Posts Tagged ‘US Department of Justice’

Legal questions swirl about off-label use of medications

CONSUMER FORUM

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.

Look out for phony charities

CONSUMER FORUM

By Russ Van Arsdale, Executive Director, Northeast CONTACT
Posted Dec. 30, 2012, at 8:11 p.m.

As the end of the year approaches, many of us are thinking about charitable donations. Let’s face facts: Many donations are tax deductible, and many of us need all the deductions we can get.

Of course, the real reason to give is to support a cause that really needs your help. So, make sure when you give, that your money is going where you intend it to go.

That means staying away from nonprofits that may exist more for the benefit of professional fundraisers or overpaid executives than for people that really need help. Unfortunately, there are far too many of these types of “charities” around.

Some are created in response to natural disasters. “Storm chasers,” as they have become known, create websites even before a major storm strikes. The sites contain key words, like “relief,” to attract web searches. They have varying records in their effectiveness in providing real help to those in need after a storm.

The IRS issued reminders earlier this month, after more than 1,000 “relief” websites popped up following Hurricane Sandy:

  1. Give to recognized charities, and beware of sound-alike names (visit the IRS website, www.irs.gov, to find bona fide charities to which contributions are deductible).
  1. Don’t give out your financial or personal information, if you can’t be sure that data won’t be misused.
  1. Don’t give cash. Make donations by check, credit card or some other way that can be documented. And never make out a check in the name of the solicitor.

Scammers may claim to be affiliated with known organizations; sometimes they even use the official logo of a government or relief organization to gain a target’s trust.

Do your own research to be sure you know where your money is going. Keep your scam radar on high: Refuse solicitors who won’t answer questions about their cause; don’t give in to high pressure pitches; and if it’s a telephone solicitation, ask if the caller is a paid solicitor and, if so, what percent of money raised actually goes to the cause. You can always ask that your name be removed from a call list.

Scammers work other angles, too. Some file claims for storm damage that never occurred. Others claim to be doctors and ask for funds “to pay medical bills of injured people.” Once you give in to a phony solicitor, you can bet your name will be shared with other scammers.

Check websites like Charity Navigator and Guidestar that rate the effectiveness of charities. The Better Business Bureau’s Wise Giving Alliance is another resource.

In Maine, check with the Charitable Solicitations Program, part of the state’s Department of Professional and Financial Regulation; call 624-8525 with questions about licensed solicitors or to file a complaint.

If you suspect someone’s perpetrating disaster fraud, notify the U.S. Department of Justice’s National Center for Disaster Fraud (toll-free, 866-720-5721). For charity fraud on the web, notify the Internet Crime Complaint Center ( www.ic3.gov), a partnership of the FBI and the National White Collar Crime Center.

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.

 

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.

 

Police launch effort to halt phone scammers | The Portland Press Herald / Maine Sunday Telegram

FairPoint officials say con artists calling from a Jamaica area code are targeting the elderly.

By David Hench dhench@mainetoday.com
Staff Writer

CAPE ELIZABETH – FairPoint Communications and Maine law enforcement agencies launched a campaign Wednesday to stop telephone scammers operating out of Jamaica from swindling money from elderly residents.

FairPoint officials said con artists are calling from a Jamaica area code and telling their intended victims that they’ve won a Jamaican lottery prize or a car, but need to pay money upfront to cash in.

“In many cases the scammer befriends the victim, going as far as professing their love, intent to marry or even praying with them,” said FairPoint Senior Manager of Security Larry Caruso in a written release. “Once a victim is scammed out of money for the first time, the scammers work to get more and more money, including access to bank accounts and credit card information.”

Fairpoint, the largest landline telephone company in northern New England, the York County Sheriff’s Office and the Cape Elizabeth Police Department announced the campaign at a press conference Wednesday. Both law enforcement agencies have investigated individual scams. Authorities in Vermont and New Hampshire are conducting their own investigations.

Sandra Raymond of Arundel said one of her relatives sent more than $140,000 to the scammers.

“These people are cruel and relentless in the way they deal with a senior,” she said. “They threaten, lie and coerce, while at the same time, they act like a friend and say they are just trying to help.”

Major Bill King of the York County Sheriff’s Office said it is important for people who have been victimized to let family members and law enforcement know about it.

“Even after realizing they’ve been deceived, some elderly victims are embarrassed or afraid to tell their family, friends or law enforcement,” he said.

Officials say the perpetrators have called some victims hundreds of times to squeeze as much money out of them as possible. They also work to isolate seniors from family members.

King has described one case in which the thieves convinced a woman to change her telephone number, making it harder for family members to communicate with her while the scam was going on.

The campaign, called “Beware: Scams from Area Code 876,” includes tips to prevent phone scams. The information can be found at Beware of 876.

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