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Category: Medical Malpractice

  • Younger Patients Opt for Joint Replacement Surgery, Increased Numbers Affected by Defective Implants Manufactured by DePuy

    In January 2011 the Washington Post reported on the recent trend of younger patients opting for joint replacement surgery. In 2008, of the 277,000 hip replacements performed in the United States, 27 percent were conducted on patients ages 45 to 64. That represents an increase of 78 percent for that age group.
    One orthopaedic surgeon believes the trend stems from younger peoples’ proactive approach to pain and aging. “Younger people are less willing to accept physical disability than older generations,” Dr. Mary O’Connor, president of the American Association of Knee and Hip Surgeons, said. “[Younger people] don’t want to hear that they should use a cane or they can’t walk or play golf…”

    But with increased joint replacement surgeries comes increased risk. Because most replacement joints are expected to last 15 to 20 years, many younger patients will outlive their artificial knees and hips. And when the usefulness of those joints diminishes, a second surgery, known as a revision, is necessary to replace the failing artificial joint with a new one. Revision surgery carries with it increased complications. “If you need a [revision surgery], that surgery is a little more difficult,” Dr. Mary O’Connor explained. Usually when [the implant] fails, it fails because one of the parts loosens…every time you have to revise it, there’s a higher risk of complications.”

    The perils of revision surgery were reported firsthand when this blog posted the story of Eugene O’Neal, a relatively younger client of the Berniard Law Firm, and a recipient of a defective DePuy ASR hip implant. On the eve of his revision surgery to extract and replace his failed DePuy ASR hip implant with a functional unit, Eugene shared with readers his fears regarding the revision operation. Denied the usual 15 to 20 years of expected durability, Eugene’s hip lasted only a couple of years before it began to fail as a result of a design flaw in the DePuy manufacturing system. Had Eugene known his DePuy ASR hip implant was going to fail so soon, it is doubtful he and the thousands like him would have opted for hip replacement surgery to begin with.

    Because there has been such an increase of younger patients receiving joint implants in the last decade, it is likely that an increased number of younger patients have been adversely affected by the defective Depuy ASR hip implant units and subsequent recall. For these younger patients, DePuy’s suspect manufacturing processes are especially troubling because such patients are often still working jobs and remain active in extracurricular sporting activities. A failure of the DePuy hip implant for these younger patients translates into an entire lifestyle change, since work and sporting activities have to be replaced with necessary revision surgery and physical rehabilitation.

    As the Washington Post article shows, DePuy’s nationwide recall affects patients of all ages. If you would like a free consultation regarding your legal right to recover against DePuy, please contact Berniard Law Firm today.

  • Darvon and Darvocet Recall Has Serious Health, Legal Implications

    Two of the most highly prescribed painkillers, Darvon and Darvocet, have recently been pulled off the market as a result of the health risk they pose to individuals. Dangerous heart side effects plagued the painkiller for years; however, it was not until November of 2010 that the FDA recommended the painkillers be withdrawn from the market completely. The estimated amount of individuals who have been prescribed such medications is in the millions, especially since Darvocet has been prescribed for over sixty years. The actual amount of people who have been prescribed or have taken either or both of these painkillers may lead to an astounding number, which no one can quite quantify as of yet. While it is sad that a prescription that is supposed to ease the pain of individuals may lead to a person suffering fatal consequences, the legal ramifications of the drug causing these problems is important to understand.

    Both types of painkillers have been criticized heavily for over thirty years, without any change or modification until now by the FDA. The common dangers element that exists in both Darvocet and Darvon is the fact they both contain propoxyphene. In fact, the Public Citizen group petitioned the FDA to ban the drug in 1978 and again in 2006. Within that time period, millions of individuals every year were being newly prescribed the painkillers or were continuing to take them, relying on their physicians assurance that the drug was safe and would help ease their pain and discomfort. Yet, in July 2009, an FDA expert advisory committee voted 14-12 to ban the drug as a result of its dangerous side effect.

    The FDA overruled the panel, instead conducting more research on the prescriptions dangerous effects. The director of the FDA’s office of new drugs at the Center for Drug Evaluation and Research, John Jenkins, MD, stated, “The drug puts patients at risk of abnormal or even fatal heart rhythm abnormalities.” Further, Jenkins admitted that it is hard to determine exactly how many individuals have passed away due to taking these painkillers, yet, the FDA study shows that more deaths are linked to the drug than to either of two alterative opioid painkillers, tramadol and hydrocodone.

