Articles Posted in Product Safety

Bracescamarrest-238x300Federal authorities have busted up what they say is a $1.2 billion Medicare fraud that should give taxpayers and patients pause about long-distance medical consultations and the huge sums of cash washing around the medical device industry.

Two dozen people, some of them doctors, have been charged in a complex ploy to gull seniors into asking about back, shoulder, wrist, and knee braces that were promoted as free on TV and radio ads nationwide. When the older adults called to inquire about the devices, they were transferred to telemarketing centers in the Philippines and Latin America.

In the far-away boiler rooms, trained operators extracted important personal information from callers, then connected them for “telemedicine” consultations with cooperating doctors. The MDs asked cursory questions before then prescribing the devices, whether needed or not. The orders were filled by select companies, which then would send out the braces and charge them to Medicare.

cpscIt may sound catchy when politicians claim to want to get Uncle Sam out of our wallets and off our backs. But the deregulatory reality may look different when hundreds of thousands of baby strollers have front wheels that suddenly fall off, or millions of family cars may be at risk of bursting into flames.

The Washington Post has dug deep into how a case involving the BOB, a British-made, three-wheeled stroller, illustrates how the Consumer Product Safety Commission (CPSC) has become more industry friendly and turned away from vigorous protections for ordinary Americans.

The political party in power, aka the Republicans, not only get to fill commission openings, they also take over the important chair of the panel. That leader sets the tone and often pushes fellow party members on the commission to hew to it. The GOP has controlled the commission for the first time in a decade, and Republican chair Ann Marie Buerkle is making herself felt in agency actions.

kneestemcell-300x169When doctors and regulators crack down on the burgeoning and risky use of purported stem cell therapies, some well-known and respected big hospitals and health systems may have their own practices to explain, too.

As Liz Szabo reported for the nonpartisan Kaiser Health News Service:

Swedish Medical Center, the largest nonprofit health provider in the Seattle area … is one of a growing number of respected hospitals and health systems—including the Mayo Clinic, the Cleveland Clinic and the University of Miami—that have entered the lucrative business of stem cells and related therapies. Typical treatments involve injecting patients’ joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best

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:

breastimplantUncle Sam has paid what critics have called long overdue attention to women’s breasts and how surgeons and diagnosticians treat them.

In an angry and emotional public hearing, women ripped the federal Food and Drug Administration for lax oversight of implants that surgeons use to augment and reconstruct breasts, even as the agency proposed its first changes in 15 years to guidelines about mammograms for patients with dense breast tissue.

The FDA has been under fire for decades over breast implants, mostly banned in 1992 but allowed anew in 2005. Experts long have debated whether materials in the implants, notably silicone and not necessarily saline fillings, may be injurious to women’s health. New concerns have developed over surface texturing on the devices, which are supposed to help in the surgery but may affect tissues around and near the breast, leading to spikes in reported cases of rare cancers.

EHRsKHN-300x230Tempting though it may be to dismiss doctors’ howls about electronic health records—maybe they’re Luddites or they’re just another group of high-paid workers beefing about their job tools—the persistent and significant nightmare of the complicated computer systems has been this: Do they harm patient care?

The answer now may be: Yes, billions of taxpayer and private dollars spent on EHRs may be reducing patient safety.

That’s the finding of the independent, nonpartisan Kaiser Health News Service, based on its extensive investigation in partnership with Fortune Magazine. The two media operations reported that:

jjbabypowder-300x300Although research has shown that asbestos can cause cancer and other harmful illnesses and the federal government has sought to limit and even ban its use, yet another sizable judgment in a tainted talc case and the discovery of the substance in a popular cosmetics line shows how America’s oversight and regulation of risky materials can be too slow and ineffective.

As the New York Times reported, a jury in the San Francisco area has joined similar deliberative panels in accepting claims that longtime use of Johnson & Johnson baby power causes cancers. The state jury decided that J&J must pay plaintiff Teresa Leavitt a total of $29 million because the company knew its talc was tainted with asbestos but failed to warn her and others. Leavitt, who used the product for three decades, was diagnosed in 2017 with mesothelioma, a cancer of the lining of internal organs that is associated with asbestos.

The newspaper said the jury told J&J to pay her “$22 million for her pain and suffering, $5 million to compensate her family members, nearly $1.3 million for her medical costs and $1.2 million for her lost wages.”

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.

dialysis-300x198Diabetics and those with failing kidneys may have gotten a glimmer of relief from the staggering costs of caring for their conditions, as Big Pharma relented a tad with news it will put out a less-costly insulin product and federal officials suggesting Uncle Sam soon may be upsetting the flush profits of the dialysis industry.

DaVita Inc. and Fresenius Medical Care AG run more than 5,000 U.S. dialysis clinics and control around 70 percent of the market, Reuters news service reported in a story describing how Alex Azar, the powerful head of the federal Health and Human Services department, wants “a new payment approach for treating kidney disease that favors lower cost care at home and transplants.”

Why? As Reuters explains, “The goal is to reduce the $114 billion paid by the U.S. government each year to treat chronic kidney disease and end-stage renal disease, a top area of spending.”

fdachiefgottlieb-150x150The Trump Administration has lost yet another top health official: So, what happens now with key policies pushed by Scott Gottlieb, the departing federal Food and Drug Administration commissioner, to battle teen nicotine abuse, cut skyrocketing drug costs, and attack the opioid crisis?

Administration officials insist Gottlieb wasn’t ousted, and the physician and onetime Big Pharma insider said he resigned from his post after a year on the job because he wanted to spend more time with his family (they hadn’t moved from Connecticut to join him in the nation’s capital).

Though Gottlieb received mixed or favorable media coverage as he leaves, his effect on the nation’s health is as cloudy as many high school vaping spots.

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