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

December 22, 2022

High court lets stand California ban on flavored tobacco products

Californians have accomplished something that federal regulators have failed to — despite long, difficult campaigning. Voters in the biggest state in the nation not only have banned Big Tobacco from peddling its flavored products that target and exploit communities of color and the young. They also have defeated the industry in its legal challenges.

Big Tobacco had launched urgent appeals of the November ballot initiative banning flavored tobacco products only to see the U.S. Supreme Court decline to consider its case, the New York Times reported:

“As is the [high] court’s practice when it rules on emergency applications, its brief order gave no reasons. There were no noted dissents. R.J. Reynolds, the maker of Newport menthol cigarettes, had asked the justices to intervene before [Dec. 21], when the law is set to go into effect. The company, joined by several smaller ones, argued that a federal law, the Tobacco Control Act of 2009, allows states to regulate tobacco products but prohibits banning them … State officials responded that the federal law was meant to preserve the longstanding power of state and local authorities to regulate tobacco products and to ban their sale. Before and after the enactment of the federal law, they wrote, state and local authorities have taken action against flavored tobacco and e-cigarettes.”

December 14, 2022

Watchdog agency taking fire for big problems safeguarding food and drugs

by Patrick A. Malone

In regular places, when alarms blare and it becomes clear that a big, important something is broken and threatens folks’ well-being, those with common sense race to make needed fixes. Washington, D.C., is different. And members of Congress, the White House, and top federal bureaucrats already may be dodging a desperately needed reckoning for the Food and Drug Administration.

This health watchdog is taking body blows about two of its biggest responsibilities — ensuring the safety, effectiveness, and affordability of prescription drugs, and its oversight of these same qualities with the nation’s food supplies.

The agency finds itself jamming the brakes on its hotly contested efforts to hurry prescription drugs onto public markets. And an independent foundation, which is often supports the agency and its work, has ripped the operations of its multiple food regulatory programs, calling them ineffective and lacking needed leadership and direction.

December 7, 2022

In nursing homes and hospices, too little oversight, too much profiteering

by Patrick A. Malone

What happens when the highly vulnerable — older, sick, injured, and debilitated people — get left in the hands of profit-obsessed private enterprises operating under woefully lax regulatory oversight? Big messes abound, as news organizations have reported after taking deep dives into the workings of the “hustle” of for-profit hospice programs, or the chronic staffing shortages that prevail at far too many private nursing homes.

Sure, this is a hectic time of the year, and it can be a challenge to carve out the time to pore over the painstaking reporting of fine journalists who race to make public their major investigations before the year’s end (including to qualify for major professional prizes).

Still, for anyone concerned about destructive failures in the U.S. health care system, how they blow up over time, and how they get ignored until they become crises, the reports by ProPublica, the New Yorker, and USA Today are important reading.

December 6, 2022

Botched. Belabored. Enough already. Fix the FDA and Philips recall

by Patrick A. Malone

While critics long have ripped the Food and Drug Administration for its weak oversight of medical devices and its too cozy relationships with their makers, the federal agency and a Dutch global conglomerate have given millions of U.S. consumers a big, infuriating, prolonged exposure to just how bungled the oversight of this industry can be.

As 2022 races to its close, the Wall Street Journal has reported on this costly, inconvenient, and unacceptable mess, as has the New York Times. And now, so has Stat, the science and medical news site, which wrote this about the “flaws in device oversight” as so many regular folks have experienced with the FDA, manufacturer Philips, and CPAP (continuous positive airway pressure) and BPAP or BiPAP (bilevel positive airway pressure) devices:

“The ongoing recall of millions of breathing devices made by Philips has been botched and belabored at nearly every turn: It took more than a decade after users first reported the soundproofing foam in their CPAP and BPAP machines breaking down for Philips to issue a recall. Even after the recall notice was issued, it failed to reach many patients, and many are still waiting on their promised replacement devices or refunds, some of which had to be recalled themselves. More than a year after the recall, the FDA has received more than 90,000 reports about problems with the devices, including 260 … deaths reportedly associated with the products. The [FDA] has pulled out all the stops — including regulatory orders not deployed in decades — to force Philips to contact users about the recall and replace the devices in a timely manner.

November 24, 2022

Giving many thanks on yet another holiday fraught with health concerns

by Patrick A. Malone

Millions of us will have much to give thanks for during the annual holiday, which, like several of its recent versions, again will be a time of health wariness and uncertainty, too.

