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Articles Posted in DePuy ASR Hip Implants
Longterm Treatment for Terminally Ill Patient Called into Question
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.
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Regular posting will resume in 2012! Have a happy, and SAFE, holiday season!
Federal 5th Circuit Decides Excess Insurers Are Not Required To Pay Pre-Judgment Interest
In order to avoid extreme costs incurred from accidents, some businesses purchase two types of insurance policies. The first and most common type of insurance is primary insurance. Under this policy, business assets and liabilities are covered in exchange for the payment of a premium. This coverage, however, is capped in order to protect the insurance company from excessive claims. For this reason, many businesses, especially those dealing with expensive equipment and goods, will carry a second insurance policy that provides coverage beyond what is offered through the primary insurer. These policies are known as excess insurance. Premiums for these excess policies are often lower and provide a much higher cap on claim amounts. Excess insurers are able to provide such cheap, yet extensive coverage because the chance of such a catastrophic accident occurring that exhausts the primary insurance cap is minimal. However, as is evident in Indemnity Insurance Company of North America v. American Commercial Lines, L.L.C., where multiple boats collided on the Mississippi River, maritime accident costs sometimes extend beyond primary insurance coverage, bringing questions of how excess insurance money should be handled by courts.
When insurance disputes arise, many times the insurance company will concede the full policy amount, deposit it with the court, withdraw from the proceedings, and leave the claiming parties to battle out their rights to the money in court. Statutory provisions guide the timeline for when primary insurance policies must be deposited with the court, but what is the protocol for an excess insurer that wants to follow the primary insurer’s footsteps? This was the main question in the American Commercial Lines case. The plaintiffs sued the excess insurers claiming that the excess insurers deposited the policy amount with the court too late, resulting in the loss of hundreds of thousands of dollars in interest that could have been distributed amongst the victims. In deciding the case the court had to analyze a couple different issues.
The first issue dealt with determining what law applies to the case. Since the case involves maritime insurance, the court had to decide between maritime law and state law. Statutes provide that if no federal maritime law controls the issue, then state law applies. Because no specific maritime provision covers when an excess insurer should deposit policy amounts with the court, Louisiana court applies. This means, as mentioned above, that excess insurance will not kick in until after all primary insurance funds have been exhausted. This essentially answers the question the second issue poses: when does the excess insurer need to deposit policy amounts with the court?
Understanding Class Action Lawsuits in Louisiana
Class actions are a common and popular legal tool for cases involving a large group of people who share the same grievance against a defendant. Specifically, the plaintiffs have to have a real and actual interest in order to join a class action. An issue may arise however, if a plaintiff’s interest is called into question. In particular, whether the plaintiff belongs to the class of persons to whom the law grants the cause of action asserted against a defendant. Essentially, the plaintiff’s have to share the same type of complaint and injury in order to form a proper class action. Many times, defendants will allege that the class action was improperly certified (allowed) in order to invalidate any complaints against them.
In a recent Second Circuit Court of Appeal Case in Louisiana, the court explored the certification of a class action in order to determine whether or not it was proper. The facts of the case include the plaintiff, representing a class of individuals, who all share a grievance against a funeral home, owners of the funeral home, and numerous banks. The gist of their complaint is that the funeral home sold prepaid funeral expenses to the plaintiffs and other putative class members. The owner of the funeral home then deposited their payments into certificates of deposit (COD) with one or more of the banks named as defendants. The bulk of COD’s were under names which included the Funeral Home, followed by either “payable on death,” or “for the benefit of” followed by the name of the individual whose prepaid funeral funds were being held on deposit. The issue became that without presentation of a death certificate as required by Louisiana statute, the law governing prepaid funeral services, and in breach of the banks’ contracts, namely, the certificates of deposit, the funeral home was allowed by the banks to withdraw the funds which they converted and appropriated for their own use. The plaintiffs argue that by accepting the deposits, the defendant banks became commonly liable with the funeral home. Yet, the appellate court is charged with the responsibility to determine whether the class action should be certified, despite the fact the trial court denied the class’s certification.
A class action must have certain definite characteristics. First, the class must be so large as to make individual suits impractical. Second, there must be a legal or factual claim in common between all the plaintiffs involved. Third, the claims or defenses must be typical of the plaintiffs or defendants. Fourth, the representative parties must adequately protect the interest of the class. Further, in many cases, the party seeking certification of a class must also show that common issues between the class and the defendants will predominate the proceedings, as opposed to individual fact-specific conflicts between class members and the defendants and that the class action, instead of individual litigation, is a superior vehicle for resolution of the disputes at hand. Here, the class certification, the plaintiffs sought to certify a class defined as “all individuals from whom the funeral home appropriated and converted funds collected by them for prepayment of funeral expenses.” Additionally, the motion asserted common questions of law and fact including:
DePuy Settlements May Offer Spectrum of Opportunities for Recovery
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.
