Articles Posted in Product Safety

cdcalcoholdriving-300x141Although drunk drivers inflict terrible carnage on others traveling on the nation’s streets and highways, law enforcement agencies and skeevy device makers may be unwinding the trust in what has become a cornerstone of the nation’s safety regimes: roadside alcohol testing machines.

The New York Times reported that it “interviewed more than 100 lawyers, scientists, executives and police officers and reviewed tens of thousands of pages of court records, corporate filings, confidential emails and contracts” to discover “the depth of a nationwide problem that has attracted only sporadic attention.”

As the newspaper noted of roadside “breathalyzer” exams and devices used for them:

Extreme sports may be to blame. Or it might be a falling tree, an error with a surgery, or an auto wreck.

As the title of the tough, direct, and new HBO documentary makes clear, “Any One of Us” might suffer from a calamitous spinal cord injury (SCI). The 1-hour and 25-minute work by first-time director Fernando Villena focuses on pro mountain biker Paul Basagoitia but is carried by a “chorus” of 17 women and men who all have had significant injuries to their spinal cords.

blindjustice-300x200The civil justice system, by regularly closing off and keeping secret key parts of lawsuits involving medical devices and prescription drugs, may contribute to patients’ serious injuries and deaths, according to a “special communication” published in a noted medical journal.

The online article in JAMA Internal Medicine argues for greater transparency and disclosures, with a table of examples that includes how:

  • With the Prempro hormone therapy drug for women, the “Manufacturer hired vendors to publish ghost written reviews and commentaries that promoted estrogen replacement for several off-label uses, including prevention of dementia, Parkinson disease, and visual impairment, and downplayed risks of hormone-associated breast cancer.”

sugarspoon-300x211Grownups shouldn’t be surprised that child obesity is a major and rising concern for 1 in 5 of the nation’s young, putting their short- and long-term health at serious peril: That’s because Big Sugar and major food makers persist in  a costly, relentless barrage on kids and adults for unhealthful products, notably sweet drinks that hook children into hard-to-break habits for a lifetime.

Although pediatricians and nutrition experts keep warning that babies and tots, especially, should get much lower amounts of sugar in various forms in their daily diet, almost “two-thirds of the $2.2 billion in beverages marketed to children contained added sweeteners, according to a report released last week by the Rudd Center for Food Policy & Obesity at the University of Connecticut,” the New York Times reported.

Rudd researchers found that just three food industry titans sprinkled $21 million in advertising for sugary liquids.

breastimplantAngry women, anxious that officials were failing to protect their health, besieged a federal Food and Drug Administration hearing in the spring. That unusual outcry may have helped push regulators off their bureaucratic backsides, getting them finally to warn about risks of one of the most commonly used medical devices for women: breast implants.

But will a similar gender uprising be required to quash a rising and dubious medical testing of women, the so-called “3D mammogram?”

The FDA’s sudden, fast stepping on breast implants is occurring after years of inaction. Under new rules proposed by the agency, the devices’ packaging would be required to carry “boxed warnings,” the FDA’s most serious caution.  The agency also would call on surgeons to step up their discussions with women about implant risks, including for rare cancers. As the Washington Post reported, doctors also would be told to tell patients:

drugbottles-300x200Tens of billions of dollars. Those sound like hefty sums. But will it ever be enough? Will, say, $50 billion offer justice and appropriate recompense to a nation wracked by an opioid and overdose crisis?

These figures aren’t pulled from thin air. They’re part of the reported settlement under negotiations to resolve more than 2,300 lawsuits, all bundled up now and under the sway of a federal judge in Ohio. He will launch a landmark opioids’ trial this week, starting with claims by two Ohio counties, unless Big Pharma firms remaining as defendants and the plaintiffs — including states, counties, cities, and Indian tribes — can strike a deal and settle.

The claimants, of course, themselves represent huge and diverse interests: their millions of individual constituents. And they disagree on how much money is fair, how it should be divided, and more. The drug makers and distributors, having seen some of their peers bail already for significant sums, assert they have reached their negotiating ceiling, somewhere around that magic $50 billion.

azarshot-300x169It’s an imperfect predictor, health officials concede. Still, a nasty season of infections Down Under has increased the urgency of their recommendations to the U.S. public to get the annual flu shot before Halloween and certainly before everyone sits down for Thanksgiving dinner.

Although concern already had been growing about bad months ahead in the United States for flu, an early and “fairly severe” season in Australia has increased officials’ worries, the New York Times reported.

That’s because the Aussies, while not a 100% reliable bellwether, showed the more populous States about flu severity as recently as last season, according to Donald G. McNeil Jr., who has reported on disease outbreaks in more than 60 countries for the New York Times. He wrote this:

dcscooter-300x150In the cooler, rainier autumnal weather, transportation officials may be planting the seeds of significant change for the health, safety, and way that residents and visitors get around Washington, D.C. They may allow a smaller number of private companies to double the number of scooters zipping around the nation’s capital by the new year. By the spring, the devices may quadruple in number.

This could mean the estimated 5,000 or more scooters in the district now would increase to 10,000 by January and to 20,000 by June.

District officials say they’re responding to a spike in demand from the public for convenient ways to get around and to do so with needing to use multiple clumsy and confusing smart phone apps.

cashrain-300x225Politicians almost by reflex decry the skyrocketing cost of U.S. health care by blaming much of it on waste, fraud, abuse. They, alas, really may be on to something, newly published research shows.

Health care experts, including a medical leader of health insurer Humana, “combed through 54 studies and reports published since 2012 that estimated the waste or savings from changes in practice and policy,” leading them to some jaw-dropping calculations about how well spent is the $3.5 trillion or so that Americans drop on health care, the New York Times reported.

Answer: Really badly. The researchers, in their published work, estimated that 20%-25% of American health care spending is wasteful. That turns into giant sums, fast, as the newspaper reported, including:

Risperdal-300x150When regular citizens get together in the civil justice system to deliberate difficult claims about complex matters, they may not get everything just right to the satisfaction of the disputing parties. But jurors’ wisdom and findings should not be taken lightly, especially by Big Pharma.

That’s why Johnson & Johnson — and other drug makers — may want to heed the message in a just-announced $8-billion verdict in a Philadelphia courtroom in a case involving a young Baltimore patient and Risperdal, a prescription antipsychotic medication.

It’s true that the whopping award to Nicholas Murray, now 26, likely will be reduced, probably substantially for J&J, a company that has built its brand on being “family friendly.”

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