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

April 14, 2021

Questions aplenty about medical device-makers paying doctors $3.6 billion

Although Big Pharma has taken deserved heat for selling its drugs by slathering doctors with cheesy tchotchkes, lavish or even cheap meals, and pricey trips, as well as lucrative consulting and speaking opportunities, medical device-makers’ physician-payment programs also should get a tougher, deeper look.

That’s because device manufacturers paid doctors $3.62 billion in the years 2014–17 — 1.7% of the revenue in their business sector and more than seven times the percentage of drug industry revenue spent on payments to MDs, according to a new study published in the respected medical journal Health Affairs.

The payments have come under increasing fire, as even the smallest sums — yes, even for a slice of pizza and a beer or a few sodas — may sway doctors in prescribing drugs or favoring treatments, notably with certain medical devices. The sketchy product-promotion spending may not benefit patients and may boost health care costs, a growing body of evidence from studies is showing.

January 21, 2021

Knee and hip surgeries offer a glimpse into disparities in health care costs

by Patrick A. Malone

With so many older Americans entering their later years in better shape than earlier generations and wanting to stay active, knee and hip replacements have become some of the most common surgeries performed in pre-pandemic times. The cost of this work, however, varies greatly. And surgeons may be promoting procedural variants to not only build business but also to increase their revenue for these operations.

Consumers, policy makers, regulators, and politicians may want to keep an eye on developments with patients’ knees and hips as indicators of what may occur in health care finances, especially if hospitals’ case loads return to something of a pre-pandemic norm and because taxpayers bear burdens from so many of the Medicare-covered procedures.

New data is emerging about hospital costs as the institutions, many of them overwhelmed now by the coronavirus pandemic, comply with Trump Administration price-disclosure regulations. These called for hospitals to post online their base costs (as earlier described in the hard-to-read charge master lists) for hundreds of common procedures and medical items, as well as previously secret prices for same, as negotiated with insurers.

November 27, 2020

U.S. health watchdog issues fraud warning about doctors’ speaker programs

by Patrick A. Malone

Buh-bye? Arrivederci? Sayonara? Can it be that the coronavirus pandemic puts an end to one of the disgraceful ways that Big Pharma and medical device makers push their wares on all-too malleable doctors — with big-money speaker programs?

The inspector general’s office of the giant federal Health and Human Services (HHS) agency has warned drug- and medical device-makers that these pandemic-paused marketing shams should not resume. The $2 billion that industry players have forked out for the in-person gab fests in the last three years looks sketchy at best to federal watchdogs and prosecutors, the HHS inspector general warned in a rarely issued “special fraud alert.” It reported this:

“The Office of Inspector General (OIG) and Department of Justice (DOJ) have investigated and resolved numerous fraud cases involving allegations that remuneration offered and paid in connection with speaker programs violated the anti-kickback statute. The Federal government has pursued civil and criminal cases against companies and individual [health care providers] involving speaker programs … Our enforcement experience demonstrates that some companies expend significant resources on speaker programs and that some [health care providers] receive substantial remuneration from companies. This Special Fraud Alert highlights some of the inherent fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration related to company-sponsored speaker programs.”

October 13, 2020

Nevada offers key lessons in challenge to U.S. virus tests for nursing homes

by Patrick A. Malone

The federal agency that regulates nursing homes and other long-term care facilities not only has cracked down on them with tough new requirements for coronavirus testing of their staff. The Centers for Medicaid and Medicare Services also has flogged its plan to provide facilities with testing equipment and sample tests.

While owners and operators have grumbled about the whole process, the state of Nevada has gone a step further: Enough, its health officials have decided. They briefly halted as unacceptable the CMS tests for the virus because they say they are flawed and may put nursing home residents at risk.

Besides casting yet more doubt on CMS’s poor pandemic response with long-term care facilities, Nevada’s balk — rescinded abruptly after federal threat — may offer an important take-away to members of the public, already flooded with findings about the novel coronavirus:

October 6, 2020

Maryland adds testing and leads area in allowing nursing homes to re-open

by Patrick A. Malone

Maryland will take the lead among states in the area in re-opening nursing homes and other long-term care facilities from months of coronavirus-related closures to family members, guests, and other visitors.

Gov. Larry Hogan (shown, right) acted as the state, for the first time in months, reported that October started with zero Covid-19 fatalities and 76 of Maryland’s 227 nursing homes had active coronavirus cases — down from 130 on Aug. 5, the Washington Post reported.

