Articles Posted in Negligence Claims

According to the American Academy of Orthopaedic Surgeons, total hip arthoplasty, which involves medical devices such as those manufactured by DePuy, is usually a very successful surgery for the majority of patients. Total hip arthoplasty, or THA, is medical code for hip replacement surgery. Hip replacement surgery involves the insertion of a hip implant unit in the affected area of the body. As the name of the surgery suggests, hip implants “replace” the original bone joint of the hip.

One of the most frequently used hip implants are metal-on-metal ball and socket units comprised of chromium alloy. Metal-on-metal hip implants were originally thought by doctors to be the safest option for patients, as they were marketed by manufacturers as having a tendency to wear out less than other types of implants. Furthermore, the metal-on-metal units feature a larger ball, which is supposed to ensure a dislocated hip does not occur. However, recent studies of metal-on-metal units have alarmed some physicians, causing them to question the safety of metal-on-metal implants.

One finding that has raised medical professionals’ eyebrows is the onset of pain in some patients after THA surgery. As a spokesperson for the American Academy of Orthopaedic Surgeons stated, ìIn general, a patient should be relatively pain-free three months after any hip replacement surgery. Any new pain or increase in pain at that point should be promptly communicated to your surgeon, as it may indicate a complication.î In a case report published in the Journal of Bone and Joint Surgery, two patients reported painful complications after receiving a metal-on-metal implant. The patients were relatively healthy 47 and 49-year old males. Further analysis of the patients showed that cobalt toxicity from their metal-on-metal implants were the source of their pain. Cobalt toxicity in a patient’s circulatory system causes metallosis, a form of blood poisoning resulting from the generation of microscopic medical debris when two metal pieces in a defective hip implant begin to improperly rub against each other.

The symptoms reported in the case report of the 47 and 49-year old males are similar to the symptoms experienced by recipients of the recalled DePuy ASR hip implants, a defective metal-on-metal hip implant unit. Up to 13% of patients who have received a DePuy ASR hip implant are susceptible to metallosis, as well as disfigurement, loss of flexibility, or even the loss of the ability to walk. In light of the recently discovered risks of the DePuy ASR hip implants and metal-on-metal implants manufactured by other companies, president of The Hip Society, Dr. Chiltranjan Ranawat, MD., warns, “[W]e want to elevate patient awareness about metal-on-metal hip replacements. We suggest any patient who received a metal-on-metal hip inform all medical care givers about their joint replacement device and pay attention to post-operative pain.”

If you have received a Depuy ASR hip implant or are experiencing complications from a metal-on-metal hip implant manufactured by another company, contact the Berniard Law Firm today.

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Attorney Jeffrey Berniard has asked the Federal Judicial Panel of Multidistrict Litigation (JPML) to consolidate at least thirty separate claims filed against DePuy for the manufacture of defective hip implants into one master case. In his motion, Berniard asks the federal court system to allow the consolidated claims to be heard in the United States District Court for the Eastern District of Lousiana, which is located in New Orleans.

Mr. Berniard points to the New Orleans court’s centralized location as one fundamental reason for litigating the DePuy hip implant cases in Louisiana. As the DePuy recall has affected consumers nationally, the Eastern Louisiana federal court is geographically best suited to meet the needs of litigants located as far away as California and New Jersey, Berniard argues. Nestled in the center part of the country, New Orleans is not only equidistant from most plaintiffs but is a convenient transportation hub as well, with mild weather and regular airline flights available to accommodate the diverse travel needs of lawsuit participants.

Mr. Berniard cites the Eastern Louisiana District Court’s expertise in managing multiparty cases involving national consumers as an added reason for locating the DePuy cases in the Eastern District of Louisiana. In his motion, he presents the Chinese Drywall consolidated cases as a significant model for judicial efficiency within the district. The Chinese Drywall cases were recently centralized in the Eastern Louisiana federal district court, and Berniard is serving as class counsel. The matter is still pending but is expected to reach a swift resolution soon.

