Articles Posted in Ethics

pills-300x200With 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.

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Even as more felony charges may follow in drug epidemic, sleep med warning suggests pill popping stays too popular

Five top executives at a major drug maker have been convicted of criminal racketeering for their aggressive and deceptive marketing of a fentanyl spray in a case that prosecutors long have said may warn corporate leaders about their culpability in the nation’s opioid painkiller crisis.

Federal jurors deliberated for 15 days before finding guilty John Kapoor, founder and CEO of drug maker Insys (shown at right). Jurors also convicted Richard M. Simon, former Insys national director of sales; Sunrise Lee and Joseph A. Rowan, both former regional sales directors; and Michael J. Gurry, former vice president of managed markets. As the New York Times described the case against them:

doud-300x175An estimated 400,000 Americans have died due to opioid drug overdoses between 1999 and 2017 — and the fatalities only are increasing. By 2025, according to expert forecasts, there will be 700,000 more opioid deaths. Prosecutors now are saying  that at least some of the causes of this crisis are nothing less than criminal behavior by people wearing white coats and ties.

Federal and state prosecutors are bringing felony charges against doctors and Big Pharma executives as if they were street drug dealers and crime bosses.

This formal faulting for the nation’s opioid crisis hasn’t yet spread widely among drug makers, those at the pinnacle of the pharma pipeline. The legal war, however, has resulted in aggressive steps by federal prosecutors accusing not only scores of doctors across seven states with improperly prescribing painkillers for cash and sex, but also with officials filing for the first time drug-trafficking charges against a major pharmaceutical distributor and two of its former executives.

Candida-aurisWhen big hospitals are locked in bare-knuckle battles against debilitating and deadly bacterial and fungal infections sweeping their institutions, don’t patients have the right to know about these situations that might affect their lives and care? According to some hospital insiders, no.

The New York Times reported that a “culture of secrecy” prevails in hospitals as they combat “super bugs,” bacteria that have become resistant to antibiotics and now fungi that have evolved immunities to antifungals.

The newspaper found the institutional opposition to making public outbreaks of hospital-borne infection as it followed up its own scary page one story about the global spread of Candida auris, a drug-resistant fungus that preys on patients who already are hospitalized and may have compromised immune systems.

kidshot-300x292As outbreaks of preventable infectious diseases rise to concerning levels, doctors, regulators, and lawmakers may need to toughen important laws requiring youngsters to be inoculated, protecting better our collective health and closing off legal loopholes for sketchy vaccination exemptions.

It would be ideal if more than a century of lifesaving experience and decades of rigorous scientific research were sufficient to persuade parents to get their children vaccinated against an array of harmful and dangerous infections. But grownups’ hesitancy or rejection of shots, out of unfounded personal belief or due to medical disinformation, has set in and spread. This has undercut local, national, and global campaigns to rid humanity of contagions like measles. Public information campaigns and evidence-based persuasion hasn’t worked as well as experts might hope, leading officials to pass vaccination laws.

But those protective measures have been eroded by the exploitation by a few, so far, of well-intentioned exemptions, reporters for the independent, nonpartisan Kaiser Health News reported.

casho-300x168Although lawsuits can result in needed financial support and welcome recognition of harms suffered by patients seeking medical services, the civil justice system has its limits. They showed in cases in the news in which disputing parties agreed to more than $1 billion in resolutions that left issues unanswered.

What to make of the:

cardinalexperts-300x195Doctors, hospitals, and their malpractice insurers like to demonize lawsuits brought by injured patients,  but these  legal actions provide a powerful way to identify problem practitioners, and the medical profession should see this truth and use it to better police its own ranks.

That’s one of the recommendations from medical-legal researchers at Stanford University, who examined more than a decade of 60,000 payments for malpractice claims against more than 50,000 doctors. They found a tiny slice of doctors rack up a disproportionate share of repeated malpractice claims. They describe these MDs as “frequent flyers,” a term familiar to the medical community because it often is applied to indigent and homeless patients who rack up big bills for repeated emergency room visits.

Profs. David Studdert and Michelle Melloound found that 2% of physicians accounted for 40% of the paid malpractice claims over a 13-year period. Further, in the report of their study in the New England Journal of Medicine, they offered details on doctors who lose, and keep losing, malpractice cases due to problem care:

carter-300x300The rich and powerful may seem to run amok as the nation lurches through its latest gilded age. But sometimes:

punchy-300x262Those who are senior enough to remember the allures of sweet drinks like Tang, Hawaiian Punch, and Kool-Aid also may need to be sage enough to share a deep, evidence-based distrust and disapproval for the nefarious actions of Big Sugar and Big Tobacco. Those suspicions may need to be renewed in regulators’ crackdowns on vaping, its flavorings, and flavored tobacco cigarettes.

Yes, the federal Food and Drug Administration now has formally detailed its plan to curb the soaring youthful purchases and uses of e-cigarettes for vaping, telling merchants that they soon will be required to keep these goods, including flavored liquids that the devices catalyze, in separate walled off areas of stores and away from those age 18 and younger. This will affect not only big retailers like Walgreens and Wal-Marts but also gas stations and convenience stores.

Online vendors soon will be required to have mechanisms, so proof of age becomes part of cyber buys of e-cigarettes and their associated products.

Kaiserexempt-300x205If a surgical staple gun malfunctioned so seriously that it generated not a few dozen formal complaints but more than 10,000 reported incidents, shouldn’t patients, doctors, and hospitals have the right to know that information from the federal agency overseeing the safety of medical devices?

Apparently not. Or maybe not without a big kick in the pants from journalists.

Instead, the staff at the federal Food and Drug Administration turned a move to ease paperwork and bureaucracy into a giant and little-known system that lets medical device makers hide serious and significant numbers of reports about failures and flaws with at least 100 products, a Kaiser Health News Service investigation found.

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