The seasonal feast — which brings so many the joy of not only a grand meal but also the pleasure of gathering with friends, family, and other loved ones — will be more costly than any in recent memory due to economic inflation and supply chain problems, the Associated Press reported:

“Americans are bracing for a costly Thanksgiving this year, with double-digit percent increases in the price of turkey, potatoes, stuffing, canned pumpkin, and other staples. The U.S. government estimates food prices will be up 9.5% to 10.5% this year; historically, they’ve risen only 2% annually. Lower production and higher costs for labor, transportation and items are part of the reason; disease, rough weather and the war in Ukraine are also contributors.”

November 23, 2022

Nursing homes reckon with big suits and prospect of tough staffing rules

by Patrick A. Malone

The Biden Administration is encountering stiff industry opposition but is forging ahead with plans to announce in coming months major regulatory reforms that advocates hope finally will force nursing homes to meet minimum staffing guidelines to care for some of the nation’s most vulnerable.

The tragic devastation of long-term care facilities and their residents by the coronavirus pandemic demonstrated the dire need for federal regulators to set baseline standards for nursing and other front-line resident care, critics say.

Their arguments have been bolstered by lawsuits against nursing homes and their subsequent disclosure of harms done to seniors, the sick, and injured — those who are so debilitated that they require substantial living assistance but too often do not get it due to substandard staffing and profit-driven decision-making by facilities’ owners and operators.

November 22, 2022

Walmart, with $3.1 billion plan, joins big pharmacies in settling opioid suits

by Patrick A. Malone

Walmart has offered to pay $3.1 billion to settle thousands of lawsuits filed against the deep-pocketed retailing giant, accusing it of complicity through its nationwide pharmacy operations in the lethal opioid abuse and overdose crisis.

The Bentonville, Ark., -based company insists it committed no wrong and the states, counties, cities, Indian tribes, and others who sued Walmart said it did not have as large a part as other pharmacy chains in inundating the country with powerful, prescribed painkillers.

Still, Walmart joins CVS and Walgreens in settling rather than confronting those who have found sustained success in seeking justice in the civil system, various news organizations have reported.

November 16, 2022

Big Tobacco may talk of transitions. Its pursuit of profits speaks louder.

by Patrick A. Malone

Consumers, politicians, and federal regulators should not make the mistake of thinking that Big Tobacco somehow will go, as the poet put it, quietly into that good night.

The fortunes are still too big to be made in peddling products that persist as some of the greatest preventable threats to Americans’ health, industry players keep reminding us all — most recently by suing to block California voters upholding a ban of flavored tobacco and by taking a last-minute investors’ reprieve to reorganize a pioneering vaping company that was on the brink of bankruptcy.

The Golden State had not even finished tallying its midterm 2022 votes when RJ Reynolds marched into federal court to challenge the newly and overwhelmingly approved referendum to allow a two-year-old state law to take effect barring within weeks the sale of flavored tobacco and vaping products. As the New York Times reported:

November 15, 2022

Hospitals assailed for Emergency Department crush, causing long, risky waits for patients

by Patrick A. Malone

Almost three dozen leading groups representing a range of doctors, specialists, and other health workers have called on the Biden Administration to deal urgently with the long-running but increasing and dangerous practice of hospitals allowing their emergency care facilities to be overwhelmed because they also are parking patients waiting for rooms and treatment.

This “boarding” crisis, already at breaking points for many exhausted ER staffs, will worsen and imperil patients even more if the nation gets hit — as growing indicators suggest is occurring — with a “tripledemic,” a choking load of coronavirus, flu, and other respiratory infections serious enough to require hospitalization.

The American College of Emergency Physicians (38,000 members), has been joined by the American Medical Association, the American Nurses Association, American Academy of Emergency Medicine (8,000 members) and groups representing family doctors, allergists, anesthesiologists, radiologists, osteopaths, psychiatrists, and many others in a recent letter to the administration, reporting:

November 11, 2022

For beleaguered consumers, key health information is deceptive or scant

by Patrick A. Malone

Already sick, injured, and debilitated by age and other circumstance, U.S. patient-consumers get battered with misleading information from shady firms about insurance coverage under the Medicare program and with too little word from hospitals about too spare charitable care that could help the beleaguered with bankrupting medical bills.

Democratic investigators for the U.S. Senate Finance Committee have ripped outfits hustling private Medicare plans to seniors, saying that companies have, among other sketchy practices uncovered, “posed as the Internal Revenue Service and other government agencies, misled customers about the size of their networks, and preyed on vulnerable people with dementia and cognitive impairment,” the New York Times reported.

The investigators said they have cataloged dubious behaviors by vendors in 14 states of Medicare Advantage programs. The newspaper earlier has reported those health plans have become a highly lucrative line of business for insurers. They overstate how sick their patients are to put a bigger bite on taxpayers’ financial support of health coverage for those 65 and older, with Advantage plans enrolling a huge chunk of seniors now.