DePuy Parent Company Johnson & Johnson Admit Flaws in Cleaning Process
Reuters News Service reports that Johnson & Johnson has blamed “lax cleaning procedures” for its massive recalls of over the counter medicines and artificial joint replacements. “Insufficient equipment cleaning procedures and instances where people failed to adequately document cleaning procedures” are among some of the identified cleaning issues. The company has cited to “label irregularit(ies)” as well.
Johnson & Johnson has recalled nearly 200 million bottles of over the counter medicine products in the past year. Benadryl, Tylenol, and Rolaids are among the brands affected. Some batches of Softchews Rolaids were found to have wood and metal bits in the tablets. What’s more, odors have been reported in some of the other products. In light of Johnson & Johnson’s lack cleaning procedures, one may wonder what sort of research went into the DePuy ASR hip implants. DePuy, a division of Johnson & Johnson, announced in August 2010 a nationwide recall of the ASR hip replacement systems. The artificial hips contain design flaws stemming from too-shallow cups that don’t properly house the ball associated with the joint replacements. Complications of this design flaw include metallosis caused by microscopic metal shavings and substantial loss of mobility, to name a few symptoms. Moreover, pseudotumors have been reported in some recipients of DePuy’s ASR joint replacement products.
In light of Johnson & Johnson’s quality control flaws, and resulting defects, the federal government is beginning to pay attention. The Justice Department is considering potential charges against the corporation. The F.D.A. has initiated an investigation. Congressman Darrell Issa has expressed concern, too. At least one shareholder has filed suit against Johnson & Johnson’s board of directors in response to the manufacturing errors the company have committed recently.
Johnson & Johnson, Parent to DePuy, Under Scrutiny for Manufacturing Practices
In August 2010, DePuy recalled thousands of its ASR hip implant units after medical watchdogs discovered the product was structually unsafe and caused many recipients metallosis, substantial loss of mobility in joints, and other symptoms. Thousands of lawsuits immediately followed, with most still pending.
Hip implants aren’t the only product produced by DePuy, and its parent division, Johnson & Johnson, that have contained flaws. According to a January 2011 New York Times story, 288 million Johnson & Johnson products, including 136 million bottles of liquid Tylenol, Motrin, Zyrtec and Benadryl, have been pulled from store shelves. Foreign bits of metal and moldy odors are among some of the chief reasons behind removal of these items. And in December 2010, 13 million packages of Rolaids, another Johnson & Johnson product, were pulled from shelves after they were contaminated with metal and wood particles.
Johnson & Johnson’s manufacturing errors have led government regulators to more closely scrutinize the company and its subdivisions. The F.D.A., for instance, has expressed that it is baffled as to why company executives have not been able to identify, prevent, or explain the recent emergence of problems that plague the medical manufacturer’s products. Even the State of Oregon has filed a lawsuit against Johnson & Johnson, claiming the company has misrepresented the quality and efficacy of its products. A shareholder’s lawsuit was filed against the company’s board of directors in December 2010 in response to the billions of dollars lost in damages payments to victims of Johnson & Johnson’s defective products.
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.”
Criticisms of Metal-on-Metal Hip Replacements May Push Physicians Away from Usage
Medical literature has showcased several problems with metal-on-metal hip implants, such as the DePuy ASR line that was recalled in August 2010. Among the various problems, soft tissue reactions and high risks associated with metal-on-metal implant materials emerge to the top. For example, some hip implant recipients are especially sensitive to cobalt and chromium, two metal alloys commonly found in metal-on-metal hip implants. Doctors have observed “soft tissue breakdown and pseudo-tumors” in patients who exhibit these types of sensitivities, as well as other symptoms. Further discussion of these symptoms can be found here.
Additionally, physicians are beginning to balk at the use of metal-on-metal implants due to the newly uncovered information on the devices just now bubbling to the surface. As a result of recent lawsuits against DePuy in relation to the company’s flawed manufacturing processes, physicians are just now realizing some of the inherent risks associated with the metal-based units. Some medical observers predict the popularity of metal-on-metal implants could decrease as a result. Not only are physicians worried about personal liability for implanting a faulty metal-on-metal product, they are increasingly concerned with the proper maintenance of their patients’ wellbeing and health as well. Certainly, the use of metal-based devices in patients can run counter to such goals.
As metal-on-metal implants have been subjected to much scrutiny, physicians are turning to alternative joint implant materials, such as ceramics or plastic. One plastic model, known as the ADM X3 Mobile Bearing Acetabular System, has a ninety-four percent reduction in wear compared to metal-on-metal implants. Although the potential risks associated with plastic hip devices are not entirely known, they do not seem to carry the same risks of metallosis or soft-tissue poisoning that occurred in the DePuy metal-on-metal implants.