Current Events

The mother of a 16-year-old Brookline boy who fell ill after eating at the Chipotle Mexican Grill in Cleveland Circle sued the restaurant in Norfolk Superior Court on Thursday, seeking damages for days of illness.

The legal action by Andrea C. Dow, mother of Alexander Keough, is the first in a likely string of lawsuits related to the norovirus outbreak at Chipotle. About 140 people, most of them Boston College students, suffered nausea and vomiting after eating there during the first weekend of December.

Read More

(Reuters) - Merck & Co should not be allowed to claim that its cholesterol-lowering drug Vytorin reduces the risk of heart attacks and strokes in patients with coronary heart disease, an advisory committee to the U.S. Food and Drug Administration concluded on Monday.

The panel evaluated data from an 18,000-patient trial known as Improve-It whose results showed that the combination treatment known as Vytorin, comprising Zetia and an older cholesterol-lowering drug, simvastatin, reduced the rates of heart attack, stroke and death compared with simvastatin alone.

But the panelists voted 10-5 against allowing Merck to make the claim, saying they were not convinced the benefit was clinically meaningful, especially since some patient data was missing.

Read More

LONDON (Reuters) - The number of new drugs approved in the United States this year has already topped last year's 18-year high, yet large pharmaceutical companies are still struggling to get a decent return on their research dollars.

In fact, returns on research and development (R&D) spending by the world’s top drugmakers have fallen to just 4.2 percent, or less than half the 10.1 percent recorded in 2010, according to a report on Monday from consultancy Deloitte.

Read More

Chipotle Mexican Grill Inc. is facing new questions about its food-safety procedures in Seattle, a sign the restaurant chain may have a hard time bouncing back from recent E. coli and norovirus outbreaks.

The city shut down a Chipotle in the South Lake Union neighborhood on Thursday after multiple inspections found it failed to keep food hot enough. The health department also gave unsatisfactory scores to nine of the 17 Chipotle restaurants in the Seattle area -- even though the company previously closed the locations to revamp their food-handling standards.

Read more.

General Motors offered nearly $595 million to surviving families of those killed and to 275 people injured in crashes that an independent compensation fund determined were caused by defective ignition switches in small cars built in the middle of last decade.

Slightly more than 90% of those offers were accepted, according the final report of the GM Ignition Compensation Claims Resolution Facility. The staff, led by well-known disaster compensation expert Kenneth Feinberg, reviewed 4,343 claims filed after Aug. 1, 2014.

Read More

Boston Scientific (NYSE: BSX), the state’s largest medical device company, has launched a product recall following reports that parts of its medical device broke off and lodged within some patients.

In an announcement Wednesday evening, Marlborough-based Boston Scientific (NYSE: BSX) said the recall of the Chariot Guiding Sheath is voluntary and was enacted three weeks ago, on Nov. 19. The Food and Drug Administration has classified the move as a Class 1 recall, the most serious type which can lead to death or serious injury.>

Read More

As General Motors publicly expressed remorse over its decade-long failure to disclose defective ignition switches, it successfully fought to retain its protection from any lawsuits for crashes that occurred before its 2009 bankruptcy.

Instead, G.M. offered compensation to those victims on its own terms, with a fund run by the lawyer Kenneth R. Feinberg and limited to 2.6 million small cars that were recalled in early 2014.

Read more.

Boston Scientific Corp.’s Maple Grove campus is recalling its global supply of 7,000 Chariot Guiding Sheaths because parts of the device can break off during medical procedures and obstruct blood flow.

The company says doctors who used the Chariot sheath for minimally invasive procedures in the legs and arms should check back with those patients to make sure they’re doing OK.

Read more.

The antitrust division of the U.S. Department of Justice has subpoenaed Mylan N.V. for information relating to the marketing, pricing and sale of its generic doxycycline antibiotic products, the drugmaker said on Friday.

The Department of Justice has sought information on any communication with competitors about the anti-bacterial products, the company said in a regulatory filing, adding it would cooperate with the federal agency.

The nearly 40-year-old antibiotic is used to treat bacterial infections such as acne, pneumonia, Lyme disease, chlamydia and syphilis.

Read More

Chipotle Mexican Grill Inc., reeling from an E. coli outbreak that has sickened dozens of customers, closed a restaurant in Boston following complaints of  “gastrointestinal symptoms” from more than two dozen Boston College students, including members of the men’s basketball team.

“Our restaurant at Cleveland Circle in Boston is temporarily closed while we work with local health officials to investigate a number of illnesses among Boston College students,” Chris Arnold, a spokesman for the chain, said in an e-mail. “There are no confirmed cases of E. coli connected to Chipotle in Massachusetts.”

Read More

Nearly 50 doctors across the United States sent an open letter to the U.S. Food and Drug Administration on Monday calling on the agency to “revise or rescind” its position on a controversial device that had been used on more than 50,000 women annually until the agency cautioned against it last year.

The device, known as a laparoscopic power morcellator, had been widely used to remove benign growths known as fibroid tumors from the uterus or to completely remove the uterus itself in a hysterectomy. A power morcellator has tiny, high-speed blades that mince tissue into infinitesimal pieces, allowing doctors to perform the entire procedure minimally invasively, removing unwanted tissue through small incisions.

Read More