Articles Posted in Defective Medical Devices

The people of Tennessee as well as many people all across the country have heard reports about problems with hip implants causing pain and other serious side effects. Many people with these Stryker hip implants may also have needed additional surgery to correct the problems. If you or someone you know has recently had a Stryker hip implant and then experienced pain and problems as a result, then you should speak to a Tennessee personal injury and Stryker hip implant lawyer as soon as possible. They will hear your case and see to it that you get the compensation that is rightfully yours.

Stryker hip lawsuits that were filed following the 2012 recall of Rejuvenate and ABG II Modular-Neck Hip Stems continue to grow in United States courts, a coalition for the public’s interest is insisting that the Food and Drug Administration take action that would encourage the development of medical device registries in the United States. Several healthcare organizations, including, the Blue Cross and Blue Shield Association indicate that device registries in other countries have been very helpful in helping to make people aware of the safety concerns with metal hip implants emerged in the last several years. The coalition states that these examples show how medical device registries help the public and post market surveillance activities in the United States as well as in other countries.

Medical device registries can be a useful tool in helping to track the performance of hip implants and other similar medical devices that may be at a higher risk for safety concerns. This will help to reduce recalls like the Stryker hip recall. Following the removal of Rejuvenate and ABG II stems from the market in 2012, over 3,700 Stryker hip implant lawsuits have been filed for people claiming to have suffered injuries from the devices. These cases claim that the Rejuvenate and ABG II stems had a defective design and were improperly tested prior to being put on the market. The claims also state that metal debris caused by the devices can lead to severe injuries such as metallosis, osteolysis, chronic pain, and failure of the hip. These injuries can make additional surgery to remove the defective implant necessary.
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More than three years after removing their defective ASR metal-on-metal artificial hip implants from the market, Johnson & Johnson and its subsidiary, DePuy Orthopaedics, are currently in talks to begin settlement negotiations. According to sources, J&J is discussing the possibility of paying more than $300,000 per case in order to settle the nearly 11,500 product liability lawsuits. This would result in J&J paying over $3 billion in total to resolve the dispute.

Such a settlement is, however, contingent on the outcome of several lawsuits currently pending. Seven trials scattered across five states are scheduled to occur before January of next year. While two verdicts involving the ASR devices have already been reached this year, the two juries reached different conclusions. A jury in California found that the ASR device was defective in design and awarded an $8.3 million verdict to the injured plaintiff. However, less than two months later, a Chicago jury found in favor of J&J, declining to hold the company liable for any harm. In addition to these seven pending suits, 8,000 federal cases have been consolidated in multidistrict litigation in the Northern District of Ohio, and 2,000 cases are pending in the California Judicial Council Coordinated Proceeding.

Despite the numerous claims, J&J and DePuy have never accepted responsibility for selling a defective product. The ASR devices-the ASR XL Acetabular System and the ASR Hip Resurfacing System-were placed in the market in 2005. Before their recall in 2010, more than 37,000 of the chromium and cobalt metal implants were sold in the United States. Patients who used the device have complained of severe pain and a condition called metallosis, both caused by the release of toxic metal debris into the hip joint. Metallosis is characterized by a harmful increase of metal ions in the bloodstream and tissue death. Some medical studies have linked the condition to cancer.
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Manufacturers of transvaginal mesh have been embattled in a flurry of lawsuits brought by women who have suffered from complications after using the product. However, lawyers for some of the largest makers of the company have recently initiated settlement talks with attorneys representing the plaintiffs. There are currently an estimated 30,000 lawsuits that have been filed in federal court against the manufacturers of the product. With the implementation of potential settlement talks, it is estimated that number could rise to upwards of 50,000 lawsuits.

Attorneys for Endo Health Solutions, Boston Scientific, Coloplast, Cook Medical, and C.R. Bard reportedly started discussing possible settlement plans earlier this month. The only manufacturer named in the lawsuits who is missing from the settlement talks is Johnson & Johnson.

Transvaginal mesh is a medical implant that is used to treat a number of conditions including pelvic organ prolapse (POP) and stress urinary incontinence (SUI). However, many women who have had the device implanted have suffered serious side effects including erosion of the mesh, organ perforation, painful intercourse, vaginal scarring, recurrence of the prolapse or incontinence, and even infections. Many women have had to have surgery to fix many of the complications caused after having the device implanted.

Attorneys representing the plaintiffs are requesting the presiding judge overseeing the federal multidistrict litigation to appoint a settlement committee. The committee will be comprised of a number of lawyers including one of the attorneys who helped to negotiate a massive $246 billion settlement in the tobacco litigation.

It is the goal of both sides that the settlement discussions will resolve the thousands of cases currently in the court systems. Settlement discussions typically layout which injuries will be compensated, how much each injury should be worth, and what sort of proof that the manufacturer would require to provide the settlement amount.

