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.
August 20th, 2015|
A settlement has been offered to as many as 3,000 women who have filed transvaginal mesh failure lawsuits against medical product manufacturer C.R. Bard, Inc. If the agreement is approved, officials say it would resolve roughly 1 out of every 5 transvaginal mesh failure cases.
The women who filed the suits had the mesh product implanted in their bodies as part of a surgical procedure to correct organ prolapse or urinary incontinence; however, the women say the product eroded over time, causing the mesh to perforate organs and tissue and cause extreme pain.
According to an article from Bloomberg Business, C.R. Bard, Inc. is offering $200 million to the victims in order to prevent the cases from going to trial. This means each victim will receive around $67,000.
The decision to settle comes on the heels of several other major transvaginal mesh manufacturers being ordered by the courts to pay their victims for their injuries. A woman was awarded $100 million in damages from Boston Scientific in May for injuries the company’s product caused her to suffer. In 2013, a West Virginia jury ordered Bard to pay another transvaginal mesh failure victim.
It’s important that victims of faulty medical devices receive the compensation they need and deserve, which is why our defective product lawyers are hopeful this settlement will bring closure to the victims who were harmed.
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.
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.
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.
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.
February 11th, 2015|
Transvaginal mesh is a material that can be used to support a woman’s internal organs following certain medical procedures; however, thousands of patients claim their device has failed, causing pain, infection, and perforation of organs and tissues.
Many of the victims have filed a transvaginal mesh failure lawsuit in order to be compensated for the damage that was done. Now, the judge overseeing more than 70,000 of the cases is urging the makers of the transvaginal mesh products in question to work harder to reach settlements with the victims.
An article released by Reuters states the judge met with top officials from the transvaginal mesh manufacturing companies and attorneys for the victims this past Thursday, February 5. During the session, the judge reiterated it would be a long and costly process to try each of the cases, but unless a settlement is reached in a timely manner between the two parties, he will send the cases to trial.
Several of the companies who made and distributed the faulty mesh have already reached settlements. American Medical Systems put up $1.6 billion to lay 20,000 transvaginal mesh failure lawsuits to rest.
At Fleschner, Stark, Tanoos & Newlin, we understand the difficulties and frustrations that can come with recovering from a transvaginal mesh failure. That’s why our defective product lawyers are hopeful that fair and reasonable settlements can be reached for each of these victims in a timely manner.
December 3rd, 2014|
Transvaginal mesh has been used for years as a means to create a support structure for the internal organs of women undergoing certain medical procedures; however, thousands of women have claimed a transvaginal mesh failure caused them serious harm and pain.
Bloomberg News reports that in 2012, the U.S. Food and Drug Administration ordered makers of transvagnial mesh devices to look into rates of complications, such as organ damage and pain, that could be linked to the products after thousands of women came forward with complaints. The claims recently came to a head when two federal juries found manufacturers of transvaginal mesh devices had failed to warn patients of the dangers associated with the product.
In Florida, a jury awarded a total of $26.7 million to four women who stated the devices had decomposed in their bodies, resulting in damage to their internal organs and pain during intercourse.
A jury in West Virginia also found in favor of four women who had made similar claims, awarding them $18.5 million—including $4 million in punitive damages.
The results of these cases means the manufacturers of transvaginal mesh devices may try to settle the thousands of other cases stemming from failures of the device.
At Fleschner, Stark, Tanoos & Newlin, we understand the harm that can result from the use of an unsafe medical device and we are here to help anyone who is a victim of such a faulty product. Our defective product lawyers can help clarify your legal rights by answering the questions you have and helping you begin the process of filing a claim. To learn more about how we can help you, call us at (800) 477-7315.