Medical Malpractice

June 5, 2019

Hospitals raise legal concerns by lavishing pay and perks on staff doctors

As hospitals boost their size and power to push their profits even higher, they’re also raising alarms with federal regulators over their too cozy relationships with doctors who are pulling down big pay from them now as part of their staffs.

Uncle Sam long has sought to ensure that the billions of tax dollars that get spent in the health care system don’t become medical spoils, riches that get passed around a select few through kick-back and self-referral schemes. These are barred by regulation, notably in Medicare- and Medicaid-funded care, and by the “Stark law.”

Jordan Rau of the Kaiser Health News service reported that a hospital in Wheeling, W. Va., has gotten regulators attention by lavishing pay and perks on specialists in its employ, including $1.2 million a year for a pain specialist and $770,000 annually and 12 weeks’ vacation for a cardiothoracic surgeon. The money is far higher than what such experts command in the area and it’s more surprising because the treatment areas these high-paid doctors work in are big financial losers for Wheeling Hospital.

June 4, 2019

Can we avoid getting dopey about hype, use, regulation of dope-derived CBD?

by Patrick A. Malone

The federal Food and Drug Administration has waded into its potential oversight of a substance that already is becoming wildly popular. The process of figuring government rules for cannabidiol, aka CBD, well could be called Confusion By Design.

The New York Times and Washington Post both reported on the parade of dozens of parties, pared from hundreds of aspirants, wanting to influence the FDA’s path with the agency’s first hearing on CBD. It already is sold in thousands of products on the market now. These include pet foods, soft drinks, bath salts, and oils and solutions that users add to food and rub on themselves.

Of great concern to the FDA are the extreme and proliferating claims that vendors are making for unproven health-related benefits of use of CBD, which is a nonintoxicating extract that can be derived from hemp and marijuana. As the popular health information WebMD site reported:

June 3, 2019

As doctors warned UNC about heart surgery program, kids kept dying

by Patrick A. Malone

Although big hospitals may love to pat themselves on the back and boost their profits and professional standings by claiming to offer “comprehensive” services, children may suffer and die due to the reality versus the hubris of institutions’ excessive initiatives with specialized care.

Officials at the University of North Carolina blew past anguished warnings from their own pediatric cardiology staff of significant problems in the pediatric heart surgery program at the medical center’s children’s hospital, the New York Times reported. Brushing aside their concerns about a lack of resources within and to support the program, UNC declined to make public, as most similar specialty efforts do, key performance measures. They would show that the UNC pediatric heart surgery program had a higher death rate than “nearly all 82 institutions that do publicly report” this and other measures of patient care.

The newspaper, in a rare move, has internal tape recordings of doctors disputing among themselves whether dwindling resources, staff departures, and other problems meant that UNC should do what many of the specialists demanded — take a long hard look at what was going wrong, and, in the meantime, refer sick kids to other institutions to safeguard their care.

May 31, 2019

FDA’s dubious oversight of heart devices: hidden complaints and shaky tests

by Patrick A. Malone

Cardiac patients may wish to take to heart how news reports have undercut federal regulators’ claims that they provide the most rigorous oversight to medical devices that treat complex conditions in ways that pose the greatest risk. With certain heart pumps and defibrillator units, both implanted in patients, the Federal Food and Drug Administration deserves criticism for putting the interests of device makers ahead of patients, excellent stories by the Kaiser Health News Service and Axios show.

KHN reporter Christina Jewett followed up her investigation into how FDA bureaucrats let device makers file 1.1 million reports of injuries or malfunctions with their products to a little-known internal agency database, discovering how this practice contributed to what one cardiologist described as “the worst cardiac device problem” he has seen in a quarter-century of practice.

The incidents involved the Sprint Fidelis, a small device surgically installed in hundreds of thousands of patients to monitor and supposedly to administer small shocks to deal with their irregular heartbeat. Instead, the device — especially due to problems with its corroding and cracking electrical leads — gave patients random jolts, failed to perform in genuine emergencies, and led to a torrent of complaints and deaths. Doctors, medical researchers, and patients forced into wide public view the substantial defects of the defibrillator, including in congressional hearings.

May 30, 2019

Congress and White House find a bipartisan target in medical bills and prices

by Patrick A. Malone

Doctors, hospitals, health insurers, and Big Pharma have become so abusive to patients with their billing and pricing that they may have accomplished what many consider a political impossibility ̶ angering Democrats and Republicans in Congress as well as the White House, pushing them all toward bipartisan legislation and executive actions.

