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

August 4, 2021

FDA may be letting medical device makers fudge safety reports, study finds

The federal Food and Drug Administration may be putting patients’ safety at serious risk by allowing medical device makers to self-police their products, notably in making crucial determinations in reporting to the agency the severity of harms the devices inflict.

Using artificial intelligence techniques to scan a sampling of filings made by makers to the FDA over nine years, Christina Lalani, MD, of the University of California San Francisco, and colleagues found that just under a quarter of the documents mis-categorized cases in which medical devices were tied to patient fatalities.

These were not reported as deaths in an important FDA information source known as MAUDE (the Manufacturer and User Facility Device Experience database). Instead, they were “classified as either malfunction, injury, or missing (the report was not put in any category),” reported the medical site MedPage Today.

August 1, 2021

Olympians offer golden insights on the importance of mental health for all

by Patrick A. Malone

The early coverage of the 2021 Summer Olympic Games in Tokyo has been dominated by an unexpected but rising concern — the importance of mental health to our overall wellbeing. Courageous efforts by young women superstars like Simone Biles and Naomi Osaka have helped raise consciousness globally about the importance of this issue, especially for elite competitors.

Their outspoken candor has made refreshingly inarguable the short-hand formula that says: mental health = health. The two are inseparable.

But can this country, with its go-go, get-ahead mentality, also absorb crucial lessons that athletes struggle with, including the power of prioritizing care of oneself, just saying no, and refusing to be forced to perform under professional or personal duress? As the Washington Post reported:

July 30, 2021

$140 billion in medical debt slams patients, especially the poor and uninsured

by Patrick A. Malone

A scandal of the U.S. health system may be far worse than imagined, with the medical debt sold to collection agencies alone amounting to a staggering $140 billion.

The $140 billion estimate came from researchers who published in a medical journal and found that such unpaid sums had increased significantly from an $84 billion calculation in a similar 2016 study, the New York Times reported (see excellent chart, courtesy of the newspaper).

The newspaper noted the debt estimate is an ugly number hanging over the finances of tens of millions of patients who are too often poor and uninsured — debtors who could benefit significantly, if politicians in their states had expanded Medicaid coverage for them as allowed under the Affordable Care Act:

July 28, 2021

Big Pharma is hard to rein in. Just look at two drug cases grabbing headlines.

by Patrick A. Malone

Consumers have gotten eyebrow-raising views of Big Pharma’s ugly business practices and the tough and sometimes sketchy efforts to rein in the industry’s ravenous pursuit of profits — in settling claims over distributors inundating the country with lethal painkillers, or with a maker’s behind-the-scenes campaign to win U.S. approval of an Alzheimer’s medication based on dubious data.

Patients are unlikely to come out ahead, or even satisfied with the outcomes of the cases involving how Johnson & Johnson (J&J), Cardinal Health, AmerisourceBergen, and McKesson handled opioids, and how Biogen and the Food and Drug Administration have dealt with Aduhelm.

A major opioids settlement

July 27, 2021

For nursing homes, a different kind of infection and unvaccinated staff raise alarms

by Patrick A. Malone

Alarms are sounding yet again that the nation’s nursing homes and other long-term care facilities may need to increase important infection control measures and reexamine what’s going on with the staff they need to safeguard patients.

Details are still emerging. But federal officials say they have sufficient evidence to report a new outbreak of Candida auris, aka C. Auris, highly drug-resistant fungus, in a nursing home in Washington, D.C., and at two Dallas-based hospitals.

This “superbug” is considered a menace because infected patients do not respond to treatment with three major drug groups. This outbreak also has experts’ attention because it shows signs of a different way of spreading — patient-to-patient transmission.

July 23, 2021

Surgical robot’s maker sued over business practices — but not patients’ care?

by Patrick A. Malone

Hospitals finally are saying bull feathers to the leading maker of surgical robots that cost institutions millions of dollars annually to buy and maintain. New lawsuits against Intuitive Surgical dispute the company’s business practices, including the exclusivity it demands for its costly services and products.

But will the civil claims also crack open the door to bigger questions about daVinci robots and other such medical devices and whether they benefit patients or just add backbreaking costs to their hospital bills?

Intuitive has declined to comment on the suits filed against it in federal courts in California by the Franciscan and Kaleida health systems. The company has denied one aspect of the media reports about the suits — that it shut down its robots remotely in the middle of a patient’s operation, forcing a surgeon and his team to improvise and finish the procedure (without problems) using standard techniques.

July 21, 2021

Worse than feared: Drug overdoses rose 30% to record levels during pandemic

by Patrick A. Malone

“It’s huge, it’s historic, it’s unheard of, unprecedented, and a real shame. It’s a complete shame”

That quote, reported by the New York Times and made by Daniel Ciccarone, a professor of medicine at the University of California, San Francisco, tragically summarizes the latest federal data on the opioid abuse and drug overdose crisis. As the newspaper and others reported:

“Drug overdose deaths rose nearly 30% in 2020 to a record 93,000, according to preliminary statistics released … by the Centers for Disease Control and Prevention. It’s the largest single-year increase recorded.”

July 19, 2021

Sharp reminders of the need to watch out for dangerous doctors

by Patrick A. Malone

Patients, politicians, and regulators may find it tough to believe, so they need sharp periodic reminders: While there are many terrific, dedicated doctors working today, there also are some truly terrible ones. And dealing with the harms of medical malpractice by the incompetent and abusive can require courage and vigilance.

Perhaps a new, streamed Hollywood serial — starring the likes of Alec Baldwin, Christian Slater, AnnaSophia Robb, and Joshua Jackson — can underscore for the public how grisly the results can be until a rare criminal prosecution derails the likes of Christopher Duntsch, a Dallas surgeon so grim he is nicknamed “Dr. Death?”

July 18, 2021

CDC official sees a ‘pandemic of the unvaccinated’ as coronavirus cases surge

by Patrick A. Malone

Coronavirus infections have increased in just a week by 70%, with hospitalizations increasing 36% and deaths rising by 26%.

Public health officials blame the Delta variant for fueling the latest surge in the coronavirus pandemic, the New York Times reported, noting:

July 16, 2021

Hospitals gouge poor and uninsured patients with top prices, cost data show

by Patrick A. Malone

Cash is king. That truism may hold for thrifty savers and businesses and individuals buffeted by economic uncertainty. But this realistic view also may be turned on its head for poorer, uninsured patients trying to cope with bankrupting medical bills.

That’s because hospitals — a leading driver of health care costs — gouge with their premium prices those who pay with cash, the Wall Street Journal reported.

The newspaper, working with previously secret pricing data that institutions across the country must disclose now, has given consumers yet another eye-popping view of the elasticity of hospital charges and how they punish the poor: