Articles Posted in Defective Medical Devices

Deborah Giannecchini, 62, had been using J&Js’ baby talcum powder as feminine hygiene for 4 decades. However, in 2012 she was diagnosed with ovarian cancer and claimed the baby powder was the cause. After hiring a talcum powder lawyer, a lawsuit was filed for compensatory damages due to negligence, and a recommendation for the company to have to attach warnings onto the product.

Only recently, the jury sitting of Mrs. Giannecchinis’ case, ruled in her favor. Her award settlement totaled $70 million; $65 million in punitive damages from J&J with a further $2.5 million for medical costs, pain and suffering. J&Js co-defendant Imerys Talc America, and supplier of the talc, are also required to pay $2.5 million to her. Johnson & Johnson says they sympathize with Mrs. Giannecchini’s situation; however, they went on to say “We will appeal today’s verdict because we are guided by the science, which supports the safety of Johnson’s Baby Powder.”

Nashville Attorneys, The Higgins Firm, are closely looking into Abilify lawsuits and claims which have raised concern amongst professionals after a number of people were said to have developed a gambling disorder, diabetes or other potentially harmful uncontrollable urges while taking the drug. These urges, the Abilify lawyers go on to say, appeared to have ceased once the medication was discontinued.

The antipsychotic drug Abilify, also known as aripiprazole, is manufactured by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. Lawsuits against these companies state that they failed to provide sufficient warnings on the label of the drug and neglected to properly educate the prescribing doctors of Abilify’s’ side effects.

Deane Berg’s doctor called her the day after Christmas in 2006 to tell her the news of her cancer diagnosis. She had her ovaries removed and the results came back Deane Berg had stage three ovarian cancer and her prognosis was poor. She had twenty-five years of experience has a physician’s assistant but knew almost nothing about ovarian cancer. When she looked up the risks, she had only one; regular use of talcum powder for feminine hygiene.

Berg learned that since the early 1980s, several studies had discovered that women who regularly used talc powder for feminine hygiene had higher than average rates of ovarian cancer. Yet the evidence which fell short of proving that it caused the cancer, was mostly confined to medical journals and had barely been made known to the public. For millions of women including Berg using powder on the the genitals or underwear was a daily ritual, like brushing teeth. Since her teens, Berg had used Johnson’s Baby Powder and Shower to Shower, another Johnson & Johnson powder marketed to women. “A sprinkle a day keeps odor away,” the ads stated. “Your body perspires in more places than just under your arms.”

Many of you may have heard about a superbug going around that is resistant to antibiotics. What you may not know about it has been linked to medical scopes known as duodenoscopes. According to this case, 500,000 Americans undergo a procedure known as Endoscopic Retrograde Cholangiopancreatography or ERCP every year using these medical scopes and this procedure has been linked to the superbug outbreak also known as carbapenem-resistant Enterobacteriaceae or CRE.

Earlier this week, Carla Warner provided emotional testimony to a U.S. Food and Drug Administration Advisory Panel about the devastating impact that as carbapenem-resistant Enterobacteriaceae or CRE had on her husband, Willie “Bill” Warner. He developed CRE after having an Endoscopic Retrograde Cholangiopancreatography procedure. Warner’s procedure used a widely sold TJF-Q180V duodenoscope, which was produced and sold by Olympus America, Inc. Carla Warner’s testimony about the death of her husband due to CRE was highlighted on the panel.

Beginning in 2010, Olympus redesigned and replaced its TJF-Q160V duodenoscope with the TJF-Q180V duodenoscope. The new 180V model had a sealed section on the device known as the “elevator wire channel.” In lawsuits that have been brought against the Olympus America Corporation after family members have died from infections using the TJF-Q180V duodenoscope, it was complained that bacteria can become trapped in the device’s sealed elevator wire channel. The elevator wire channel on the device is not easily accessed for proper cleaning so it becomes the source for the outbreak of the deadly superbug CRE infections that patients are developing.

There are many medical devices and products on the market that are used to reduce medical complications for people and to help improve their quality of life. Unfortunately, sometimes these devices or products can have defects and cause additional complications or medical problems for many people. If you or someone you know had an IVC Filter implanted and are now experiencing serious side effects or more medical problems as a result, then it is important that you speak to a IVC Filter and dangerous device lawyer with the Higgins Firm. We will listen to your case and determine if you may be eligible for compensation for what you have been through.

