Defective Medical Device

FDA Warns Coatings on a Medical Device Could Pose Health Risks

by Staff | December 23rd, 2015

The human body is made up of as much as 65 percent water, which is why it’s crucial that many medical devices that are implanted into the body have a hydrophilic or hydrophobic coating. However, the Indiana personal injury lawyers at Fleschner, Stark, Tanoos & Newlin point out that records show many of these coatings can separate from the device, causing patients serious harm.

In 2010, the U.S. Food and Drug Administration (FDA) initiated the first recall of medical devices that were found to have a waterproof or water resistant coating peel off. Since that time the number of such claims have skyrocketed. According to an article from Medscape, the agency received 500 reports of coatings separating from medical devices last year alone.

The results of these coatings peeling away can be deadly as well. There have been at least nine deaths linked to a defective medical device that was known to have hydrophilic or hydrophobic coatings that can peel away. Even more patients have suffered serious injuries as a result of these separations.

These accidents prompted the FDA to request that anyone who has been harmed as the result of the coating peeling off of a medical device to report the incident to the agency.

The legal staff at Fleschner, Stark, Tanoos & Newlin have seen first hand the devastating results the use of a defective medical device can have on the user, and we’re hopeful the actions being taken by the FDA will protect the public from the risks of the coating on medical devices peeling away.

 

Investigation Shows Company Knew of IVC Filter Injury Risk and Took No Corrective Action

by Staff | October 1st, 2015

An investigation has determined the brand of inferior vena cava (IVC) filters made by medical device manufacturer C.R. Bard, Inc. could pose a serious health risk to patients. Furthermore, documents show the company may have taken no corrective action despite being aware of the risks of patients suffering an IVC filter injury.

Data from the U.S. Food and Drug Administration (FDA) shows that during a decade-long span, the C.R. Bard, Inc. Recovery filter was responsible for at least 27 deaths and reports of as many as 300 patients suffering a serious IVC filter injury. A majority of those who were harmed experienced complications associated with the filter breaking or not functioning properly within the body.

NBC News reports that as these injuries and fatalities began to surface, Bard began to look further into the matter. The company funded a study that found their brand of IVC filter posed more of a health and safety risk than any competitor’s product. Furthermore, one Bard employee who helped get the Recovery filter approved by the FDA stated she felt she would lose her position if she voiced concerns about the safety of the company’s product.

Rather than address these issues, Bard continued to sell the faulty filters, distributing as many as 34,000 units to Americans facing serious health problems.

Many patients who suffered an IVC filter injury have gone on to file defective product lawsuits against those who manufactured and distributed the products that harmed them. Visit our website to learn more about what legal options may be available to you if you or a loved one have been harmed by a faulty medical device.

 

Congress Calls for Further Investigation Into Morcellator Cancer

by Staff | September 1st, 2015

The laparoscopic power morcellator is a medical device that is used to grind tissues so they can easily be removed from the body. The device was lauded as revolutionary when it was first released due to its ability to allow once complicated surgeries to be done faster and less invasively than traditional methods of performing the procedures; however, data tend to point to an increased risk in women developing deadly forms of cancer when the device is used.

Hundreds of cases of morcellator cancer have been reported over the years. The claims are supported by evidence that shows dormant cancerous cells can be released into the body when the device is used to grind tissue. These cells can then metastasize in other parts of the body. Studies have shown 1 in 350 women are at an increased risk of developing cancer as a result of undergoing a procedure utilizing the device.

While these findings have prompted the U.S. Food and Drug Administration (FDA)—the federal agency charged with regulating the safety of medical devices in our country—to issue warnings against the use of the device, congress is calling for a further investigation. The Wall Street Journal reports 12 members of Congress have called on the U.S. Government Accountability Office to look into the safety of the device and the decisions the FDA made in regards to use of the device.

Protecting the public from the dangers of potentially faulty medical devices should be a top priority in the U.S. and our defective product lawyers at Fleschner, Stark, Tanoos & Newlin are hopeful a closer examination will be made by the federal government into the use of the power morcellator.

 

Could the 21st Century Cures Act Compromise Patient Safety?

by Staff | August 14th, 2015

The U.S. Food and Drug Administration (FDA) is responsible for regulating the safety of medical products released in the United States. They achieve this through strict policies that require testing of any new drug or medical device. Our defective product lawyers at Fleschner, Stark, Tanoos & Newlin explain a new law has been introduced to federal lawmakers that could potentially compromise the agency’s ability to ensure the safety of medications and medical devices in our country though.

