Articles Posted in Product Defect

New information has come to light suggesting that DePuy may be in the process of conducting destructive testing on hip implants previously inserted into patients that were affected by the company’s defective ASR product line. Soon after DePuy announced its nationwide recall of its ASR XL Acetabular System/Depuy ASR Hip Resurfacing System from the American marketplace in August 2010, the manufacturer began to send letters to hospitals and physicians. These letters requested the hospitals’ assistance in retaining explanted hip implant components, as well as related tissue samples following revision surgery. Notably, the letters contained language indicating DePuy would be sending the extracted hip implants to “third-party retrieval laboratories to receive and analyze explanted components and related tissue samples.” Unfortunately for plaintiffs, such third-party analysis can spoil and/or destroy the hip implant, resulting in lost evidence.

This development is highly problematic for persons who have experienced complications from the defective DePuy hip implant units and who are looking to pursue a legal case against the company. Since a patient’s hip implant unit is the centerpiece of product liability litigation against a manufacturer-defendant such as DePuy, should the unit somehow be destroyed before civil trial by a third party laboratory’s testing, plaintiffs could suffer enormous setbacks to their otherwise valid cases. Without the ability to admit evidence of the defective hip implant into court, plaintiffs are unable to meet their burden of proof necessary to prevail in their civil claims against DePuy.

Because retrieval and possession of an extracted hip implant cannot be performed by DePuy without prior consent by the patient, patients should communicate to their physicians prior to revision surgery that they do not want their DePuy hip implant handed over to DePuy. If a patient believes their physician will be uncooperative in this request, the patient can retain an attorney who will draft a letter to their physician explaining the patient’s instructions not to hand over the explanted hip implant to DePuy. Whether or not a patient uses an attorney to revoke such consent, it should be noted that it is always illegal for doctors to give DePuy a patient’s extracted hip implant if the patient has effectively communicated otherwise.

In October, this blog published a post discussing the potential interplay between the preemption rules of In re: Medtronic, Inc., and the forthcoming DePuy hip implant litigation. If one recalls, In re: Medtronic involved defective heart defibrillators that shocked implant recipients. When patients affected by the shocks attempted to file lawsuits to recover for their injuries against Medtronic, the federal Eighth Circuit Court of Appeals ruled that the plaintiffs’ state law claims were preempted by the FDA, and, therefore, plaintiffs could not proceed with their lawsuits. This blog then surmised in its original posting on the subject that recipients of recalled DePuy ASR hip implants might face similar hurdles in their own claims against DePuy. Since that time, however, further legal analysis by attorneys have discovered that the In re: Medtronic, Inc. ruling may in fact have no effect on recipients of defective DePuy hip implants after all.

The reason why DePuy plaintiffs may fair better than their Medtronic counterparts has to do with the different approval processes conducted by the Food and Drug Administration (FDA). While both the heart defibrillators manufactured by Medtronic and the ASR hip implants manufactured by DePuy were considered by the FDA to be Class III medical devices, each was subjected to a differing approval standard. In the case of the heart defibrillators, those medical products were subjected to a strict review standard and were scrutinized carefully for years by the FDA before given final approval. On the other hand, the DePuy ASR hip implants were considered by the FDA to be “substantially equivalent to legally market predicate devices marketed in interstate commerce,” and were accordingly not subjected to the same strict review standard.

From a legal perspective, the FDA testing standard a medical product is subjected to is very important. For example, when the FDA has highly scrutinized a manufacturer’s product and subsequently approves it for marketing, courts are reluctant to hold that manufacturer responsible for defects that are later discovered by consumers. The rationale behind this is that the FDA has been granted the power to set minimum safety standards for medical products by Congress. These minimum safety standards cannot be contradicted by higher safety standards a state legislature or court might promulgate. Consequently, courts believe it is unjust for the FDA to declare a product to be in compliance of FDA regulations when, simultaneously, the same product might be in violation of a more demanding state standard. In order to maintain a fluid marketplace, courts prefer manufacturers comply with one, uniform federal safety standard, rather than fifty opposing state standards.

Devices that are held to be “substantially equivalent,” on the other hand, are not scrutinized or tightly investigated by the FDA. Instead, products approved under the “substantially equivalent” standard are simply given administrative approval for marketing without any assurances by the FDA that the device complies with FDA regulations. The FDA does not set a minimum safety standard when it declares a medical device to be “substantially equivalent.” This means that if the device is discovered to be defective later on by consumers, those consumers can sue under their state tort laws without running into any of the preemption issues that the strict testing standard presents, as explained in the previous paragraph.
Because the DePuy ASR hip implants were given “substantially equivalent” approval, it is likely that the In re: Medtronic preemption rulings will not bar patients from suing DePuy for injuries caused by the defective hip implants. This is encouraging news for patients who wish to retain an attorney in order to recover for harm they have experienced.

As additional information arises pertaining to the potential legal difficulties plaintiffs might face when pursuing a claim against DePuy, Berniard Law Firm will continue to keep abreast of such developments.

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In August 2010, Johnson & Johnson subsidiary, DePuy, announced a recall of its ASR XL Acetabular System and ASR Hip Resurfacing System, two hip replacement components used in total hip replacement surgery. In the months that have followed, this blog has told readers about metallosis, one of the possible symptoms resulting from implantation of the DePuy ASR hip units. Metallosis is an allergic reaction by the body to metal ions contained in hip implant metal components such as High Carbon Content Steel, a cobalt-chromium alloy. But metallosis is not the only symptom of the defective DePuy hip implants.

