Category: Product Defect

In August 2010, medical device manufacturer DePuy announced a recall of thousands of its defective ASR hip implants. Since that time, implant recipients have reported receiving letters mailed from their physicians’ offices urging them to visit their doctors so that MRIs and other tests can be conducted. The timing of these mailings is no coincidence. Patients who receive these letters should contact an attorney before acting or responding.

At first glance, these letters appear to be nothing more than innocuous correspondence to patients from their physicians. However, included within these letters are multiple requests to sign a release form authorizing DePuy access to the patient’s medical information, as well as an enclosed copy of the release form itself. The letters urge patients to sign the authorization form so that DePuy can efficiently process the patient’s claim for follow-up treatment or revision surgery.

While recipients of the DePuy ASR hip implants should visit a doctor to discuss any potential medical problems, they should under no circumstances sign any authorization form which allows DePuy access to their medical records. By signing an authorization form, a patient effectively allows DePuy to scrutinize their health information for evidence that might supply a basis to deny coverage for any follow-up medical treatment, even if that evidence is dubious or scientifically questionable. If DePuy altruistically wished to stand by its initial claim of paying for follow-up treatments and revision surgeries associated with the recall, medical authorizations of this type would be unnecessary. Indeed, the authorization forms patients have reported have conspicuously stated that DePuy will use the patient’s released medical information for purposes of “manufacturer’s investigation.” This language suggests DePuy may be using the authorization forms as a guise to limit its liability towards recipients rather than for good faith efforts to fix any problems its defective hip implants have created.

Another legally questionable aspect of the letters are statements urging patients to cooperate with DePuy so the company can process patients’ claims more efficiently. These statements are presumptuous in so much they surmise that patients will agree to use the DePuy internal claims process in the first place. Patients are under no obligation to remedy their injuries by using the DePuy claims process. Instead, they have every right to utilize the judicial system for resolution of their claims. Certainly, use of the civil legal system with the assistance of an attorney is the recommended approach when negotiating a claims settlement with DePuy. Alternatively, if patients do decide to use the DePuy internal claims scheme, DePuy will likely settle for only pennies on the dollar since such patients do not have the assistance of legal counsel. Utilization of the DePuy internal claims system would likely result in a decidedly one-sided resolution largely in favor of DePuy. For this reason, patients should proceed cautiously.

If you have received a letter from your physicians’ office requesting you come in for MRIs, blood tests, or other examinations to tell whether your DePuy ASR hip implant is compromised, you should contact the attorneys at Berniard Law Firm for timely advice.

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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.

As seasoned counsel of several products liability cases, Berniard has established himself as a national expert in product defect lawsuits that are nationwide in scope. In past suits, he has established an effective leadership structure amongst class counsel that have led to the swift resolution of multiparty claims. Notably, Berniard has also implemented a state of the art electronic discovery system which has noticeably expedited the distribution of vital documents to plaintiffs’ counsel located throughout the country. The sophisticated case management structure Berniard utilizes is yet another compelling reason to locate the DePuy lawsuits in New Orleans, he urges in his motion.

In addition to the DePuy and Chinese Drywall cases mentioned above, Berniard has also exhibited an extensive track record prosecuting products claims in the Eastern District of Louisiana. Included among these achievements are lawsuits against Dow Chemical for a chemical leak, Hydroxycut Marketing for deceptive sales practices, Cox Communications for antitrust violations, AIG for bad faith denials of insurance claims, and British Petroleum for the harms stemming from the explosion of the Deepwater Horizon oil rig and subsequent oil spill. Moreover, Berniard has shared his extensive knowledge with other local practitioners, teaching various seminars on products liability issues.

The Federal JPML is in the process of reviewing Berniard’s consolidation request, and it will be making a ruling soon. This blog will continue to keep its readers informed of any legal developments in the DePuy hip recall litigation as they are publicized.

In the meantime, if you have received a hip implant in the last eight years or know somebody who has, and you believe your health may be at risk due to the DePuy recall, do not hesitate to contact attorney Jeffrey Berniard. In light of his extensive experience, he is consistently eager to counsel clients on their rights and any potential legal claims they may have.

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.

Ever more disheartening, DePuy has yet to publicize its own claims adjustment procedures. To this day, the company has refused to announce the parameters of its claims process. Indeed, it appears the only governing principle behind DePuy’s reimbursement program is that of unfettered discretion by its adjusters. Such a system is manifestly unfair, if not downright dishonest.