    Lawsuits filed against the drug manufacturer, Xanodyne Pharmaceuticals, and Eli Lilly (the pioneer of the drug) are beginning to grow steadily as individuals learn about the danger they have been relegated to by taking such harmful prescription drugs. The suits claim strict liability and negligence. Strict liability for products liability type cases such as this, will involve the injured party proving that the item was defective, that the defect proximately caused the injury, and that the defect rendered the product unreasonably dangerous. A plaintiff, under this cause of action, may recover damages even if the seller has exercised all possible care in the preparation of the sale of the product. Another important aspect of liability is to protect the public against harm that may result from a specific product, such as the drug here, propoxyphene.

    The common element between Darvon and Darvocet, propoxyphene, may not be safe if taken at any level. Even when the drugs are taken at “safe” and prescribed levels, studies show the drug still causes the individual to have an irregular heartbeat. Whereas the irregularity will stop in some individuals, others are not so lucky. Despite the declaration by the pharmaceutical companies that causation will be hard to prove, the studies performed by the pharmaceutical companies themselves and the FDA, illustrate the causal link between the painkillers with the common element drug, and the serious heart conditions that result.

    If you have taken either Darvon and/or Darvocet, and want to know your legal rights please call The Berniard Law Firm. We are here to answer your questions and guide you through the legal process while protecting your legal rights along the way. Call Toll Free The Berniard Law Firm at 504-521-6000. Our attorneys will protect your legal rights every step of the way.

  • DePuy Had Time to Recall Device, Chose to Not Notify Public

    This blog has noted several times that DePuy knew of the likely failure rates of its ASR hip implants several years before the medical device manufacturer issued its 2010 recall of the product. In light of this knowledge, DePuy nevertheless waited years before it decided to remedy the dangerous situation caused by its defective hip implants. Instead, it chose to shift the blame for reported problems elsewhere before finally initiating the recall.

    New evidence has been uncovered showing that DePuy had received credible notification of its ASR hip implant failure rates as far back as 2007. According to The Independent, the Australian joint registry, the second largest registry of its kind in the world, informed DePuy of identified problems in seven separate reports. One of the most striking findings made by the registry was the higher than usual amount of revision surgeries needed to replace previously-implanted ASR hip units. DePuy sat on this knowledge until 2009, when the company finally withdrew the ASR hip implants from the Australian marketplace, citing “commercial reasons.” DePuy initially blamed the Australian joint registry findings on “imprecise surgical techniques” by doctors, but was forced to retreat from that position in response to the multiple reports of problems sent the company’s way.

    Director of the Australian joint registry, Stephen Graves, has since stated DePuy behaved “irresponsibly and very badly.” Graves warns, “This is why regulators should not rely so heavily on manufacturer data. It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people.”

    British officials have also noted that the ASR hip implant recall is not the first time DePuy has recalled one of its products. In 2003, the company had to issue a recall for its Hylamer hip and shoulder components in British markets. Similarly, during the summer of 2009, DePuy-manufactured knee components were withdrawn because of aluminum leakage into the bodily tissue of British patients.

    In the United States, DePuy began issuing letters to physicians in March 2010, notifying them of the high failure rate of its hip implants. Nevertheless, the implants remained in the American marketplace for nearly half a year until the American recall was announced in August 2010. Moreover, by March 2010, DePuy was aware that patients with smaller bones were the highest at risk for failures, yet the company continued to market the hip implants to those very patients until the recall.

    Based on the reports cited above, it is apparent DePuy had scientifically-backed data illustrating the propensity of its ASR hip implants to fail. Furthermore, the company’s track record of recalling other implant products elsewhere shows DePuy has a tendency to forego consumer safety in exchange for maintaining its profit margins. Had DePuy acted responsibly in 2007, and removed the defective hip implants from the marketplace, thousands of patients would have been spared the pain, suffering, and economic damages they’ve experienced as a result of the medical problems the ASR implants create.

    The attorneys at Berniard Law Firm will continue to make efforts to uncover reports DePuy ignored when it continued to market the hip implants to the American public. If you have received a hip implant since 2003 and are interested in knowing whether your legal rights have been impacted, feel free to contact Berniard Law Firm today.

  • Artificial Hip Recall Shows Dangers of a Broken Medical Implant System

    The A.S.R., or Aritcular Surface Replacement, artificial hip was promoted by Johnson and Johnson as a breakthrough in design that would last 15 years or more and provide patients with more natural movement. Now, the device has been recalled due to patients developing inexplicable pain and surgeons discovering mysterious masses of dead tissue in patients who are having the device replaced. DePuy Orthopedics, the Johnson and Johnson unit responsible for the hip and the largest maker of replacement hips worldwide, maintained that the hip was working for a long time despite warnings that it was a failure.

