Insurance Dispute Lawyer Blog

Longterm treatment and care can oftentimes be difficult and emotionally taxing for all involved. What's more, when an already arduous process is muddled by improper actions by the medical staff, legal resolutions do exist but are unlikely to remedy the problems caused.

After what seemed like a never-ending nap, an individual who will not be named was transferred to Our Lady of Lourdes Regional Medical Center in Lafayette, Louisiana, where she spent the last nineteen days of her life. Her family, including her husband and three children, brought a medical malpractice case against her treating and diagnosing physicians as well as their insurance carrier. After a grant of summary judgment and a denied motion to continue, the decedent's family followed with an appeal against the treating neurologist, Dr. Steven Snatic, and his medical malpractice insurance provider, Louisiana Medical Mutual Insurance Company (hereinafter "LAMMICO"), claiming the denial of appropriate care, misdiagnosis and resultant death. Upon further analysis of the underlying issues, the court reversed the grant of summary judgment and the matter was remanded to the trial court.

An expert witness testified to the medical review panel that the decedent was properly diagnosed and treated, despite the fact that she was treated for a condition she did not have. The basis for this argument was that the treatment for the misdiagnosis of cryptococcal meningitis was supportive for her true condition, cerebritis. Simply stated, this is a bit like saying if you have a headache and take an aspirin, which happens to also cure the pain in your back, then you're covered. While this seems to be a difficult legal argument, the expert explained that because the decedent had lupus, it was difficult to make an accurate diagnosis.

The appellate court reviews appeals of summary judgments de novo, basically starting from scratch, with an eye toward determining three issues: (1) whether the decision of the lower court was appropriate; (2) whether there was a genuine issue of material fact; and (3) whether the appellant was entitled to judgment as a matter of law. Verbatim, the Louisiana Code of Civil Procedure Article 966(C)(2) states: "the movant's burden on the motion [for summary judgment] does not require him to negate all essential elements of the adverse party's claim, action or defense, but rather to point out to the court that there is an absence of factual support for one or more elements essential to the adverse party's claim, action, or defense." Additionally, in a medical malpractice case, a plaintiff is required under Louisiana Revised Statutes 9:2794(A) to prove the three following elements: "(1) the standard of care applicable to the defendant; (2) that the defendant breached the standard of care; and (3) that there was a causal connection between the breach and the resulting injury."

The real questions that remained included if there a genuine issue as to material fact and is the family entitled to judgment as a matter of law? It is safe to speculate that a person without an advanced degree in medicine can see a problem with a patient being misdiagnosed and treated for an ailment she did not have. Under these details, it is probably safe to go one step further and conclude that summary judgment was not rightfully granted. Doubt and questions as to material fact are dripping all over this case.

So, why was the summary judgment motion granted? In this case the decedent's family had the burden to prove that there was a breach in the standard of care administered by the physician. In order to accomplish this task, it was necessary to present an affidavit from an expert. It turns out the decedent's family was not able to obtain an expert neurologist in time to draft an opinion. After two failed attempts with motions to continue, the decedents engaged a cardiologist, who was also a board certified internist, for a supporting affidavit. However, the court looked right through the substance of the documents, or lack thereof, and granted the summary judgment motion, which brings us to the present.

Basically, by the structure of law, the defendants had to show that factual evidence exists to adequately establish there is no genuine issue of material fact in order to be successful with the motion. Here, it is not readily apparent that the healthcare and insurance providers were able to complete such a weighty task. The defendants argued that the expert's opinion failed to identity his training or experience, as required under the statute, since he did not specialize in the desired field of neurology. However, Hebert v. Podiatry Ins. Co. of America determined that the particular field of specialty is not the crucial point, but instead the knowledge of the subject matter, such that the individual possesses the capacity to testify as to the matter at hand in satisfying the plaintiff's burdens. Due to the fact that the cardiologist was not a neurologist, the lower court determined that he was not credible. However, it was strictly stated in the doctor's opinion that "the standards of care 'are common to both the specialties and are equivalent and known' to him." The doctor also discussed how it was obvious that the misdiagnosis combined with the complications of lupus dramatically reduced the decedent's chance of survival.

Accordingly, it was determined that the lower court got it wrong. The cardiologist was in fact capable of testifying as to the standard of care that should have been given to the decedent. This leads to the conclusion that an expert witness need not have the exact same training or specialty in order to testify as to the burdens a plaintiff must meet in a medical malpractice case, so long as they are equipped with the knowledge and experience to competently answer the questions. The grant of summary judgment in favor of Dr. Snatic and LAMMICO was reversed.

Continue reading "Longterm Treatment for Terminally Ill Patient Called into Question" »

The Berniard Law Firm would like to wish everyone a Happy Holiday.

