Articles Posted in Medical Device Defect

Published on:

Cook Medical is going to soon find themselves in court according to recent court developments. This news comes in the light of thousands of lawsuits that have been filed against Cook Medical and their IVC filters. The first bellwether trial is now on the horizon, after Cook Medical, Inc. was unsuccessful in their motion for summary judgment earlier this month.

According to the Southern District of Indiana, the jury selection process for the first trial will begin on October 23, 2017. Overall, a total of three bellwether trial are slated to take place, which will allow those negatively affected and their representation a range of settlement values regarding IVC filter lawsuits.

The case that has been selected for first bellwether trial is Hill v. Cook Medical, Inc., et al. This case involves Elizabeth Hill, a Florida resident. She was implanted with a Cook Celect IVC filter prior to her scheduled back surgery. Hill has alleged that she was negatively affected by her Cook Medical IVC filter and subsequently required multiple medical corrective procedures. Her complaint has alleged that Cook Medical had a “duty to act reasonably to design, develop, manufacture, market and sell a product that did not present a risk of harm or injury.”

Published on:

Recently, in the Northern District of Texas, the fourth bellwether trial focused on allegedly defective metal on metal hip replacement devices began. This bellwether trial is concentrated on the DePuy Orthopedics’ Pinnacle Hip Replacement System. The bellwether trial has consolidated six hip replacement lawsuits filed by plaintiffs and their family members who allege that they suffered unwanted complications or serious negative side effects due to the premature failure of their DePuy Pinnacle Hip Replacement System device.

This bellwether trial also focuses on the allegations that Johnson & Johnson, and its subsidiary company DePuy, brought their metal-on-metal hip replacement devices to market albeit knowing the device was or may have been manufactured with defects. Among the alleged defects was the low-level quality equipment used to make the devices. Due to the material used in the production of the devices, many patients suffered the negative side effects, including having toxic metal debris to be allowed into their bloodstream or tissue surrounding their joints.

Moreover, through examination of their marketing process, emails and commissioned studies counsel for the plaintiffs has argued it may be shown that Johnson & Johnson, and DePuy took part in deceptive behavior. That highlighted conduct was allegedly aimed toward deceptively encouraging the use of their metal on metal hip replacement devices in hip implant surgeries.

Published on:

Last week, the subsidiary of Johnson & Johnson, Ethicon was order to pay Ella Ebaugh an amount that totaled $57.1 million of damages due to receiving defective pelvic mesh implants. As a result of the defective implants Ebaugh claimed that she was in constant pain and left incontinent.

Ella Ebaugh, a 51-year-old resident of York County, Pennsylvania, brought the suit against Johnson & Johnson. She was initially implanted with two Ethicon devices, the TVT and TVT-Secur, in 2007 in order to treat her stress urinary incontience. Both Ethicon devices eroded ultimately traveling to her urethra. Subsequently, Ebaugh had to endure three agonizing corrective surgeries in order to remove the damaged devices. According the lawsuit, her injuries included vast scarring to her urethra, intrinsic sphincter deficiency, chronic urinary tract infections, chronic pelvic pain and dyspareunia, chronic pain during sex. Ebaugh even stated that somedays she can’t even get out of bed.

Ebaugh’s counsel based their argument around the claim that Johnson & Johnson manipulated information that was available to their company and withheld that information from medical professionals and consumers. Ultimately, this decision is the fifth successful suit in Philadelphia related to these devices. The breakdown of Ebaugh’s award is: $7.1 million in compensatory damages and $50 million in punitive damages.

Published on:

On August 7, Endo International Plc agreed to a settlement amount of an additional $775 million that will allow the company to settle the remaining 22,000 mesh suits brought against them. This additional settlement agreement has now brought the settlement figure to a staggering $2.6 billion. The lawsuits brought against the company alleged that the company’s vaginal-mesh implants left some women incontinent and in extreme pain due the mesh implants eroding.

The August settlement agreement comes only a year after Endo International was slammed with over thousands of complaints due the devices produced by the company. As a result, the company chose to close and shut down one of the units that was based on producing mesh implants. Paul Campanelli, Endo’s CEO and president issued a statement last week in which he called this settlement an “important milestone” for the company. He also made a point to express that this settlement also allowed the company to “resolve virtually all known U.S. mesh product liability claims” against the company.

On the other hand, other companies that are producers of mesh devices, such as Boston Scientific Corporation and Johnson & Johnson, are still facing thousands of complaints from women who had one of their mesh products inserted/implanted and as a result suffered painful or unwanted negative side effects. Overall, mesh based lawsuits are showing to be one of the main mass tort claims in history with the total number of transvaginal mesh lawsuits currently rising to over 100,000 filed complaints.

Published on:

3M’s Bair Hugger surgical blanket is at the center of nearly 2,000 lawsuits due to allegations of the device causing unwanted side effects, including serious infections in patients that used the device. A set of eight bellwether trials have been selected, from the proposed trial pool which consisted of 16 potential lawsuits, according to the May 2017 pretrial order. The first Bair Hugger trial is set to begin in February 2018.

The 3M Bair Hugger is a device that may be placed over an individual after an orthopedic implant or replacement surgery in order to warm their body temperature in order to assist in speeding the recovery process. Ultimately, the surrounding area’s warm air is facilitated through a hose into the blanket and then onto the patient, this is known as “forced air warming.” Almost 80% of the leading hospitals across the United States use the Bair Hugger surgical blanket to assist in the prevention of patient’s hyperthermia. There are 25 different designs, shapes and sizes in order to meet the individual patient’s body and type of surgery. These blankets are also known as one-use blankets because they are disposed of after being used in the patient’s overall procedure.