    As pointed out in a recent New York Times article, the trouble with the hip is an indicator of a bigger problem: a piecemeal, broken medical implant system. Critical implants are sold without going through medical trials and testing or gaining FDA approval if the device resembles an implant that has already been approved. Theoretically, this allows manufacturers to make small changes to devices without having to jump through approval hoops; however, according to experts, it has also created a loophole that allows manufacturers to bundle an unapproved component into an existing design and sell it with minimal testing.

    This is what happened with the A.S.R. as DePuy announced late last year that it was phasing the device out. However, the company blamed lagging sales rather than safety issues. In a recent statement an official stated that, “We believe we made the appropriate decision to recall at the appropriate time given the available information.”
    DePuy does not know how many patients received the faulty device but estimated that about one third of 93,000 patients worldwide who received the implant were in the United States. This lack of exact numbers or documentation brings up another problem: the lack of an independent monitoring system in this country to track implant failures. If the U.S. had a database like those used elsewhere, doctors may have been clued into the problem a lot sooner.

    Some doctors did try to get the word out about the problem but were rebuffed by DePuy. In fact, according to the director of Austrailia’s orthopedic database, data showed that the A.S.R. was failing earlier and at a higher rate than other devices all the way back in 2008.

    Patients who have a defective A.S.R. require additional painful surgery to replace the device. Worse yet, some are permanently disabled due to damage to their bone, muscles, and nerves. Suffering patients often do not even know that the hip component that caused their disability is part of another device the FDA never approved.

    DePuy initially developed the A.S.R as a “resurfacing implant,” composed of a cup and thigh component, used in a procedure where less of a patient’s thigh bone is removed compared to a standard hip replacement. However, because the resurfacing was a new procedure, the FDA required that implant be tested in a clinical trial before it could be sold in the US. So, in 2005, the FDA allowed DePuy to sell another version of the same device, a modified standard hip replacement containing the same cup found in the resurfacing device, thus, getting around the clinical trial requirement. Current rules do not even require producers to notify the FDA when they bundle components from approved and unapproved devices.

    According to British doctor Antoni Nargol, in 2007 his A.S.R. patients started complaining of groin pain. Nargol claims he told DePuy officials that he found an explanation for why the device was failing. However, the company did not stop selling it, or even issue a warning. Instead, the company blamed the failures on the doctor’s surgical technique. At first, Dr. Nargol thought surgical technique could have been the problem. However, another orthopedic resident, Dr. Langton was not so sure so he began taking blood samples of patients using the A.S.R. and a competing device who were not experiencing pain. The tests showed elevated levels of cobalt and chromium in A.S.R. patients (used in the device) and soon proved that placement error was not the problem. As doctors in Britain and other countries operated on patients to remove the device, they found metallic debris shed by the device was causing a chemical reaction that destroyed muscle and bone. By early 2009, more testing revealed that the cup that the FDA had allowed to be sold without testing was the heart of the problem due to an interior surface that was too shallow.

    This case is not the first time that problems with orthopedic implants emerged in registries outside the U.S. well before doctors here stopped using defective devices. Device companies, rather than doctors, patients, or regulators determine when safety alerts are issued or products are withdrawn from the market. DePuy actually did issue a safety alert about the A.S.R., a year after data revealed it was dangerous, and even then it was still on the market.

    This episode has led to a wave of litigation around the world. In addition, officials have renewed there efforts to begin an orthopedic registry in the US. Many believe that such a system will only be effective if the federal government mandates reporting of data as a condition of payment of taxpayer funded programs like Medicare. The FDA has recently proposed rules that could require implanted devices to undergo more thorough testing before they are approved for sale, however, the fate of the proposals is unclear and receiving opposition from the device industry.

  • Louisiana Residents With Personal Injury Questions

    For those Louisiana residents, whether you live in Lake Charles, Shreveport, Baton Rouge, New Orleans, Kentwood or any other of the great cities across this state, looking for more information on their possible personal injury claim, check out our blog dedicated to these legal matters:

    Louisiana Personal Injury Blog

    This blog discusses the legal issues relating to Admiralty/Maritime law, Animal/Dog Bites, Car Accidents, Chemical/Industrial Spills, the intricacies of Expert Testimony, Insurance Disputes, employee rights under the Jones Act, Legal Duty, Civil Lawsuits, Criminal prosecution, Medical Malpractice, Mesothelioma/Asbestos, Motorcycle Injury, Negligence, Offshore Accidents, Product Defects, Chinese Drywall, Strict Liability, Workers’ Compensation and Wrongful Death. All of these issues are crucial to citizens rights and residents of Louisiana.

