Allergan settles health fraud accusations involving Lap-Band device for $3.5M | C.R. Bard ordered to pay $68M in vaginal mesh case | Ohio judge sets trial date for opioid-drug marketing, distribution cases
April 19, 2018
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Allergan settles health fraud accusations involving Lap-Band device for $3.5M
Allergan settles health fraud accusations involving Lap-Band device for $3.5M
(Pixabay)
Allergan entered into a $3.5 million settlement deal to resolve a whistleblower lawsuit accusing the company of violating the False Claims Act by causing health care providers who used its Lap-Band Adjustable Gastric Banding System to improperly bill government health care programs including Medicare. Authorities say that from 2008 to 2010 the New Jersey firm provided false information to health care professionals and sold the weight-reduction device despite knowing that it had flawed or defective access ports, and from 2008 to 2012 deliberately marketed the device for use in procedures that did not have FDA approval.
HealthLeaders Media (4/18),  Reuters (4/16) 
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C.R. Bard ordered to pay $68M in vaginal mesh case
A jury determined C.R. Bard should pay $35 million in punitive damages and $33 million in compensatory damages to a woman who said she was injured by the company's vaginal mesh devices. C.R. Bard still faces about 150 more lawsuits in New Jersey and thousands of lawsuits that have been consolidated for consideration before a federal judge in West Virginia.
Bloomberg (free registration) (4/13),  NorthJersey (Woodland Park, N.J.) (free registration) (4/13) 
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Liability and Safety
Canada Drugs fined $34M over importing counterfeit, unapproved drugs
The online pharmacy Canada Drugs was fined $34 million by US federal prosecutors over the importation of misbranded and unapproved drugs from all over the world into the US, including counterfeit versions of two cancer drugs that had no active ingredient. The decision also included a $250,000 fine for company founder Kris Thorkelson plus six months' house arrest with five years' probation.
The Hill (4/14) 
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"Evergreening" schemes increasing
The use of tactics to extend patent or regulatory monopolies is on the rise, according to Chip Davis, president and CEO of the Association for Accessible Medicines, who notes that nominal changes can result in a new patent. The AAM has proposed a number of policies to fight such "evergreening" strategies, he said.
Drug Topics (4/16) 
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Business and Market Trends
Shire sells cancer business to Servier for $2.4B
UK's Shire is selling its oncology interests to France's Servier in a $2.4 billion deal. This move may be an attempt to discourage a takeover by Japan's Takeda Pharmaceutical.
Reuters (4/16) 
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Government and Regulatory
Health Care and Policy
Md. drug-price law declared unconstitutional
Maryland's 2017 law enabling the attorney general to sue drugmakers for sharp price increases on generics was declared unconstitutional by a federal appeals court because it regulated the price of transactions that occur outside the state. Nevertheless, "we in no way mean to suggest that Maryland and other states cannot enact legislation meant to secure lower prescription drug prices for their citizens," US Circuit Judge Stephanie Thacker wrote.
Reuters (4/13) 
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News from Aon
Cyber and the C-Suite: Breaking down silos to take on the hacker
An increasingly connected world has brought new business opportunities, increased efficiency and consumer convenience. But it has also increased risk. 2017 saw many organizations suffer significant financial damage as a result of cyberattacks. As these attacks affect all areas of operation, cybersecurity is no longer simply an IT issue. How should the C-suite be preparing for cyberthreats? Read more.
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Aon publishes 2018 Risk Maps for political risk, terrorism, political violence
Political violence risks are rising globally because of geopolitical tensions, a weakening of liberal democratic governance and the repercussive effects of chronic conflicts around the globe. For the third successive year, more country risk ratings have increased (17) than decreased (six). Aon's Risk Maps provide comprehensive insights into some of the most challenging risks facing firms operating worldwide, acting as an invaluable barometer for those seeking to understand and respond to the risks they face internationally. How do these findings affect your firm? Learn more.
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