product liability attorney

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.

 

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.

$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.

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.

Does the da Vinci® Surgical Robot Put Patients’ Health at Risk?

by Staff | April 8th, 2015

Fifteen years ago, many medical experts believed the da Vinci® surgical robot was going to be the next great advancement in surgical technology, boasting the ability to perform minimally invasive procedures; however, numerous reports of complications have arisen in the wake of procedures utilizing the device, leaving many to question its safety.

The da Vinci surgical robot allows doctors to sit at a computer screen that shows a magnified view of the surgical location and manipulate controls that operate the machine’s robotic arms that are performing a medical procedure. The problem is, mistakes are too common of an occurrence when the device is used.

Data from the U.S. Food and Drug Administration shows that in the span of a single year, the number of reported medical errors that were made using the da Vinci surgical robot increased by 34 percent. Other studies have also shown an increased chance of mistakes when using the device.

This leaves citizens and medical professionals alike wondering what the cause of so many of these mistakes could be. An article released by Healthline tends to point to the doctors operating the device, rather than the system itself, as the reason mistakes occur.

Regardless of how a medical error occurred, the Terre Haute personal injury attorneys with Fleschner, Stark, Tanoos & Newlin want you to know that help is available if you’ve been the victim of a mistake while undergoing a procedure utilizing the da Vinci surgical robot. We are available to answer your legal questions at any time by calling (800) 477-7315.

Studies Highlight Severity of Morcellator Cancer Risks

by Staff | March 18th, 2015

Just a few years ago, a new medical device—the power morcellator— was considered groundbreaking because of its ability to allow doctors to remove organs and tissues from a patient’s body in a minimally invasive manner. Now, evidence shows operating with the device may put patients at a significantly increased chance of developing cancer.

The morcellator cancer risk is caused by how the equipment functions. The device simply grinds tissue and organs to a size where it can be removed through a small incision in the abdomen. Unfortunately, the grinding of tissue can release dormant cancer cells into the body where they can then metastasize.

The Wall Street Journal reports studies show 1 in 368 women had undetected uterine sarcoma cells in their body that could be spread through the use of a power morcellator. Researchers also explain the risks of developing cancer after undergoing a medical procedure utilizing the power morcellator significantly increased with age as well.

Findings like these have prompted the U.S. Food and Drug Administration to advise doctors not to use power morcellators during certain medical procedures. Unfortunately, these defective medical devices have already harmed a large number of patients here in the United States.

The Terre Haute personal injury lawyers with the law firm of Fleschner, Stark, Tanoos & Newlin want anyone who has developed cancer, or is at risk of developing cancer, because of a procedure involving a power morcellator to know that help is here. We are available to speak with you anytime regarding your condition and case by calling (800) 477-7315.

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.

Lawsuits and Warnings in the Wake of IVC Filter Injury Reports

by Staff | February 25th, 2015

Blood clots can be extremely hazardous to your health and can even lead to death. A device known as an inferior vena cava (IVC) filter has been developed as a way to reduce the chances of blood clots traveling to areas of the body that can result in a fatality—such as the lungs—but using these devices can present another set of risks to patients.

Numerous patients have reported suffering an IVC filter injury after the device was implanted in their body. Such injuries occur when the device breaks or migrates inside the body. Injuries that have been reported include pulmonary embolism, constant chest pain, respiratory distress, hemorrhaging, and perforation of the vessels, tissues, and organs.

These risks resulted in the U.S. Food and Drug Administration outlining a set of guidelines and warnings for the use of IVC filters, which are highlighted in an article released by Endovascular Today; however, many of those who have been harmed as the result of using IVC filters have filed lawsuits against the manufacturer of the product.

Settlements are beginning to be reached in these suits as well. Earlier this month, CR Bard—a company known for manufacturing IVC filters—reached a settlement for an undisclosed amount in damages with a Nevada man who was allegedly harmed by their product.

It can be extremely difficult to overcome the injuries that are caused by using a defective medical device. That’s why our attorneys at Fleschner, Stark, Tanoos & Newlin are hopeful settlements such as this one will bring closure to the victims who were injured.

How Can I Find Out if I Have a Defective Medical Device or Recalled Drug?

by Staff | December 31st, 2014

Drugs and medical devices are regularly recalled due to problems with their design, marketing, or function, or because new and dangerous side effects are discovered. But how are consumers supposed to keep track of these recalls and know if a drug or product is safe?

There are numerous resources available to find out if a medication or medical product you use has been recalled. Typically, the U.S. Food and Drug Administration (FDA) or the manufacturer of a defective medical device or drug will inform consumers and suppliers of the problem that was discovered. So speaking with your doctor about any concerns you may have should be the first option you explore.

Doctors sometimes make mistakes or overlook information though, which is why it’s always wise to conduct your own safety research. An article from Everyday Health suggests consumers regularly check government websites—like the FDA or Consumer Product Safety Commission—to see if the product you’re concerned about is included in recall lists. You can also create settings that will send you automatic updates if a product you use is ever recalled.

Unfortunately, the use of defective products or recalled drugs often results in accidents or injuries before the victim is ever made aware of a recall. If you’re ever harmed as the result of using a defective medical device or medication with dangerous side effects, it’s important to know that you have legal rights that need to be protected. Having a qualified legal representative on your side is the best way to protect those rights.

At Fleschner, Stark, Tanoos & Newlin, we know what it takes to successfully fight for your rights if a faulty product or dangerous drug has harmed you. Our personal injury lawyers are available to answer any questions you may have about your case by calling (800) 477-7315.