Individuals have brought lawsuits against the 3M, and its subsidiary Arizant Healthcare, due to the negative side effects that are allegedly caused by the device’s defective design. Many have made claims that the device’s design allows for contaminated air from the surround area, such as the operating room floor, to travel towards the sterile area that the patient just received surgery. If these contaminants or bacteria do reach the sterile surgical site the risk for infection, whether it in the form of sepsis (blood infection), deep joint infection, septic hip or knee or MRSA, is significantly increased for patients. Plaintiffs have also seen unwanted or negative side effects including, but not limited to:

Published on:

In two separate federal litigations, the number of lawsuits filed against C.R. Bard and Cook Medical has reached nearly 4,000. According to the U.S. Judicial Panel on Multidistrict Litigation May report, Cook Medical’s Gunther Tulip and Celect IVC filter blood clot filters are at the center of 1,918 current product liability claims. While C.R. Bard is the named defendant in 1,851 claims due to alleged complications and negative side effects involving their IVC filters, including Recovery, G2, Meridian and Denali.

IVC filters are used to intercept blood clots before they are able to reach an individual’s heart or lungs. The filter is implanted into the inferior vena cava, the body’s largest blood vessel. The filter is most commonly used to prevent a blood clot in the lung, known as pulmonary embolism.

The FDA issued an alert in 2014 to the public that explained the risk of injury outweighed the potential benefits of having the IVC filter implanted and that the devices should be removed as soon as the risk of pulmonary embolism is no longer at issue. The device is meant to be retrievable, but if it migrates into the vein it may become impossible or extremely painful and difficult to remove. Other complications related to the device include the device: breaking; moving or migrating of the filter or pieces of the filter into the lungs or heart; tilting within the inferior vena cava after being implanted; perforation of the inferior vena cava vein.

Published on:

A woman who suffered from complications regarding her Ethicon’s Prolift transvaginal mesh has been awarded $2.1 million in damages. A Pennsylvania jury awarded her more than $2 million after it had been discovered that the mesh had deteriorated while in her body resulting in unwanted negative side effects.

In total, this was the fourth consecutive decision in the Pennsylvania court system regarding transvaginal mesh rendered against Johnson & Johnson, and its Ethicon division. Overall, thousands of women have filed suit or are in the process of filing suit against Johnson & Johnson and Ethicon because of complications, or the negative side effects in various forms, resulting from their transvaginal mesh procedure, due to the type of mesh used in those procedures.

The woman involved in the most recent litigation underwent a mesh procedure in 2006. During this procedure, Prolift mesh was implanted in order to assist in treating her pelvic organ prolapse and stress urinary incontinence. Although, according to the complaint, due to the the type of mesh that was used throughout the procedure she sustained serious permanent and complications. These severe complications included pelvic pain, incontinence, urinary tract infections as well as excruciating pain during sexual intercourse.

Published on:

In today’s day and age there are different corrective procedures that an individual suffering from the unbearable or unwanted pain of a hernia can undertake. One of the more common procedures is to undergo hernia repair mesh surgery. When a hernia repair mesh surgery is undergone, the medical professional must choose the type of mesh that is going to be used during the procedure.

One of the mesh materials that may be used by the medical professional is the Atrium C-Qur Mesh. Atrium C-Qur Mesh is known for combining Atrium’s polypropylene mesh and an Omega 3 gel coating. Although, polypropylene may cause damage to the surface of any organ that it is contact with. Recently, the C-Qur mesh material has been under the spotlight and at the helm of injured individuals’ lawsuits, after undergoing surgery that used this type of C-Qur mesh material, against Atrium.

One of the motivations behind the lawsuits is focused of the belief that the FDA should issue a recall on the C-Qur mesh due the frequent reports of patient’s negative side effects linked with Atrium C-Qur Mesh. Atrium has recalled the C-Qur’s packaging, but has not recalled the hernia mesh itself. Many of the individuals that are pursuing lawsuits also allege that Atrium knew or should have known about the potential negative side effects of internal injuries to the patients, but chose to withhold that information from the public as well as those throughout the medical field.

Published on:

A hernia exists when there is a hole or an overall weak area in the muscular wall that typically maintains organs located in the abdominal region in their place. In many instances, individuals will produce a noticeable bulge as a result of the push through the hole or overall weak area. For some individuals, their hernia may be painless, for others it may cause serious pain or overall discomfort and as a result must take the necessary actions to help alleviate their ultimate suffering.

Typically, an individual will have a hernia located in upper stomach, groin, belly button, high in the thigh or near a past surgical scar/incision. Those diagnosed with a hernia frequently have pain in the area, which can be found in the form of pressure or heaviness on the affected area or a burning or aching responsiveness at the affected area.

The most common leading causes of a hernia include, but are not limited to:

Published on:

On Thursday, Boston Scientific Corporation issued a statement in which it recalled all of its Lotus Valve heart devices in Europe. This recall consists of both clinical and commercial sites. Also, the Lotus Valve has been removed from all clinical sites in the United States, where the valve is not yet approved for sale.

Overall, the recall is due to major manufacturing defects that have found to be present in the device.

The serious defects that has caused this recall are centered around a manufacturing problem that is linked to the premature release of the mechanism containing a pin that is used to implant the device into the heart in patients. The recall was made voluntary by the company. This is similar to mechanism issues that resulted in the Lotus recalls of 2014 as well as 2016.