Among the additional complications from defective hip implants are loose cups and pseduotumors, as well as fractures and friction transfer problems around the pelvis area. These symptoms can cause inflammation and loss of mobility, including loss of the ability to walk. Needless to say, these symptoms result in pain and frustration for many patients.

Several medical experts have stated that the DePuy hip implants were “too shallow” for implantation to begin with. They say the lack of depth within the hip implant units are one of the primary causes of patients’ complications. These experts have suggested that even the most skilled of doctors are likely unable to implant the flawed hip component in such a way to avoid complications. This means that the blame for DePuy rests primarily with its manufacturing process and not with surgeons. Predictably, DePuy denies that its ASR hip implants are too shallow and has attempted to shift responsibility to physicians.

Although not as likely to occur as metallosis or cobalt poisoning, pseudotumors and cancer remain possible symptoms for patients who have received a DePuy ASR Hip Implant since 2003. In August 2010, Depuy, a division of Johnson & Johnson, recalled hundreds of thousands of its ASR hip implant components from the American marketplace and began notifying physicians of the potential failure rates of these units. Thousands of patients have been affected by the recall, with billions of dollars in damages are at stake.

Because the hip implant cups’ defective design results in the unit oftentimes being too shallow for safe function, bits of metallic debris can generate when patients stand up and place natural forces on the hip implant joints. As a result of this metallic debris, patients’ bodies can begin to experience a wide array of adverse reactions. One such reaction is pseudotumors. Pseudotumors are a soft mass of tissue that form in response to a toxic reaction to the excess metal debris and can be a fluid-filled sac or a solid mass. These unfortunate tumors have been specifically found to oftentimes emerge around the hip implant site. Studies show that pseudotumors cannot be eradicated until all metal debris is purged from the body.

Another adverse reaction the body can have to excess metal debris is the onset of cancer. While this is an unsettling and, at this point, theoretical development, some medical researchers speculate that there may be a scientifically valid link between the chromium contained in DePuy hip implants and cancer. According to a report published by the EPA, chromium is a cancer causing agent. Depending on the class of chromium a human is exposed to, symptoms can range from the severe (hemorrhage and vomiting in the case of Chromium IV), to the relatively mild (moderate toxicity from oral exposure to chromium III). While the chromium contained in DePuy ASR hip components were originally designed to shield the chromium parts from the rest of the body, the excess metal debris generated by latent defects have increased chromium exposure in some patients. Although it is way too early to tell whether cancer is a legitimate consequence of DePuy’s defective ASR hip components, it is certainly a consequence that requires further looking into.

The purpose of alerting recipients to the potentialities of pseudotumors and increased cancer risks is not to instill fear into patients. Rather, it is to illustrate the fact that affected patients may face a multitude of complications that aren’t necessarily readily apparent today. For this reason , it is essential that patients do not sign any waivers or consent to any settlements with DePuy until an attorney has had the opportunity to calculate lingering risks that may still exist ten to twenty years after the recalled DePuy hip implant has been replaced by a functional and safe one.

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Of the many symptoms stemming from the recalled DePuy ASR Hip Implants, perhaps metallosis is the most alarming. Metallosis is a form of metal poisoning caused when metal parts of the implant rub up against each other, generating large quantities of microscopic metallic debris that is absorbed by surrounding bodily tissue and the blood stream. The metal parts can rub together as a result of fracture, loosening, or dislocation of the hip implant component parts. Under normal operating conditions, hip implants should not generate noticeable amounts of metallic debris.

When the microscopic metallic debris enters the bloodstream, the body’s immune system recognizes the metallic debris as foreign agents, much like a bacteria or virus. This is a form of blood poisoning. As a consequence, the body creates an immune response that can include swelling, inflammation, and internal scarring. Further, reactions from the white blood cells generated by the immune system in order to stave off the invasion of the metallic debris can cause the loss of muscle, nerve, and bone tissue around the hip implant location, resulting in the inability to walk, as well as the onset of severe pain, in some individuals. Tumors have even been observed forming around the areas of the body where large quantities of metallic debris have developed in those with metallosis.

In its Recall Reference Guide, DePuy notes that recipients of the defective hip implants should receive a number of tests to detect for metallosis, including blood tests for elevated cobalt and chromium levels by way of a Mars MRI or ultrasound. It could take at least a couple of these tests to determine whether a patient’s blood has toxic levels of chromium or cobalt, and the results of these tests aren’t always immediately available. In fact, the DePuy reference guide suggests follow-up tests for some individuals as long as three months after the initial MRI to see if the metal debris levels have increased or subsided. If a final test shows a positive toxicity of metal in the patient’s blood, then the only remedial medical action available is a revision surgery to extract the flawed hip implant and replace it with a functional unit. Revision surgeries are not only costly, but they can bring with it risks and dangers inherent in any major medical operation.

Due to the serious nature of metallosis, and the corresponding revision surgeries associated with the recalled DePuy ASR hip implants, it is likely DePuy will be legally responsible for billions of dollars worth of damages. Unquestionably, DePuy’s legal and scientific teams understand the dire consequences the recalled hip implants have created and will do everything possible to lessen the amount it owes to victims. With the potential for crippling ailments such as metallosis listed above, it is critical hip implant recipients consult an attorney before making a final settlement with DePuy.

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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.

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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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