Don’t bet on the exact outcome of the latest stirrings. They’re grist for a surge in coverage by the New York Times (click here), Washington Post (here), Wall Street Journal (here), Kaiser Health News (here), Modern Health Care (here), Stat (here), and Pro Publica (here). The stories point out that the partisan divide is too great for Congress and the White House to get near serious work on big health care-related issues like improving the Affordable Care Act.

So, instead, as the articles report, lawmakers are taking varying approaches to attack medical billing, particularly so-called surprise bills (out-of-pocket charges patients get hit with when they get medical services from providers outside their health insurance networks) and balance billing, when medical providers chase patients for charges above what they’ve already recouped from insurers. Health reporters have drilled down on stories about such billing outrages. Drug and hospitals prices also are big targets.

May 28, 2019

Prescriptions for this painkiller abound. Evidence of its effectiveness doesn’t.

by Patrick A. Malone

Patients’ struggles with medical pain are a major problem. So, too, is the proclivity of Big Pharma, doctors, hospitals, insurers, and many others to respond to pain not only by pushing more prescription pills but also by overstating their benefits and downplaying their costs and potential harms.

As the nation grapples with an opioid painkiller crisis, New York Times columnist Jane E. Brody deserves credit for drilling down on gabapentin, “taken by millions of patients despite little or no evidence that it can relieve their pain.”

The drug won approval from the federal Food and Drug Administration a quarter century ago for treatment of seizure disorders. But it since has become a go-to medication for doctors who write “off-label” prescriptions for it to care for “all kinds of pain, acute and chronic, in addition to hot flashes, chronic cough and a host of other medical problems,” Brody wrote.

May 27, 2019

High court leaves it to Congress to restore service members’ basic rights

by Patrick A. Malone

The U.S. Supreme Court has left it up to Congress to decide if service members may pursue in the civil justice system claims that they have suffered harms while seeking medical services, a fundamental civil right now denied to military personnel.

Justices Clarence Thomas and Ruth Bader Ginsburg — who rarely agree on much — both wanted but were unsuccessful in getting their high court colleagues to revisit an inequitable, 69-year-old Supreme Court ruling involving the Federal Tort Claims Act. That act governs who can bring a claim for negligence at a military or other government health care facility.

Active duty military personnel cannot bring a medical negligence claim for care at a military facility. This is called the “Feres doctrine,” after the Supreme Court decision, Feres v. United States, 340 U.S. 135 (1950). Under the Feres doctrine, members of the United States armed forces are barred from making a claim against the United States for personal injury or death arising “incident to service.” Military medical treatment received by a service member, while on active duty, has been held by the courts to be “incident to service,” and, thus not actionable, even if that treatment was for a purely elective procedure, and even if the procedure was performed negligently.

May 24, 2019

Walmart sees a bigger picture with costly imaging: frequent misdiagnosis

by Patrick A. Malone

As Walmart tries to work with its 1 million-plus U.S. employees in controlling health care costs, the retailing giant has not only struck a blow for quality medical treatment, it also has raised key questions about a costly and booming specialization in health care: medical imaging.

Walmart decided to shake up this diagnostic field by telling its employees to pay more themselves or to first seek CT scans and MRIs at one of 800 imaging centers that a company-retained health care consulting firm has identified as providing high-quality care. Covera Health, a New York City-based health analytics company, “uses data to help spot facilities likely to provide accurate imaging for a wide variety of conditions, from cancer to torn knee ligaments,” Kaiser Health News Service reported.

KHN reporter Phil Galewitz said Walmart targeted improved imaging based on the giant retailers’ experiences already in funneling workers to select facilities its research has found to offer efficient, high-quality care in specific areas, such as organ transplantation, back and knee surgeries, and heart and cancer treatment.

May 23, 2019

Generic drugs ensnared in price-fixing and shoddy manufacturing claims

by Patrick A. Malone

With Big Pharma pressing the limits in promoting and pricing prescription medications, patients and their advocates long have hoped that generic drugs might be difference-makers on costs and practices. Those positive wishes, however, may be dying out by the day.

The attorneys general of dozens of states have sued major generic makers including Teva, Pfizer, Novartis and Mylan, accusing them of conspiring to inflate generic drug prices by as much as 1,000%, the New York Times and other media organizations reported.

The makers’ price-fixing affected more than 100 generics, including “lamivudine-zidovudine, which treats H.I.V.; budesonide, an asthma medication; fenofibrate, which treats high cholesterol; amphetamine-dextroamphetamine for A.D.H.D.; oral antibiotics; blood thinners; cancer drugs; contraceptives; and antidepressants,” the New York Times said.