However, experts caution that plaintiffs should be “cautiously optimistic” about the news of settlement discussions. These settlement discussions are still in the early stages, but it will be important to monitor as talks progress.

While settlement talks are ongoing, manufacturers have already had to pay out large jury verdicts in some cases. A jury in California awarded over $5 million to a woman who had suffered serious side effects from transvaginal mesh, and similarly a West Virginia jury awarded a woman $2 million after she suffered injuries after having the product implanted. One particular manufacturer has already paid nearly $55 million in settlements for an unspecified number of claims. Another manufacturer was ordered to pay over $11 million to a woman who had 18 surgeries to correct the serious complications suffered following the implant of transvaginal mesh.
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Millions of women across the country utilize some form of birth control. However, the safety of a popular form of birth control has come into question after a large number of women have complained of serious side effects after using the product. Manufactured by Bayer Healthcare Pharmaceuticals, Mirena IUD has over 2 million women that use the birth control device. With such a large number of Mirena IUD users, there is obviously reason for caution assuming there is a link to any potential serious side effects. Any negative side effects could have the potential to affect thousands of women. If you have a Mirena claim, you should speak with a Tennessee Mirena lawyer.

How exactly does the device work? Mirena IUD is a small piece of plastic that has a hormone built into it. The device is implanted into the uterus to prevent pregnancy. The device was supposed to be an easy alternative to other forms of birth control. However, many of the side effects have left women searching for other alternatives.

There have been close to 70,000 complaints filed with the FDA regarding Mirena IUD side effects since the U.S. Food and Drug Administration’s (FDA) approval of the device in 2000. There have been a wide range of side effects that many women using Mirena IUD have experienced. Some of the side effects are minor and include acne, backaches, and headaches. Some of the side effects are much more serious. Since 2008, nearly 4,000 women using the device have complained about abdominal pain. In the same five year span approximately 5,000 women using the device have experienced the device moving around after the insertion. Upon moving, the device can perforate organs and migrate into the abdomen. Whenever this occurs, a doctor is required to remove the device from the patient. Some reports of device migration have reportedly led to liver lacerations, uterine perforations, or other serious complications. As a direct result, these serious side effects can lead to serious surgery including an appendectomy or even a hysterectomy.

There are nearly 220 cases involving Mirena IUD injuries that have been filed in federal and state courts. Many more are expected to be filed as women become more aware of the serious side effects of Mirena IUDs. Many of the suits accuse Bayer of using misleading marketing materials, producing a defective product, and even failing to disclose the dangerous side effects of the device. In the midst of these lawsuits, Bayer Healthcare continues to stand by the safety of Mirena IUDs.
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The first of several transvaginal mesh lawsuits set for trial is currently underway after a jury has been selected in federal court in West Virginia. Women across the country and even right here in Tennessee have turned to transvaginal mesh to treat a number of conditions. However, thousands of patients have had complications following the insertion of transvaginal mesh.

Transvaginal mesh is a device that many women use to treat certain conditions including pelvic organ prolapse or stress urinary incontinence. However, many women have experienced complications with the device such as erosion of the device, infection, perforation of organs, intense pain, and several others. As a result, a bevy of lawsuits have been filed against the manufacturers of the device.

The U.S. District Court in the Southern District of West Virginia is hearing the first of four selected bellwether vaginal mesh lawsuits that will be heard in succession. Commonly known as bellwether trials, courts use these trials as a litmus test. Bellwether trials are used when there is a large group of plaintiffs who have filed suit against a defendant based on the same claim. These trials are important because they tend to indicate future trends in a specific litigation. Typically following a bellwether trial, the plaintiffs and defendants will have a better idea how any other lawsuits may fair. Based on the amount of evidence and any outcome at the bellwether trial, future plaintiffs and the defendants are able to weigh the costs of any further potential litigation and any potential settlement amounts.

The first bellwether case can be a key milestone in litigation because of the amount of time that the legal process can take. This case, Cisson v. C.R. Bard Inc., was the case that was selected first in the series of trials. However, even this case had its delays. The case has actually undergone its second jury selection after the first attempt to try the case ended in a mistrial. The presiding judge ruled that a witness’ testimony was prejudicial and that the jury would not likely be able to disregard the statements from the witness. The presiding judge described the prejudicial testimony as “a bell that cannot be unrung.”

The jurors will likely hear testimony and be presented with evidence about the alleged complications that the patients have experienced with the transvaginal mesh. In addition, the jurors will likely hear evidence about the potentially faulty design of the product. According to court documents, the plaintiff alleges that the defective product caused her very serious injuries and that the C.R. Bard failed to properly test the safety of the transvaginal mesh.
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There have been an increasing number of lawsuits filed against Fresenius, the manufacturer of the GranuFlo dialysis treatment, based on serious health problems following use of the product. GranuFlo is a dialysate that is used during hemodialysis to offset the acid created by kidney failure. The acting agent within the product can convert to dangerously high levels of sodium which often cause serious heart problems.

