Articles Posted in Medical Device Defect

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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.

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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:

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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.

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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.

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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.

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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:

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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.

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In the United States, a leading health concern is coronary heart disease. Currently, this health concern is amounting to over 370,000 deaths per year. Individual’s with a coronary heart disease suffer from plaque, a waxy substance, buildup that can have a serious impact on an individual’s health. Subsequently, the buildup of unwanted plaque results in the narrowing of the individual’s arteries. This narrowing allows for the reduction of proper oxygen-rich blood flow to the individual’s heart. In order to combat this, individuals have options, one being to elect to have a heart stent procedure.

In today’s society there are hundreds of thousands individuals that have chosen to have a heart stent implanted due to health complications.

Heart stents, in the past, were primary made using bare-metal or mesh and are still presently an option. Although, for over a little more than a decade, drug-eluting stents have been manufactured, approved and used in the United Stated as well. Two popular types of drug-eluting stents being used currently are the Boston Scientific Taxus Stent and the Johnson & Johnson Cypher Stent. Regardless of the type, all of the heart stents are the subject of some criticism and documented complaints due to their potential risks and side effect(s).

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In 2002, the U.S. Food and Drug Administration (FDA) approved the Conceptus Inc., a subsidiary of Bayer since 2013, manufactured Essure Permanent Birth Control System. The contraceptive is marketed as the “only permanent birth control you can get with a non-surgical procedure.” Furthermore, a focal marketing attribute of Essure is that the procedure is quick, most times only lasting approximately 10 minutes and can be executed without the need for any anesthesia. Also, the procedure is done with no need for incisions during the entirety of the process. The procedure consists of implanting a small flexible coil, that reaches 1.5 inches once implanted and expanded. The doctor implants the coil through the cervix and vagina ultimately positioning it at the entrance of each fallopian tube.

According to a clinical study, produced by the makers of the birth control system, Essure was allegedly shown to maintain an almost perfect percentage of effectiveness in preventing pregnancies. Although, many of the women that have used Essure would strongly disagree as well as complain about the various side effects they have suffered from having the procedure.

Since the product’s existence there have been around 10,000 documented complaints due to ineffectiveness and various side effects, even multiple deaths, related to Essure. The side effects, include but are not limited to, are:

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The Michigan based Stryker Corporation, a medical technology firm, has been the under the spotlight due to their medical device recalls. In 2012, Stryker was forced to recall the popular surgical implant or replacement medical products Rejuvenate and ABG II Modular-Neck Hip Stems due to their connection to patient problems and negative side effects.

Rejuvenate and ABG II Modular-Neck Hip Stems were unlike any of the current hip implant technology on the market. At that time the market was known for using a one-piece neck and stem construction, but the Rejuvenate and ABG II Modular-Neck Hip Stems were constructed using a system of multiple stem and neck mechanisms. The multiple components were instrumental in allowing for a more custom fit for implant or replacement patients. The products’ qualities including the system of multiple components, coupled with theoretical stability, longevity and larger range of motion, allowed Stryker Corp. to advertise the Rejuvenate and ABG II Modular-Neck Hip Stems as one of the top of the line performance surgical products, especially to younger patients in need of implant procedures.

Stryker also made their Rejuvenate and ABG II Modular-Neck Hip Stems with an alloy that allegedly was stronger than other alloys being used on that time’s current market. Stryker additionally claimed that their alloy blend “resembles that of bone.” The alloy blend consisted of titanium, iron, molybdenum and zirconium. Stryker maintained that this blend would deter metal corrosion and fretting, which is where small metal flakes break off and enter into the body. Unfortunately, Stryker was incorrect and the alloy blend based products caused serious negative side effects, predominantly the release of combinations of toxic metals into the body of the implant or replacement patient.