News & Results
April 26th, 2013
In our representation we find that our clients are hungry for information regarding the Stryker hip implant recall and the health effects associated with the recalled device. Unfortunately, we are finding that many clients are unhappy and often unable to get answers to questions they have from their surgeon and other trusted sources in order to evaluate their need for monitoring and/or revision surgery. To that end, we have devised the Top 10 Things All Stryker Hip Implant Patients Need To Know to further address many of the common questions we are asked. We sincerely hope this information will help better inform those affected by the Stryker Rejuvenate and ABG II Modular-Neck Stem hip implant recall and make everyone aware of both their medical and legal options.
1. Why were the Stryker Rejuvenate and ABG II Modular-Neck Stem Hip Implants Recalled?
On July 6, 2012 – Stryker announced it had voluntarily recalled its Rejuvenate and ABG II modular-neck stems. The issue stems from mechanically assisted corrosion and release of metal ions of Cobalt and Chromium that affect surrounding tissue and bone over time. The company was non-specific in its press release as to the exact reason or failure rate.
“While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action,” said Stuart Simpson, Vice President and General Manager, Hip Reconstruction.
Stryker’s Rejuvenate Modular system was approved by the Food and Drug Administration (FDA) in June 2008. The ABG II system received FDA approval in November 2009. The earliest implanted devices that we have seen were in late 2010 because of the timing to distribute and market the new product to physicians.
2. What signs or symptoms do I look for if my hip implant is failing?
You may be having pain around your hip, difficulty walking, inflammation or other symptoms. Your physician has the ability to evaluate you to determine if you are at a greater risk of injury or complication. The inflammatory response from the metal sometimes occurs with little or no symptoms until there is harm to the surrounding tissue and loss of bone. An early X-ray is good to look at bone and device placemen, but without an MRI or blood work to measure the metal ion levels, a patient may not recognize the harms that may be occurring until they develop symptoms. Your orthopedic surgeon can help you with these matters. Call their office to discuss your plan of care and treatment.
3. Why in particular is the level of Cobalt important and what is the FDA saying about monitoring?
Cobalt is one of the many metals that is found naturally in the body, but as is common with most all metals, levels in excess can become toxic and lead to many harmful and potentially harmful side effects. Cobalt poisoning has caused cardiomyopathy, hypothyroidism, and neurological damage as well as impairing the sense of sight and hearing. As far as the device goes, excess amounts of cobalt in the bloodstream lead to inflammation which can seriously damage surrounding tissue and bone.
If the Doctor does not independently research studies regarding toxic values of Cobalt, patients will likely not be informed if the level of cobalt present in their blood is actually elevated, or even toxic, thereby subjecting them to prolonged issues and injuries.
Here are the overall guidelines issued January 17th on the FDA website that I believe will now become standard of care.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241667.htm
Safety Communication:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm
Information about Imaging and Metal Ion Testing
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm331971.htm#metal
4. Is additional surgery necessary?
That is a question for your physician and the evaluation must be made in the cost benefit analysis of the potential harms of removing the device to that of replacing it all together. Many factors such as one’s age, health, weight and other risk factors must be carefully considered. See your orthopedic surgeon to discuss this potential problem and other avenues of medical treatment to see what is best for you and your family. You will find that surgeons that are experienced with the harms from this device may not be the same surgeon that put in the device. You may also want to get a second opinion and ask what components are going to be utilized and if the physician is limited by contract or experience to a certain manufacturer. Experience related to this modular component matters. Stryker in 2012 even has released an extraction protocol for the benefit of the surgeon. http://literature.ortho.stryker.com/files/LSP70.pdf
5. Are there any risks to having revision surgery?
There are risks to having any type of surgery but knowing more about the procedure and how to deal with it is key. This is a very painful and complicated procedure. A second hip surgery is usually longer and more intense than the first and not all patients are candidates for a revision surgery. Only a trained medical doctor can make this determination with you after conducting the requisite blood tests, x-rays, MRIs and other medical examinations.