Individuals seriously injured following the use of GranuFlo have filed suit in courts all across the country. With Fresenius serving up to one-third of Americans requiring dialysis, it is expected for that number to only rise as patients and families learn of the high risks associated with GranuFlo.

Recent suits have highlighted the damage caused by GranuFlo. Last month, an individual filed suit seeking $6 million from Fresenius after suffering cardiac arrest and other ongoing serious health problems allegedly as a result of using GranuFlo. The plaintiff is seeking compensation for medical expenses and legal costs, pain and suffering, emotional distress, as well as lost wages and earnings.

After beginning hemodialysis in 2008, the plaintiff experienced cardiac arrest in 2010 and subsequently required surgery to fit a pacemaker. The plaintiff alleges that Fresenius failed to adequately warn consumers and the medical field of the full extent of risks associated with GranuFlo.

Other recently filed Tennessee GranuFlo lawsuits involve wrongful death actions as a result of the deceased using product during dialysis. One of the lawsuits involves two sisters filing on behalf of their late mother, while another suit involves a widow seeking compensation following the death of her husband. These lawsuits are the only recourse for families heavily burdened from the fatal effects of GranuFlo.
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The past few years have been very hard for patients effected by metal on metal hips. There have been hundreds of lawsuits filed in relation to the DePuy Hip and the Stryker Metal hip recalls. In fact the Stryker Rejuvenate and ABG II hip implants have been recalled. It is estimated that 500,000 patients throughout the United States have received metallic hip implants.

According to some experts the risk of these metal on metal hip implants is that some of the devices can rapidly begin to wear. When this happens high volumes of metallic debri can be absored in the patients body which can create an inflammatory reaction that results in pain in the groin and death of tissue in the hip join area. It can also call a loss of surrounding bone.

Recently, one of the first DePuy case went to trial. In that case the jury found for the plaintiff and awarded him 8.3 millions dollars in damages. Recently, I was interviewed about this defective hip case. You can watch the interview below:

 

 

Our Tennessee Defective Hip Lawyers are working with several families throughout the state who have had failure of the metal on metal hip. These cases can be devastating to not allow the patient but to the entire family. To undergo such a painful and dangerous surgery will obviously create a significant hardship Continue Reading

The Stryker hip metal on metal implant recall has affected many patients and their loved ones. These patients who live all across the country and even in Tennessee have suffered with pain, squeaking, popping, and various other complications due to the defective medical devices. If you or someone you care about has experienced these or other problems after receiving a medical implant or device, then you are encourage to contact a Tennessee personal injury and defective medical device lawyer right away. They can hear your claim and help you determine the compensation you may be entitled to based on your claim and your injuries.

According to this lawsuit, Darlene Gray received her Trident hip replacement device in August, 2005, and began experiencing complications from her hip a short time later, including popping, squeaking, and ongoing pain. Gray eventually underwent hip revision surgery to remove and replace the faulty implant.

Judge Tanya W. Pratt denied the defendant’s request to dismiss the case. According to Gray’s initial complaint, Stryker Corp. was listed as the only defendant. The plaintiff amended her original complaint to include Howmedica Osteoncics Corp., which also conducts business as Stryker Orthopedics Inc. Howmedica has been named on other lawsuits involving the Trident hip implant.

Howmedica stated in their request that Gray’s allegations are barred by the Medical Device Act. This act preempts claims against class III devices, like the Trident hip replacement listed in Gray’s lawsuit. Class III devices are subject to a vigorous premarket approval process, a fact that is not included in Gray’s amended complaint.

Howmedica also asserts in their request for dismissal that Gray did not specify in her complaint whether her injuries were a result of manufacturing defect or physician error. She did not specifically list the components of the device that led to her injuries. The defendant argued that Gray also failed to offer details of the FDA’s findings on the device or the Stryker Trident recall that was issued in 2008.

Judge Pratt, stated, however that Gray sufficiently alleged a manufacturing defect to avoid Medical Device Act preemption. Although Gray made no specific allegations of federal law violations, Judge Pratt determined that the plaintiff did clearly allege that complications were due to manufacturing defect and lack of quality control in the manufacturing process. Judge Pratt explains that Gray’s complaint “puts defendants on notice that her claims are premised upon allegations that some federal law or regulation was violated.”
Judge Pratt also states in her decision that Gray has shown in her complaint that the Stryker Trident recall was based on the FDA’s findings that the device was not manufactured properly.
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Tennessee residents and people all across the United States have heard about the Stryker hip implant recall from the news, television, the internet or some other source. Many people have also been personally affected by these hip implants and may have needed additional surgery to replace the defective hip implant. Hip implants and other types of medical devices like them are typically needed for people who suffer from arthritis or massive bone fractures.