IVC Filters are implanted in people who have problems with blood clots. They are used to trap the clots in order to help prevent them from becoming pulmonary emboli. When they were originally marketed, they were permanent implants. However, over the last ten years, they were redesigned so that they could be retrievable, which means that the doctor could implant them and take them out at a later date. These retrievable filters were marketed first in 2003. One of the makers of these filters that is now facing lawsuits is C.R. Bard, maker of the Recovery, G2 Filter and Eclipse; and Cook, which makes the Celect and the Gunther Tulip.

According to a study from the Journal of Vascular Interventional Radiology, after five and a half years, forty percent of people who have a retrievable filter have experienced some type of fracture in the filter. Other side effects could include the filter moving, titling or perforating and these side effects can cause perforation of organs or vessels next to the filter. A fracture in the filter could travel to the patient’s heart, which can result in death of the patient or the need for open heart surgery to remove the fractured filter. Another study in the JAMA Internal Medicine discovered that many retrievable filters are actually left implanted permanently . That study discovered that of six hundred and seventy-nine retrievable filters implanted from August 1, 2003 to February 28, 2011, at Boston Medical Center, only fifty-eight were s removed with success and seventy-four people suffered a thrombotic event after filter placement.

According to a recent lawsuit, the plaintiff alleges that due to a faulty robotic surgery performed in 2011, by an improperly trained surgeon, she has suffered from tremendous pain and injuries including an anastomotic leak and a rectovaginal fistula, which she needed additional surgery in order to fix the problem. The plaintiff also claims that the da Vinci Company knew about the risks and injuries associated with robotic surgery but did not properly warn patients about the dangers involved. According to her claims, Intuitive Surgical Inc, the producer of the da Vinci Surgical System told surgeons that they would no longer be competitive if they did not perform surgeries using the da Vinci Surgical System.

You can watch an interview on the case here:


 

The Food and Drug Administration allowed the da Vinci Surgical System to be sold in 2002 under the premarket notification process that does not make trials or safety measures mandatory. They did require surgeons to receive extensive training if they used the system. In 2002, the seventy question exam and three day training that Intuitive Surgical originally had became a ten question online exam and one day of training. This meant that the surgeons were not properly trained to perform the robotic procedures.

A study done in 2013 revealed that even though Intuitive Surgical Inc. stated that robotic surgical procedures were safer and more-effective than non-robotic surgical procedures, the complication risks were actually the same.

There have been seventy reported deaths linked to robotic surgery complications since 2009. The plaintiff is seeking general damages, medical expenses and additional compensation for her loss of income and distress.

In Tennessee and all across the United States, when we go to the doctor or a surgeon to have a surgery performed or to be treated, we expect that the doctor will warn us about possible risks and that the surgery will help us to feel better or to enhance our quality of life. Unfortunately, however, sometimes doctors are aware of risks but fail to inform their patients and this can lead to serious injuries or the need for additional surgery. If you or someone you love has been injured after having da Vinci Robotic surgery, then you should speak to a Tennessee personal injury lawyer right away. They will hear your case and get you the compensation you need for your injuries.
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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 you may be entitled to.

You can watch a recent interview about these lawsuits below:


 

The Federal Judge in charge of managing the Stryker Rejuvenate and ABG II Hip recall lawsuits issued an order last week increasing the collection of cases to be set for early jury trials. These hip implants have been on the market since 2009 and were recalled in 2012. This order by the judge is considered a good sign that the cases are moving forward quickly.

The Stryker Rejuvenate and ABG implants are not metal on metal hips like some of the other hip implants that have been recalled in recent years, however, the injuries a person might suffer are similar. Each kind of implant can cause metal to leak into the hip tissues which can lead to inflammation, pain, and ultimately the failing of the implant. This can cause a medical condition known as metallosis.

The Stryker hip implants leak metal caused by an improperly fitted joint in the stem of the implant. The metal on metal implants that were recalled, such as the DePuy ASR and Smith & Nephew R3, leak metal from the interface between the metal cup and the metal ball on the femur. If a patient needs surgery these types of implants the can be more invasive and serious than the metal on metal hip implants. This surgery means that the doctor would have to remove the stem from the person’s femur as well as remove the cup and the ball. Removing the stem part of the implant from the femur may require the femur to be spilt or broken in order for the stem to be taken out. This may lead to a longer recovery process for the patient.

An estimated one hundred out of four thousand cases have reached settlements with Stryker. Based on these settlements, it is apparent that Stryker is offering a sufficient amount of money to people that they are willing to take a settlement. These lawsuits are not class action suits so the people are allowed to determine if they wish to settle or go to trial. There have been no jury trials thus far in Stryker lawsuit cases.
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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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