In response to the uncertainty of DePuy’s internal claims process, many implant recipients are turning to legal professionals for advice and assistance regarding their rights in the DePuy hip implant recall. So far, at least thirty private lawsuits have been filed by individuals hoping to recover for injuries associated with the defective implants, as well as to hold DePuy accountable for its own intentional and negligent behaviors.
Attorneys at The Berniard Law Firm have been rapidly preparing for litigation against DePuy and its parent company, Johnson & Johnson, in the last few months. Based on his previous experience as lead counsel in other complicated multiparty products liability suits, attorney Jeff Berniard has anticipated DePuy’s propensity for denying its own inherent legal responsibilities. Accordingly, he has prepared pleadings and other court documents designed to ensure recipients of the defective hip implants will receive a fair and adequate recovery.

Individuals who have received hip implants since 2003 are urged to contact the Berniard Law Firm to determine whether they are entitled to any monetary damages DePuy may be forced to pay. Don’t wait until it’s too late and a problem unfortunately arises. Make contact with the the Berniard Law Firm today to learn what your rights are at stake in the DePuy hip implant recall.

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.

Although most victims of a defective product do not consciously try to avoid mitigating their injuries, it often occurs instinctively as a consequence of innocent inaction on the victim’s part. Moreover, even when victims make a valid attempt towards preventing further harm to themselves, they may naively forget to document their efforts. Months or years later, when the manufacturer challenges the plaintiff’s mitigation attempts in court, the plaintiff is consequently unable to recall which actions they took, generating doubt in the eyes of the jury.

Compatible with the duty to mitigate principle, recipients of the recalled DePuy hip implants should take proactive steps to ensure their legal claims and rights are not diminished. Recipients should contact their doctors in a timely manner for medical advisement. They should keep notes of any pain or complications they immediately notice after either the injury first surfaces or after they first receive notice of the recall. Most importantly, recipients should contact an attorney for advisement on which steps they can take to avoid weakening their case. Equally vital, recipients should not make contact with DePuy before they consult with a lawyer.

If you have been affected by the DePuy hip implant recall and are unsure of how to meet your duty to mitigate damages, please contact The Berniard Law Firm. Not only will you receive valuable instruction on how to meet your legal responsibilities, Berniard attorneys will also advise you of the best course of action available to recover for any actual or potential harm stemming from the defective Depuy hip implants.

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 case of the DePuy hip recall, many recipients have found themselves suffering from metallosis, disfigurement, and extreme pain and suffering after the defective artificial hip joints were implanted into their bodies. The position the recipients were in before receiving the defective implants was much more favorable than their position after implantation. While time travel does not exist to reverse the damage the hip implants caused, other effective substitute methods of pre-harm restoration do exist. These include monetary damages for actual harm caused, rehabilitative procedures, revision surgeries, and future harm due to diminished earning capacity caused by the resulting injury.

In addition to making individuals whole, litigation is also important in deterring manufacturers from producing defective products through the adjustment of economic risk. When manufacturers create their business plans, they are aware that not every product can be made to be 100% fail-safe. Such a scheme would be unfeasible and too burdensome for the manufacturer. Accordingly, manufacturers know that some product failures will be acceptable to regulators and to the public. Aware that some unit failures are tolerable, manufacturers often try to implement the least amount of safety measures acceptable in order to produce the greatest amount of profit possible. By suing companies when their products fail, litigants effectively raise the cost of production for defective products, thus preventing their sale in the first place. Another way of conceptualizing this is by saying that litigation makes it more expensive for companies to skimp on protective measures than it is for them to sell the product without such restraints.

Relating this deterrence rationale to the DePuy hip recall, litigation sends an economic message to the company that neglecting the quality of its product in exchange for greater profits will, in the end, result in an even greater monetary loss than would have been incurred had the company implemented a functional artificial hip joint design in the first place.

In the face of significant product failures produced by multinational conglomerates such as DePuy/Johnson & Johnson, litigation is often the great equalizer between the individual and the billion dollar corporation. Attorneys at The Berniard Law Firm have taken on several large organizations in successful efforts to recover for their clients’ harms. If you feel you may be impacted by the DePuy hip recall, contact The Berniard Law Firm today.

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.

As medical device manufacturers increasingly fail to maintain suitable quality standards for their products, artificial joint databases such as the AJRR will continue to grow in importance. For example, in August 2010, DePuy, along with parent company Johnson & Johnson, announced the recall of nearly 100,000 ASR hip implant units. The implants are prone to short lifespans and have resulted in thousands of patients experiencing life altering injuries, including metallosis and disfigurement. Because the recall was publicized only a few months ago, a comprehensive estimate of the bodily and monetary toll is not yet ascertainable, although it is likely to be substantial. Some documents have suggested DePuy was aware of the likely failure rate of its hip implants for years while it continued to market them to the public.
If you are concerned with the alarming defects present in DePuy’s hip implants or any other medical device, please contact The Berniard Law firm for a free consultation. Lawyers are available to explain what impact the DePuy hip implant recall may have on you or a loved one. They can also look into any other potential legal issues involving alleged medical devices manufactured by other companies as well.

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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