6. Who is Broadspire and what is their role in the recall?
Broadspire was announced to have been hired by Stryker on or about January 3, 2013 According to reports, Broadspire is a division of Crawford and Company that is touted as the world’s largest insurance and claims adjuster. Broadspire is funded by Stryker to gain access to the medical records of patients affected by Stryker’s recent hip implant recall through medical authorizations. There can be a benefit to the uninsured patient seeking reimbursement for medical expenses or gaining approval to have expensive procedures paid for by the company, but keep in mind that making a claim for out of pocket expenses or medical bills not paid for by insurance is all that Broadspire is really doing based on our findings. If your claim is not filed in a civil action before the expiration of the statute of limitations, you will not be able to pursue a claim for the harms that you have experienced, or may experience, in the future including but not limited to pain and suffering from the recalled Stryker hip implant.
7. What responsibility does my Physician have ?
One common question many patients have is what responsibility, if any, do the doctors and/or orthopedic surgeons that implanted these have in this nationwide Stryker hip implant recall. Our firm’s research and findings are clear: NONE in the cases we have seen and reviewed to date. Stryker has failed to convey their findings on the increasing failure rates of Stryker Rejuvenate and ABG II Modular-Neck Stem devices to surgeons and made the product that was defective.
8. Should I hire an attorney?
Along with the medical costs from eventual hip replacement revision, a failed hip replacement can cause a lot of other hardships, including effects on the patient’s lifestyle. Too many patients with defective hip replacements struggled through extensive rehabilitation therapy to pursue a more active life after the hip replacement only to have their activities slowly restricted again when the Stryker systems began to manifest problems. The representation of our clients is on an individual one-on-one basis. We are not representing folks in a class action basis, nor do we believe it would be in your best interest to be in a class action. Our firm is committed to zealous and effective representation of clients who are affected by this defective device for all harms associated with this recalled device. Stryker claims it will cover reasonable and customary costs of monitoring and treatment but, in reality, Stryker’s intentions may not be so transparent. Stryker has requested that patients submit all of their bills to private health insurance (including Medicare and employer sponsored – ERISA – health insurance plans), offering only to pay the patient’s out-of-pocket co-pays and deductibles. This is an excellent deal for Stryker, but not justice for the patient or your health insurance carriers who are in essence paying for Stryker’s mistakes.
9. What are examples of harms that are evaluated in a civil suit against Stryker and related entities?
A jury can consider the following list concerning non-economic factors for the Stryker Rejuvenate and ABG II Modular-Neck Stem hip replacement recall lawsuit:
1) Any lost wages or loss of earning capacity;
2) The effect the Stryker hip injury had on the individual’s overall mental and physical well-being;
3) The duration and extent of the injury the individual suffered;
4) The mental anguish and pain suffered by the individual;
5) The amount of past or future medical expenses was caused by the defective Stryker Rejuvenate and ABG II Modular-Neck Stem hip replacement implants;
6) The extent of any disfigurement or any scarring that was caused by the defective Stryker Rejuvenate and ABG II Modular-Neck Stem hip replacement implants.
10. Should I surrender my defective hip implant to the company?
You should ask an attorney about this question. Our position is that you should retain the hip implant hardware with an approved medical device retrieval company per an agreed protocol. We have retained a company that works directly with the hospital and surgeon in having the device preserved for any subsequent testing and/ or failure analysis. This is a very important decision because the removed hardware will become critical evidence in your claim against Stryker in the days ahead. It is your hardware because you paid for it so do not let anyone tell you anything to the contrary. If you have questions about the retention of your implanted hardware give us a call as we are happy to help.
Tags: Childers Schlueter & Smith; cobaltism; css; css firm; FDA Website on Hip Implants; Stryker Mediation; Stryker hip Settlements; georgia attorney Hip Implant; Hip Implant Attorney; Hip Implant Lawye
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April 23rd, 2013
On January 3, 2013, Stryker announced that it had hired Broadspire, a third party claims administrator and subsidiary of Crawford & Company, to handle the Stryker Rejuvenate and ABG II Modular-Neck Stem Hip Implant recall lawsuits and related injury claims. Broadspire is the same entity that has been retained by DePuy Orthopedics in the DePuy ASR recall that was announced in 2010. We would encourage consumers to read up on them at their website: http://www.choosebroadspire.com/.