The 21st Century Cures Act was passed through the House of Representatives last month and will now go before the Senate for consideration. The bill is intended to enhance the development of medical technology in the U.S., but in doing so, could put the health and safety of patients at risk.

According to Health News Review, the 21st Century Cures Act would allow new medical devices to submit case studies as evidence of a product’s safety for premarket approval. Current law requires these new products to undergo rigorous studies that can quantify the safety of a product, rather than simply depending on the results that were found in a small batch of tests.

Not only would the bill lower the standards for proving a product’s safety, but it could also present a conflict of interest in how evidence of a product’s performance is gathered. That’s because the bill allows companies to hire independent, third parties to conduct the testing of devices.

Protecting the public from the dangers of a defective medical device is a top priority for our Terre Haute personal injury attorneys at Fleschner, Stark, Tanoos & Newlin and we’re hopeful lawmakers will carefully consider the benefits and risks of the 21st Century Cures Act before voting on the measure.

Are IVC Filters an Ineffective Treatment for Blood Clots?

by Staff | June 3rd, 2015

There are many conditions that can cause serious, life-threatening blood clots in our bodies. Luckily, there are treatment options that are available to help prevent blood clots from occurring. It’s important to know that some of these options may put your health at serious risk while offering minimal benefits.

Take, for instance, inferior vena cava (IVC) filters. IVC filters are small, web-like devices that are inserted into an artery in the body in order to catch and break up blood clots before they can make their way to the lungs, heart, or brain, which can cause serious adverse health events like strokes and heart attacks.

The problem with the device is that it can easily malfunction, and at least one new study shows the devices may be ineffective. According to an article from Medscape, researchers have found that a using a combination of IVC filters and anticoagulant drugs in no more effective than simply using the medication to treat a patient.

The team used concealed randomization in order to ensure the confidentiality of the treatment each patient was receiving. They concluded the use of an IVC filter plus an anticoagulant offered no better results in preventing embolisms in patients after three months than just using an anticoagulant medication.

If you’ve been harmed as the result of having an IVC filter implanted into your body, you may have a right to compensation and discussing your case with a qualified legal representative may be wise. Our team of defective medical device lawyers at Fleschner, Stark, Tanoos & Newlin are available anytime to answer any questions you may have.

$119 Million Settlement Reached In Transvaginal Mesh Failure Cases

by Staff | May 27th, 2015

Several years ago, transvaginal mesh was being lauded as a breakthrough in medical technology that would allow patients undergoing procedures like hysterectomies and corrective surgery to undergo less invasive surgeries. But with the devices eroding in the body and perforating bowels, organs, and other tissues, many of the devices were recalled.

Reports of transvaginal mesh failure led to a large portion of the patients who were harmed filing lawsuits against the manufacturers of the defective transvaginal meshes. Now, one of those companies is settling almost 3,000 of the cases for an estimated $119 million.

A story from Injury Lawyer News explains Boston Scientific Corp. has agreed to pay the sum to lay to rest 2,970 lawsuits that claim their Pinnacle mesh, used to support organs within patients’ bodies, failed. Cases settled by the agreement can expect to start receiving payments by October 1 of this year.

The settlement comes on the heels of decisions by two separate juries that found Boston Scientific was responsible for the failure of the transvaginal mesh that was used on patients. Those plaintiffs were each awarded millions in compensation.

At Fleschner, Stark, Tanoos & Newlin, we have seen the struggles of those who were harmed by a transvaginal mesh failure and that’s why our defective product lawyers are hopeful this settlement will bring a sense of peace and closure to those who were affected by the problems with the Pinnacle device.

The da Vinci® Surgical Robot: Cutting-Edge Technology With Risks

by Staff | May 13th, 2015

Technological advancements present options for performing medical procedures, but the attorneys at Fleschner, Stark, Tanoos & Newlin point out they may not always be proven safe.

The da Vinci® surgical robot is a prime example of the risks of new medical technology. The device can be used to perform minimally invasive surgeries that can reduce recovery times and the chances of excessive blood loss. In fact, a recent article from CBS News contained a video showing the device being used to sew a grape’s skin back together.

But the da Vinci surgical robot has come under scrutiny after studies showed the device was linked to a roughly 34 percent increase in surgical errors. Many of the complications encountered using the da Vinci surgical robot required a more invasive follow up surgery to repair the damage caused by the initial procedure. Some researchers believe lack of surgeon experience and tactile feel could also play a role in the number of injuries.

