Defendants concerning off-label sales.”

Click here to read Financial Writer Al Lewis’ story on Ryan and here for his article on The Wall Street Journal’s MarketWatch.

Returning Money to Taxpayers

Endo Health Solutions and its subsidiary Endo Pharmaceuticals, Inc. agreed to pay $192.7 million in February of 2014 to settle civil and criminal charges that stemmed from Ryan’s suit.  Ryan alleged the company illegally marketed a pain treatment patch called Lidoderm for ailments far beyond its approved use.

The off-label marketing led to hundreds of millions of dollars in improper Medicaid and Medicare payments.  This settlement serves to return a portion of that money to the taxpayer.  From the total settlement, $21 million is allocated to resolve the criminal charges, and $172 million will go to settle civil charges under the state and federal False Claims Acts.

The Whistleblower

Ms. Ryan was an Endo sales person hired in 2002 to sell Lidoderm.  She became concerned when the company pressured her to sell the drug off-label.  The pain patch was only approved to treat symptoms of postherpetic neuralgia, a rare disease which is a complication of Shingles.  “Lidoderm had not been proven safe or effective for other uses, but the company pushed me and all the other sales people to sell Lidoderm for everything from low back pain, to carpel tunnel syndrome to neuralgia, and I just did not feel comfortable doing that,” Ryan said.

After filing suit, Ryan was enlisted to aid the FBI in its investigation.  She turned over hundreds of documents, internal voicemails, and even wore a wire for the FBI, recording hundreds of hours of conversations with supervisors.

“Peggy Ryan was a tireless advocate for the taxpayer,” said Chris Hoyer, Founding Partner of the James Hoyer Law Firm.  “She worked closely with the FBI and Department of Justice for nearly a decade providing invaluable testimony and evidence.”

The Settlement

In addition to the monetary portion, the settlement also includes a deferred prosecution agreement, in which Endo admitted that it intended that Lidoderm be used for unapproved indications and that it promoted Lidoderm to health care providers for those unapproved indications, according to the Department of Justice.   As part of the settlement, Endo agreed to enter into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General that requires the company to implement measures designed to avoid or promptly detect conduct similar to that which led to this resolution.

The False Claims Act

The False Claims Act allows private citizens to bring civil actions on behalf of the government in order to recover taxpayer money when fraud is suspected.    Under the law, the whistleblower is entitled to a 15-30% share of a civil recovery.  Ryan’s share of the settlement has yet to be determined.

“Whistleblowers, like Peggy Ryan, are to be commended for their bravery and perseverance,” Attorney Hoyer said.  “It’s very easy for a private citizen who sees wrong-doing to look the other way, but Peggy didn’t do that. She did the right thing, and with her help, the taxpayers will now receive restitution from Endo Pharmaceuticals.”