The Parent company, Crawford and Company, claims to be the world’s largest insurance and claims adjuster. Broadspire will seek to gain access to the medical records of patients affected by Stryker’s recent hip implant recall through medical authorizations being provided by the implanting surgeon’s office, or directly by Broadspire itself.
In June, 2012, Stryker recalled two versions of the company’s artificial hip implants: Stryker Rejuvenate and Stryker ABG II Modular-Neck Stem. http://www.fda.gov/safety/recalls/ucm311043.htm
According to reports, thousands of recall letters to hip replacement recall victims have been sent notifying patients directly from doctor’s offices. These letters ask patients to sign medical authorization forms and provide other personal forms of information. The forms would release detailed information contained in the patients’ medical records to Stryker and third party contractors. It also allows Stryker to have unfettered access to patients’ medical providers and further allows them the ability to inquire into unrelated medical conditions and issues without notice to the patient.
The reality of this situation is that if a patient signs this release form without other safe guards being in place when doing so, they effectively waive their federally protected rights to medical privacy and the information released to Stryker can be used as evidence in court against them as their claim progresses or in the alternative, of cost containment of medical billing review. The majority of consumers have done little in the way of researching the purpose of Broadspire and their role of representing Stryker. This potential for abuse of utilization of medical information gathered, based on the conflicting role of Broadspire interest, is all too familiar. We have been dealing with these issues and Broadspire for years now and, therefore, know how to navigate these important issues for our clients. Because many doctors and their offices require these forms to be completed and submitted to Broadspire for continued care and treatment, it is important to talk to an experienced group of hip implant attorneys to better understand the best way to do this.
Before signing anything, you need to contact the Stryker Rejuvenate Recall Attorneys at Childers, Schlueter, & Smith, LLC for a free consultation and review. Childers, Schlueter & Smith, LLC continues to investigate and review the claims of patients nationwide who received a Stryker hip implant device. If you, or a loved one, has received the Stryker Rejuvenate and/or Stryker ABG II Modular-Neck Stem and have experienced some type of hip pain, elevated blood ion levels, developed metallosis, required an additional hip surgery, or any failure with your hip replacement device, you may want to contact CSS Firm for a free case evaluation and consultation. Our experienced team of hip implant lawyers will work closely with you and see to it that you get the medical treatment you need and that your legal rights are fully protected.
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April 15th, 2013
Many problems have been associated with the faulty Stryker hip implant recall. According the FDA, there have been numerous reports from patients about serious side affects associated with the Stryker Rejuvenate and ABG II modular-neck stems hip implants. Now the company faces many lawsuits as a result of these faulty hip implants.
Earlier in April 2013, a judge recommended that the Stryker hip lawsuits that were consolidated in New Jersey in January should all go through mediation.
There are currently 50 Stryker lawsuits consolidated in Bergen County with hundreds more expected in the next few months alone. It is Judge Brian R. Martinotti who is overseeing these Stryker hip implant lawsuits. In the Stryker Rejuvenate and ABG II, according to court documents for New Jersey MCL-296, the Plaintiffs are alleging that one of the side effects of these faulty hip implants is metal poisoning.
Childers, Schlueter & Smith have been monitoring updates regarding metal-on-metal hip replacement trials and lawsuits. Apparently, each side will pick five cases for mediation. Depending on how they go, more cases may go down the same route towards mediation in the months ahead.
