Tagged Articles

Massachusetts 328 articles

Pfizer Pays U.S. $23.85 Million For Illegal Kickback Arrangements

Pfizer has agreed to pay the U.S. government $23.85 million to resolve allegations that it used a charitable foundation as a conduit to pay out-of-pocket copayments required of Medicare patients taking three Pfizer drugs. The U.S. Department of Justice said the settlement resolves allegations resulting from an industry-wide probe of unlawful business practices led by Massachusetts U.S. Attorney Andrew Lelling. According to federal prosecutors, Pfizer worked with the Patient Access Network Foundation to cover the copayments of Medicare beneficiaries taking Pfizer’s kidney cancer drugs Sutent and Inlyta and its heart drug Tikosyn. The federal Anti-Kickback Statute and False Claims Act ... Read More

Reported fatality leads to recall of ethyl alcohol product

Lake Michigan Distilling Company LLC, doing business as Ethanol Extraction, is recalling its 95% ethyl alcohol product after receiving news of a man in Massachusetts who allegedly ingested the product and later died as a result. There have been no other injuries or reports of any ingestion or injury since the product was first marketed in October 2016. The company said its ethyl alcohol may be contaminated with methanol, a highly toxic type of alcohol that can cause serious and sometimes fatal damage if ingested by humans or animals. The product was sold through the company’s website and delivered by ... Read More

FDA recalls supplements containing illegal prescription drugs

Shoreside Enterprises Inc., is recalling two dietary supplements promoted for male sexual enhancement after an analysis conducted by the Food and Drug Administration (FDA) revealed the products contained undeclared pharmaceutical drugs. The affected supplements – 7K and Poseidon 4500/Extreme 1000 mg  – contain sildenafil and/or tadalafil, the active ingredients in the prescription erectile dysfunction drugs Viagra and Cialis, respectively. Not only does the presence of these drugs in the dietary supplements render them unapproved drugs for which the safety and efficacy cannot be established, they also pose health risks to some people. Sildenafil and tadalfil may interact with nitrates found ... Read More

Investigation of Deadly Tesla Crash Focused on Lithium Battery Fire

Two Florida high school students were killed and a third seriously injured when their fully electric 2014 Tesla Model S crashed in Fort Lauderdale, causing an intense lithium battery fire that reportedly consumed the vehicle before two of the occupants could escape. Barrett Riley and Edgar Monserratt Martinez, both 18-year-old seniors, were killed when the Tesla Model X spun out of control on a road in Fort Lauderdale known as “Dead Man’s Curve.” The all-electric vehicle slammed into a concrete wall, causing its lithium batteries to burst into flames. A third student, Alexander Berry, also 18, was traveling in the ... Read More

Dräger Medical recalls anesthesia machines

Dräger Medical is recalling its Fabius Anesthesia machines because they may have excessive oil that was not removed during production of the machines. This oil may interfere with the position detector of the ventilation motor during operation and cause the ventilation to fail, which can lead to serious patient injury or death. The recall affects several lots of Fabius Anesthesia machines including Fabius GS Premium, Fabius Tiro, Fabius Tiro M, and Fabius MRI. A total of 62 machines are being recalled from the following states: Arizona, California, Colorado, Idaho, Illinois, Kansas, Massachusetts, Michigan, Mississippi, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, ... Read More

Worker Safety Group Names 12 Most Unsafe Employers

A national worker safety watchdog group has announced its annual list naming the companies it says put workers and communities in danger with their unsafe workplace practices. The list, compiled by the National Council for Occupational Safety and Health (National COSH) in observance of Workers’ Memorial Week, names 12 employers that the group calls “The Dirty Dozen” for exposing their workers to injury, illness, and death. “It’s heartbreaking to see workers lose their lives when we know these tragedies could have been prevented,” said Marcy Goldstein-Gelb, co-executive director of National COSH. “Time and again, employers are warned about unsafe conditions. ... Read More

Whistleblower Pilot Gets Boston MedFlight Job Back

Federal officials have ordered a Massachusetts-based emergency medical air transport company to compensate and reinstate a pilot whistleblower who was fired after reporting concerns about safety violations to federal regulators. While stationed at Hanscom Air Force Base in Bedford, Massachusetts, in December 2015, the helicopter pilot voiced his apprehension to his employer, Boston MedFlight, about whether a new scheduling policy provided pilots with the required rest time as mandated by Federal Aviation Administration (FAA) regulations. The following month, the pilot contacted the FAA to register his concerns about the scheduling. Boston MedFlight fired the pilot in March 2016 after he ... Read More

More kratom recalled as part of Salmonella investigation

Two distributors of kratom-containing dietary supplement capsules and powders have issued recalls after being connected to a multistate outbreak of Salmonella poisonings that have infected at least 87 people in 35 states, sending at least 17 to the hospital for admittance. The investigation was launched last month by the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and local and state agencies. Multiple distributors have recalled dozens of kratom-containing products, and officials are urging the public not to purchase or consume any kratom products because they could be contaminated with Salmonella as well. Salmonella can ... Read More

Whistleblower Helps U.S. Recover $33.2 Million From Alere Inc.

Massachusetts medical device maker Alere Inc. will pay the United States $33.2 million to settle a whistleblower lawsuit that alleged the company knowingly sold unreliable testing devices to hospitals. The U.S. Attorney’s Office for the District of Maryland said that from 2006 to 2012, Alere sold its “Triage” cardiac testing devices to hospitals even when it knew that the devices provided unreliable results. Alere’s Triage devices are frequently used in emergency departments for the quick diagnosis of acute coronary syndrome, heart failure, drug overdose, and other serious conditions. The whistleblower lawsuit, filed by former Alere senior quality analyst Amanda Wu, ... Read More

Endocrine Society recommends against prescribing testosterone to older men

The Endocrine Society, the world’s oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology, is recommending against prescribing testosterone replacement therapy to men 65 years of age and older because the risks and benefits are unclear. The recommendation is part of new guidelines called “Testosterone Therapy in Men with Hypogonadism: An Endocrine Society Clinical Practice Guideline,” which was published in The Journal of Clinical Endocrinology & Metabolism. The recommendation is an update to the Society’s 2010 guideline. The recommendation is based on new scientific evidence from large randomized clinical trials. Testosterone treatments ... Read More