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NY Times Slams FDA Over Faulty Medical Devices

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The NY Times editorial pulls no punches.  It’s right in the headline.  “80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.”  The editorial doesn’t let up either.  In the first paragraph it clearly states that the governmental agency in charge of supervising and regulating medical devices in the United States came to a conclusion most of us have already known.

“When the Food and Drug Administration announced last month that it couldn’t guarantee the long-term safety and efficacy of vaginal mesh products — medical devices that have been on the market for decades — the collective response from tens of thousands of women harmed by the products sounded something like this: Duh.”

It’s harsh language for a governmental agency.  However, as a consumer justice lawyer who has represented victims of these failed devices for the last 20 years, I agree.  Why hasn’t the FDA been tougher in regulating these devices?  Too many people have been catastrophically injured and far too many have lost their lives because of a faulty medical device.  It is time that someone lay the blame where it belongs-at the feet of the federal government and the FDA.

“It seems incredible that products meant to reside inside the human body would be used on patients without any proof of safety or efficacy. But thanks to regulatory loopholes and lax oversight, most medical devices are poorly vetted before their release into the marketplace and poorly monitored after the fact.

Problems can take years to emerge and can be impossible to correct, in part because permanent implants are not easily extracted from the body. (Removing mesh from pelvic tissue has been likened to removing chewing gum from long, thick hair). When trouble does arise, device makers often equivocate, regulators dither and patients seeking redress are forced into lengthy and expensive court battles. In the end, faulty products can remain on the market for years.”

Incredible, but true.  Medical device companies, like pharmaceutical companies, make huge profits and they have well-paid lobbyists fighting in Washington DC to ensure that their products make it to the marketplace.  For them, the issue isn’t about safety it’s about economics and the FDA is not able to compete with these huge companies.  The FDA brings a knife to a gun fight and loses.  The result-innocent people are maimed and injured, some lose their lives.

“There have been metal hips that released poisonous debris into the body, implantable defibrillators that shock people at random (causing indescribable terror) and artificial heart valves with questionable shelf lives. In operating rooms, there have been staplers that misfire; temperature control machines that spray bacteria into open chest cavities; and robotic surgeons that slap, burn and, in some cases, maim patients.

In every one of these cases, a combination of dubious regulatory approvals, skimpy post-market surveillance, and faltering responses from regulators caused irrevocable harm that might have been avoided.”

While the FDA continues to make public promises that it will tighten regulations and close loopholes, just the opposite is taking place.  Regulators have accelerated the device approval process, not slowed it down.

Dr. Jeffrey Shuren, head of the agency office in charge of device regulation, has suggested that the benefits of bringing innovative products to market quickly are worth the increased risks.

The Times’ editorial suggests no new or innovative changes to fix the system.  We’ve heard them before-tighten approval standards and close the regulatory loopholes.  But this won’t happen until the device companies recognize that it’s no longer worth the financial risk to skirt the system.  Presently, there is no disincentive to fix the system.  The device companies can continue to pay fines and fight lawsuits in the courts.  They can afford it with the money they are making with their devices on the market. 

If it’s about profit margins, that’s where the solution has to originate.  Until these companies recognize that it isn’t worth the financial risk to produce a potentially flawed medical device, they will continue to do it.  Unfortunately, that’s the real bottom line.

Diocese of Sacramento Releases List of Priests Who Abused Children

The Diocese of Sacramento has become the most recent Catholic diocese to release a list of priests’ names who’ve been accused of the sexual abuse of minors.  The list contained the names of 44 priests and deacons who served in the Diocese since the 1950’s.  Bishop Jaime Soto had vowed to release the list lateContinue Reading

Diocese of Allentown Opens Compensation Plan for Survivors of Abuse

The Diocese of Allentown has launched its compensation plan for survivors of priest sexual abuse.  Survivors have until Sept. 30 to file claims, and they are confident that most could be settled by the end of the year. It opens as state lawmakers renew a long-running debate over whether now-adult victims who long ago passedContinue Reading

Lawsuits Mount Against Mattel for the Fisher-Price Rock ‘n Play Sleepers

Pediatricians have long recommended that infants sleep on flat surfaces without restraints. But Fisher-Price’s inclined Rock n’ Play sleepers required babies to being buckled into the sleeper, and was marketed with phrases such as “baby can sleep at a comfy incline all night long.” That same sleeper has now been linked to at least 32Continue Reading

FDA Stops Sales of Pelvic Mesh in US

Citing safety concerns for women, the FDA took the most severe measure available to the federal agency that it would halt sales of the controversial pelvic mesh. Transvaginal mesh products have been used worldwide for about 15 years, mostly to treat pelvic organ prolapse (POP) and stress urinary incontinence problems in women. Since that time,Continue Reading

Fisher-Price Recalls Rock n’ Play Sleepers

After being linked to 32 sleep-related infant deaths Fisher-Price has issued an immediate recall of all of its Rock n’ Play sleepers. The recall came after a Consumer Reports magazine study linked the dangerous sleeper to infant deaths. Following that report a statement was also issued by The American Academy of Pediatrics (AAP) urging parentsContinue Reading

Another Recall of Irbesartan

There has been another new development in the growing number of blood pressure and heart medication recalls as Camber Pharmaceuticals announced a recall of 87 lots of Losartan Potassium for having too much NMBA. Torrent recalled 60 lots of Losartan potassium tablets and 54 lots of Losartan potassium/hydrochlorothiazide tablets because of NMBA’s presence. The activeContinue Reading

FDA Hides Reports of Harmful Medical Devices

In a shocking report just released by Kaiser Health News it was revealed that the Food and Drug administration has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions.Continue Reading

NY Governor Cuomo to Sign Child Victims Act Tomorrow, February 14

The Fighting for Children PAC released a statement that Governor Andrew Cuomo plans to sign the 2019 Child Victims Act into law on Thursday, February 14, 2019.  The Child Victims Act was overwhelmingly approved by the NY Legislature at the end of January.  Every senator, Republican and Democrat, voted for the bill — even thoughContinue ReadingContinue Reading

New York Passes Child Victim Act: What This Means for Sexual Abuse Victims

Monday, January 28th, saw the passing of the Child Victims Act in New York. This new law will see stronger protection for all victims of child abuse, extending the state’s statute of limitations beyond the age of 23. The act is a major victory for survivors of abuse, allowing their sexual assault cases to includeContinue ReadingContinue Reading



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Saunders & Walker
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