After DePuy announced its nationwide recall of nearly 100,000 hip implant units, the company indicated it would reimburse affected consumers and their insurers for “reasonable and customary costs of testing and treatment… including revision surgery if it is necessary.” Unfortunately, the medical device manufacturer has not specified which expenses will be deemed “reasonable” and “customary,” nor which revision surgeries are “necessary.” Such uncertainty has spawned confusion among affected recipients.

Although DePuy’s official statements tend to suggest they will pay claims in an efficient and equitable manner, recent court action shows otherwise. For example, in response to a lawsuit filed by Gulf War veteran Scott Almhjell to recover for injuries associated with the complex revision surgery required to remove a defective implant from his body, DePuy lawyers immediately resisted and denied Almhjell was injured by the implants at all. As a matter of fact, the company accused Alhmjell, himself, of causing his injuries in court documents and flat out denied any responsibility. This legal positioning certainly runs counter to DePuy’s original promise to pay for remedial medical action associated with the recall.

In light of DePuy’s reluctance to assume responsibility for its own manufacturing mistakes, several commentators have wondered who will ultimately end up paying the costs associated with the recall. As many patients are insured by Medicaid and Medicare, there has been some speculation that taxpayers may end up shouldering the monetary burden associated with revision surgery, as well as other costs. Because Medicaid and Medicare are government-funded insurers, any uncompensated losses related to the recall will materialize as substantial deductions from federal and state coffers, potentially affecting the viability of other publicly financed programs. Private insurers are not immune either. Any costs they are unable to be reimbursed for will be passed on indirectly to policyholders in the form of premium increases.

Manufacturers who market products to the general public are legally vested with a responsibility to ensure their products are reasonably safe and do not pose unnecessary risks to consumers. DePuy, a company that manufactures and markets medical devices, is currently being scrutinized by regulators and consumer advocates for failing to meet that responsibility when it released thousands of defective hip implants into the marketplace. Since admitting to the material deficiencies of the hip implants in August, DePuy has subsequently issued a massive recall potentially affecting 13% of the individuals who received the implants.

Just as manufacturers have certain legal responsibilities toward the public, victims of product defects likewise have certain responsibilities toward themselves should they wish to maximize any recovery they may be entitled to for manufacturer wrongdoing. Under the law of Louisiana and most other states, injured parties have a duty to mitigate their damages. In the case of bodily harm, this means the injured person should seek out the expertise of a doctor as soon as they are aware, or should have been aware, of the injury. Additionally, injured parties should avoid putting off remedial treatment when possible.

The principle behind the “duty to mitigate” rule is to prevent individuals from taking advantage of another’s wrongful act for the bad faith purposes of experiencing a windfall. When a defendant commits a negligent act, the law strives to hold that person responsible only for the actual and legal consequences of that act. Any other harm that occurs, which cannot be traced to the bad act itself, will not be chargeable to the alleged wrongdoer.

For anyone finding themselves with a heavy heart toward DePuy when they think of the mounting litigation sure to take place in response to the company’s recent hip implant recall, this should give them pause. In the third quarter of 2010, Johnson & Johnson, DePuy’s parent company, announced sales of $15 billion in total sales. In fact, Johnson & Johnson credits DePuy’s orthopedic joint reconstruction operations as a critical source of this massive profit.

Standing alone, companies should not be criticized for generating profits. Indeed, that is the inherent purpose behind most corporate charters. On the other hand, when companies generate large profits by marketing defective products because they fail to maintain adequate quality controls, then censure is warranted. Investigations into the DePuy hip implant recall have revealed not only unacceptable quality standards, but have also suggested DePuy knew of the defects in the implants and continued to sell them for years before it finally issued the recall. Such unsavory business practices are inconsistent with traditional notions of accountability and integrity expected of market participants.

