Legal questions swirl about off-label use of medications

CONSUMER FORUM

By Russ Van Arsdale, executive director Northeast CONTACT

Posted Aug. 23, 2015, at 1:38 p.m.

Maine is among the states that will share in a $71 million settlement of the lawsuit against drug manufacturer Amgen.

Click image to see other Off-Label decisions on the DOJ site

The states bringing the suit alleged Amgen promoted biologic medications Aranesp and Enbrel for off-label uses. Their complaint said the company promoted the use of Aranesp for longer periods than the U.S. Food and Drug Administration approved.

The complaint also charged that Amgen claimed Aranesp could fight anemia caused by cancer without having either FDA approval or scientific research to support that claim.

The complaint said the company also promoted Enbrel as effective in treating mild plaque psoriasis; the FDA has approved use of the drug only to treat chronic-moderate to severe plaque psoriasis. The complaint also charged that Amgen overstated the length of time Embrel was effective in treating psoriasis.

The settlement was announced last week by several state attorneys general. In a statement, Amgen said the settlement resolves some of the same matters as in a 2012 settlement with the federal government. Under the settlement with the states, Amgen did not admit any wrongdoing or liability.

Maine also was a party to the December 2012 settlement. A U.S. Department of Justice news release at that time said the company paid $612 million to resolve lawsuits under the False Claims Act and $150 million in criminal penalties and forfeiture.

In its statement sent to Northeast CONTACT, Amgen said, “separate state and federal resolutions of the same underlying issues is the normal practice in such legal matters.”

The company added it has a “strong compliance program, and our management is dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law.”

The company also says all Aranesp-related conduct that riled regulators took place during the years 2002 and 2007; it says all Enbrel-related conduct happened between 2004 and 2011.

Over the years, pharmaceutical companies have handed over billions of dollars to settle claims of misbehavior. Federal regulators don’t want drug company reps talking to doctors about off-label uses of drugs; manufacturers have maintained they should be able to have such conversations, as long as they are truthful.

In May, Amarin Pharma filed suit against the FDA, saying it had a constitutional right to share information with doctors. Lawyers for the company say they believe it is the first time the FDA has been sued pre-emptively over the free speech issue.

Floyd Abrams, attorney for Amarin, put it this way in an interview with Business Day: “If you tell the truth — if you’re not misleading — then the First Amendment protects you when you provide this sort of information.”

Dr. Michael Carome of the advocacy group Public Citizen holds the opposite view.

“If this lawsuit were to succeed, it would be devastating for drug safety and undermine the drug approval process,” Carome said.

If it goes that far, a court might rule either broadly or narrowly, making an outcome tough to predict. Consumers can best protect themselves by carefully reading the data sheets that come with their prescription meds. If what your doctor tells you doesn’t match the intended uses in the instructions, start asking questions.

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer, ME 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.

MoneyGram settlement – WABI-TV

The U.S. Department of Justice has reached a settlement earlier this month that could award consumers of MoneyGram $100 million. These consumers are mostly in United States and Canada who fell victim to wire fraud.

People who may have fallen victim to wire fraud from MoneyGram can check the U.S. Department of Justice website at  justice.gov/criminal/vns/caseup to get information on how to file a claim. If you have questions or need to file a claim, and can’t access the information available online you can call 1-877-282-2610.

Watch Russ and Joy’s discussion.

 

MoneyGram settlement could mean payout for scam victims – Bangor Daily News

CONSUMER FORUM

By Russ Van Arsdale, executive director, Northeast Contact
Posted Nov. 23, 2012, at 12:41 p.m.

Over the years, Northeast CONTACT has received complaints from Maine consumers about all kinds of fraud schemes: calls from “relatives” needing cash fast, promising big cash awards or lottery payouts, or working as “secret shoppers.” It turns out a number of those calls were likely from MoneyGram agents who were breaking the law.

MoneyGram International Inc. has agreed to a $100 million settlement of charges that it criminally aided and abetted wire fraud and failed to maintain an effective anti-money laundering program. If you lost money to a scam involving a MoneyGram agent, you may be entitled to some compensation.

Federal Department of Justice (DOJ) prosecutors say the global money services firm with headquarters in Dallas allowed the rip-offs to go on from 2004 until 2009. And the DOJ news release earlier this month pulled no punches.

“MoneyGram knowingly turned a blind eye to scam artists and money launderers who used the company to perpetrate fraudulent schemes targeting the elderly and other vulnerable victims,” said Assistant Attorney General Lanny A. Breuer. Tens of thousands of U.S. and Canadian customers were hoaxed, and complaints grew from 1,575 reported instances of fraud in 2004 to 19,614 instances in 2008. In all, the reported fraud topped $100 million.

Many of those complaints were investigated by MoneyGram’s fraud department, which apparently was routinely overruled by the sales department. DOJ pointed to an April 2007 meeting attended by senior MoneyGram execs in which the fraud department identified 32 of the “worst of the worst” Canadian outlets and recommended they be closed. Sales disagreed. The outlets were not closed and, while the complaints piled up, MoneyGram kept processing transactions from those outlets.

MoneyGram executives have agreed to take a number of steps, including:

• Adopting rules to ensure that company agents at a minimum meet U.S. anti-money laundering standards;

• Adopting tougher due diligence for agents termed high-risk or operating in high-risk areas;

• Creating an independent compliance and ethics committee of the board of directors, overseen by the chief compliance officer and compliance program;

• Setting up a bonus system rating all executives on success of the new compliance requirements (failure would make that executive ineligible for a bonus that year).

MoneyGram has also agreed to hire an independent corporate monitor, who will report regularly to DOJ on the effectiveness of the anti-fraud and anti-money laundering efforts. All of this is spelled out in a deferred prosecution agreement; if MoneyGram lives up to the terms for five years, DOJ will recommend dismissing the criminal information filed in court this month.

In 2009, MoneyGram paid $18 million to settle claims by the Federal Trade Commission that it allowed its money transfer system to be used by fraudulent telemarketers to bilk consumers out of millions of dollars. Part of that settlement required MoneyGram to set up a comprehensive anti-fraud program.

DOJ says it will post information about redress on its website atwww.justice.gov/criminal/vns/caseup/. In the meantime, people who believe they were victimized between 2004 and 2009 can provide their contact information by calling toll-free 1-877-282-2610 (it’s a toll call internationally, 317-324-0390).

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.