Current Events

Dive Brief:

• Mylan has started a voluntary nationwide recall on three lots of a commonly prescribed stomach ulcer drug after finding trace amounts of a probable human carcinogen, the drugmaker stated Wednesday.
• The recall is focused on three batches that were distributed in 2017 and 2018. Testing found low levels of NDMA, or N-nitrosodimethylamine, a likely carcinogen and environmental contaminant. Mylan said it had received no reports of related adverse events.
• The medicine, nizatidine, is approved as a short-term ulcer treatment as well as for the treatment of esophagitis and heartburn from gastroesophageal reflux disease, or GERD.

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Three people who say they were seriously injured by Medtronic surgical staplers are suing the company for knowingly selling defective devices and intentionally hiding risks from doctors and patients.

An attorney for one of the plaintiffs said the three cases, filed in Minnesota and Texas courts in the waning days of 2019, might signal the beginning of litigation against Medtronic over the way it sells and reports safety information on its now-recalled staplers.

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Recent news:

• Massachusetts announced its fourth vaping-related death, bringing the total to 57 deaths in 27 states.
• A Trump administration decision on an e-cigarette flavor ban could come this week.

Cases and Deaths

The Centers for Disease Control and Prevention and state agencies have reported 2,602 lung injury cases that required hospitalization and 57 deaths linked to vaping.

Mylan (NASDAQ:MYL) announced today that its American-based business issued a voluntary nationwide recall for its ulcer medication after discovering trace amounts of carcinogens in some of its old batches. Three different lots of nizatidine capsules, including both the 150mg and 300mg dose variants, were found to contain small amounts of N-Nitrosodimethylamine (NDMA), and the company has since issued a voluntary recall for all capsules suspected to be contaminated.

The U.S. National Highway Traffic Safety Administration (NHTSA) said on Wednesday it was launching an investigation into the Dec. 29 crash of a Tesla Model 3 that left a passenger dead after the vehicle collided with a parked fire truck in Indiana.

The crash is the 14th involving Tesla that NHTSA’s special crash investigation program has taken up in which it suspects the company’s so-called Autopilot or other advanced driver assistance system was in use.

The recent outbreak of lung injuries linked to vaping has highlighted the dangers of e-cigarettes. A new study puts the warning in big, red letters.

Often promoted as a healthier alternative to smoking, vaping increases the chances of developing chronic pulmonary diseases like emphysema, asthma and bronchitis by 30%, the report said. And people who smoke both conventional and electronic cigarettes – the majority of vapers 18 and older – more than triple their risk of having respiratory illnesses.

The conclusions come from the first study on the long-term health impacts of vaping on a representative adult population, conducted by the University of California-San Francisco and published Monday in the American Journal of Preventive Medicine.
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Boeing Co said on Monday it would suspend production of its best-selling 737 MAX jetliner in January, its biggest assembly-line halt in more than 20 years, as fallout from two fatal crashes of the now-grounded aircraft drags into 2020.

Boeing, which builds the 737 south of Seattle, said it would not lay off any of the roughly 12,000 employees there during the production freeze, though the move could have repercussions across its global supply chain and the U.S. economy.

The decision at a two-day board meeting came after the Federal Aviation Administration (FAA) refused to approve the jet’s return to service before 2020 and delivered what was seen as a public rebuff to Boeing’s hopes of moving faster.
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Following a series of deadly outbreaks in hospitals around the country, the Food and Drug Administration on Friday approved the first fully disposable version of the medical device implicated in the infections.

Reusable versions of the device — a long, snakelike tube with a fiber-optic camera at one end, called a duodenoscope — are inserted in one patient after another to diagnose and treat diseases of the pancreas and bile duct, like tumors and gallstones.

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Lt. Rudolph Feres parachuted into the darkness in the first hours of D-Day in 1944. He fought his way through the hedgerows of Normandy and the snows of the Bulge to the final defeat of Nazi Germany, and was highly decorated for valor.

Generations of servicemen and women since then have heard his name, but not for any of that. Instead, it has been invoked time and again to deny active-duty members of the military a right extended to nearly every other American — to sue for injuries.
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The U.S. Food and Drug Administration and other healthcare regulators are investigating whether diabetes drug metformin had contaminations of a cancer-causing chemical that prompted a recall of a commonly used heartburn medication this year.

The move is part of the FDA’s broader push to investigate a range of drugs for the presence of the carcinogen, known as N-nitrosodimethylamine (NDMA), with heartburn drug Zantac being recalled this year for fear it contained NDMA.

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The parents of a 3-year-old who died after heart surgery at North Carolina Children’s Hospital in 2016 are suing the institution, saying it failed to disclose internal concerns about the quality of its care.

Tasha and Thomas Jones, the parents, also allege that doctors didn’t warn them about problems with the heart surgery program, and “instead chose to protect their own reputational and monetary interests” by continuing to refer patients to the Chapel Hill hospital, according to a complaint filed on Thursday in North Carolina state court.

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