One method of restoring accountability to the marketplace is through the court system. Litigation is sometimes criticized by commentators who fail to understand its process or purpose, but lawsuits are often the only remedy available to those harmed by manufacturer irresponsibility. When an individual loses something—a limb, general wellbeing, or wages–as a result of corporate impropriety, it is only equitable to provide the injured party with recompense to restore that person to the place in life they were before the loss.

In the wake of such medical product failures as the DePuy ASR hip implant, medical doctors are uniting to create the American Joint Replacement Registry (AJRR). Developed by the American Academy of Orthopaedic Surgeons, the AJRR will help doctors monitor artificial joints throughout a patient’s lifetime and will document the names of the surgeon and the facility where the artificial joint procedure took place. Other data would also be included.

Advocates of the AJRR point to the sheer amount of unnecessary medical costs attributed to medical manufacturer defects in the United States. In 2006, of the nearly 1 million hip and knee replacement procedures conducted throughout the U.S., 7.5% were revision surgeries, those operations performed to remedy injuries caused by an artificial joint defect. The price tag on revision surgeries amounted to more than 3.2 billion dollars in 2006. In an attempt to abate these staggering figures, the AJRR would be adopted in order to prevent revision-related costs, with some analysts estimating $65 million a year in savings. In Canada, Great Britain, Australia and Sweden, countries that have already implemented their own Joint Replacement Registry, incidents of revision surgeries there have already decreased 10%. The same rate of reduction could be expected to occur in the U.S. as well.

Besides reducing medical costs, a primary function of the AJRR would be to aid in the identification of poorly performing medical devices. By documenting the longevity of the device, as well as the fail rate amongst a diverse population of participants, the AJRR would help doctors and patients prevent serious injuries to artificial joint recipients. Furthermore, it would create a uniform reporting standard for each state on a non-profit basis. Currently, local and regional databases exist, but they are unable to provide maximum benefit due to inconsistent reporting techniques and burdensome maintenance fees.

The DePuy hip implant recall has received numerous publicity since it was first announced in August. DePuy estimates that at least 13% of the hip implants the company manufactured have failed, causing various injuries for its recipients. The hip plant recall is by no means the first manufacturing error to plague the DePuy corporate family.

On Tuesday, The Christian Science Monitor reported that Johnson & Johnson, DePuy’s parent company, has issued a sixth recall of Tylenol caplets due to a chemical defect in the medication. A telltale sign of the defect is a moldy odor that accompanies the caplets. Johnson & Johnson has not ascertained what additional consequences the recalled Tylenol may present to the consumer, but the corporation has urged purchasers to not ingest any of the recalled caplets. Since November 2009, Johnson & Johnson has issued recalls for Motrin, Tylenol Arthritis Caplets, Benadryl, as well as other forms of Tylenol. The most recent recall pertains to Tylenol 8 Hour Caplets.

Notwithstanding the ultimate harm that may come to users of the defective products, the past recall events by Johnson & Johnson and DePuy showcase a pattern of problematic manufacturing practices within the Johnson & Johnson corporate family. Based on these occurrences, it appears that the DePuy hip implant recall is by no means an isolated occurrence. Indeed, it is plausible that the DePuy report that accompanied the hip implant recall has underestimated the true number of patients affected by its defective hip implants.

Because Johnson & Johnson has issued many recalls in the past, the corporation is likely quite familiar with attempts at limiting its legal responsibility for defective products. For this reason, it is essential that patients who have received a DePuy hip implant retain legal counsel to recover for any injuries sustained. If a patient chooses to deal with DePuy without the assistance of a competent legal representative, they risk losing the right to a full and equitable recovery.

Oftentimes individuals affected by an incident find that offers from the offending party are offered a settlement that prevents future litigation. However, when the case involves matters where future difficulties can emerge, it is important that a proper attorney is hired. In instances like the BP claims in the Gulf, settlements are offered with the caveat that future litigation is prohibited. The future is unclear, though, and without proper calculations and expert testimony/appraisals, one may be left not receiving the proper monetary offer they deserve.