It was on July 6, 2012, Stryker issued a voluntary recall of its Rejuvenate and ABG II modular-neck stems. Some of the problems associated with the faulty hip implants include:
- Infection
- Inflammation
- Necrosis
- Loosening of implant
- Hypothyroidism
- Damage to bone and tissue surrounding the hip joint
- Hip replacement failure
- Metallosis
- Osteolysis
Those patients who have any problems associated with Stryker’s Rejuvenate and ABG II modular-neck stems may be entitled to compensation. Our Georgia Hip Implant Recall Lawyers are offering free personal injury lawsuit consultation to victims affected by Stryker’s faulty hip implants. If you or someone you love has been affected by Stryker’s Rejuvenate and ABG II modular-neck stems, please contact our Georgia Hip Implant Recall Lawyers. Our Georgia Hip Implant Recall Lawyers can provide helpful insight with these devastating injuries and suggest options you should consider.
Tags: Childers Schlueter & Smith; cobaltism; css; css firm; FDA Website on Hip Implants; Stryker Mediation; Stryker hip Settlements; georgia attorney Hip Implant; Hip Implant Attorney; Hip Implant Lawye
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March 25th, 2013
Many problems have been associated with the faulty Stryker hip implant recall. According the FDA, they have received numerous reports from patients about serious side affects associated with the Stryker Rejuvenate and ABG II modular-neck stems hip implants.
On July 6, 2012, Stryker voluntarily recalled its Rejuvenate and ABG II modular-neck stems. The problems patients were having with the faulty hip implants include:
- Necrosis
- Metallosis
- Osteolysis
- Loosening of implant
- Hypothyroidism
- Damage to bone and tissue surrounding the hip joint
- Infection
- Inflammation
- Hip replacement failure
The Stryker Rejuvenate System was approved in 2008 for sale by Stryker. The faulty metal on metal hip implant device was designed to promote quicker installation with varieties of component designs. The necks are composed with heavy metal cobalt and chromium. The Rejuvenate and ABG II devices were designed to employ a two-piece modular neck and stem for enhanced flexibility and stability. According to Stryker, this design allows surgeons to choose a range of femoral neck and stem combinations and make it unique to each patient. However, the results of these recalled hip implants have been devastating. Components of the recalled hip implant contain metal and this can lead to fretting. This can then send particles into the patient’s tissues and even bloodstream.
Those patients who have any problems associated with Styker’s Rejuvenate and ABG II modular-neck stems may be entitled to compensation. Our Georgia Hip Implant Recall Lawyers are offering free personal injury lawsuit consultation to victims affected by Stryker’s faulty hip implants. If you or someone you love has been affected by Styker’s Rejuvenate and ABG II modular-neck stems, please contact our Georgia Hip Implant Recall Lawyers. Our Georgia Hip Implant Recall Lawyers can provide helpful insight with these devastating injuries and suggest options you should consider.
Tags: Childers Schlueter & Smith, cobaltism, css, css firm, ethics, FDA Website on Hip Implants, georgia attorney, Hip Implant, Hip Implant Attorney, Hip Implant Lawyer, Hip Implant Lawyers, Hip Implant Recall, hip pain, hip replacement, Hip Replacement Device, hip revision, Johnson & Johnson, MDL 2197, Medical Devices, Metal on Metal Hip Implant, Metal-on-Metal hip implants, New York Times recall, recalled hip implant, recalled medical devices, Rejuvenate and ABG II modular-neck stems, Stryker, stryker hip, stryker Hip Recall, stryker hip recall attorney, stryker orthopaedics, Stryker Recall, surgery on hip
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March 8th, 2013
In an update on our previous posts concerning the first DePuy ASR hip implant case to go to a jury verdict, Kransky vs Depuy, the California jury just ordered DePuy and Johnson & Johnson to pay Mr. Kransky $8.38 Million in damages finding a design defect in the ASR hip device. No punitive damages were part of the award. It is believed that Johnson & Johnson will be appealing the verdict.