    To better understand the complexity of the law, contacting an attorney is crucial. However, to get a better understanding of the general issues, we hope this resource is invaluable. Feel free to browse this legal resource dealing with a variety of harms or damages you may have suffered in order to understand how your issue matches up with the law.

    If you would like to speak with an attorney, check out our contact information. We represent Louisiana residents across the state and would be happy to discuss with you how to move forward with your unfortunate circumstances.

  • Louisiana law regarding embryo care

    When handling frozen embryos, as previously discussed, there is a specific duty of care owed by the hospital to the parents to maintain the embryos properly and sufficiently so as to preserve them from harm and maintain them for usage by the donor couple. In Louisiana, lawyers have been filing lawsuits regarding a mixup at Ochsner Hospital Elmwood in which a mislabeling matter led to what may end up being a complete disposal of a number of embryos because of a lack of screening that also occurred.

    ABC recently profiled a series of mishaps, including that in Louisiana, occurring in the world of in vitro fertilization. With loose regulations, there is a huge possibility of error, as is the case here.

    Louisiana law clearly stipulate facets involved in the adoption or change of possession regarding frozen embryos. It does this to try to protect families from the improper transfer of an embryo to another individual, among other reasons. The law states

    La. Rev. Stat. Ann. § 9:130 An in vitro fertilized human ovum is a juridical person which cannot be owned by the in vitro fertilization patients who owe it a high duty of care and prudent administration. If the in vitro fertilization patients renounce, by notarial act, their parental rights for in utero implantation, then the in vitro fertilized human ovum shall be available for adoptive implantation in accordance with written procedures of the facility where it is housed or stored. The in vitro fertilization patients may renounce their parental rights in favor of another married couple, but only if the other couple is willing and able to receive the in vitro fertilized ovum. No compensation shall be paid or received by either couple to renounce parental rights. Constructive fulfillment of the statutory provisions for adoption in this state shall occur when a married couple executes a notarial act of adoption of the in vitro fertilized ovum and birth occurs.

    In this way, the law hopes to prevent the malicious transfer of frozen embryos to a woman other than the donor. However, recent events have proven the transfer can occur outside of intent and that an escalation of regulation may be required to prevent such tragedies from occurring down the road.

  • Name mixup possible reason for wrong embryo implantation

    The news has widely covered the story of how one woman, Carolyn Savage, of Toledo, Ohio, found out during her pregnancy that the embryo she had been impregnated with was, in fact, from another couple. Mrs. Savage gave birth to that child and, in an act of extreme charity and kindness, turned it over to its biological parents, Shannon and Paul Morell. The story, found here, has received so much attention because of the extreme amount of compassion it would take for a couple like the Savages, who are themselves looking to have their own child, to give birth to a child that is not theirs, let alone readily hand that child over upon birth. It also shows the possibility for mistakes that recently occurred in New Orleans most recently.

    In the case of the Morells and Savages, a name-error may have caused the mislabeling, or incorrect usage, of the embryo that was used to impregnate Mrs. Savage. The American Chronicle reports

    In an interview with The Blade yesterday afternoon, Carolyn’s husband, Sean Savage, said it’s possible the error occurred because the mothers share a name, and when it was mentioned that it seems to be a very odd coincidence, he commented “which makes it probably not a coincidence.”

    The Savages aren’t related to the woman who will take the baby boy home, but most assuredly, there will always be a connection.

    Although the baby won’t be living under their roof, he will always be there, “a part of us,” Mr. Savage said.

    The Elmwood branch of Ochsner Hospital closed down their in vitro fertilization program last week after reports that an unknown number of frozen embryos were mislabeled and/or not properly screened for disease before storage. The mixup is itself a tragedy for the couples involved who had turned to the hospital as a means in which they could finally have a child.

    A blatant example of Medical Malpractice, anyone who has had embryos stored at Ochsner Hospital or that already knows the mislabeling occurred with their frozen supply should contact an attorney immediately. The Berniard Law Firm does have extensive experience in medical malpractice issues and is willing to discuss with anyone their legal rights in matters involving this case or others.

  • Lab tech responsible for embryo mixup may not have been certified

    A recent twist to Ochsner Elmwood’s recent embryonic disaster regarding the mislabeling and invalidation of an unknown number of frozen embryos complicates the matter even further. It is now alleged that the individual responsible for the mixup may not have even been an employee of the hospital and, further, even certified to be working in the professional capacity he was working in.

    While contracting out medical specialists is not new for hospitals, this new kink adds fuel to the fire of the argument some have regarding the lack of concrete regulation in regards to fertilization and embryonic storage.