Regular posting will resume in 2012! Have a happy, and SAFE, holiday season!

Lawyers are professionals and are held to a certain standard of care by the law due to the delicate nature of their work. A lawyer is not required to win every case he or she takes - such a standard would be impractical and impossible to maintain. However, a lawyer must advocate to the best of his or her ability for a client at all times. This includes a myriad functions such as filing documents, arguing before judges and tribunals and negotiating on behalf of clients. If a lawyer fails to live up to a client's expectations of professionalism and conduct, that client may file suit for malpractice.

To be successful in such a suit the client must prove that the lawyer's conduct breached the standard of care for an attorney practicing within the jurisdiction. Once malpractice has been alleged and proven, it falls to the attorney to prove that even if he or she had been operating under the standard of care, the client would have lost his or her case. This second burden ensures that clients only collect when they suffer an actual loss.

In Semmes v. Klein, a legal malpractice case originating in St. Tammany Parish, Mr. Klein, the attorney, originally filed a suit on behalf of the wrong person. He realized this error and partially corrected it by withdrawing that suit. However, Mr. Klein failed to file a new suit on behalf of the correct party. Mr. Klein was fortunate because the potential plaintiffs in this case no longer possessed the legal interests that they thought they did by the time the case would have begun.

The facts of this case are confusing at best as they involve corporations and individuals comingling in all manner of contracts and deals. No party in this matter can be held truly blameless because all had a part in gumming up the legal framework in which they were all operating. Due to this confusing legal climate, the trial court did not render a verdict entirely favorable to either party. The trial court dismissed the malpractice claims of the plaintiffs at the defendant's cost and both parties appealed. On appeal, the trial court's decision was affirmed.

As professionals must be held accountable for their actions, attorneys are no different and are meant to act on behalf of their clients. This case showcased the type of situation that can arise when an attorney fails to do his or her due diligence. Through a full disclosure of information it could be found that the true interests of the clients may not have been upheld by the attorney in question. In this case, according to the filing of misconduct, Mr. Klein failed to make even the slightest inquiry into the situation in which he was becoming involved. As a result, his clients continued to operate under false assumptions until it was too late.

This case highlights the complexities of insurance litigation, as well. The owner of a particular piece of real property (real estate) insured the property. Then the owner gave the rights to collect the insurance proceeds to a separate entity. After Hurricane Katrina hit, the property was damaged and had to be repaired. Who would do the repairs? Who would actually collect the insurance payouts? Apparently, the answers to these questions were not the same. Enter Mr. Klein. According to his former clients, Klein made the situation worse by failing to behave according to the requisite standard of care. For this, his clients alleged to have suffered a bit of hardship and, in the end, was held accountable in the amount of their legal fees for the malpractice suit against him.

This case demonstrates not only the rules upon attorneys but also the need for clients to hire carefully. By being selective in who represents your case, you prevent not only having your case go poorly but also having to resort to such measures as suing your legal representative.

Continue reading "The Delicate Nature of Lawyer Malpractice" »

As we have discussed previously on our blogs, Louisiana courts apply "ordinary contract principles" when interpreting insurance policies. "Words and phrases used in an insurance policy are to be construed using their plain, ordinary and generally prevailing meaning." Cadwallader v. Allstate Ins. Co. The U.S. Court of Appeals for the Fifth Circuit, applying Louisiana law, recently utilized this approach when reviewing an appeal in a case involving a tragic medical injury.

Dr. Robert Lee Berry, an anesthesiologist, was employed by Louisiana Anesthesia Associates (“LAA”), a practice that provided anesthesia services to hospitals throughout the state. In March, 2001, Berry's employment was terminated by Dr. William Preau, a shareholder of LAA, when it was discovered that Berry had been abusing narcotics while on duty. Yet, less than four months later, Preau wrote an unqualified letter of recommendation on Berry's behalf when Berry applied for a job at the Kadlec Medical Center in Richland, Washington. Preau did not disclose Berry’s known drug use at work or his employment termination from LAA. On November 12, 2002, Berry improperly anesthetized a patient, Kimberly Jones, at Kadlec while under the influence of drugs. As a result of Berry’s mistake, Jones suffered an anoxic brain injury and emerged from the surgery in a permanent vegetative state. Jones's family sued Kadlec Medical Center and Berry in Washington, ultimately arriving at a settlment with Kadlec for $7.5 million. Kadlec then brought suit against LAA and Preau in the district court for the Eastern District of Louisiana. At that trial, the jury found that Preau had committed "intentional and negligent misrepresentation" by failing to disclose Berry’s drug abuse and employment termination in his recommendation letter. The jury awarded Kadlec damages of over $8 million. This amount reflected Kadlec's settlement with the Jones family plus approximately $750,000 in attorney's fees Kadlec incurred defending the suit.