These findings leave many patients wondering what they should do if they were injured during surgery. The Terre Haute personal injury lawyers at Fleschner, Stark, Tanoos & Newlin suggest speaking with a reputable and qualified legal representative about your potential rights to compensation. Doing so can help ensure you have the information you need to protect your rights.

Doctors Urged to Find Alternative to Power Morcellators After FDA Recalls Defective Medical Devices

by Staff | April 17th, 2015

Scientists, doctors, and medical professionals are always looking for new and better ways to perform medical procedures. But sometimes advancements that are made in the field of medicine end up doing patients more harm than good.

The power morcellator is a prime example of an advancement in technology that eventually ends up being a defective medical device.

Before the device was on the market, women undergoing hysterectomies, myomectomies, and fibriod removal surgeries had to have large incisions made in their bodies in order to remove organs and tissues. With the power morcellator though, doctors were able to grind those organs and tissues to a size where they could be removed through a small incision in the abdomen, reducing both bleeding and recovery time.

The problem is, when the device is used to grind tissue, it can release dormant cancerous cells into the body where they can then spread and metastasize.

The discovery of the health risk has prompted the U.S. Food and Drug Administration to advise doctors and medical professionals to consider finding an alternative to using a power morcellator on a patient. An article from The Wall Street Journal says some of the nation’s largest insurers are also encouraging medical professionals to find alternative methods to performing certain medical procedures.

If you’ve been harmed as the result of undergoing a medical procedure utilizing a power morcellator, the Indiana personal injury lawyers at Fleschner, Stark, Tanoos & Newlin explain that you may be entitled to compensation. The process of applying for such an award can be quite complex though, so it may be wise to have legal representation by your side. Give us a call at (800) 477-7315 to discuss your rights with our legal staff.

Improving How the FDA Reviews Medical Device Safety

by Staff | April 15th, 2015

The U.S. Food and Drug Administration is tasked with the job of regulating which medical devices are made available on the market; however, some feel as though better policies and more thorough safety inspections could help reduce defective medical device numbers in the U.S.

Two experts in medical device safety, former FDA deputy commissioner, Scott Gottlieb, and cardiology professor at the University of California at San Francisco, Rita Redberg, recently sat down and discussed what can be done to reduce injuries and fatalities that are caused by faulty medical devices with The Wall Street Journal. They both tend to agree that the current methods being utilized to ensure medical device safety could be improved.

Gottlieb stated he felt the FDA was taking too much of a “uniform” approach to determining the safety of medical devices by trying to create broad safety standards for all devices. Redberg pointed out these broad standards have numerous loopholes that allow dangerous devices to make their way onto the market.

Redberg then goes on to say she feels public device registries where issues and problems can be tracked in real time is one of the best solutions she’s heard of to improve the safety of medical devices in the U.S.

Even with safety improvements, it’s clear that a small percentage of unsafe medical devices will always find their way on to the market and our Terre Haute personal injury lawyers want you to know help is available if you or a loved one have been the victim of such an accident. Feel free to call us anytime at (800) 477-7315 to discuss your case with our legal staff today.

Heart Pump Recalled Amidst Defective Medical Device Allegations

by Staff | March 4th, 2015

New medical devices that are being released onto the market must undergo rigorous testing in order to help ensure the products function properly. Unfortunately, not all problems are identified during testing and are only discovered once they are used in a real-world setting. Such issues often result in companies initiating recalls for defective medical devices.

For instance, a company that manufactures a heart pump—Heartware—has announced the recall of the 1400 and 1401XX Ventricular Assist Systems (VAS) after discovering an electrical malfunction that could be extremely harmful to the patient.

According to the U.S. Food and Drug Administration, the device is prone to a glitch that can cause data errors when it is exposed to a discharge of static electricity. The glitch can lead to the pump not functioning as it was designed, which can in turn result in the patient being seriously injured or killed. It’s estimated that as many as 120 patients could be affected by the defective heart pump.

In response to the problem, health care providers who supplied patients with the device are being instructed to inform those individuals of the recall and to discuss with them how they can reduce the chances of a static electricity discharge. The device should also be exchanged for a new one. Patients are also being given instructions on how to handle the faulty units.

It’s important to remember this information may come too late for some patients whom the device has already harmed and it’s important for those individuals to know that help is available. At Fleschner, Stark, Tanoos & Newlin, we have a team of Terre Haute personal injury attorneys who are standing by to answer any questions you may have regarding the legal processes of filing a claim for compensation if you’ve been injured by a defective medical device. Call us today for a free consultation of your case at (800) 477-7315.