Insurance Dispute Lawyer Blog

In its October 13th Enforcement Report, the Food and Drug Administration released the lot numbers for hip implants affected by the DePuy recall. The defective implants include models within the ASR 100 and ASR 300 series. The enforcement report mentions “component loosening, component malalignment, infection, pain, fracture, dislocation and metal sensitivity” as reasons behind the recall. According to the report, there are 36,486 defective models in the stream of commerce at the time of publication.

A federal agency, the FDA, is charged with administering rules and regulations pertaining to food and medical products sold and marketed throughout the United States. The agency also acts as a watchdog to ensure medical devices are safe for consumer use prior to market approval. When the FDA or a manufacturer discover a product is defective after it has entered the marketplace, the FDA can use its regulatory powers to enforce a market recall.

As a matter of FDA compliance, DePuy, a Johnson & Johnson company, announced the recall of thousands of its hip implants in August amidst reports that 1 in 8 recipients had incurred some type of injury after insertion. Perhaps the most severe injury reported was metallosis, a condition that occurs when metal shavings from the implant lodge themselves into surrounding muscle and skeletal tissue. Metallosis is caused by the defective design of the DePuy implant, especially metal components that rub together without any lubricant or cushion in between them.
Due to the sheer amount of defective units released into the marketplace, DePuy hip implant recipients have been retaining attorneys for legal advisement during the past few months. One issue sure to define the direction of upcoming litigation is how long DePuy had knowledge of the hip implant defect before initiating the recall. Surfaced documents have suggested the company knew as far back as 2005 that the implants posed serious dangers to its users. Moreover, similar documents indicate the recalled hip implants were never properly approved for domestic use in the United States and thus were never scrutinized under usual consumer safety testing procedures. If this is the case, then the potential remedies for aggrieved individuals are sure to increase in scope.

Additionally, complications have arisen for recipients whose injuries were so serious that revision surgery was required. For those who had to incur a second surgery to rectify the harm caused by the implants lost wages, increased medical bills, and pain and suffering were all dreadful consequences these particular individuals endured in order to remedy their injuries. Clearly, the fallout from this recall will prove to be substantial.

The Berniard Law Firm has worked diligently in the past months to gather the facts and circumstances surrounding the DePuy hip implant recall. The firm has been adequately preparing for eventual litigation in order to assist recipients in the recovery for injuries caused by the implants.

Continue reading

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.

Continue reading

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.

Continue reading

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.