Addiction Category Archives — DC Medical Malpractice & Patient Safety Blog Published by Washington, D.C. Personal Injury Lawyers

November 30, 2021

Ohio jurors fault big pharmacy chains for role in opioid drug crisis

The 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.

November 19, 2021

Opioid court cases offer hard evidence: Path to justice can be rocky

by Patrick A. Malone

Patients 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.

November 3, 2021

Health experts offer anti-drug strategy and fret over cigarette sales spike

by Patrick A. Malone

Americans 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.

October 23, 2021

Cut the salt in prepared and packaged food, U.S. urges makers and sellers

by Patrick A. Malone

Americans of all ages adore fast food and prepared meals, but one of the lures is these tasty items are loaded with salt. Now federal regulators have proposed new guidelines that they say could save millions of lives by reducing the salt content of commercially prepared and packaged foods.

The Food and Drug Administration’s standards, directed at food that flies out of restaurants, as well as from grocery freezers and shelves, seeks to get manufacturers, restaurants, and food services to help people cut their sodium intake by 12% in the next 2.5 years.

That may seem like a slight amount, but it could have significant effects, the New York Times reported:

October 20, 2021

FDA gives Big Tobacco a big win — approval for e-cigarette for vaping

by Patrick A. Malone

The federal Food and Drug Administration has infuriated health and anti-smoking advocates by handing Big Tobacco a major first — the agency’s seal of approval for an e-cigarette as a way for consumers to reduce or stop harmful use of burning tobacco cigarettes.

The decision allowing RJ Reynold’s Vuse product (shown, left) to stay on public markets is the latest in a series of disastrous actions by the agency, putting a smoking alternative for adults ahead of the health and safety of young people, critics said. They repeated their contention that with bungled oversight on alternative delivery devices and the vaping fad, the FDA has opened the way for a new generation to get addicted to toxic nicotine and lethal tobacco items.

Erika Sward, national assistant vice president for advocacy at the American Lung Association, told the New York Times this of the FDA ruling allowing an e-cigarette delivering high levels of nicotine:

October 13, 2021

Nothing to see here? Consultant advises drug makers — and their regulators

by Patrick A. Malone

When Big Pharma gets jammed up by federal regulators overseeing what may be risky prescription drugs, what to do? How about hiring the help of a powerful, secretive business consulting company — which also happens to be advising the feds on how best to regulate drug companies?

That’s the gist of yet more disturbing findings about McKinsey and Co.’s sketchy dealings with Big Pharma and now the federal Food and Drug Administration.

The corporate consulting titan, though it was required to do so, failed over a decade to formally disclose its work for drug makers, including those involved in the opioid abuse and drug overdose crisis, at the same time as it won big contracts with the FDA, according to excellent digging by ProPublica, a Pulitzer Prize-winning investigative site.

October 6, 2021

Fake pills, laced with lethal fentanyl, are circulating widely, U.S. warns consumers

by Patrick A. Malone

Federal officials have sharply escalated their battle with opioid painkiller abuse and overdoses, issuing an urgent public warning that street drugs of many different varieties may be tainted with tiny but lethal doses of the synthetic painkiller fentanyl.

The U.S. Drug Enforcement Administration and the Justice Department also provided stark evidence of the risks involved, announcing a bust involving 810 people and the seizure of “8,843 pounds of methamphetamine, 1,440 pounds of cocaine and 158 weapons,” CBS News reported. Officials asserted that the seizure contained enough illicit materials to “kill more than 700,000 people and to potentially make tens of millions more lethal pills.”

The DEA said it has recorded a scary spike in cases involving pills sold in illicit fashion, fake medications of many different kinds, that are tainted with fentanyl, which pushers say provides a powerful high but which doctors and law enforcement warns can kill in minute doses:

October 5, 2021

FDA dithers dangerously on regulating sketchy ‘stem cell’ care and kid vaping

by Patrick A. Malone

Yet more derelictions of duty by the federal Food and Drug Administration are happening now, in its handling of largely hokum treatments and health-threatening devices. The latest examples: drug safety regulators step back from their oversight of those who peddle sketchy “stem-cell” treatments for a bevy of ills. And twiddle their thumbs as who knows how many more young people get addicted to nicotine because experts just aren’t ready to regulate e-cigarettes and vaping.

Here’s what the Associated Press reported about the agency and how it has allowed a boom in unsupported therapies using so-called stem cells (real versions, shown above):

“Hundreds of clinics pushing unproven stem cell procedures caught a big break from the U.S. government in 2017: They would have three years to show that their questionable treatments were safe and effective before regulators started cracking down. But when the Food and Drug Administration’s grace period expired in late May — extended six months due to the pandemic — the consequences became clear: Hundreds more clinics were selling the unapproved treatments for arthritis, Alzheimer’s, Covid-19 and many other conditions. ‘It backfired,’ said Leigh Turner, a bioethicist at UC Irvine. ‘The scale of the problem is vastly larger for FDA today than it was at the start.’ The continuing spread of for-profit clinics promoting stem cells and other so-called ‘regenerative’ therapies — including concentrated blood products — illustrates how quickly experimental medicine can outpace government oversight. No clinic has yet won FDA approval for any stem cell offering and regulators now confront an enormous, uncooperative industry that contends it shouldn’t be subject to regulation.”

September 21, 2021

Nursing homes misdiagnose and sedate residents with strong drugs but lag on vaccinating staff

by Patrick A. Malone

The nation’s nursing homes, battered by the coronavirus pandemic, are under more fire for their resurgent reliance on powerful and risky psychiatric drugs and shaky diagnoses of mental illness to treat elderly residents, as well as for the institutions’ inability to safeguard the old, sick, and injured in their care by ensuring their staff are vaccinated against Covid-19.

Facilities across the country have recorded a 70% spike in dubious designations of elderly residents as schizophrenic. This means they may be dosed with potent antipsychotic drugs, which, critics say, act akin to pharmaceutical restraints and can reduce the vulnerable to near vegetative states, the New York Times reported, based on its investigation of the issue.

The newspaper noted that federal regulators and mental health professionals have campaigned for years to get nursing homes and other long-term care facilities to stop using certain medications, which once were more routinely administered and pack more than a wallop for the old:

September 15, 2021

FDA snuffs out cloud of e-cigarette and vaping products but delays big ruling

by Patrick A. Malone

The federal Food and Drug Administration punted on a scheduled showdown over e-cigarettes, delaying decisions on whether to allow Juul and other market-dominating firms to keep selling trendy “smokeless” devices while also banning millions of vaping products from other, mostly smaller manufacturers.

The agency argued with a defensive and defiant tone that it had acted on 6.5 million filings and 93% of the requests for approval to market e-cigarette and vaping-related products, rejecting most (including millions of flawed applications from a single applicant).

But the FDA said it needed more time — how much it didn’t say — to weigh evidence from big e-cigarette makers who hold sway over 40% of the market. They claim their products’ benefits in helping adults stop smoking tobacco, especially killer cigarettes, outweighs the harms they cause to young people, likely addicting new generations to health-damaging nicotine and opening a gateway to tobacco and marijuana consumption.