In this case, Richard Lynn Torbett claims that after receiving the Rejuvenate hip device, he suffered serious injuries, which required him to need a revision surgery in order to correct these problems. During the surgery, his doctors discovered that he had a deep pocket of swelling around his joint. He also had a large amount of fluid swelling around the joint, and finally, had fretting and corrosion around the joint as well. The release of cobalt and chromium from the fretting and corrosion also caused him to suffer damage to tissue around the medical device and elevated blood serum levels of cobalt and chromium. He will continue to need medical treatments, rehabilitation, and medicine because of these injuries.

He seeks to hold Stryker Orthopedics liable for his medical expenses, pain, and suffering, and seeks in excess of $75,000 in damages.

The Stryker Company released the Rejuvenate hip implant in February 2009. Stryker claimed that the titanium alloy used in the device was stronger than other titanium alloys, and had been tested and proven to resist the effects of fretting and corrosion.
The device was also marketed as providing options that enhanced stability and intra-operative flexibility, providing surgeons with more options to better personalize the implant to a patient’s unique anatomy.

In April 2012, Stryker released an urgent safety notice to surgeons and hospitals in the United States. In the notice, the company stated that it had received reports of premature Rejuvenate device failure because of heavy metal contamination. The notice specifically mentioned failures occurring at the neck junction between the two-part neck and stem, due to fretting and corrosion. This was exactly the same fretting and corrosion that Stryker had warranted would not occur because of the Rejuvenate design and composition.

Stryker stated that these issues could cause tissue necrosis (tissue death), metallosis, adverse soft tissue reactions, and the formation of pseudotumors (deep pockets of swelling). In July 2012, the company issued a voluntary Stryker hip replacement recall of all Rejuvenate and ABG II modular stems, stating the components had been linked to reports of premature failure due to heavy metal fretting and corrosion.

Many medical devices and implants like the Stryker hip implants are designed properly and are very effective and beneficial to patients in helping them to lead fulfilling and active lives. However, sometimes medical devices do have defectives and problems. When this occurs, it is necessary to hold the company responsible for any design defectives that may have caused the problems as well as their failure to properly warn doctors and patients about the potential risks involved. It is important to hold them accountable for any negligence on their part.
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In Tennessee and all across the country and even the world, we have all heard reports about the Depuy hip implant recall and metal on metal hip recalls. The original Depuy hip recall occured in August of 2010. Since then, many people have experienced pain and problems and even needed additional surgery to fix or replace their implants. If you or someone you love have had pain or hip problems since your implant and think you may have a Depuy hip implant, you should talk to a Tennessee hip implant recall lawyer right away. They will hear your case and work with you to make sure you get the compensation you deserve.

In the first hip recall case to go to trial, a jury on Friday, March 8th, 2013, found that the hip implants were defective, but that DePuy did not act with fraud or malice. DePuy was ordered to pay more than $338,000 in medical costs and $8 million for pain and suffering to plaintiff Loren Kransky. No punitive damages were awarded. Another case involving a lawsuit filed by a retired prison guard suffering from kidney cancer and other ailments, states that this verdict bodes well for this case as well as other cases, while DePuy said it would appeal.

Jeff Jonas, an analyst for Gabelli & Co, stated that Johnson & Johnson unit will eventually offer a national settlement, under which thousands of hip plaintiffs would likely take what is offered rather than face years of litigation and appeals. The recall of the Depuy hip implants began in 2010, prompted by recognition that the devices were failing at higher-than-expected rates. Some 93,000 ASR hips were sold prior to the recall.

Loire Gawreluk, a spokeswoman for DePuy stated that, “We believe ASR XL was properly designed, and that Deputy’s actions concerning the product were appropriate and responsible.” She also stated that, the planned appeal will be based on grounds including the fact that the court did not allow the company to tell the jury that the U.S. Food and Drug Administration had reviewed the device and cleared it for sale.

In Loren Kransky case, it has been stated that, “the jury’s decision is the first day of reckoning for DePuy and Johnson & Johnson … We expect to get punitive damages in the next trial.” The case claimed that the ASR hip resulted in elevated levels of cobalt and chromium in Kransky, causing him pain that required the hip to be replaced. The J&J lawyers that there is no medical consensus on what levels of the metals may cause harm to patients and said Kransky’s other medical problems, including diabetes, heart disease, and kidney cancer, were the source of his pain and suffering.

Another hip implant trial in Illinois state court starts on Monday March 11, 2013. Two cases in federal multi district litigation are set for trial in May and July in Ohio.
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