The attorneys at Berniard Law Firm have an extensive track record dealing with large multinational corporations such as Johnson & Johnson and DePuy. They are aware of DePuy’s likely legal defenses and have developed tried and true legal strategies that can maximize their clients’ chances at receiving a full recovery. Moreover, they are conscious of DePuy/Johnson & Johnson’s flawed track record when it comes to releasing unsafe and unreliable medical products into the marketplace.

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The forthcoming DePuy Hip Replacement litigation will become ever more intricate as victims rapidly continue to seek legal counsel. Reports released by DePuy show that as many as 1 in 8 patients who have received a hip replacement device manufactured by the company since 2003 have experienced injuries ranging from loss of movement and flexibility to metallosis and disfigurement. Furthermore, DePuy, a division of Johnson & Johnson, has been quick to limit its responsibility towards those harmed by its defective hip parts.

For these reasons, Berniard Law Firm has regularly urged potential clients with DePuy hip replacements to retain counsel so that they can effectively navigate the legal claims process. Now, a recent ruling from the United States Eighth Circuit Court of Appeals further supports this suggestion. In re: Medtronic, Inc. is a case that involved defective heart defibrillators. Due to defects in the defibrillator, several heart patients experienced unnecessary electrical shocks. Even after being informed of the defects by medical investigators, Medtronic, the manufacturer, sat on the information for several years before finally issuing a recall in 2007. After the recall, affected heart patients filed suit against Medtronic for the injuries caused by the shocks.

The plaintiffs in the Medtronic litigation made the “state law claims” of manufacturing defect, design defect, failure to warn, breach of express warranty, and negligence. These types of claims are known as state law claims because their legal force originates by state statute or state judicial opinion, as opposed to federal legislation or regulation. Typically, there are no issues when filing state law claims. Because each of the fifty states are sovereign legal entities, each state’s respective law usually has as much force as federal law. However, sometimes state law and federal law conflict. When such a conflict arises, the courts must determine whether the Constitution has vested control over the conflicted legal area to the states or, instead, to the federal government. This jurisdictional question is known as preemption.

In the case of Medtronic, the Eighth Circuit ruled that the state law claims filed by the plaintiffs conflicted with a Congressional statute called the MDA, and were therefore preempted by federal law. The MDA (Medical Devices Act) declared that state laws could not impose legal restrictions on medical device manufacturers that were different or more burdensome than legal restrictions already promulgated by the Food and Drug Administration (FDA), a federal agency.

While the plaintiffs’ state law claims asserted that the defibrillators were “unreasonably dangerous,” the FDA had already approved the devices for sale and concluded they were safe. According to the Eighth Circuit, because Medtronic had already met the FDA safety standards, it would be a contradiction of the MDA for the Medtronic defibrillator to also be simultaneously “unreasonably dangerous” under state law. As such, the Eighth Circuit dismissed the plaintiffs’ state law claims.

Although the Eighth Circuit may have ruled in favor of the manufacturer in the Medtronic case, the court still left open the possibility for a plaintiff’s state law claims to prevail in qualified circumstances. One such circumstance is when a state law claim neither conflicts nor adds to a federal law, but instead runs “parallel” with federal legislation. Although the appellate courts have not yet defined what “parallel” means, it is understood by many commentators to include any claim that does not run afoul of the FDA’s regulatory scheme nor interfere with the FDA’s discretionary powers.

The attorneys at Berniard Law Firm are well aware of the limitations presented when pursuing a medical products liability claim. In terms of the forthcoming DePuy hip replacement litigation, the Berniard Law Firm is fully prepared to present a DePuy recall case in a viable and sustainable manner, so as to avoid the preemption result that occurred in the Medtronic case. Indeed, Berniard attorneys have been closely following legal developments in this area, and they are well aware of which legal arguments are likely to withstand judicial muster.

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