Articles Posted in Negligence Claims

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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Recently, DePuy Orthopaedics, Inc., announced they were recalling the DePuy ASR Hip Replacement System as a result of serious device complications. However, DePuy has known since approximately 2005 that the ASR system was defective and causing individual’s unnecessary pain and discomfort. Additionally, the ASR system has caused almost 13% of patients to undergo a second corrective surgery that completely takes out the DePuy device due to the severity of resulting complications. In short, patients who have received the DePuy ASR Hip System have reported experiencing difficulty maintaining daily routines, or even enjoying simple acts such as walking, or bending down past the waist.

DePuy has limited its offer of compensation to the costs of medical care provided. Particularly, in DePuy’s published reports, the company states they will cover, “reasonable and customary costs of monitoring and treatment services.” However, before an individual contacts DePuy or Johnson & Johnson, they should be aware of their legal rights and have them protected throughout this process. DePuy’s limitation on compensation ignores the other experiences and factors individuals will most likely go through after having a defective DePuy hip implant. For instance, DePuy will not cover the costs associated with the daily physical pain experienced, nor the additional hospital monitoring, prescription costs, lost wages or decreased earning capacity, disfigurement, or even disability. These are just a handful of damages that may be claimed against DePuy that they are stating they will not cover.

Patients have reported time and time again that, after receiving the DePuy ASR Hip Replacement System, they experienced complications that caused them severe physical and mental stress. For instance, a plaintiff who filed recently against DePuy in Maryland claimed that the metal on metal device actually became disassociated and the neck of the device became stuck in their anterior capsule, while the other part of the device slid along the iliopsoas tendon up to the hemipelvis anterior to the acetabulum. Essentially, the device was injuring the person’s entire hip area causing severe damage. As a result of the disassociation of the device, the plaintiff had to undergo a separate abdominal incision to remove the disassociated components. The plaintiff suffered numerous complications, including deep vein thrombosis, external iliac artery thrombosis, and damage to the left hip and left foot. The plaintiff claimed permanent damage and pain associated with the defect of the DePuy device. Further, as a result of DePuy keeping the defective product on the market (when they had almost four years of complaints and reports illustrating the defects in the device)the plaintiff suffered great pain, loss of mobility, emotional upsetment and anxiety, and has incurred and will continue to incur large sums of medical care and attention.

Having legal representation can help guide affected individuals throughout these serious issues associated with the recalled DePuy ASR Hip replacement System. Financial compensation may be available to those who have received the DePuy ASR hip replacement system. Also, patients may be entitled to damages including pain and suffering, past and future pain, lost earnings, medical bills, disfigurement, monitoring, rehabilitative and pharmaceutical costs. Contact the Berniard Law Firm for help throughout this difficult process. You do not have to go through this ordeal alone, especially when an attorney can help you navigate this process.

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On August 26, 2010, the Johnson & Johnson subdivision known as DePuy recalled the DePuy ASR Hip Replacement System due to the overwhelming number of individuals who have experienced serious complications due to the implant. The recalled DePuy Total Hip System has been implanted in individuals since 2005 in the United States and since 2001 internationally. This has resulted in over 93,000 individuals who have received the DePuy Total Hip Replacement System. Below, the DePuy Recall is discussed in a clear and understandable format to help individuals explore the issues that might be affecting them.

What are the Specific Problems?

The DePuy ASR Hip Implant system has caused thousands of individualís difficulty in performing even the most simple daily tasks, causing unnecessary stress for individuals who have already experienced the traumatic event of undergoing an invasive and serious surgery. Further, the DePuy Hip System has caused approximately 1 out of every 8 individuals to undergo at least one corrective surgery in order to completely remove the DePuy device. Some of the physical complaints patients experienced and expressed after receiving the initial operation have included:

– Pain
– Swelling
– Inflammation
– Difficulty walking
– Trouble bending
These symptoms can continue months and even years after the initial implantation of the DePuy device. Further, these symptoms may be a sign of a larger problem, such as an infection or damage to the hip area as a result of the DePuy metal on metal device defects.

Why is the DePuy Device Causing these Symptoms?

The DePuy ASR Hip Replacement System is a metal on metal device that has multiple issues that has resulted in individuals needing the second corrective surgery to completely remove it. Specifically, the ASR Hip is designed to mirror a person’s natural hip, utilizing a ball and socket that move against each other in order to function as a person’s natural hip would when moving. However, this back and forth movement of the metal ball in the metal socket creates friction and then produces metal shavings that become lodged within the socket as well as the surrounding soft tissue of the individual. A person’s body may have different reactions to this metal build up, including creating fluid to collect in the joint and in the muscles around the joint, resulting in severe pain and swelling that could damage the muscles, bones, and nerves around the person’s hip area.

Further, the DePuy ASR Hip System also has problematic issues that include the device loosening. The metal on metal device is constantly rubbing against itself, causing metal shavings, as well as becoming loose. Once the device becomes loose it may not stay attached to the bone in the correct position in the person’s hip. Thus, creating severe pain, swelling, difficulty moving, and even bone fractures.

Dislocation of the device is also a troubling element, where the two parts of the implant move against each other become dislocated, and no longer are aligned, the device may actually cause the bones in the area to break, fracture, or become severely bruised.

What You Can Do
If you have had hip surgery since July 2003, you may have received the recalled DePuy ASR Total Hip System. With medical test and legal guidance you may be awarded financial compensation. Contact the Berniard Law Firm for help throughout this difficult process. You do not have to go through this ordeal alone. Damages patients may be entitled to include pain and suffering, past and future pain, lost earnings, medical bills, disfigurement, monitoring, and rehabilitative and pharmaceutical costs.

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As over 93,000 DePuy ASR Hip Implant recipients face the reality of the recent recall that requires the replacement of the orthopedic device, many wonder if they need an attorney to represent their legal rights. The reality of the matter is that all indications show that the company, owned by Johnson & Johnson, is attempting to limit its legal responsibilities in the wake of the failing implant at the expense of government agencies and insurance companies. What’s more, the company has not shown any significant interest in compensating those who have been affected by the need to replace or fix their implant and, instead, appears to be looking out for itself.

While these are bold accusations, all signs indicate that DePuy is taking a hands-off approach from this matter. Specifically, the company has made no public statements regarding compensating people for their pain and suffering. In fact, DePuy’s only demonstration of regret and interest in paying individuals for their losses surrounds compensating patients for out-of-pocket expenses. Encouraging those with failing implants to document the costs relating to the implant, the company is, at least publicly, only encouraging claims of things like gas and medical expenses related to replacing the joint substitute.

On its own website, DePuy acknowledges this interest of repaying implant recipients for “reasonable and customary costs of testing and treatment if you need services, including revision surgery if it is necessary, associated with the recall of ASR.” Nowhere in this passage does the company acknowledge the months to years of pain and damage caused by a failing implant that the company knew, as far back as 2007, was problematic. This is not acceptable to our law firm, much less the many implant recipients who have suffered limited mobility, extreme pain, difficulty with movement or general use of the implant and issues of metal shavings in the soft tissue. What’s more, those who have had to undergo revision surgery before the recall would argue the stress and undue problems relating to undergoing another effort at replacing a failing hip is nothing to be ignored.