In 2001 when Preau wrote the recommendation letter on Berry's behalf, LAA was insured under a commercial general liability policy issued by the St. Paul Fire & Marine Insurance Co. The policy covered covered LAA's shareholders, including Preau. When St. Paul declined coverage of the judgment against Preau in the Kadlec suit, Preau filed an action against St. Paul. Following cross-motions for summary judgment, and the district court entered judgment for Preau. The main issue on appeal was whether the damages that Preau was obligated to pay Kadlec were covered under the policy's "bodily injury" provision, which defined the term as "any physical harm, including sickness or disease, to the physical health of other persons." The Fifth Circuit held that characterizing the judgment against Preau as requiring him to pay Kadlec damages for "bodily injury" was inaccurate. Instead, the judgment required Preau to pay economic damages to Kadlec for the losses it suffered due to Preau's misrepresentation. "The economic damages Kadlec sought for Preau’s tortious misrepresentation are distinct from the damages Jones or any other party might seek for her bodily injuries." In the court's view, even though the amount of the damages that Kadlec sought from Preau was directly related to the amount it had paid to defend and settle the Jones family's claim, the damages were still of the economic variety, and therefore not of the type covered by the St. Paul policy. The court further explained the distinction by noting that Preau's liability to Kadlec arose from his breach of an independent duty he owed to Kadlec--Preau did not become legally responsible to Kadlec Suit for Jones’s bodily injuries, but rather the losses Kadlec faced due to Preau's breach. Accordingly, the court reversed the district court's judgment and remanded with instructions to enter judgment in favor of St. Paul.

Although the courts claim reliance on "ordinary" contract principles when interpreting insurance policies, this case shows how a court's analysis of a policy--which to most consumers is already a particularly dense and forbidding document--can be anything but straightforward and obvious. If you are in a dispute with an insurance company over coverage, seek counsel from an experienced attorney who can help you navigate the complexities of the policy language and Louisiana case law to determine the strength of your claim.

Continue reading "Court Finds No Insurance Coverage for Negligent Doctor After Medical Injury " »

Nearly ten years ago, consumers sued Sulzer Medica for producing defective hip and knee implants. The company ultimately settled with the affected parties. Although the underlying facts of the Sulzer Medica litigation are technically different from those of DePuy, the Sulzer Medica outcome is nevertheless instructive. If anything, the outcome of the Sulzer Medica recall may reflect the outcomes that will emerge in forthcoming DePuy litigation.

For those unfamiliar with the Sulzer Medica situation, here is a brief synopsis:

Sulzer Medica is a Swiss company that produces artificial joint replacements. It has since changed its name to Centerpulse. In December 2000, the company discovered that machinery oil had contaminated some of its knee and hip implant parts. Consequently, affected joint replacement units failed to adhere to the bone of recipients. Sometime in 2000, the company recalled the defective units. affecting approximately 32,000 people in the United States. Many had to undergo revision surgeries to remedy the problem.

After several years of litigation, Sulzer Medica agreed to settle for a collective $1 billion. Depending on the severity and class of each affected patient's injury, the company doled out as much as $206,000 to impacted individuals. The settlement amounts offered to recipients decreased as the level of associated injury lessened in severity. In some instances, spouses of recipients received payments. Ultimately, Sulzer Medica obtained the settlement funds through a combination of stock sales, bank borrowing, and insurance.

While there is no guarantee that pending DePuy lawsuits will yield similar settlement results, Sulzer Medica may be a useful guide because the situation in Sulzer Medica was very similar to that of DePuy. In both instances, medical manufacturers failed to safeguard their products, and consumers suffered as a consequence. Because strict liability is the governing standard in both situations, the courts will likely hold DePuy to a much higher level of care as they did in Sulzer Medica. Accordingly, settlement amounts comparable to Sulzer Medica will probably be necessary to make recipients whole for the harms they have suffered at the hands of DePuy.

Certainly, in regard to pending DePuy lawsuits, there is much left to be fleshed out. Plaintiffs' attorneys are still in the process of subpoenaing records and deposing DePuy officials on what level of knowledge they had pertaining to faulty manufacturing processes and whether they could have feasibly implemented a safer alternative design. Moreover, DePuy attorneys are still busy researching and mounting defenses. Only until all facts are revealed can the likelihood of DePuy settlement amounts be adequately estimated.

Stay tuned to this blog for more developments relating to the nationwide DePuy ASR hip implant recall. Additionally, if you believe you have been affected by the DePuy recall, please contact Berniard Law Firm for a free consultation.

