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Massachusetts 328 articles

Kratom linked to reports of Salmonella infections

The Food and Drug Administration (FDA) is continuing its crackdown on the herbal supplement kratom announcing this week that it, along with the Centers for Disease Control and Prevention (CDC) and other state and local officials are investigating a multi-state breakout of Salmonella infections linked to products reportedly containing kratom. Because of this health risk, the FDA is advising consumers to avoid kratom and kratom-containing products. Salmonella infections cause symptoms such as diarrhea, fever and abdominal cramps. Most people recover without treatment, but the diarrhea may be so severe for some people that they need to be hospitalized. In some ... Read More

Women sues IVC filter maker alleging serious injuries

A Massachusetts woman is suing Argon Medical Devices and Rex Medical over claims the companies’ blood clot-catching device became embedded in her body, causing her serious injuries. Julie M. filed the lawsuit earlier this month claiming that she had been implanted with the companies’ Option ELITE Retrievable IVC filter and suffered injuries. The cage-like device was inserted into her inferior vena cava (IVC), a large vein that delivers deoxygenated blood from the lower extremities to the heart and lungs. The device is designed as a short-term treatment to capture blood clots that form in the legs before they travel to the ... Read More

Shredded coconut linked to salmonella outbreak

The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and public health and regulatory officials in several states are investigating a multistate outbreak of Salmonella infections linked to Coconut Tree Brand Frozen Shredded Coconut, distributed by Evershing International Trading Company. The outbreak has sickened at least 25 people in nine states. Six of those infected were hospitalized. To date, no deaths have been reported. On Jan. 3, 2018, Evershing International Trading Company recalled all 16-ounce packages of Coconut Tree Brand Frozen Shredded Coconut after the product was identified by Massachusetts officials as the source of ... Read More

Orange cream bars recalled due to Listeria scare

Boxes of Tops brand Orange Cream Bars and Meijer Purple Cow brand Orange Cream Bars may look innocent enough with adorable animals posing next to the tasty treats. But buyer beware. Fieldbrook Foods Corporation, maker of the products, has issued a recall of 20 cases of the Tops brand product and 320 cases of Meijer Purple Cow brand cream bars because they may be contaminated with Listeria monocytogenes. The nasty organism can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. While healthy individuals may suffer only short-term symptoms such as ... Read More

NC sues Insys for illegally pushing opioid spray Subsys

North Carolina’s attorney general is suing drug maker Insys Therapeutics Inc., over allegations that the drug company paid kickbacks to doctors to prescribe its potent opioid Subsys to patients who didn’t meet the requirements for the medication, then lied to insurers to get them to cover the cost. Attorney General Josh Stein’s Consumer Protection Act lawsuit is one of several against Insys and its executives, including criminal racketeering and fraud charges in Massachusetts and civil and consumer protection claims in New Jersey. The drug company and its executives, who are not named in the North Carolina suit, are accused of ... Read More

Opioid addiction complications seen in body scans

Victims of the nation’s opioid epidemic, particularly younger people, are showing up in emergency departments with serious complications caused by pill fragments becoming lodged inside their bodies, according to a report presented at the annual scientific sessions of the Radiological Society of North America. Signs of opioid abuse that can be seen in radiological scans include pulmonary embolism and cerebral embolism, which can cause stroke. But instead of blood clots, these emboli are composed of pill fragments. “We’ve seen a dramatic increase in the past year of patients coming into the emergency department with complications related to substance use disorders,” Efren ... Read More

Insys founder freed from ankle monitor for daily jogs

John Kapoor, billionaire founder of Insys Therapeutics, can rid himself of his cumbersome electronic monitoring device to take his daily jogs just so long as he doesn’t try to run out of the country, a Massachusetts federal judge ruled. Kapoor, who is facing charges that his company bribed doctors to needlessly prescribe his company’s fentanyl-based opioid spray, said the GPS-enabled device makes it “virtually impossible for him to run,” his attorneys said. The device “interferes with a lot of things, including jogging, but rest assured he’s not running from the case,” his attorneys said to U.S. Magistrate Judge Jennifer Boal. ... Read More

Auto Auction Co. Faces Steep Safety Penalties After Deadly Crash

Federal officials have cited a Massachusetts automobile auction company with multiple safety violations and proposed more than a quarter million dollars in fines after five people were struck and killed by a runaway Jeep being exhibited at auction in May. Several others gathered for the auction were seriously injured. The citations stem from a May 3 investigation triggered by a May 1 incident involving a 2006 Jeep Grand Cherokee that suddenly accelerated to about 40 mph and plowed into a crowd of people gathered inside the Lynnway Auto Auction in Billerica, Massachusetts. The Occupational Safety and Health Administration (OSHA) said ... Read More

AED maker slapped with consent decree of permanent injunction

Philips North America LLC, doing business as Philips Medical Systems and Philips Healthcare, and two of the company’s employees, were slapped with a consent decree of permanent injunction prohibiting them from manufacturing, processing, packing, holding or distributing medical devices until the facilities comply with federal law. The action was initiated by the U.S. Department of Justice on behalf of the Food and Drug Administration (FDA), which raised concerns with the quality control at the manufacturing plants in Andover, Massachusetts and Bothell, Washington. The consent decree named the companies along with Carla Kriwet, business group leader for the Patient Care and ... Read More

Insys founder resigns from board amid opioid scandal

The billionaire founder of Arizona-based Insys Therapeutics, John Kapoor, has resigned from the company’s board of directors following his arrest on charges he participated in a scheme to bribe doctors and mislead health insurance companies in an effort to boost sales of the company’s powerful opioid painkiller Subsys. Subsys is a highly potent, fentanyl-based spray that is only intended for breakthrough pain in cancer patients. Kapoor, Insys’ majority shareholder, resigned as chief executive officer in January after being charged with engaging in conspiracies to commit racketeering, mail fraud and wire fraud. Board members Patrick Fourteau, also resigned citing personal reasons. ... Read More