Defective Medical Device

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.

Bair Hugger™ Hospital Infection Lawsuits Are Mounting

by Staff Blogger | November 10th, 2015

In 1987, the Bair Hugger forced air warming blanket was introduced to keep patients warm while undergoing surgical procedures. Since that time, the device has been used by more than 200 million people. However, patients may not realize the device may be threatening their health.

The Bair Hugger works by blowing warmed air through the blanket. But the device’s blower can release air that contains dangerous pathogens onto the patient’s wounds or incisions. This can result in deep tissue infections.

Some of those infected after using the Bair Hugger system filed Bair Hugger hospital infection lawsuits. The victims claim the maker of the device was aware of the risks it posed, yet took no corrective action to protect the public from harm.

In 2010, the inventor of the Bair Hugger blanket told the The New York Times about the potential dangers his device posed. Yet, 3M, the device’s manufacturer, continued production despite being aware of the risks it posed. An article from Outpatient Surgery explains that 3M has denied the claims are true.

At Ferrer, Poirot & Wansbrough, we recognize the serious harm that a defective medical device can cause, and our legal staff is hopeful the outcome of the Bair Hugger injury lawsuits will help protect the health and safety of those undergoing all types of medical procedures.

Injuries, Deaths, and IVC Filter Lawsuits Prompt Investigation

by Staff Blogger | October 6th, 2015

Companies that manufacture medical devices are required by law to ensure the safety and proper function of their products. However, an investigation has shown that C.R. Bard, Inc.—a medical device manufacturer—may have known about risks that its Inferior Vena Cava (IVC) filter posed to patients without taking corrective action.

An IVC filter is a small spider-like medical device inserted into the largest vein in the body to prevent blood clots from making their way to the heart and lungs. At least 27 deaths and hundreds of injuries have now been associated with the use of the IVC filter made by C.R. Bard, Inc. A number of IVC filter lawsuits have led to an investigation into how the C.R. Bard, Inc. Recovery IVC filter made it’s way onto the market in spite of serious safety concerns.

NBC News reports that the company hired a consultant to help get the Recovery IVC filter approved by the U.S. Food and Drug Administration after a failed initial attempt. The consultant explains she voiced concerns over the safety of the device and refused to sign the applications for the device to seek approval. Documents show the consultant’s signature on those documents, though.

At Ferrer, Poirot & Wansbrough, we believe in protecting the health and safety of medical patients, and our defective medical device lawyers are hopeful the discovery of C.R. Bard’s potentially negligent handling of the Recovery filter’s approval process can result in action towards creating accountability among medical device manufacturers.

Settlement Offered to Victims of Transvaginal Mesh Complications

by Staff Blogger | September 15th, 2015

Many women suffering from conditions like pelvic organ prolapse or urinary incontinence undergo corrective procedures utilizing transvaginal mesh. Many of these patients have suffered transvaginal mesh complications, including pain, swelling, and perforation of organs or tissue.

Some patients who suffered injuries filed civil litigation against the makers of the transvaginal mesh products. A large portion of these cases may soon be resolved if a settlement offered by one transvaginal mesh maker is approved.

According to Bloomberg Business, transvaginal mesh manufacturer, C.R. Bard, Inc., has offered $200 million dollars to settle roughly 3,000 transvaginal mesh lawsuits filed against them. If the terms of the settlement are approved, it could mean each victim getting as much as $67,000 in compensation.

The decision to offer the settlement came on the heels of a court order for the company to pay a West Virginia woman $2 million in compensation for injuries she sustained due to transvaginal mesh implanted into her body.

At Ferrer, Poirot & Wansbrough, we recognize the struggles many victims of a transvaginal mesh failure face along their journey to recovery. That’s why our transvaginal mesh lawyers are hopeful the settlement will bring a sense of closure to each of the victims harmed by Bard’s product.

 

 

The Latest on Bair Hugger™ Hospital Infection Lawsuits

by Staff Blogger | September 1st, 2015

Patients undergoing surgical procedures often need assistance in maintaining their core body temperature while under anesthesia. However, the defective medical device lawyers at Ferrer, Poirot & Wansbrough say new studies show one popular medical device used to keep patients warm may be putting their safety at risk.

The Bair HuggerInflatable blanket fills with warm air to keep a patient’s body temperature from dropping to a dangerous level. In fact, it’s so popular, as many as 80 percent of hospitals in the U.S. utilize the device.

While the device may be effective in keeping patients warm, research shows it can increase a patient’s chances of developing an infection. A study published in the The Bone and Joint Journal found that patients who underwent a procedure utilizing the Bair Huggermay face up to a 380 percent increase in the chance of serious infection.

These injuries have resulted in some victims filing Bair Hugger™ hospital infection lawsuits. The victims claim they were not warned about the risks posed by the blanket.

According to Reuters, attorneys for the victims in some of these cases have filed a motion to move certain claims to the U.S. District Court for Minnesota.

At Ferrer, Poirot & Wansbrough, we are aware of the serious damages defective medical devices can cause, and our staff is hopeful that the decision reached in the Bair Huggerhospital infection lawsuits will help bring closure to victims and their families.

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.

Drug Injury Lawyers Discuss Improper Medication and Medical Device Labeling

by Staff Blogger | April 21st, 2015

What happens when important safety information is omitted from a drug or medical device label? The drug injury lawyers at Ferrer, Poirot & Wansbrough explain that, unfortunately, medical product labels may not always carry all the necessary information required by law—which can often lead to injury.

An article from Healthcare Packaging touched on two specific cases where drug manufacturers failed to supply adequate information on a label. And, in one case, even allegedly used packaging sizes to manipulate consumers into buying certain products.

Pfizer, Inc. supposedly placed misleading labels on certain products. This caused consumers receive less information than they were supposed to while boosting sales of items that contained less product than it seemed to hold.

Another article stated Ban, a deodorant manufacturer, is also being sued after research uncovered the company wasn’t supplying consumers with as much product as was printed on the label.

If you’ve been harmed by a defective medical device, you may have rights to compensation. The attorneys at Ferrer, Poirot & Wansbrough want to help. Call us anytime at (800) 210-8503 to discuss your case.

New Sanitation Policies Help Prevent Medical Devices From Spreading Contamination

by Staff Blogger | April 14th, 2015

After a deadly “superbug” contamination left hundreds of patients ill and fighting for their lives in numerous hospitals across the country, the U.S. Food and Drug Administration (FDA) has announced they’re taking action to prevent such incidents in the future.

The defective medical device lawyers with Ferrer, Poirot & Wansbrough explain that hospitals are required to vigorously clean all devices and equipment used to perform procedures. Sometimes though, the sanitation steps that are taken just aren’t enough.

Officials have determined this lack of effective sanitation procedures is what allowed a drug-resistant strain of bacteria called carbapenem-resistant Enterobacteriaceae, or CRE, to be spread through specialized endoscopes.

The devices were used to gather images from inside the bodies of patients to determine what was ailing them. However, when the devices were not being effectively cleaned, patients were exposed to the CRE superbug.

This lack of effective sanitation prompted the FDA to issue a press release with a new set of standards to be utilized when sterilizing medical devices that are reprocessed.

The new standards require more extensive safety testing before the device can be released to the public. Manufacturers of medical devices are also encouraged to take reprocessing into consideration when designing new products.

At Ferrer, Poirot & Wansbrough, our personal injury attorneys are hopeful the new procedures being implemented will reduce the rates of hospital-acquired infections in patients after medical procedures.