Articles Posted in DePuy ASR Hip Implants

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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Recently, Johnson & Johnson’s DePuy Orthopaedics unit recalled their ASR Total Hip System due to serious issues that have caused thousands of individuals serious problems. The company said it will pay any medical expenses related to having the hip implant device; however, the patients have had to agree to certain conditions in order to receive such compensation. Many analysts warn that agreeing to such conditions may hurt individual’s legal rights and that the company is attempting to protect themselves from further legal trouble instead of protecting the people they have hurt.

The DePuy ASR hip implant became available initially in July 2003, and, from 2003-2010, over 95,000 individuals worldwide have received the implant. However, serious complications have been found after having such implantation. First, the device has been found to become loose, causing bone fractures and even bones breakage. Further, the metal on metal piece creates friction when the individual simply walks, causing soft tissue damage surrounding the device. One out of 8 individuals had to receive a second corrective surgery in order to completely remove the DePuy device, however, many remain in pain and discomfort, unable to do daily tasks that were once second nature.

The company has listed on their website a list of steps individuals should take if they have had such an operation. First, the individual is asked to, if they have had any hip implant since 2003, go to their doctor and/or hospital and receive documentation of such procedure, with proof they have had a DePuy implant. This alone is not problematic; however, the company continues to say that they will, “cover all reasonable and customary costs of testing and treatment, including revision surgery if it is necessary, and associated with the ASR recall.” This single phrase alone has a lot of indefinite terms — they “may” cover, and “reasonable,” what do they consider reasonable? How are they defining such terms? What is more troubling is the fact that patients are required to provide DePuy with their medical records, as well as the faulty hip implant. This is in addition to signing a consent form, without such signature the company stipulates that “it is unlikely that we will be able to consider the patient’s claims for reimbursement and prompt resolution of their claim may not be possible.” Thus, this forces individual’s to sign a consent form, without legal representation, and places them in a vulnerable position that may hurt their chances at receiving just compensation in the future.

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