DOJ ANNOUNCES COURT INJUNCTION AGAINST MEDICAL LASER MANUFACTURER

FROM:  U.S. JUSTICE DEPARTMENT 
Friday, January 16, 2015
Federal Court Issues Preliminary Injunction Against South Dakota Medical laser Manufacturer

A federal court has barred a Rapid City, South Dakota, company and its president from further manufacturing and distributing its laser devices, which they marketed to treat a variety of medical conditions and diseases, the Justice Department announced today.

U.S. District Court Chief Judge Jeffrey L. Viken for the District of South Dakota entered the preliminary injunction on Wednesday against Robert “Larry” Lytle and his businesses, QLasers PMA, 2035 PMA, and 2035 INC., in an action filed by the Justice Department to enforce provisions of the federal Food, Drug, and Cosmetic Act (FDCA).  The court’s order prohibiting the manufacture and distribution of the QLaser devices also applies to Lytle’s business affiliates and franchisees.

Last October, the Justice Department and the U.S. Attorney’s Office for the District of South Dakota filed a civil complaint for injunctive relief against Lytle and his businesses, alleging that they have been violating the FDCA by nationally marketing Lytle’s laser devices for the treatment of more than 200 different diseases and medical disorders without clearance or approval from the U.S. Food and Drug Administration (FDA).  The preliminary injunction entered on Wednesday takes effect immediately and will remain in force while the government’s case seeking a permanent injunction proceeds to final judgment.

Judge Viken found, based on what he called an “extensive and well developed record,” that Lytle and his various businesses “have shown no intent to discontinue their activities and voluntarily comply with the FDCA.  “The injunction bars the defendants from continuing to market and distribute any medical devices until they receive written permission from the FDA to do so.

Lytle, whom the court noted was a dentist in Rapid City until his license to practice dentistry was permanently revoked by the South Dakota Board of Dentistry in 1998, markets the devices by soliciting purchasers to join his “private membership associations” or “PMAs” before purchasing his lasers.  As the court explained, however, “Hiding behind a curtain of private membership associations, 2035 PMA and QLaser PMA, does not shield Mr. Lytle from the authority of the FDCA or the jurisdiction of the court.”

“With the entry of this preliminary injunction, we have taken another step toward ensuring that only medical devices that have been shown to be safe and effective are placed in the hands of the American consumer,” said Acting Assistant Attorney General Joyce R. Branda for the Justice Department’s Civil Division.  “Everyone who deals in products that affect people’s health must comply with the FDCA.”

According to court documents filed in the case, the defendants have been distributing the QLaser devices with labeling that contains false and misleading claims, touting their use in treating such serious conditions as cancer, HIV/AIDS, venereal disease and diabetes.  Although two of his laser devices were FDA-cleared for providing temporary relief of pain associated with osteoarthritis of the hand, none of the devices has been cleared or approved to treat any other medical conditions.  The government alleges that not only are there no published clinical studies to support the use of Lytle’s lasers to treat other serious medical conditions, but that in fact, using the devices according to the device’s labeling could be dangerous to health.  The court’s order finds that the United States is substantially likely to succeed on the merits on this claim and the others within the government’s complaint.

“The preliminary injunction granted should provide consumers a renewed sense of confidence,” said U.S. Attorney Brendan V. Johnson for the District of South Dakota.  “This action is crucial to prevent the company from continuing to operate on the periphery of the law, and potentially jeopardize the health and safety of its consumers.”

The FDA referred this enforcement action to the Department of Justice.  The government’s case is being litigated by Trial Attorney Ross S. Goldstein of the Civil Division’s Consumer Protection Branch, with assistance from the U.S. Attorney’s Office for the District of South Dakota and the FDA’s Office of Chief Counsel.