    The Times-Picayune reports

    A embryologist who is accused of mislabeling human embryos at Ochsner’s in vitro fertilization center in Elmwood was not employed by the clinic and may not have had proper professional certification, according to a report by New Orleans CityBusiness.

    Vincent Williams is being sued by a couple who names him as the lab worker they believe was responsible for the problems at the clinic. But the report contends Williams did not work for Ochsner, but rather had a contractual relationship with the clinic.

    CityBusiness quotes the administrator of the American Association of Bioanalysts, the health system contracted with Vincent Williams’ company to run the clinic, as saying that nobody by the name of Vincent Williams is certified with its board.

    This new facet to the case shows an even bigger element of responsibility that Ochsner, or the company through which they contracted, will have to overcome to avoid responsibility for this matter. Any couples or women who froze their embryos at the Elmwood location of Ochsner are encouraged to contact an attorney immediately to find out their legal rights in this chaotic matter.

  • Louisiana embryo law clear on patient rights

    In order to help readers understand more about the embryo debacle and ensuing lawsuits that recently occurred at Ochsner Hospital Elmwood, outside New Orleans, an explanation of relevant Louisiana statutory law is a helpful tool. The Louisiana law provides a specific comprehension for lawyers and citizens to understand regarding embryos frozen at facilities and does not fail to mention the proprietary rights that go with the storage. While a couple may freeze embryos and store them with a hospital, they do not give up any of their rights over those embryos and they are handled as if they were never removed from the woman.

    Louisiana law states

    La. Rev. Stat. Ann. § 9:126 An in vitro fertilized human ovum is a biological human being which is not the property of the physician which acts as an agent of fertilization, or the facility which employs him or the donors of the sperm and ovum. If the in vitro fertilization patients express their identity, then their rights as parents as provided under the Louisiana Civil Code will be preserved. If the in vitro fertilization patients fail to express their identity, then the physician shall be deemed to be temporary guardian of the in vitro fertilized human ovum until adoptive implantation can occur. A court in the parish where the in vitro fertilized ovum is located may appoint a curator, upon motion of the in vitro fertilization patients, their heirs, or physicians who caused in vitro fertilization to be performed, to protect the in vitro fertilized human ovum’s rights.

    In this way, the law specifically notes that the hospital is a guardian in function only and has no legal rights over the embryos frozen at its facility. As a result, the loss of embryos, as seems imminent given the recent revelation that since they were not screened for sexually transmitted diseases, they are not viable for implantation, falls solely on the hospital for responsibility. It is the couples who chose to have their embryos stored at the hospital who are the only losers in this matter and it is important that they receive the justice they deserve.

    If you or someone you know stored embryos at the Elmwood facility, please contact the Berniard Law Firm at (504) 521-6000 or text 24-7 at (504) 521-6000 to find out what your legal rights regarding the matter are. With our wide range of medical experts, our firm will knowledgeably and effectively defend your rights in the matter.

  • Ochsner embryo mixup develops as government investigates

    While the embryo mixup that occurred in the Louisiana hospital outside New Orleans was bad news for families who had stored there, recent news makes the situation worse. The unfortunate reality, it appears, for those couples whose embryos were kept at Ochsner Hospital Elmwood is that, even if they could be identified after being mislabeled, a failure to screen them for sexually transmitted diseases when freezing took place makes them inviable to implant. The suit filed a couple earlier this month is the second filed against the hospital after another couple found that the embryos they had frozen at Ochsner Hospital Elmwood went missing. That the mislabeled embryos are not even viable even if identified is a harsh addendum to an already tragic and sad event.

    The hospital has shut down its in vitro program indefinitely so as to attend to the problems that obviously exist before continuing. Ochsner CEO Pat Quinlan has stated the problem and shutdown arrives from a “significant labeling issue, which makes us unable to account for all the frozen embryos in our IVF center.”

    What this means to New Orleans residents is simple: any couple or woman who has had embryos frozen at Ochsner Hospital Elmwood needs to contact the hospital immediately to find out the status of their frozen embryos. The hospital has stated any patients concerned with the status of their embryos should call concerns can contact Ochsner by calling 866.631.9783 or send e-mails or questions to questions@ochsner.org. As both of these appear to be public manners of contact, an important next step for patients would be to attain legal counsel.

    In matters involving medical malpractice, legal counsel is essential. By hiring an attorney with experience in malpractice issues and a series of experts, legal and medical, to use in pursuing the case, clients will be in much better standing to handle the hurdles that loom in this matter. Contact the Berniard Law Firm at (504) 521-6000 or text (504) 521-6000 24 hours a day, 7 days a week to find out your legal rights regarding this matter. For more information on medical malpractice matters, click here.