It took more than 6 weeks to complete the trial, and many months to prepare this case for trial in the fall and winter of 2012 by the California trial team. Mr. Kransky suffered from very high cobalt and chromium levels, and had good testimony from his hip replacement surgeon documenting significant metalosis caused by his ASR device that resulted in revision. Because this was the first DePuy ASR hip implant trial, the significance of getting a plaintiff’s verdict was critical. This was not a Bellwether case (a case representative of the average case) but rather was a case selected to go first because the claimant from Montana was ill from unrelated renal cancer. The next ASR hip implant trial is scheduled to begin on March 11, 2013 in Cook County, Illinois. That case is Strum vs Depuy, and it certainly will be of interest to see the outcome in it as well. The first Federal MDL trial begins on May 6, 2013 in Ohio. That case is Dorney–Madgitz vs. DePuy.
The verdict was broken down as follows:
$338,136 in damages for medical expenses
$8 million for physical pain and emotional suffering.
Bloomberg News has also reported the following on this trial:
http://www.bloomberg.com/news/2013-03-08/j-j-must-pay-8-3-million-in-suit-over-defective-hip-jury-says.html
Tags: Childers Schlueter & Smith, chromium poisoning, chromium toxicity, cobalt cancer, cobalt kidney, cobalt level, cobalt poisoning, cobalt test, cobalt toxicity, cobaltism, Depuy, DePuy ASR Hip Implant, DePuy ASR Hip Resurfacing System, DePuy ASR XL Acetabular System, depuy hip, depuy hip recall attorney, Depuy recall, depuy recall lawsuit, FDA Website on Hip Implants, featured, georgia attorney, Hip Implant Attorney, Hip Implant Lawyers, Hip Implant Recall, hip pain, hip revision, MDL 2197, Metal on Metal Hip Implant. DePuy ASR Hip Recall, recalled hip implant
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February 28th, 2013
In an update on our previous posts concerning the transvaginal mesh implant case of Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey, the same jury just returned a verdict of $7.76 Million more dollars in punitive damages. This amount is in addition to the compensatory verdict of $3.35 Million awarded earlier this week for a grand total of $11.1 Million in all.
Jurors in Atlantic City made the award today to punish J&J, the world’s largest seller of health-care products. The verdict came in the first of 4,000 lawsuits to go to trial over J&J’s pelvic mesh, including 2,100 in New Jersey. The jury of six men and three women declined to comment on its decision.
The total of $11.1 million goes to Linda Gross, a South Dakota nurse who complained of constant pain and underwent 18 operations after J&J’s Gynecare Prolift was implanted to shore up weakened pelvic muscles. On Feb. 25, the panel found that J&J and its Ethicon unit failed to warn her surgeon of the risks of the device and fraudulently misled her about the risks.
The Bloomberg news has just reported the events of the case here:
J&J Owes $7.76 Million in Punitives in Vaginal Mesh Case
Tags: J&J Prolift, Mesh Trial, Mesh Verdict, TVM
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February 28th, 2013
After Johnson & Johnson lost the first vaginal mesh device trial, the company is now seeking to avoid punitive damages. The plaintiff, Linda Gross, was awarded $3.35 million by the jury. In the lawsuit you can see what pains Ms. Gross went through.
According to an article by David Voreacos in Bloomberg, Gross’ attorneys now are asking the jurors in Atlantic City on the first vaginal mesh implant trial to punish Johnson & Johnson by paying punitive damages. The initial amount awarded to Mrs. Gross was compensatory damages. The jury awarded Mrs. Gross this amount after they found that Johnson & Johnson failed to warn Mrs. Gross’ surgeon of the risks of the company’s Gynecare Prolift vaginal mesh implant device and misled her about the risks.
Mrs. Gross sued Johnson & Johnson along with her husband after receiving the vaginal mesh implant device. She went through 18 operations after the initial device was implanted and she experienced great pain and weakened pelvic muscles.
In this case, the cap for punitive damages that the jury can award Mrs. Gross is $16.75 million. According to New Jersey law, caps on punitive damages are at five times the compensatory damages awarded. However, when jurors are deliberating on whether punitive damages should be awarded, they are not told about this cap.
Mrs. Gross’s attorney, Adam Slater, told the jury of six women and three men: “Tell them through your verdict, don’t do this again, change your way of business. You’ve already found they knew what they were saying was untrue. When you make a punitive damage award and you want to deter them, you take into account how much money they have.”
