Articles Posted in Product Safety

aduhelm-300x250Taxpayers and patients are suffering the rising negative consequences of the federal Food and Drug Administration’s dubious decision to overrule its own independent expert advisors and to approve on scant evidence Aduhelm. It is a prescription drug targeting Alzheimer’s disease, and concerns are rising about the medication’s safety and costs, not to mention whether it really works.

FDA advisors had argued against the drug, cautioning  that it carries significant potential side effects including swelling and bleeding in the brain. Those taking Aduhelm have been warned to undergo frequent, regular, and pricey brain scans as safeguards.

Still, experts have been startled by a much-discussed death of a 75-year-old Canadian woman, who was taking the drug as part of a clinical trial. She suffered seizures, was hospitalized, had brain scans, and was diagnosed with brain swelling shortly before she died.

lotsapills-300x200The regular folks who make up juries may give more heed than judges and justices do to the how and why of patients’ push for justice in the civil system, as has been shown in yet another bellwether decision involving major drug store chains and claims they contributed to the nation’s worsening opioid abuse and drug overdose crisis.

CVS, Walgreens, and Walmart all contributed substantially to creating a public nuisance by failing to ask appropriate questions and flooding Lake and Trumbull, two Ohio counties, with countless numbers of prescription painkillers, 12 jurors in a Cleveland court found after a six-week trial and 5½ days of deliberation. As the New York Times reported of the lawyers for the plaintiff counties and their successful argument, the “first time the retail segment of the drug industry has been held accountable in the decades-long epidemic….”

“After hearings in the spring, the trial judge will determine how much each company should pay the counties. The verdict — the first from a jury in an opioid case — was encouraging to plaintiffs in thousands of lawsuits nationwide because they are all relying on the same legal strategy: that pharmaceutical companies contributed to a “public nuisance,” a claim that plaintiffs contend covers the public health crisis created by opioids. The public nuisance argument was rejected twice this month, by judges in California and Oklahoma in state cases against opioid manufacturers. The judges found that according to the specifics of their own states’ public nuisance laws, the companies’ activities were too removed from the overdoses and deaths and that the laws had been applied too expansively.

opioidtoll21wp-300x185Federal officials have confirmed that 2021 will go in the record books as a calamitous time in the battle against the opioid painkiller abuse and overdose crisis, with more than 100,000 U.S. lives lost this year alone to a long-running public health nightmare.

In case anyone might suffer “compassion fatigue” or fail to see how unacceptable this mess has become, news articles in major media offered disconcerting contextual statements, including:

  • 2021’s toll will be the highest of any single year in the crisis, which has killed more than 500,000 Americans over a decade

oksct-300x211Patients who say they were injured by wealthy corporations must possess great fortitude as they seek justice in the civil system, as has been reaffirmed by the courts in California and Oklahoma that rejected   separate cases involving the harms of prescription painkillers.

All the parties in the two matters agreed that Big Pharma’s opioid drugs have killed a half million Americans over a decade, addicted and debilitated vast numbers of patients, and laid waste to communities across the country.

But in strict legal terms, a trial judge in Orange County, Calif., ruled that pharmaceutical giants would prevail in a lawsuit filed against them by aggrieved California counties. They claimed that, with opioids, “drug manufacturers misled both doctors and patients by downplaying the risks of addiction, overdose, death, and other health complications while overstating the benefits for long-term health conditions,” the Associated Press reported.

leadpipes-300x178Although the chattering classes may have beat the term infrastructure into a hoary cliché, regular folks may see major benefits over time to their health and well-being from the Biden Administration’s finally passed, bipartisan $1 trillion bill that invests desperately needed money into the nation’s roads, highways, bridges, and more.

The law will send a giant funding surge into improving water quality and eliminating dangerous and antiquated lead pipes. This toxic threat, as evidenced in the mess in Flint, already has resulted in a $600-million-plus settlement — mostly to be paid by the state of Michigan — for residents of the lead-polluted town.

The infrastructure measure will help officials deal with polluting, nerve-wracking, time-sucking transportation logjams, financing repairs and upgrades to public transit, rail, ports, and airports from coast to coast.

debt-300x200Soaring medical costs crush the finances of far too many patients, as the public was reminded by the release of an annual report on the high toll of cancer-care spending and a surprising congressional reverse aimed at reining in runaway prescription drug prices — or at least attempting to.

Leading organizations dealing with cancer treatment — including the American Cancer Society, the National Cancer Institute, the Centers for Disease Control and Prevention, and the North American Association of Central Cancer Registries — found that patients in 2019 (the most recent year data were available) “shouldered a whopping $21.09 billion in costs,” the Washington Post reported.

Patients and their loved ones get hit with major costs in the first year of disease diagnosis, as well as the highest expenses at the ill individuals’ end of life, the report found.

dcautowreck32821wusa-300x1942021 has become a torment for the safety of the nation’s roads, as the country between January and June hit its largest six-month percentage increase in fatalities in the half-century U.S. officials have kept such records.

In the first half of ‘21, 20,160 people died in vehicle wrecks — an 18.4% increase over the comparable period in the year before.

That six-month vehicular death toll, which only now is becoming official, also was the highest recorded in 15 years.

hhsdrugfightingstrategy-300x169Americans have gotten stark reminders of the nation’s struggles with harmful substances and how the coronavirus pandemic has worsened these problems, with the Biden Administration outlining its strategy to combat the opioid abuse and drug overdose crisis and Big Tobacco reporting a rare spike in cigarette sales.

The opioid crisis — which is sending the country toward a grim 100,000 fatalities this year alone — has forced the federal government into urgent steps, including “harm reduction” strategies as one of its four pillars of U.S. plans to combat drug abuse, according to Xavier Becerra, head of the Health and Human Services department.

Harm reduction approaches can be controversial, as critics assail them as officials going soft on law enforcement and criminal prosecution of drug use.

referee-300x176While Republicans and a handful of Democrats in Congress may be filling campaign coffers and pleasing wealthy corporations to the nth degree during the current lawmaking session, regular folks have reason to be aghast at how companies are throwing around their money and weight to get their way.

The signs are evident as to how companies are maneuvering to:

  • keep prescription drug prices sky high

halloweenkids-300x200It’s boo-yeah and not a boo-hoo time for kids of all ages when it comes to Halloween merry-making this year. And while experts may feel more confident about trick-or-treating during the coronavirus pandemic, grownups need to take special care to ensure the safety of costumed, candy-seeking kids.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, has told multiple news outlets that he thinks the Oct. 31 holiday, a favorite among adults as well as youngsters, will be safer in coronavirus terms than last year, NPR reported, quoting him from an appearance on CNN:

“’I think that, particularly if you’re vaccinated, you can get out there and enjoy it. This is a time that children love. It’s a very important part of the year for children.”

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