Current Events

(CNN)The US Food and Drug Administration is not doing enough to prevent medical devices such as pacemakers and insulin pumps from being hacked, a report from the US Department of Health and Human Services' Office of the Inspector General said Thursday.

"FDA had plans and processes for addressing certain medical device problems in the postmarket phase, but its plans and processes were deficient for addressing medical device cybersecurity compromises," the report says.

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The US Food and Drug Administration is alerting patients of another recall of medicine used to treat high blood pressure, for a potential cancer risk due to contamination. This time, SciGen is recalling certain lots of irbesartan.

The recalled lot will have "Westminster Pharmaceuticals" and "GSMS Inc." on the label, according to the FDA list.
Another heart medicine, valsartan, has also been recalled recently due to contamination.

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(Reuters) - A proposed class action lawsuit in San Francisco federal court accuses Wells Fargo of making tens of thousands of automatically dialed, or “robo,” calls to cell phones without consumers’ consent.

Filed on Thursday on behalf of a nationwide class, the lawsuit accuses Wells Fargo of calling wrong numbers with auto-dialing equipment and failing to honor requests to stop. The complaint seeks triple damages under the U.S. Telephone Consumer Protection Act, or up to $1,500 for each call.

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Four pharmacy benefit managers must face a lawsuit alleging they breached their duties as administrators of employee health insurance plans’ drug benefits by causing Mylan NV to raise the EpiPen allergy medication’s price, a federal judge has ruled.

U.S. District Judge Paul Magnuson in St. Paul, Minnesota on Friday denied motions by CVS Health Corp, Express Scripts Holdings, UnitedHealth Group Inc and Prime Therapeutics to dismiss a proposed class action by participants in employee health insurance plans.

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Earlier this year, the Centers for Disease Control and Prevention released a stunning statistic. Seventy-two thousand people, it estimates, died of drug overdoses in 2017. The huge increase in deaths is largely due to heroin and powerful synthetic opioids like fentanyl.

One of the tools being used to fight that wave of deaths is the drug naloxone. It's been called the Lazarus drug for its ability to revive people dying from overdoses. It can be injected or simply administered through a nasal spray. (The spray form of the drug is known by the brand name Narcan.)

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WASHINGTON (Reuters) - Wells Fargo & Co will not finish paying back the estimated 600,000 customers it wrongly charged for auto insurance until at least 2020, the bank said in a letter to U.S. lawmakers seen by Reuters.

U.S. regulators slapped Wells Fargo with a $1 billion penalty in April when it admitted to wrongly forcing drivers into auto insurance policies. That agreement envisioned the customer payouts would finish within months.

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The Food and Drug Administration is poised to approve a new form of a powerful opioid for use in hospitals and emergency rooms despite opposition from the head of the committee that reviewed the drug.

The FDA is scheduled to decide by Nov. 3 whether to allow a California company to produce a 30-microgram pill form of sufentanil, a potent painkiller commonly used after surgery.

Federal regulators are investigating Mercedes-Benz over whether it was too slow to mail out notices for a recall of 1.4 million cars in 2017.

The National Highway Traffic Safety Administration sent the German carmaker a 14-page letter asking it to explain why customers weren’t informed of the recall within the federally mandated time period.

The threat posed by the overuse of antibiotics is becoming increasingly worrying. Last week, a Public Health England report warned that antibiotic-resistant superbugs – resulting from prolific prescriptions – are now killing more than 2,500 Britons every year.

On August 29, 2018, Alcon announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advised surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This action was based on an analysis of five-year post-surgery data from the FDA-mandated post-approval safety study.

Ridgefield, Connecticut-based Boehringer Ingelheim Pharmaceuticals Inc. was not upfront about the risks of its blood thinner, Pradaxa, a federal jury found Wednesday evening before returning a $1.25 million award for the family of an 84-year-old woman who died of severe bleeding.

The nine-person jury in the Southern District of West Virginia, Huntington Division, found for the family of Betty Knight on the count of fraud, awarding $50,000 in medical expenses and $200,000 in pain and suffering. It also awarded the family $1 million in punitive damages. But jurors found for the company, which is headquartered in Germany, on the first four counts regarding adequacy of warning labels and warrant claims.
Boehringer said in a statement that it would appeal to the U.S. Court of Appeals for the Fourth Circuit in Richmond, Virginia.c

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