CDC SAYS E-CIGARETTES, HOOKAHS GAINING POPULARITY WITH STUDENTS

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION
Press Release Emerging tobacco products gaining popularity among youth
Increases in e-cigarette and hookah use show need for increased monitoring and prevention

Emerging tobacco products such as e-cigarettes and hookahs are quickly gaining popularity among middle- and high-school students, according to a report in this week’s Morbidity and Mortality Weekly Report.

While use of these newer products increased, there was no significant decline in students’ cigarette smoking or overall tobacco use. Data from the 2012 National Youth Tobacco Survey (NYTS) show that recent electronic cigarette use rose among middle school students from 0.6 percent in 2011 to 1.1 percent in 2012 and among high school students from 1.5 percent to 2.8 percent. Hookah use among high school students rose from 4.1 percent to 5.4 percent from 2011 to 2012.

The report notes that the increase in the use of electronic cigarettes and hookahs could be due to an increase in marketing, availability, and visibility of these tobacco products and the perception that they may be safer alternatives to cigarettes. Electronic cigarettes, hookahs, cigars and certain other new types of tobacco products are not currently subject to FDA regulation. FDA has stated it intends to issue a proposed rule that would deem products meeting the statutory definition of a "tobacco product" to be subject to the Federal Food, Drug, and Cosmetic Act.

Another area of concern in the report is the increase in cigar use among certain groups of middle and high school students. During 2011-2012, cigar use increased dramatically among non-Hispanic black high school students from 11.7 percent to 16.7 percent, and has more than doubled since 2009. Further, cigar use among high school males in 2012 was 16.7 percent, similar to cigarette use among high school males (16.3 percent).

“This report raises a red flag about newer tobacco products,” said CDC Director Tom Frieden, M.D., M.P.H. “Cigars and hookah tobacco are smoked tobacco – addictive and deadly. We need effective action to protect our kids from addiction to nicotine.”

WYETH PHARMACEUTICALS AGREES TO PAY $490.9 MILLION FOR MARKETING DRUG FOR UNAPPROVED USES

FROM:  U.S. DEPARTMENT OF JUSTICE 

Tuesday, July 30, 2013
Wyeth Pharmaceuticals Agrees to Pay $490.9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses

Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer, Inc. in 2009, has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the U.S. Food and Drug Administration (FDA), the Justice Department announced today.  Rapamune is an “immunosuppressive” drug that prevents the body’s immune system from rejecting a transplanted organ.

 “FDA’s drug approval process ensures companies market their products for uses proven safe and effective,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division.  “We will hold accountable those who put patients’ health at risk in pursuit of financial gain.”

 The Federal Food, Drug and Cosmetic Act (FDCA) requires a company such as Wyeth to specify the intended uses of a product in its new drug application to the FDA.  Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses.  In 1999, Wyeth received approval from the FDA for Rapamune use in renal (kidney) transplant patients.  However, the information alleges, Wyeth trained its national Rapamune sales force to promote the use of the drug in non-renal transplant patients.  Wyeth provided the sales force with training materials regarding non-renal transplant use and trained them on how to use these materials in presentations to transplant physicians.  Then, Wyeth encouraged sales force members, through financial incentives, to target all transplant patient populations to increase Rapamune sales.

“The FDA approves drugs for certain uses after lengthy clinical trials,” said Sanford Coats, U.S. Attorney for the Western District of Oklahoma.  “Compliance with these approved uses is important to protect patient safety, and drug companies must only market and promote their drugs for FDA-approved uses.  The FDA approved Rapamune for limited use in renal transplants and required the label to include a warning against certain uses.  Yet, Wyeth trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales.  This was a systemic, corporate effort to seek profit over safety.  Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties.”

Wyeth has pleaded guilty to a criminal information charging it with a misbranding violation under the FDCA.  The resolution includes a criminal fine and forfeiture totaling $233.5 million.  Under a plea agreement, which has been accepted by the U.S. District Court in Oklahoma City, Wyeth has agreed to pay a criminal fine of $157.58 million and forfeit assets of $76 million.