Johnson & Johnson’s attorney, Christy Jones, said, “I understand that Johnson & Johnson and Ethicon didn’t do as good a job as they could have. I understand they could have given better warnings.” However, in light of this, she asked the jurors to look at the burden for finding punitive damages. The burden is clear and convincing evidence, not by a preponderance of the evidence, which is the standard for finding compensatory damages.
Throughout this trial, Gross’ attorneys called a forensic economics expert, Frank Tinari. Mr. Tinari testified about Johnson & Johnson’s financial condition. He told the jury that Johnson & Johnson had total assets of $121.3 billion and a net worth of $64.8 billion. The company’s annual profit from 2009 to 2012 was about $11.5 billion.
Gross’ other attorney, David Mazie, called Johnson & Johnson a “big giant” and urged jurors to send a “loud message” in order to punish the company for its conduct.
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February 25th, 2013
The jury in the Johnson and Johnson/Ethicon’s Gynecare Prolift mesh trial just awared $3.35 million for compensatory damages to Mrs. Gross. The Court is deciding now whether to go into the punitives phase of trial. As more information is discovered we will update it here given the momentious events of this case.
The intial break down of the damages are as follows:
DAMAGES:
Past and present for pain and suffering: $1,100,000
Past lost wages: $180,000
Future lost wages: $500,000
Past medical expenses: $385,000
Future medical and household services: $1,000,00
Loss of consortium $185,000
The case of Gross v. Gynecare Inc., Atl-L-6966-10, filed in the Superior Court of Atlantic County, New Jersey (Atlantic City) involves the first lawsuit to go to trial over whether Johnson & Johnson’s (“J & J”) Ethicon unit properly designed a vaginal mesh implant and adequately warned of its risks.
The Plaintiff who is a nurse from South Dakota has sued Ethicon’s design over her Gynecare Prolift mesh saying that the mesh was defective. She says that the mesh caused her to have 18 serious surgeries.
As noted previously, here is a previous update of this transvaginal mesh implant case:
New Jersey Prolift Trial
Tags: Gross v. Gynecare Inc. Atl-L-6966-10, Mrs. Gross, New Jersey Prolift Trial Verdict, TVM
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February 23rd, 2013
Johnson & Johnson is now under investigation by federal prosecutors regarding the company’s practices in marketing a line of hip implant replacements recalled in 2010.
According to an article by Linda Johnson from the Associated Press, the U.S. Attorney’s Office in Massachusetts and the U.S. Justice Department sent Johnson & Johnson an “informal request” last August for information on its ASR hip replacements.
This investigation comes after many of the hip replacements had to be replaced within a few years and more than 30 products were recalled within the last 3 to 5 years by Johnson & Johnson.
The government’s filing did not specify what exactly they were looking for. However what is known is that J & J has been struggling with legal problems even before problems with the ASR systems arose. Before the ASR systems were recalled, the Food and Drug Administration told DePuy, one of the world’s largest makers of joint replacements and other orthopedic surgery products, to stop marketing the Corail Hip System for two unapproved uses.
In 2007, the company paid $84.7 million in fines in a settlement for alleged kickbacks. From 2002 through 2006, J & J, as well as several other top U.S. makers of replacement knees and hips, were accused of paying kickbacks to surgeons to use their specific product exclusively.
In August 2010 DePuy announced the recall of two artificial joint systems—the ASR XL Acetabular System and the ASR Hip Resurfacing System due to high rates of failure. More than 90,000 of these hip replacement devices were recalled. These failing hip implant devices caused extreme pain and difficulty for patients.
At least one in eight patients who had this recalled hip implant device needed theirs replaced within five years.
Now as a result, J & J faces numerous lawsuits. Attorneys representing the patients claim that J & J knew about the problems with the DePuy hip implant systems back in 2008 and still continued selling them until 2009. J & J claims that they acted properly. The first of these recalled hip implant trials started last month. This is among thousands of lawsuits brought against J & J by those patients affected by the recalled hip implant device.
