Articles Posted in Medical Device Safety

fdanulogo-300x126The federal Food and Drug Administration may be putting patients’ safety at serious risk by allowing medical device makers to self-police their products, notably in making crucial determinations in reporting to the agency the severity of harms the devices inflict.

Using artificial intelligence techniques to scan a sampling of filings made by makers to the FDA over nine years, Christina Lalani, MD, of the University of California San Francisco, and colleagues found that just under a quarter of the documents mis-categorized cases in which medical devices were tied to patient fatalities.

These were not reported as deaths in an important FDA information source known as MAUDE (the Manufacturer and User Facility Device Experience database). Instead, they were “classified as either malfunction, injury, or missing (the report was not put in any category),” reported the medical site MedPage Today.

davincirobot-300x176Hospitals finally are saying bull feathers to the leading maker of surgical robots that cost institutions millions of dollars annually to buy and maintain. New lawsuits against Intuitive Surgical dispute the company’s business practices, including the exclusivity it demands for its costly services and products.

But will the civil claims also crack open the door to bigger questions about daVinci robots and other such medical devices and whether they benefit patients or just add backbreaking costs to their hospital bills?

Intuitive has declined to comment on the suits filed against it in federal courts in California by the Franciscan and Kaleida health systems. The company has denied one aspect of the media reports about the suits — that it shut down its robots remotely in the middle of a patient’s operation, forcing a surgeon and his team to improvise and finish the procedure (without problems) using standard techniques.

devicemakerdocpay-300x225Billions of dollars have flown from medical device makers to specialists performing back, spine, knee, and hip surgeries, with unsavory cash and practices also accompanying that fiscal tide.

Industry officials and doctors defend the sizable and growing payment program, saying it results in better medical hardware that ultimately benefits patients, the independent, nonpartisan Kaiser Health News service reported. Data show the bulk of payments from medical-device makers to doctors were for royalties and licensing of products and consulting on them.

But investigative reporters Fred Schulte and Elizabeth Lucas have found that the enriching bonanza concerns regulators, ethicists, and patient advocates:

tbbacteria-300x200A rare outbreak of tuberculosis among dozens of surgical patients — some of them at hospitals in northern Virginia — is under investigation by federal health authorities, including the Centers for Disease Control and Prevention.  The CDC  suspects the infections may be tied to a malleable bone putty used in spinal and other orthopedic procedures.

The substance includes human cells harvested from cadavers, according to Aziyo Biologics Inc., a regenerative medicine company that has voluntarily recalled 154 containers of its FiberCel product.

Patrick Malone & Associates represents patients infected with tuberculosis apparently from this FiberCel bone putty product. Our firm is actively investigating what happened to determine the legal liability of everyone involved and to see where the  breakdowns occurred in the checks and balances intended to keep medical products safe.

devicemakerpaymentsHA-300x257Although 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.

kneelady-300x222With 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.

oighhslogo-150x150Buh-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.”

covidtestswab-282x300The 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:

govhogan-283x300Maryland 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.

cdcinoculate-300x240The “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.

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