The resolution also includes civil settlements with the federal government and the states totaling $257.4 million.  Wyeth has agreed to settle its potential civil liability in connection with its off-label marketing of Rapamune.  The government alleged that Wyeth violated the False Claims Act, from 1998 through 2009, by promoting Rapamune for unapproved uses, some of which were not medically accepted indications and, therefore, were not covered by Medicare, Medicaid and other federal health care programs.  These unapproved uses included non-renal transplants, conversion use (switching a patient from another immunosuppressant to Rapamune) and using Rapamune in combination with other immunosuppressive agents not listed on the label.  The government alleged that this conduct resulted in the submission of false claims to government health care programs.  Of the amounts to resolve the civil claims, Wyeth will pay $230,112,596 to the federal government and $27,287,404 to the states.  

“Wyeth’s conduct put profits ahead of the health and safety of a highly vulnerable patient population dependent on life-sustaining therapy,” said Antoinette V. Henry, Special Agent in Charge, Metro-Washington Field Office, FDA Office of Criminal Investigations.  “FDA OCI is committed to working with the Department of Justice and our law enforcement counterparts to protect public health.”

Pfizer is currently subject to a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services’ Office of Inspector General that it entered in connection with another matter in 2009, shortly before acquiring Wyeth.  The CIA covers former Wyeth employees who now perform sales and marketing functions at Pfizer.  Under the CIA, Pfizer is subject to exclusion from federal health care programs, including Medicare and Medicaid, for a material breach of the CIA, and the company is subject to monetary penalties for less significant breaches.

“We are committed to enforcing the laws protecting public health, taxpayers and government health programs, and to promoting effective compliance programs,” said Daniel R. Levinson, Inspector General, Department of Health and Human Services.  “Our integrity agreement with Pfizer, which acquired Wyeth, includes required risk assessments, a confidential disclosure program, and auditing and monitoring to help prospectively identify improper marketing.”

 The civil settlement resolves two lawsuits pending in federal court in the Western District of Oklahoma under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and share in any recovery.  The first action was filed by a former Rapamune sales representative, Marlene Sandler, and a pharmacist, Scott Paris.  The second action was filed by a former Rapamune sales representative, Mark Campbell.  The whistleblowers’ share of the civil settlement has not been resolved.

 "The success obtained in this case is an excellent example of how we address the threats to our nation’s health care system; the importance of the public reporting of fraud, waste, or abuse; and the significant results that can be obtained through multiple agencies cooperating in investigations,” said James E. Finch, Special Agent in Charge of the Oklahoma City Division of the FBI.

 The criminal case was handled by the U.S. Attorney’s Office for the Western District of Oklahoma (USAO) and the Justice Department’s Civil Division, Consumer Protection Branch.  The civil settlement was handled by USAO and the Justice Department’s Civil Division, Commercial Litigation Branch.  The Department of Health and Human Services’ (HHS) Office of Counsel to the Inspector General; the HHS Office of General Counsel, Center for Medicare and Medicaid Services; the FDA’s Office of Chief Counsel; and the National Association of Medicaid Fraud Control Units.  These matters were investigated by the FBI; the FDA’s Office of Criminal Investigation; HHS’ Office of Inspector General, Office of Investigations and Office of Audit Services; the Defense Criminal Investigative Service; the Office of Personnel Management’s Office of Inspector General and Office of Audit Services; the Department of Veterans’ Affairs’ Office of Inspector General; and TRICARE Program Integrity.

 Except for conduct admitted in connection with the criminal plea, the claims settled by the civil agreement are allegations only, and there has been no determination of civil liability.  The civil lawsuits are captioned United States ex rel. Sandler et al v. Wyeth Pharmaceuticals, Inc., Case No. 05-6609 (E.D. Pa.) and United States ex rel. Campbell v. Wyeth, Inc., Case No. 07-00051 (W.D. Okla.).