Articles Posted in Medical Device Recalls

Medical device maker Ethicon is one of the two chief manufacturers of surgical staplers in the U.S.  Surgical staplers are widely marketed and used as an alternative to manual sutures made by surgeons to close internal wounds, their greatest benefit being reducing a patient’s time in surgery. However, Ethicon and other stapler makers have long been dogged by reports that their products frequently malfunctioned, causing serious injury and even death to patients.

Now Ethicon has initiated a recall of more than 8,000 of its Echelon Flex Endopath staplers, announced by the U.S. Food and Drug Administration in October. The FDA has identified this as a Class I recall, which indicates the devices could cause life-threatening injuries or death. As of October 3, seven serious injuries and one death had been reported to Ethicon for the affected products.

The Echelon Flex Endopath staplers are designed for use on only one patient, in major or minimally invasive surgical procedures including gynecologic, urologic, thoracic, pediatric, and general surgeries. They were manufactured between July 18 and August 3, 2019, and distributed to healthcare providers between August 1 and September 26.

Women looking for a simple alternative to traditional methods of sterilization have turned to the Essure Permanent Birth Control System, which is marketed and sold by Bayer. The contraceptive device was originally developed by Conceptus Inc. and approved in 2002. Bayer purchased Conceptus and the rights to the Essure System in 2013 and is now under fire for numerous complications that women using the system have suffered. These complications are so severe that the FDA has implemented a black box warning for the devices— which requires patients to sign a waiver stating that they have been notified of the risks associated with the devices prior to use.

How the Essure System Works

The Essure Permanent Birth Control System is a non-hormonal birth control method that prevents pregnancy through sterilization. Two flexible coils are inserted into the fallopian and over time, scar tissue develops around the coils and causes permanent infertility by creating a barrier that prevents eggs from reaching the uterus. The simple outpatient procedure has made the system an attractive alternative to tubal litigation and the devices can be inserted without any need for anesthesia.

Five lawsuits filed against DePuy over its Pinnacle metal-on-metal hip implant were consolidated into a single trial that began on January 8, 2016 and the trial is the second major bellwether trial that has been heard since numerous injuries have been linked to the device. The result of this trial will have an impact on thousands of cases yet to be heard, and if things do not go DePuy’s way, it could open the door for a settlement program to compensate those who have suffered injuries or required revision surgeries after receiving the devices.

DePuy Had Knowledge of Potential Concerns

Evidence brought forward for the trial suggests that DePuy was aware of manufactural defects and safety concerns related to the Pinnacle hip replacement as early as in 2008, but delayed the recall of the device to the detriment of thousands of patients. One of the report’s details an error in the measuring techniques used to ensure that the metal-on-metal components of the hip implants would not wear excessively or present a risk of metalosis— a condition that occurs when heavy metals such as chromium and cobalt reach the bloodstream. Additional evidence shows that DePuy reduced its investment in quality control measures in 2006 and continued to spend less time inspecting its products despite the concerns that surfaced in 2008.

3M Bair Hugger manufactures and sells a forced air warming blankets that are used during implant surgeries nationwide. The blanket helps patients who are under anesthesia regulate their body temperature while it prevents hypothermia. Using a surgical hose, the system forces hot air into the disposable blanket draped over the patient’s larger body areas during surgery. The warming blanket has been used by many surgeons during millions of surgical procedures each year as a way to reduce the chance of hypothermia, when the patient loses body heat at a rate faster than it can be produced.

While designed to reduce the potential risks of developing an infection, the device might actually cause an infection by blowing highly contaminated bacteria-laden air from the tainted floor area into the patient’s opened surgical site. The potential risk of developing an infection is especially severe for individuals undergoing artificial heart valve implant surgery or joint replacement surgeries including knee and hip replacements.

The Inventor Speaks Out

Many patients have developed serious life-threatening infections after hip and knee replacement surgeries from using temperature management systems developed and sold by 3M Bair Hugger. Many of these individuals have filed lawsuits against the manufacturer of the device claiming negligence of its potential risks and safety hazards.

These warming devices are used during surgical procedures as a way to regulate body temperature. Currently, more than 50,000 warming systems sold by the device manufacturer are used in nationwide hospitals and have warmed millions of patients since the products were first brought to the medical marketplace.

Many personal injury attorneys, including Rosenfeld Injury Lawyers LLC, have claimed that the forced air warming blankets have design defects that cause a disruption of laminar flow during surgeries in operating rooms nationwide. The defects allow bacteria and other dangerous contaminants to transfer from the floor and enter the patient’s surgical site. The defect increases the potential risks of knee and hip implant patients to develop a life-threatening joint infection after surgery.

The Chicago IVC filter attorneys of Rosenfeld Injury Lawyers LLC have been investigating numerous claims on behalf of clients who believe that the devices were directly responsible for severe bodily harm. In response to a mounting number of cases against C.R Bard on behalf of those who were injured by the Recovery and G2 IVC filter product lines, a multidistrict litigation has been formed to hear facts that are common to all of the cases involved. The result of this multidistrict litigation will have an impact on the cases currently being heard as well as any that will be filed in the future.

