Current Events

A collection of third-party insurance payers has filed a class-action lawsuit seeking $9.9 million from St. Jude Medical and parent company Abbott Laboratories, claiming St. Jude knew about a battery defect in its cardiac defibrillators nearly five years before issuing a recall.

Filed Sept.
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The FDA has warned health care providers about deaths related to intragastric balloon systems developed by both Apollo Endo-Surgery and ReShape Medical.

The devices - used to treat obesity – are inserted into the stomach through the mouth and are then filled with saline until they expand, leaving the patient feeling full to help them lose weight.

The FDA states that all five deaths occurred within a month of balloon placement, with three patients dying as soon as one to three days after being fitted with the device.

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(Reuters) - The U.S. Food and Drug Administration (FDA) warned on Thursday that Intercept Pharmaceuticals Inc’s drug Ocaliva was being incorrectly dosed in some patients with a rare liver disease, increasing the risk of liver injury and death.

The U.S.
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Abbott (NYSE:ABT) is facing an investor suit from an Alaskan union-benefits fund over allegations that St. Jude Medical, which it closed its acquisition of in January, failed to notify regulators about defective lithium batteries in its implantable defibrillators.

In the lawsuit, plaintiffs allege that St. Jude was informed of the battery defect “as early as 2011”, but it failed to take action and would wait 5 years before issuing a recall for the devices.

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So Fiat Chrysler (FCAU) is recalling almost 50,000 Pacifica vans in the U.S. and Canada from the 2017 and 2018 model years, all with an eight-passenger seating option.

The automaker said during sporting driving, the center buckle in the second row could hit the release button on the left buckle and cause it to unlatch.

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An Alaska union-benefits fund is suing Abbott Laboratories over allegations that Minnesota-based medical device company St. Jude Medical, which is owned by Abbott, failed to warn the public and regulators for years that thousands of its implantable defibrillators contained defective lithium batteries.

The federal lawsuit, filed in northern Illinois late Monday, alleges that St. Jude knew more than 250,000 defibrillators it sold in the United States between 2011 and October 2016 contained batteries that could abruptly short out and cause the lifesaving devices to lose power with little or no warning. Abbott acquired St.
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Smiths Medical, the Plymouth-based maker of hospital infusion pumps, confirmed earlier this month cybersecurity vulnerabilities in its Medfusion 4000 drug pumps, which are used in pediatric cases worldwide.

The company said Monday that it has received no reports of computer hackers exploiting the ­vulnerabilities.

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WASHINGTON (Reuters) - Equifax said on Friday that it made changes in its top management as part of its review of a massive data breach, with two technology and security executives leaving the company “effective immediately.”

The credit-monitoring company announced the changes in a press release that gave its most detailed public response to date of the discovery of the data breach on July 29 and the actions it has since taken.

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 Antidepressant use during pregnancy is tied to an increased risk of psychiatric illnesses, especially mood disorders, in children, according to a new study.

The overall risk is low, though. Only about 3 percent of the nearly 905,383 children in the study were diagnosed with a psychiatric disorder by age 16.

But compared to the children of women who took antidepressants before pregnancy but not during, kids whose mothers continued taking the medications in pregnancy were 27 percent more likely to be diagnosed with mood, anxiety, behavioral or autism spectrum disorders.

Lead author Xiaoqin Liu, an epidemiologist at the National Center for Register-based Research at Aarhus University in Denmark, said the study is the first to look at a wide range of psychiatric disorders, instead of a single psychiatric illness, among children exposed to antidepressants in utero.
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The last dinner Wendy Dolin had with her husband, Stewart, he was so agitated that he was jiggling his leg under the table and could barely sit still. He had recently started a new antidepressant but still felt very anxious. “I don’t get it, Wen,” he said.

The next day, Mr. Dolin, a 57-year-old Chicago lawyer, paced up and down a train platform for several minutes and then threw himself in front of an oncoming train.
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Two key U.S. senators Monday sought detailed information from Equifax about the cyberbreach that potentially compromised the personal information of 143 million U.S. consumers.
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