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Current Events
Wednesday, April 21, 2021
The perception that self-driving cars can really operate themselves without driver involvement is worrying automotive watchdogs, who say that some Americans have grown dangerously confident in the capabilities of semi-autonomous vehicles.
Their comments come as electric vehicle maker Tesla's so-called Autopilot system is under scrutiny once again following a crash that killed two passengers in the Houston area late Saturday.
"I would start by saying there are no self-driving cars despite what you may read about or what you’ve seen advertised," said Jake Fisher, senior director of auto testing for Consumer Reports. "And there's certainly nothing anywhere close to self-driving that is in production right now."
Read more . . .
Tuesday, April 20, 2021
New York (CNN Business)Peloton shares fell more than 7% Monday following an "urgent warning" from the United States government telling owners of the company's Tread+ to stop using the machine.
On Saturday, the Consumer Product Safety Commission said it has become aware of 39 accidents involving the $4,295 treadmill, including "multiple reports of children becoming entrapped, pinned, and pulled under" the machine. The CPSC said it's urging customers with small children and pets to stop using the machine immediately. A child died in March in an incident involving the machine.
That prompted a strongly worded statement from Peloton (PTON), claiming the federal agency's notice is "inaccurate and misleading. Read more . . .
Monday, April 19, 2021
An infant teething toy sold exclusively at Target has been recalled because it poses a choking hazard, according to the U.S. Consumer Product Safety Commission (CPSC).
According to the agency's warning notice, Battat's B. toys Firefly Frank Infant Teethers, which is shaped like a firefly, could harm a young child because its "plastic wings can detach from the body of the teether. Read more . . .
Monday, April 5, 2021
For years, the FDA has warned the industry of the risks of improperly cleaned and reusable endoscopes designed to visualize the stomach and intestines. Now, it’s doing the same with urological scopes following the reports of patient deaths from bacterial infections outside the U.S.
The agency said it is investigating “numerous medical device reports” describing contamination issues and the patient-to-patient transfer of pathogens from devices used to view and access the urinary tract, bladder and kidneys, including cystoscopes, ureteroscopes and cystourethroscopes.
Read more . . .
Tuesday, March 30, 2021
GlaxoSmithKline’s vaccine cash cow Shingrix has a new safety warning on its label, although regulators still maintain the shot’s benefits outweigh risks.
Wednesday, the FDA alerted the public that it has added to the “warnings and precautions” section of the shingles vaccine’s label language about an increased risk for a rare neuro autoimmune disorder called Guillain-Barré Syndrome (GBS).
The update came after a post-marketing observational study by federal health agencies noted the risk during the 42 days following vaccination with Shingrix. The FDA stressed that “available evidence is insufficient to establish a causal relationship,” and that the “benefits of vaccination with Shingrix continue to outweigh its risks.”
Read more . . .
Friday, March 26, 2021
WASHINGTON (Reuters) - The U.S. Supreme Court on Thursday unanimously ruled against Ford Motor Co in a case in which the second-largest U.S. automaker had sought to bar two state courts from hearing product liability suits involving a pair of serious crashes. Read more . . .
Thursday, March 25, 2021
General Motors is recalling certain 2021 model-year Cadillac Escalade and Escalade ESV, Chevrolet Suburban and Tahoe, and GMC Yukon and Yukon XL vehicles with third-row seating.
The problem stems from outboard seat belts that may have been misrouted or trapped behind the folding apparatus for the third-row seats during vehicle assembly. This could result in damaged seat belts that can break during a crash, increasing the risk of injury to the seat occupant.
All of the affected models are from the 2021 model year and were built before Nov. 18, 2020. Read more . . .
Thursday, March 25, 2021
The founder of bottled-water maker Real Water has publicly apologized after five kids who drank its product came down with liver failure.
Real Water president Brent Jones issued the mea culpa amid a Food and Drug Administration probe of the alkaline water, which has been linked to several cases of hepatitis.
“We’d like to expressed our deepest sympathy and concern over the events that have led to the inquiry,” Jones said in a roughly two-minute video message released Tuesday.
Read more here Read more . . .
Wednesday, March 24, 2021
NEW YORK (Reuters) -Boston Scientific Corp agreed to pay $188.7 million to settle claims by most U.S. states that it deceptively marketed its surgical mesh devices to consumers.
The settlement with 47 states and Washington, D. Read more . . .
Wednesday, March 24, 2021
The good news, is patients are entitled to access and retrieve their electronic medical records at little or no cost. The latest federal regulations under the 21st Century CURES Act of 2016, which become effective April 5, 2021, allow patients simpler, less expensive and faster access of their electronic medical records upon request. Patients can now request copies of their medical records through the patient portal provided by the health care provider or one maintained for the patient’s representative allowing downloading of electronic medical records. Read more . . .
Wednesday, March 24, 2021
Pfizer and Eli Lilly’s long journey to a potential FDA approval for tanezumab still looked rocky today after review documents from the regulator cast doubt over its safety.
Ahead of an outside expert committee meeting midweek, the FDA as always released its thoughts and discussion points on the drug, and, while finding strong evidence that it helps osteoarthritis patients, it says there are critical safety risks that may cost the partners a straight shot on goal.
The main safety worry is so-called rapidly progressing osteoarthritis, or RPOA, which the companies are aware of. They are looking to run the drug under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) to try to keep a close eye on this issue.
Read more . . .
Alan W. Clark & Associates represent clients throughout Long Island and the New York Metropolitan Area, including New York County, Richmond County, Kings County, Queens County, Bronx County, Nassau County, Suffolk County, and Westchester County.
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