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

September 16, 2022

$439 million settlement shows Big Tobacco sees riches still in vaping

Parents, educators, politicians, federal regulators, and advocates for Americans’ better health all should pause and consider the prime takeaways from a company’s willingness to strike a $439 million settlement with three dozen states figuratively shutting a barn door long after the nag has bolted.

Hint: Big Tobacco is relentless in its efforts to addict regular folks to products proven to destroy their health — and the financial payoff for doing so continues to be so potentially lucrative that most of us can hardly imagine.

Let’s back up just a bit for the basic facts: Juul, a San Francisco-based firm that federal officials have blamed for almost single-handedly creating the e-cigarette and vaping fad in recent years, reached a deal with 33 states and a U.S. territory to pay almost half a billion dollars over the way it marketed its products to teenagers and young adults.

September 13, 2022

Hospital shielded heart surgeon with 21 malpractice claims, probe finds

by Patrick A. Malone

He cut a dashing figure in ads and billboards for a New England community hospital, which had an administration desperate for a lucrative heart care program in a region with famous academic medical centers. Dr. Yvon Baribeau, a Canadian-trained heart surgeon, seemed a perfect fit for the Catholic Medical Center, a place where he told colleagues he practically lived because he became one of the institution’s best-paid and busiest specialists.

He earned more than $1 million annually, and just one of his many operations brought in $200,000 to CMS before Baribeau suddenly retired at age 63.

What patients and the public didn’t know about the much-promoted surgeon was his shocking mistreatment of patients in a variety of ways, a notoriously poor medical performance that the Boston Globe has reported made him the holder of “one of the worst surgical malpractice records among all physicians in the United States.”

August 8, 2022

Senate panel assails transplant system for causing deaths and disease

by Patrick A. Malone

UNOS, the independent medical network responsible for procuring and distributing human organs for transplants in this country, needs big changes because it is failing desperate patients, making screening errors, among other missteps, that have killed dozens of them and caused hundreds to develop procedure-related diseases.

The U.S. Senate Finance Committee reviewed hundreds of thousands of pages of subpoenaed documents and other material and investigated the nation’s transplant network for 2½ years, assailing UNOS for its operational and oversight laxity, the Washington Post reported:

“Testing errors and overlooked communications [in organ procurement] allowed the transmission of cancer, a rare bacterial infection, and other diseases …The errors included failures to identify disease in donor kidneys, hearts and livers, as well as mix-ups in matching blood types and delays in blood and urine tests that were not completed before transplant surgeries occurred, the investigators concluded in a report obtained by The Washington Post. The Senate committee partly blamed lax oversight of organ procurement organizations (OPOs), the regional nonprofits responsible for collecting donated organs, by the United Network for Organ Sharing (UNOS), the Richmond-based contractor that oversees the system. It listed as problems careless treatment of donated organs, organs lost in transit, and technological issues.”

August 5, 2022

A top FDA tobacco expert suddenly quits — to work for Big Tobacco

by Patrick A. Malone

The ink was barely dry on statements from the head of the federal Food and Drug Administration about a planned external, independent review of the agency’s tobacco oversight division when one of its top regulators created a personnel stink of his own.

Matt Holman, chief of the office of science in FDA’s much-criticized Center for Tobacco Products, ended his 20-year government career.

He quit — to go to work for Philip Morris International, the global tobacco conglomerate and maker of Marlboros.

July 22, 2022

Heart association adds a new safeguard to its list: a good night’s sleep

by Patrick A. Malone

Get some sleep!

That’s not just a late-night nudge for the kids from their parents. It is strong new advice patients will hear from their cardiologists and other doctors, as the American Heart Association has added sleep to its list of important ways for folks to avoid cardiovascular conditions, stay healthier, and live longer, the Washington Post reported.

The association has focused on behavioral and other factors for a time now to battle the leading cause of death in this country: heart disease. The federal Centers for Disease Control and Prevention has reported that almost 700,000 Americans died of heart disease in 2020. The ailment costs the country $230 billion annually. The heart association experts added sleep to the “Life’s Essential 8” list of safeguards, reporting this in an article published in a medical journal:

June 28, 2022

FDA bans Juul vaping products and seeks to slash nicotine in cigarettes

by Patrick A. Malone

Federal regulators have cracked down on Big Tobacco and its zealous, profit-seeking promotion of products that fuel some of the leading causes of preventable disease in this country: cigarette smoking and vaping.

The federal Food and Drug Administration ordered the maker of Juul, a pioneer in pushing so-called e-cigarettes and vape flavorings on the young, to pull its products off the markets.

Agency experts also made public their plans to order Big Tobacco to slash the nicotine in conventional cigarettes, a move designed to gut the addictive allure that is foundational to an estimated $95 billion-a-year industry.

May 6, 2022

A major reversal on long-held view of low-dose aspirin’s heart benefits

by Patrick A. Malone

Aspirin has gotten its crown knocked askew as a cheap, effective low-dose heart problem preventer for older Americans.

That’s because the U.S. Preventive Services Task Force has weighed the evidence, heard the comments, and recommended against patients 60 and older taking the common drug to avert cardiovascular diseases. The experts gave this purportedly protective step a “D” grade.

The USPSTF is an elite, independent, and influential group of experts who advise the federal government, insurers, and clinicians about the safety and effectiveness of medical tests and procedures based on rigorous consideration of their merits.

March 18, 2022

As ‘synthetic’ nicotine loophole shuts, warnings about cannabis edibles

by Patrick A. Malone

Grownups have gotten stark reminders why they must stay vigilant against buck-raking enterprises that exploit young people’s experimentation with intoxicants. Even as Congress has shut a legal loophole used by the vaping industry to keep addicting its customers to harmful nicotine, other dealers are pushing candy-like marijuana edibles on youths.

In passing a $1.5 trillion bill to keep funding the federal government, lawmakers on Capitol Hill also extended the authority of the federal Food and Drug Administration to regulate not only nicotine from tobacco but also its synthetic varieties.

This was not an esoteric matter of chemistry or pharmacology. It became a flashpoint between regulators anxious to crackdown on harmful vaping and vendors who tweaked their products, so customers could get potent, addictive jolts from nicotine purportedly was made in a lab. This, vendors claimed, put their vaping devices — notably the pen-like “Puff Bar” that surged in popularity among youths — beyond FDA oversight.

January 11, 2022

Poor FDA communication harms patients, taxpayers, other agencies

by Patrick A. Malone

Critics are slamming the federal Food and Drug Administration for dropping the ball in informing the U.S. officials who run the Medicare, Medicaid, and veterans’ health programs about crucial regulatory decisions, leading the federal government apparently to pay hundreds of millions of dollars for patients to get a defective heart device and potentially to pay billions of dollars for a prescription medication targeted at Alzheimer’s but with questionable evidence of its effectiveness.

FDA officials insist that they acted in patients’ best interests when they posted on an agency website, along with thousands of other public communications, a warning letter issued to the maker of the HeartWare Ventricular Assist Device, or HVAD. That missive told the device maker HeartWare — and later its acquiring company Medtronic — that the FDA found serious problems with the HVAD tied to patient injuries and deaths.

The FDA eventually would amass “thousands of reports of suspicious deaths and injuries and more than a dozen high-risk safety alerts from the manufacturer,” ProPublica, the Pulitzer Prize-winning investigative new site found. “One horrifying device failure after another” led HVAD’s maker to halt the manufacture of the supposed life-sustaining heart pump. The firm has agreed to a long-term plan to deal with the calamity of patients who now cannot have the defective device removed.

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: