defective medical products

Letter to the FDA Addresses Risks of Power Morcellator Cancer

by Staff Blogger | December 29th, 2015

Controversy continues to swirl around the use of a device known as the power morcellator to remove uterine fibroids from the bodies of women.

In 2014, the U.S. Food and Drug Administration (FDA) ordered doctors and surgeons to discontinue the use of the power morcellator when performing procedures like hysterectomies due to an increased risk of the patient developing cancer. Research linked the disease to the device after it was discovered that dormant cancerous cells could be released into the body by the device, which led to several power morcellator cancer lawsuits being filed.

Doctors are now contesting these claims, saying the FDA relied on flawed research when issuing the ruling. An article from Reuters explains the medical professionals say the studies that were used during the FDA’s decision-making process were flawed and lacked credibility. For instance, the studies included three cases where the patient developed leiomyoma, which doesn’t meet the current standards and definitions for cancer.

The doctors go on to claim that making women undergo more invasive procedures than the use of the power morcellator increases the risks for hospital-acquired infections and other surgical complications, including death.

The legal staff at Ferrer, Poirot & Wansbrough recognize the dangers the use of a defective medical product can pose to patients and our team is anxiously awaiting the FDA’s response to the claims that have recently been made regarding the use of the power morcellator during surgery.

Automated Endoscope Washing Machines to be Recalled by the FDA

by Staff Blogger | December 22nd, 2015

Hospital-acquired infections are one of the leading causes of hospital readmittance in the United States today. The Centers for Disease Control and Prevention says that as many as 700,000 such infections are reported each year.

With so many infections being reported, many wonder what is causing this phenomenon. The defective medical device lawyers at Ferrer, Poirot & Wansbrough explain that it seems as though a lack of proper sanitation may be to blame in a number of cases.

Becker’s Infection Control & Clinical Quality reports the U.S. Food and Drug Administration (FDA) has recalled as many as 2,800 automated endoscope washing machines made by Custom Ultrasonics after it was discovered that the devices may not completely sanitize the devices they cleanse.

The problem was first discovered in 2007, but the company was allowed to continue marketing the devices after changes were made to the product’s software. However, continued violations were highlighted during a recent FDA inspection of the company’s manufacturing facility and has resulted in the agency calling for the defective medical products to be pulled from the market.

The FDA is also encouraging anyone who has acquired an infection as a result of using a device that wasn’t properly sanitized by the affected machines to report their injuries to the agency.

The legal staff at Ferrer, Poirot & Wansbrough are hopeful these actions will be enough to protect the health and safety of patients undergoing medical procedures nationwide.


Boston Scientific’s Chariot Guided Sheath Faces FDA Recall

by Staff Blogger | December 15th, 2015

The U.S. Food and Drug Administration (FDA) is charged with the task of regulating the safety of medical products in our country. When a product doesn’t meet certain standards, the agency initiates a recall. One of the latest potentially defective medical products to face an FDA recall is Boston Scientific’s Chariot Guided Sheath.

A long tube that’s used to diagnose and clear blockages in a patient’s blood vessels, reports indicate the shaft of the Chariot Guided Sheath’s catheter can separate from the insertion device during an implant procedure.

Officials say the pieces that can break free from the device may become lodged in a patient’s circulatory system, which can lead to stroke, heart attack, or damage to the kidneys. According to the Boston Business Journal, there have been 21 reports received of the Chariot device malfunctioning. No fatalities have been reported.

This is the second recall involving the company this year. In November, Boston Scientific partnered with the FDA to recall the RotaWire Elite Guidewire system after documents surfaced indicating the device could break in a patient’s body and cause serious harm.

Being aware of the risks that medical products can pose is one of the best ways to avoid injury. That’s why the defective medical device lawyers at Ferrer, Poirot & Wansbrough are hopeful this information helps keep you and your loved ones safe.

Popular Medical Devices That Can Prematurely Fail

by Staff Blogger | December 1st, 2015

When Medical Devices Fail

Before the U.S. Food and Drug Administration (FDA) approves a medical device, the product must undergo rigorous testing. However, problems with medical device are often discovered after the product is released to the public.

One of the most common issues with medical devices is abnormal wear and breakage of the device. The attorneys at Ferrer, Poirot & Wansbrough want to share just a few of the high-profile cases involving medical products linked to an increased risk of patient injury.

Rotablator System Breakage

Boston Scientific Corp. has recalled its RotaWire Elite Guidewire and wireClip Torquer Guidewire as part of a system that is used to clear clogged arteries and improve blood flow. The recall was initiated after reports began to surface that the wires could break free from the device, causing perforations. The Boston Globe says that at least one patient has died as a result of the malfunction.

IVC Filters

An inferior vena cava (IVC) filter is a spider-like device implanted into the largest artery of the body to prevent blood clots from reaching the heart or lungs. The wiry legs of the device have been known to break free though, causing a number of serious health complications.

Hip Replacement Devices

A number of metal-on-metal hip implant devices have been recalled after they were found to prematurely wear out, causing users to suffer pain, inflammation, swelling, and a condition known as metallosis. Many of these cases resulted in the filing of a hip recall lawsuit.

Know Your Rights

If a defective medical product has harmed you, it’s important to be aware of your legal rights. You can learn more about your rights and what you can do to protect them by visiting our website.

Cybersecurity Risks Present New Challenges for Medical Device Manufacturers

by Staff Blogger | August 18th, 2015

Many manufacturers of medical devices now design products that can be integrated with wireless technology. While this can be convenient for sending and receiving data, the defective medical device lawyers at Ferrer, Poirot & Wansbrough explain this technology may also compromise the safety and security of the device.

For example, infusion pumps deliver small amounts of medication to patients over an extended period of time. The amount of drug being delivered can be altered wirelessly in certain units, which may present serious safety risks if a unit is ever hacked.

The U.S. Food and Drug Administration (FDA) recently announced that the U.S. Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team identified cybersecurity vulnerabilities in the Symbiq Infusion System. This prompted the agency to instruct facilities using the devices to switch to alternative infusion pump systems immediately. The FDA also offered tips on how to safely make the transition to another system.

While no injuries or deaths have been reported , not all problems with defective medical products are discovered before an incident occurs.

At Ferrer, Poirot & Wansbrough, we understand the risks defective medical products pose to patients, and we are hopeful the warnings issued regarding the Symbiq Infusion System can prevent patients from serious harm.


New Regulations May Increase Defective Medical Device Injury Risk

by Staff Blogger | August 11th, 2015

Regulations set by the U.S. Food and Drug Administration (FDA) are supposed to ensure the safety of all drugs and medical devices in the United States. But the defective medical device lawyers at Ferrer, Poirot & Wansbrough point out that a proposed law may do more harm than good.

According to Health News Review, the 21st Century Cures Act was passed last month by the House of Representatives and consists of new regulations that would overhaul the FDA’s pre-market approval process for medications and medical devices. The act would allow companies to submit sources other than clinical trials as evidence of a product safety. This would allow simple case histories to replace hard data and facts as proof that a medical device functions properly.

The new rules would also require all companies marketing “breakthrough technologies” to have products approved for use even faster than current laws allow. Considering the number of recalls on defective medical products approved based on minimal safety evidence, this change could present an increased safety risk to the public.

The 21st Century Cures Act would also allow companies to be able to hire third parties to conduct safety testing on products, which may present serious conflicts of interest.

Promoting the protection of the public’s health and safety is a top priority of the legal staff at Ferrer, Poirot & Wansbourgh. That’s why we’re hopeful lawmakers will carefully consider the impact of the 21st Century Cures Act will have on the lives of Americans.

Tiger Paw System II Recalled Due to Risk of Heart Tissue Tears and Serious Bleeding

by Staff Blogger | May 26th, 2015

The Tiger Paw System II is a medical device used during open-heart surgery that is manufactured by Maquet Medical Systems. The device is used to obstruct the left atrial appendage during the procedure. But numerous reports of the Tiger Paw System II causing patients serious injury have surfaced recently, and the device is being recalled and added to the U.S. Food and Drug Administration’s (FDA) list of defective medical products.

The Tiger Paw System II can tear the atrial appendage during open-heart surgery, which can lead serious bleeding. According to an FDA press release, these bleeding events have resulted in 51 reports of adverse health events and one fatality.

Facilities that use the Tiger Paw System II have been instructed to examine their inventory of devices to see if any are included in the recall. Any affected products should be removed from inventory, quarantined, and sent back to the manufacturer along with a completed recall form.

Anyone who has been harmed by the device during a surgical procedure should contact their surgeon and FDA officials to report the issue.

At Ferrer, Poirot & Wansbrough, our personal injury lawyers are here to help protect the rights of defective medical device injury victims. If you believe you were injured by the Tiger Paw System II, contact us today.