Articles Posted in Product Safety

pregnant-300x200Expectant parents have gotten an ugly exposure to a rapacious aspect of modern medicine: Over testing, over diagnosis, and over treatment, specifically with a new, fast-growing high-tech twist.

The grownups — whether over-reaching to safeguard the unborn or in a simply silly way to determine the gender of their hoped-for bundle of joy — are ordering unnecessary, expensive, and too often alarming prenatal genetic blood tests. These rapid exams purport to tell whether a fetus may have the rarest of congenital diseases, the New York Times reported in some admirable digging, triggered by a stack of patients’ surprise medical bills.

Reporters Sarah Kliff and Aatish Bhatia found a big problem with the high-tech prenatal screens: The tests too often are dead flat wrong.

fdanulogo-300x126Critics are slamming the federal Food and Drug Administration for dropping the ball in informing the U.S. officials who run the Medicare, Medicaid, and veterans’ health programs about crucial regulatory decisions, leading the federal government apparently to pay hundreds of millions of dollars for patients to get a defective heart device and potentially to pay billions of dollars for a prescription medication targeted at Alzheimer’s but with questionable evidence of its effectiveness.

FDA officials insist that they acted in patients’ best interests when they posted on an agency website, along with thousands of other public communications, a warning letter issued to the maker of the HeartWare Ventricular Assist Device, or HVAD. That missive told the device maker HeartWare — and later its acquiring company Medtronic — that the FDA found serious problems with the HVAD tied to patient injuries and deaths.

The FDA eventually would amass “thousands of reports of suspicious deaths and injuries and more than a dozen high-risk safety alerts from the manufacturer,” ProPublica, the Pulitzer Prize-winning investigative new site found. “One horrifying device failure after another” led HVAD’s maker to halt the manufacture of the supposed life-sustaining heart pump. The firm has agreed to a long-term plan to deal with the calamity of patients who now cannot have the defective device removed.

boozing-289x300The government statistics paint a persistently grim picture of the nation’s health, notably as it is measured in a fundamental way — our plummeting, average life expectancy. But who wants to be another tragic bit of mortality data?

Can we resolve to stay healthier in the year ahead — especially by slashing the skyrocketing numbers of us who are dying on the roads and due to the opioid abuse and drug overdose crisis?

The coronavirus pandemic led to surges, too, in excess alcohol consumption, which only  increased during the holiday festivities.

The Omicron variant swiftly has become the nation’s dominant strain, with coronavirus infections skyrocketing from coast to coast.

Officials are anxiously awaiting data to gauge the severity of Omicron infections and if the sharp rise in cases involving this variant will mean overwhelming numbers of patients requiring care in hospitals, too many of which already have been swamped, treating those infected with the deadly Delta variant.

COgeneratorrisk-300x140If you or someone you know has concerns enough about extreme weather events and the electrical failures that too often accompany them  to look into buying a portable generator, be sure to take great care to examine the pricey device’s safety features.

Thousands of consumers have been poisoned or killed by carbon monoxide (CO) fumes from emergency household generators, according to ProPublica, the Pulitzer Prize-winning investigative site, which joined the Texas Tribune and NBC News in digging into records on the dangers posed by the combustion engines that can provide power in critical moments.

But just as motorists must take care to avoid running their vehicles in closed environs, and consumers should not run fuel-burning heaters in confined, indoor spaces, so too, users of portable generator  must safeguard themselves and those in a wide area around them from their units’ powerful but odorless fumes. The generators, costing from $400 to $2,500, should not be run near or inside homes. As ProPublica and its partners found:

sacklerdendurtemple-225x300Fortunately for desperate regular folks, Big Pharma doesn’t always carry the day with its rapacious schemes.

Just look at how a federal judge has upended a plutocratic family’s ploy to shield themselves from a wave of lawsuits over their company’s deceitful inundating of the country with powerful painkiller, or how public furor has pummeled a firm that wanted to charge nosebleed prices for a dubious prescription medication targeted at treating Alzheimer’s.

Officials from the District of Columbia and Maryland helped stymie the wealthy Sacklers from an ugly legal bargain in a multilbillion-dollar bankruptcy case involving the family-run Purdue Pharmaceuticals and thousands of lawsuits over the company’s OxyContin painkiller.

carolynmaloneypresser-300x184Regular folks have known it, chapter and verse, forever. They experience it every time they pay for their prescription drugs. But Democrats in the U.S. House report in a 269-page study that they have spent three years on, have concluded that Big Pharma runs a world-class cash-raising racket that would make street crooks blush.

Well, formally, the House Committee on Oversight and Reform majority has assailed U.S. “drug-pricing practices that are ‘unsustainable, unjustified and unfair,’” the Washington Post reported. As the newspaper also said:

“[C]ompanies studied by the committee raised prices of common brand-name drugs during the past five years by nearly four times the rate of inflation. The report seeks to debunk industry contentions that companies’ price strategy is needed to plow money back into researching and developing new medicines, finding that revenue is substantially greater than those investments.”

anxietygal-300x200Not all grievous injuries are apparent to the eye, as anyone who has experienced catastrophic illness or injury can attest. And now we’re learning a lot more about the hidden costs — mental, emotional, social, and spiritual — inflicted by the coronavirus pandemic.

Reporters Emily Baumgartner and Russ Mitchell of the Los Angeles Times surfaced intriguing points of view on what has now become normalized but widely aberrant behaviors in the age of Covid. They did so, as they dug into the reasons for the unacceptable increase in road fatalities at a time when the public, overall, drove less and many people had open byways. The deadly toll that took in 2020 was expected to, but did not, reverse in 2021.

It got worse — and the reasons why need urgent attention, sources told the newspaper, which reported:

Family decorating Christmas treeWith seasonal festivities getting into their full swing, be sure to take common sense steps to ensure that the holidays stay safe and healthy as well as fun.

As the federal Consumer Product Safety Commission has reported:

“Unsafe toys, cooking fires, decorating, holiday trees and candles lead to thousands of injuries and deaths each year. People can celebrate more safely this holiday season by making a list of safety precautions and checking it twice.”

covidshots-241x300The steady, global spread of the Omicron variant and the huge uncertainty about what menace it may pose also may provide a powerful prod for anyone still fence-sitting to finally get those coronavirus vaccinations, including booster shots.

Experts are furiously researching and may not know for weeks or longer whether Omicron will be worse than the Delta variant, which rages still in parts of the country, overwhelming health systems in the cooling North, notably in New HampshireMichigan and Minnesota.

But the Biden Administration and governments around the world are racing to get ahead of vigorous responses to Omicron.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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