Clients Allege IVC Filters Cause Bodily Harm

The devices produced by C.R Bard and other IVC filter manufacturers are designed to prevent pulmonary embolism and other events that are the result of blood clots moving from the leg to other areas of the body. They work by trapping the clots and then holding them in place until they dissolve or break into smaller pieces that are able to pass through the bloodstream safely. C.R Bard is the largest manufacturer of these devices, and the first to be named in lawsuits that claim a new line of recoverable filters have been released with numerous defects that pose significant risks and that those risks were not communicated properly to patients.

In the five year span between 2005 and 2010, the FDA investigated 921 claims by patients receiving IVC filter implants and their families, stating that the devices were responsible for serious injuries due to fragmentation, migration, and punctured organs. In light of the sea of litigation that followed the FDA’s warning regarding the risks associated with the devices, a study was conducted to determine the efficacy of the IVC filter and how well it compares to the traditional treatment options involving anticoagulants to shrink and break up the blood clots without the need for surgical intervention. The results of the study were surprising and suggest that IVC filters are not worth the risk.

Evaluation of Recurrent Pulmonary Embolism

In a study conducted by French physicians, four hundred patients were monitored to determine whether IVC filters were more effective than blood thinning medications at preventing pulmonary embolism, which results when a blood clot reaches the lungs. The general consensus among the researchers was the hypothesis that anticoagulants— which come with risks of their own, such as uncontrolled bleeding— would be far less effective in the reduction of recurrent pulmonary embolism and mortality. At the conclusion of the study, it was revealed that both treatment options had the same level of impact.

Power morcellator manufacturers and practitioners performing hysterectomies and other uterine procedures with the devices have come under fire following the discovery of a strong link between power morcellation and the spread of cancerous tissue to the uterus. The son of a woman who died from uterine cancer not long after undergoing a procedure which implemented the use of a power morcellator is seeking damages from multiple parties he alleges failed to warn his mother of the risks associated with the elective procedure and that had she underwent a more traditional procedure, she would still be alive today. The lawsuit was filed on April 10, 2015 and is being heard by the United States District Court for the District of South Carolina.

Storz Morcellator Cited as Responsible for Spread of Cancer

The plaintiff’s mother was advised to undergo a laparoscopic procedure to remove uterine fibroids and was diagnosed with adenosarcoma and sarcomatous overgrowth less than a week after the procedure. It is alleged that the Storz power morcellator used during her surgery disseminated cancerous tissue and spread it into her abdomen; she died of her ensuing condition on April 13, 2012. The plaintiff is seeking damages from Karl Storz Endoscopy-America, Inc., Karl Storz Endovision, Inc., and Karl Storz GMBH & Co. KG for wrongful death, misconduct and the failure of the device manufacturer to provide adequate warnings about the risks of power morcellation procedures.

Transvaginal mesh products became extremely popular around 2005 as alternatives for the treatment of conditions that include pelvic organ prolapse and incontinence but evidence later surfaced questioning the safety of the devices and whether they could cause serious injuries to the patients implanted with them. By October of 2008, the FDA needed to issue a warning to surgeons conducting transvaginal mesh procedures due to over a thousand reports of significant complications associated with the devices. At the moment, we are on the brink of a wave of litigation being brought against major transvaginal mesh manufacturers due to the damage that has been caused and the failure of the manufacturers to provide sufficient warnings about their risks.

Types of Transvaginal Mesh and Uses

The primary purpose of transvaginal mesh products is to treat pelvic organ prolapse and stress urinary incontinence which are caused when pressure is placed against the bladder from reproductive organs which have fallen into the pelvis. In both cases, the mesh products are used to return the affected organs to their correct positions and reinforce the pelvic floor to keep them there. There are two different forms of mesh cited in transvaginal mesh litigation.

You’ve probably felt a sense of frustration if you ever purchased a device that suddenly failed to work and demanded a prompt refund or exchange from the manufacturer. You may be able to forgive the manufacturer if the device is an IPod or a cellphone, but imagine that your ability to breathe rested squarely on the device in question. CareFusion recently announced the global recall of nearly 16,000 ventilators citing that the devices may spontaneously stop working, causing “adverse health consequences or death.” It is purely terrifying to imagine that a device which you or a loved one may rely on for survival could simply stop working.

Recall Designated as Class I by the FDA

Avea ventilators mechanically control respiration in patients that are unable to breathe or have difficulty breathing without assistance. They are most frequently used during medical transport, as a component of home care or nursing care and during critical care. The Avea product line monitors oxygen levels and delivers a predetermined quantity of oxygen during ventilation. CareFusion highlighted the ability of Avea ventilators to monitor and regulate oxygen levels its ability to provide detailed information to medical professionals in its advertising of the devices.