In addition, J & J very recently recalled a different line of hip implants called the “Adept” brand. “Adept” is an all-metal total hip replacement system and is now recalled because of the higher-than-expected percentage of one part of the system that has to be replaced. This specific hip implant system was manufactured between 2004 through September 2011.
If you or someone you love have fallen victim to the failed DePuy ASR hip implant or an any other Johnson & Johnson recalled hip implant, contact CSS Firm for a free case evaluation and consultation. Our hip implant recall lawyers continue to review claims all over the country in an effort to help those affected by this dangerous product. Our experienced Georgia hip implant lawyers at Childers, Schlueter & Smith will work closely with you to ensure you get the care and justice you deserve.
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February 20th, 2013
One of the first transvaginal mesh cases to be tried to a jury is currently being decided by a New Jersey jury of 9. The case of Gross v. Gynecare Inc., Atl-L-6966-10, filed in the Superior Court of Atlantic County, New Jersey (Atlantic City) involves the first lawsuit to go to trial over whether Johnson & Johnson’s (“J & J”) Ethicon unit properly designed a vaginal mesh implant and adequately warned of its risks. A panel of 9 jurors are currently deliberating.
The Plaintiff who is a nurse from South Dakota has sued Ethicon’s design over her Gynecare Prolift mesh saying that the mesh was defective. She says that the mesh caused her to have 18 serious surgeries.
Linda Gross, the lady who suffered from the mesh device, told the jury that J&J failed to warn her and her doctor of the risks and made fraudulent misrepresentations to her. Ms. Gross claims that her chronic pain and other health problems were risks Ethicon knew about before first selling the Prolift in March 2005, and that Ethicon knew the device caused pain and often became exposed through the vaginal skin. The device also hardened in women’s bodies, caused severe pain, sometimes uncontrollable urinary incontinence and was difficult for surgeons to remove. The Prolift, made of a polypropylene mesh, was inserted through an incision in the vagina. Ms. Gross had multiple surgeries following the insertion of the mesh to repair it, yet she is still in pain.
J&J, the world’s largest seller of health-care products, claims Prolift is safe and effective, and Ethicon warned properly of the risks.
As jurors continue into their second day of jury deliberations they are discussing whether Prolift was defectively designed; if J&J failed to provide adequate warnings to Ms. Gross and her first surgeon; and whether J&J made a fraudulent misrepresentation to Ms. Gross? If answering yes to any of those sets of questions, jurors would then consider damages for Gross’s pain, suffering, lost wages and medical expenses, as well as the changed/strained relationship with her husband.
The case is the first of 1,800 such lawsuits to go to trial. Ms. Gross is asking the jury to award $3.38 million for her lost earnings and her past and future medical expenses. She also seeks damages for pain and suffering. Jury deliberations are expected to last for two to three days.
Jurors will consider the testimony from the surgeon who performed the surgery. He previously testified that he no longer uses mesh for the type of condition that Ms. Gross had in 2006. He also said that while his conversation with Ms. Gross over the risks probably took 15 or 20 minutes, it now would probably consist of two one-hour discussions.
In the event the jury awards damages to Ms. Gross, the judge presiding over the case, Superior Court Judge Carol Higbee, will decide whether Ms. Gross can seek punitive damages from J &J. States vary on how they treat punitive damages; in New Jersey, punitive damages can be awarded up to five times compensatory damages or $350,000, whichever is higher.
Regardless of what the jury decides, the fact is that in in August, J&J stopped selling four mesh devices in the U.S., including the Prolift. The company, based in New Brunswick, New Jersey, said in June that it would end sales worldwide.
If you have questions about any mesh product or have had problems since having a mesh insert, you may wish to contact our Georgia Transvaginal Mesh Lawyers based in Atlanta, Georgia. We can further explain why we think the surgeons are not the source of your problems and pains and why Johnson and Johnson and other mesh manufacturers are responsible. You can also reach us at 800-641-0098.
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