After struggling through some of the worst outbreaks in long-term facilities in the area, Maryland will put significant resources into safeguarding nursing homes as they reopen, Hogan said.

September 15, 2020

With speeding vaccine clinical trials, a pause that may prove reassuring

by Patrick A. Malone

The “warp speed” race to develop a Covid-19 vaccine has gotten hit with a yellow flag.

It could be a good thing that the product’s makers — Oxford University and AstraZeneca — followed medical-scientific protocols and paused their Phase III clinical trial due to a participant’s unexplained illness.

Officially, the company offered spare information about the occurrence, especially because it affects the private medical information of a single individual.

April 8, 2020

Zantac warnings offered early hint of big problems with Big Pharma practices

by Patrick A. Malone

Big Pharma’s slavish devotion to maximizing profits and “enhancing shareholder value” has led industry executives to shove the manufacture of their products to far-flung shores. The dubious consequences of these moves have become clear not only with common, over-the-counter medications but also — with potentially tragic results — with drugs needed in the war on the Covid-19 pandemic.

Even before the world was terrorized by the coronavirus outbreak in China, safety advocates warned about serious “supply chain” issues in drug making, with one small lab sounding alarms about Zantac, a widely used over-the-counter heartburn pill.

Valisure, a commercial pharmacy that sought to distinguish itself by testing and assuring consumers of the quality of the drugs it sold, provided the federal Food and Drug Administration its lab tests and analyses as evidence that Zantac (aka ranitidine) was contaminated with, what the New York Times has described as, “a type of nitrosamine called N-nitrosodimethylamine, or NDMA, which is believed to be carcinogenic in humans and is found in a variety of products, including cured meats.”

February 7, 2020

Deceptive software pushed MDs to prescribe opioids at overdose crisis’ peak

by Patrick A. Malone

Federal prosecutors have provided 145 million reasons why enthusiasts may want to curb their exuberance about how high tech will work miracles in the U.S. health care system.

That’s because investigators have ferreted out “abhorrent” conduct by Practice Fusion, a San Francisco firm that specialized in electronic health care records software, according to the U.S. Attorney’s Office in Vermont.

“During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids,” Christina E. Nolan, U.S. Attorney for the District of Vermont, said in a statement. Practice Fusion, she added, “illegally conspired to allow [a] drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient’s medical care, including the need for pain medication and prescription amounts.”

January 7, 2020

A caution about rising hype for artificial intelligence in medicine

by Patrick A. Malone

In recent years, doctors, hospitals, and popular media have promoted emerging treatments to the public with enthusiasm that in each case would turn out to be overblown. Just consider the red-hot chatter that once surrounded regenerative medicine, precision medicine, gene therapy, or immunotherapy. And now, it may be the turn of artificial intelligence to be hyped hard in health care.

Caveat emptor, as Liz Szabo reported for the Kaiser Health News Service. She sets the stage, thusly, about developments in a field that might worry some who remember Hal 9000 from “2001: a Space Odyssey”:

“Health products powered by artificial intelligence, or AI, are streaming into our lives, from virtual doctor apps to wearable sensors and drugstore chatbots. IBM boasted that its AI could ‘outthink cancer.’ Others say computer systems that read X-rays will make radiologists obsolete. ‘There’s nothing that I’ve seen in my 30-plus years studying medicine that could be as impactful and transformative’ as AI, said Dr. Eric Topol, a cardiologist and executive vice president of Scripps Research in La Jolla, Calif. AI can help doctors interpret MRIs of the heart, CT scans of the head and photographs of the back of the eye, and could potentially take over many mundane medical chores, freeing doctors to spend more time talking to patients, Topol said. Even the Food and Drug Administration ― which has approved more than 40 AI products in the past five years ― says ‘the potential of digital health is nothing short of revolutionary.’”

December 30, 2019

Some Grinch-y news about a few popular holiday gifts

by Patrick A. Malone

Consumers may need to give a few seasonal gifts a second look about their safety and other health-related issues:

Powerful rare-earth magnets, used in many toys and especially in shape construction kits, pose big risks to kids when swallowed.
Widely used over-the-counter genetic testing kits may subject users to major privacy concerns they never contemplated. The risks have risen enough so the Pentagon has issued a warning to service personnel.