Clinical guidelines Category Archives — Page 2 of 57 — DC Medical Malpractice & Patient Safety Blog Published by Washington, D.C. Personal Injury Lawyers

December 6, 2022

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

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 30, 2022

As STD epidemic rages, the sexually active scorn a familiar protection

by Patrick A. Malone

In some not-so-great news for the nation’s sexual well-being, the rubber has hit the road for too many guys.

The familiar and oft-ridiculed prophylactic could play a significant role in battling an epidemic of sexually transmitted diseases (STDs) that has engulfed the nation, the Washington Post reported. But condom use has declined significantly, for example, as a leading means for family planning, falling in opinion surveys from 75% in 2011 to 42% among men polled.

Public health experts confront multiple challenges in trying to slash the soaring tide of chlamydia, gonorrhea, and syphilis, partly because medical advances with HIV-AIDS mistakenly have the sexually active, especially young men, believing that they can forgo condoms and be safe, the newspaper reported:

November 29, 2022

Cautions increase on link between problem pregnancies and heart disease

by Patrick A. Malone

As cardiologists and other medical specialists grow increasingly aware of big differences in the heart and circulatory health of men and women, researchers also are prodding doctors who take medical histories of female patients to be sure to ask simple but important questions about their experiences with problem pregnancies.

That’s because vital preventive information can be surfaced, if clinicians learn, for example, that their patients had preeclampsia, “a complication that occurs in about 5% of pregnancies and in which dangerously high blood pressure can lead to seizures, organ failure, and death,” according to Stat, a science and medical news site. As Stat reported:

“Women who have preeclampsia have more than twice the chance of developing cardiovascular disease later in life compared to women who had pregnancies without it …Today, a growing subset of care providers is advocating for closer follow-up of the millions of people who have had preeclampsia and other complications during pregnancy that signal an increased risk for cardiovascular disease. Given that about one in three women in the U.S. have cardiovascular disease, better screening of people with pregnancy complications could help protect them before they develop the disease in the first place.

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 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 13, 2022

Voters got their say on major health concerns in 2022 midterms

by Patrick A. Malone

Voters from coast to coast made decisions last week not just about which candidates to favor but also about an array of health-related concerns from abortion to health insurance expansion to legalized ways to get high.

Women’s reproductive rights: a big deal

A major motivator in the 2022 midterm elections was the U.S. Supreme Court’s decision to abolish the constitutional right to abortion and leave it to the states to decide women’s reproductive health rights.

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.

November 9, 2022

FDA knew of, but didn’t act on little devices’ deadly racial problems

by Patrick A. Malone

Until the coronavirus pandemic struck, few regular folks knew about pulse oximeters, much less had one on hand for urgent use. The devices, which fit over a finger, are supposed to give fast readings on the levels of oxygen in patients’ blood — a key measure of their respiratory wellness.

But the devices, whether in relatively inexpensive consumer versions or in medical-grade units used in doctor’s offices, clinics, and hospitals, are far from perfect. They suffer major inaccuracies when used by those with darker skin.

Federal regulators have known about this flaw for years. But at a time when patients, families, doctors, and hospitals relied on the devices routinely to make critical treatment decisions affecting those struggling with likely coronavirus infections, an information chasm opened. Doctors urged people to pop by drug stores and other retailers to pick up the devices, saying that they could be helpful in letting them know when their oxygen levels were dipping in concerning enough fashion that they should seek emergency treatment.