Articles Posted in Medical Device Safety

epipen-300x119Big Pharma’s rapacious profit-seeking can seem to hit no bounds, even if it afflicts millions: Just consider what federal and state regulators are mulling about the makers of a popular anti-allergy therapy and those who supply a critical diabetes medication.

The federal Food and Drug Administration has replied to Bloomberg News Service that, so far, in 2017, it has recorded 228 reports of EpiPen or EpiPen Jr. failures, and the failure of EpiPens to deploy correctly has been cited in seven deaths through mid-September.

The agency said it is monitoring closely these “adverse event complaints.” These are unconfirmed reports that do not necessarily tie a product to a harm. But they might constitute sufficient grounds to investigate further and to potentially order product recalls, though, so far, the FDA says it believes patients can keep using EpiPens on the market without worry.

pacemaker-300x186Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents innovative, life changing and lifesaving products from reaching the public. Most of this criticism has been targeted at the federal Food and Drug Administration, which under the Trump Administration, has promised to speed and ease its industry oversight.

But internal watchdogs for the Health and Human Services department have provided a rebuke to the move-faster crowd, detailing the costly cleanup—paid for by taxpayers like you and me— that results from defective medical devices.

The HHS inspector general’s office, in what some patient advocates are calling “a drop in the bucket” of the magnitude of this concern, has found that Medicare paid “at least $1.5 billion over a decade to replace seven types of defective heart devices [that] apparently failed for thousands of patients,” according to a story by Pro Publica, the Pulitzer Prize-winning investigative reporting web site.

IBM_Watson-300x201Watson_bruce-150x150Technology is  transforming medicine without a doubt, but its proponents—including one of the computing industry’s titans—may be getting ahead of themselves in boasting about their devices’ capacities.

Stat, the online health information news site that had a rocky week of its own, deserves credit for reporting  that IBM at present is overselling the medical capacities of its Watson super computer.

Big Blue’s “Dr. Watson,” promoted as an innovative, speedy, and influential diagnostician and medical advisor nonpareil, may be more like the Dr. Watson played by Nigel Bruce in black and white Sherlock Holmes movies starring Basil Rathbone. Watson’s pleasant, records what somebody more important is doing, and, occasionally, with bumbling good luck, he stumbles his way into valuable insight.

knees-300x81Although grandma and grandpa and even older ancestors before them didn’t live as long nor usually as well as many of us do, they still can provide valuable insights into how modern Americans can avoid painful debilitation that now leads to some of the most commonly performed surgeries on seniors.

Want to avoid an inconvenient, costly knee or hip replacement?

Keep your weight down and keep moving—two steps that researchers say may have helped reduce the prevalence of the joint rheumatoid arthritis (RA) that pushes tens of thousands of baby boomers each year to seek medical treatment, up to and including knee and hip procedures that cost taxpayers billions of dollars through the Medicare and Medicaid health programs.

fda-300x125Pro-business and anti-consumer  lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed and some even killed already by defective and dangerous medical devices.

The dispute focuses on a provision to triple the time that companies would get to report product issues to the federal Food and Drug, giving medical device makers three months to do so, rather than 30 days as now required. They still must report to the agency immediately any incident in which a patient is harmed.

Although consumer safety advocates are decrying the oversight changes that GOP members of Congress are pressing, medical device makers are downplaying the regulatory shifts, saying they will eliminate needless bureaucracy. They say that if lawmakers don’t approve the rule changes it may sink the broader and crucial legislation they’re embedded in. The House has just approved and sent to the U.S. Senate the bigger FDA bill, which also provides 60 percent of the fee-based funds for agency drug and medical device reviews.

Blausen_0601_LaparoscopicGastricBanding-300x300They once got a ton of hype with radio, TV, and print ads, as well as billboard campaigns by proponents who later proved to be nothing less than sketchy. But the much-touted lap-band weight surgeries have fallen out of favor. The number of the procedures performed annually has nose-dived.

Researchers, based on a longer view, are finding that, among bariatric weight-loss options, lap-band surgeries offer some of the poorest results and result in frequent added procedures—at big costs, both economic and to disappointed, suffering patients.

Vox, the online news site, deserves credit for pulling together a painful review of what once was the most common way for overweight Americans, mostly women, to tackle one of the nation’s epidemic conditions: obesity.

defib-st-judeThe serious, slowly disclosed problems of a manufacturer and its implanted heart defibrillators may offer more needed cautions to Food and Drug Administration critics who want regulators to rush the oversight of drug and medical device makers and make the agency more welcoming to big business.

St. Jude Medical, the New York Times has reported, has received a written rebuke that the FDA has hit the wall with the company and wants it to deal with its product problems. The agency says it is fed up because the company has dawdled for years in letting patients, as well as its senior management and medical advisory board know that it long has experienced major woes with its heart devices batteries.

St. Jude has been forced to issue recall notices on hundreds of thousands of its defibrillators. Hundreds of cases have been reported in which their batteries died unexpectedly. Dozens of patients have suffered “adverse effects,” and at least two deaths have been attributed to device failures.

23andMetest-300x229Federal regulators have reversed themselves and approved a company’s controversial plan to sell direct to customers saliva-based tests that can predict their genetic risk for diseases like Alzheimer’s and Parkinson’s.

Officials of the federal Food and Drug Administration emphasized that the tests cannot show conclusively if individuals will develop conditions for which they may have genetic risk. They said any health test results should be discussed fully with doctors.

The FDA said it would keep close tabs on the online-order products of  23andMe, which previously had sought to market its saliva tests not only for consumers’ genealogies but also for their health interests. The FDA slapped down the firm’s first foray into health measurements:  23andMe in 2013 had charged $99 for a test that it claimed gave information, genetic and otherwise, on 240 conditions and traits. Regulators halted those tests, requiring 23andMe and others in the field  to prove their products’ accuracy and to clarify that users understood what they were paying for and any test data.

cdc-logo-300x226When it comes to the nation’s health, the Trump Administration and the GOP-dominated Congress seem determined to prove they know how to do penny-wise and pound-foolish. They’re amply demonstrating this with proposed slashes in the nation’s basic budget for public health. They’re calling for a $1 billion cut for the Centers for Disease Control and Prevention, notably in the agency’s funding to combat bioterrorism and outbreaks of disease, as well as to battle smoking and to provide critical medical services like immunizations. Their target is the Prevention and Public Health Fund, set up under the Affordable Care Act, aka Obamacare. With the ACA under fire by partisans who want to repeal and replace it, the fund was already imperiled. GOP lawmakers, determined to cut domestic spending, seem disinclined to come up with substitute sums.

Andy Harris, a Maryland Republican congressman, physician, and House appropriations health subcommittee member, has been quoted as calling the public health money, “a slush fund.” He argued that, “It’s been used by the secretary [of health and human services] for whatever the secretary wants. It’s a misnomer to call it the Prevention and Public Health Fund, because it’s been used for other things, and it’s about time we eliminated it.”

The Obama Administration did embarrass Congress by tapping the fund to provide emergency aid last summer to Florida, Puerto Rico, Hawaii, and other states battling tropical infections, including Zika and dengue fever. Congress took a long recess vacation, as states clamored for help for mosquito eradication and vaccine development to deal with Zika, a virus that can cause severe birth defects and other harms.

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