Insurance policy coverage can be very confusing regardless of how simple televisions commercials may claim it can be. Sometimes insurance companies limit their liability by setting a time period within which the policy applies. In other circumstances, insurance policies limit their liability by creating categories of actions that can be instituted against it. For example, if an insurance policy states that it protects a health care provider for one year after the policy begins, this may mean that 366 days later a patient is out of luck if the doctor performs malpractice. Some insurance companies create distinctions on the types of actions that fall under the policy. For example, coverage can extend either based on occurrence or claims.

The distinction here is important, especially as it relates to the time period to bring a claim. If an insurance policy begins on January 1 and ends on December 31, the malpractice occurs on November 10, and the plaintiff files suit in March of the next year, the definitional difference is important. If the policy is occurrence based, the plaintiff will likely have no problem. In an occurrence based policy, coverage extends to any malpractice which occurred within the policy period. In our set of facts, since the malpractice occurred on November 10, it is covered because it is within the policy period. In a claims based policy, coverage extends to any claim that is filed within the insurance coverage period. In this case, although the malpractice took place within the time period of the insurance policy, the claim was not filed until after the coverage period had extinguished. Thus, in out facts, if the policy was claims based, the insurance company would not be liable for the malpractice.

In a recent case, Dewayne Wright v. Willis-Knighton Medical, the plaintiff, Ms. Wright suffered cramps, a coma, insulin shock, and stroke as a result of medical malpractice. The mother of the plaintiff filed suit on behalf of Ms. Wright. She filed initial suit against the facility, Willis-Knighton Medical. At a later date she amended her brief and added the ER doctors to the suit as well. Later, the plaintiff discovered that the insurance policy did not include the health care facility and only included the medical practitioners who decided to join under the coverage. The doctors that she added under the amended brief were originally protected by the coverage.

The problem for the plaintiff begins, though, when the insurance company that she sued later based its policy with the doctors on a claims based basis. Only the claims that were filed within the insurance coverage period were covered. Unfortunately for Mr. Wright, the period ended the day before the brief was amended. Mr. Wright argued that because the doctors were employed by Willis-Knighton, they were solidary defendants. However, because the policy did not cover the medical facility there is no legal basis to extend the coverage of the policy more than the contract states. Thus, because the coverage period had expired by the time the claim was brought against the insurance company and doctor, the claim failed to meet the requirement within the policy's scope and thus must fail in court to make the insurance provider liable for the alleged malpractice.

This case shows that if you feel that your rights have been violated or that you have been injured because of medical malpractice that you should seek legal counsel as soon as possible. By waiting before speaking to an attorney you increase the chance that time may run out on your ability to protect your rights.

Continue reading "Understanding Terms: Claims Based Insurance v. Occurrence Based Insurance" »

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.

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 1-866-574-8005. Our attorneys will protect your legal rights every step of the way.

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.

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.

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

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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.

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.

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.

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.

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 504.527.6225 or text 24-7 at 504.458.6225 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.

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 504.527.6225 or text 504.458.6225 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.

It is hard to think of something that could be more traumatic or concerning for families looking to in vitro for pregnancy options beyond what seems to now be the reality many are facing today. In New Orleans, Louisiana, Ochsner hospital has shut down their in vitro fertility program after realizing that their Elmwood facility is currently facing a huge mismanagement issue of embryos. As embryos are an integral part of in vitro pregnancy for families looking to have children, the fear for some is that this mismanagement has led to terrifying questions that remain to be sufficiently answered.

The Times-Picayune reports that the facility has shut down its program indefinitely in light of a recent discovery that its embryos have been mislabeled.

In her feature, Michelle Hunter reports

Hospital officials believe about 100 couples have been affected by the labeling errors, and began contacting them on Thursday. Officials could not say the cause of the mix-up but said, out of an abundance of caution, they are conducting an audit of the entire in vitro fertilization program, which began in 2003.

"Until we complete the full audit, we can't really speculate on what happened," said Chief Medical Officer Joseph Bisordi. He offered no other details than to say there were embryos that appeared to be mislabeled and unaccounted for."

The problem first surfaced a year ago, according to Bisordi. Ochsner officials began an evaluation and brought in an "outside expert" who determined the department needed to expand its audit.

This is a huge matter that has to leave many unsettled. While CEO Pat Quinlan claims that "no embryos had been implanted in the wrong mother," until an investigation occurs, many will be likely concerned. It will be important to see how the hospital responds to the matter and how transparent their investigation will be as the article notes the matter affects approximately 100 different families.

Embryo storage is an extremely important and emotionally significant matter for families to face and when a hospital mishandles the situation, the best case scenario is still disheartening and problematic. This blog will continue to follow the story and readers can feel free to contact our offices and bookmark the site to find out the latest information as it becomes available. If you need legal advice or need an attorney regarding this matter, please contact the Berniard Firm at (504) 527-6225 or text with your name (504) 458-6225. We will alert you to your legal rights and connect you with medical and other relevant experts who can let you know just what your rights are in this matter.