Articles Posted in Negligence Claims

Earlier this month, U.S. District Judge David A. Katz issued an order calling for applications from attorneys interested in serving in leadership roles for the DePuy Orthopaedics hip recall case. On December 7, 2010, Jeff Berniard, the sole principal of Berniard Law Firm in New Orleans, Louisiana, answered Judge Katz’s call by submitting a letter seeking a spot on the integral Plaintiffs’ Steering Committee for the DePuy case. A Plaintiff’s Steering Committee is responsible for making strategic decisions that affect the execution and administration of large scale class action lawsuits. Mr. Berniard will find out if he has been selected for this leadership post sometime soon.

Despite establishing his own law firm only five years ago, Berniard has quickly emerged as a foreperson in complex litigation. The Louisiana attorney, who already has extensive experience representing claimants in complex product liability litigation, has been recognized as an expert in the DePuy Hip Recall lawsuits. He has taught continuing legal education courses on the DePuy Hip Recall lawsuits for Thomson Reuters and he plans on continuing in his role as a lecturer on the topic for as long as the DePuy legal situation continues to unfold. Additionally, Berniard maintains this blog, a website devoted to regularly informing the general public of various issues surrounding the DePuy Hip Recall litigation.

In support of his application to the Plaintiff’s Steering Committee, Berniard pointed to his professional history as class counsel for lawsuits involving toxic torts, Sherman Antitrust, and first party insurance litigation in his letter to Judge Katz. Consistent with Berniard’s varied experience, at least one court overseeing some of his cases praised the Louisiana attorney saying, “This Court finds that Class Counsel are highly skilled attorneys with experience in class action litigation. The substantial settlement amount negotiated by Class Counsel further evidences their competence.” The court further noted that Berniard and his colleagues had devoted “an exorbinant [sic] amount of time [to the lawsuit while] assuming substantial risk that they might not be compensated for their efforts” during the case in question. Combined with his varied experiences in class action lawsuits similar to DePuy, these complimentary observations of Berniard’s past professional successes by the judiciary buttress his assertion that he is a suitable candidate for the DePuy Hip Litigation Plaintiff’s Steering Committee.

Joint replacement surgery is just what it sounds like: it is the removal of a damaged joint and the subsequent replacing of it with a new, artificial one by an orthopaedic surgeon. Depending on the severity of damage, a surgeon won’t always replace the entire joint. Instead, she may replace or reconstruct only the damaged parts. In either case, the purpose of joint replacement surgery is to improve a patient’s quality of life by relieving pain and increasing mobility.

Allured by the promised benefits of joint replacement surgery, as many as 773,000 Americans have their hips or knees replaced each year. But like any surgery, joint replacement operations carry with it certain inherent risks. Such risks are unique, depending on the patient-type, which is why every doctor should be sure to inform every patient of the risks unique to that individual. If the patient fully understands these risks and is comfortable with them, the patient can consent to the replacement surgery and the operation can move forward.

While some risk is inherent to any surgery, there are certain dangers that are simply uncalled for. A prime example is the product defect manifest in the recalled DePuy ASR hip implants. Unlike medical issues which doctors spend many years studying and training to spot, physicians do not have the engineering expertise necessary to identify latent product defect issues that may exist in a manufactured medical device. Therefore, manufacturers are on the hook when their medical products cause harm to a patient.

One system that may assist doctors in spotting problematic medical devices is a National Joint Replacement Registry. While Sweden, Finland, Norway, Australia and Denmark all have national joint replacement device registries, the United States does not. In a study published in the November issue of the Journal of Bone and Joint Surgery, researchers examined 80,000 total knee and hip joint replacements and 5,000 ACL reconstruction surgeries in a preexisting registry. During the study, the registries effectively tracked and red flagged eight recalls and advisories, allowing doctors to quickly identify affected patients and to respond accordingly. One of the researchers even concluded that a national registry could greatly improve patient safety and provide a basis for future registry research projects that would supply even better outcomes.

Had such a registry been in place, it seems likely that doctors would have been able to realize the danger contained in the DePuy ASR hip implants much sooner, thus preventing implantation in tens of thousands of patients. Unfortunately, such a warning system was not in place, meaning thousands of patients are experiencing complications arising from being fitted with one of DePuy’s defective ASR hip implant units.

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The Honorable David Katz has scheduled a status conference to be held January 20, 2011 at the Paul G. Rogers Federal Building in West Palm Beach, Florida. The purpose of this status conference is to allow applicants for the Plaintiff’s Steering Committee in the DePuy hip recall litigation an opportunity to speak for a few moments in support of their application. As this blog recently reported, New Orleans attorney, Jeffrey Berniard, recently submitted a request for one of these leadership positions.

Berniard says he plans on using the two minutes allocated to him for oral argument to remind the court of his past successes leading other complex litigation, including, but not limited to, suits filed against Cox Communications, Iovate Health Sciences, and Dow Chemical Company. Additionally, Berniard has established his expertise in the DePuy ASR Hip Implant recall matter by lecturing other attorneys in ongoing continuing legal education (CLE) classes held in the Greater New Orleans area, and he wishes to remind the court of this as well.

Since the nationwide recall of DePuy’s ASR hip implants was announced in August 2010, Berniard has continuously accepted new clients to represent in this matter. Moreover, he has maintained this blog, which has effectively informed the general public of the risks associated with the faulty manufacturing techniques of DePuy Orthopaedics. These actions showcase Berniard’s willingness to lead and share his skills with those most affected by the defective medical products.

Owning property can be fulfilling for individuals but, with this sense of accomplishment comes extensive legal responsibilities. Owning non-residential property, in particular, can be stressful, particularly when a landowner is seeking compensation for property damage. In a recent case, the Court of Appeals for the state of Louisiana evaluated potential benefits of landowners suing for property damage. More specifically, the court evaluated whether landowners had a right to sue for damages caused by a party who obtained a mineral lease from prior landowners. The Court of Appeals agreed with the findings of the lower court and held that the plaintiffs could not recover because they were either: not the party who was entitled to compensation or that too much time passed and it was too late to sue.

In 1945, Chevron obtained three mineral leases from the Pasternack family for a 193-acre tract of land located in the Lake St. John Oil and Gas Field in Concordia Parish, Louisiana. Operations on the property were commenced by Chevron in 1945 pursuant to three mineral leases obtained from the previous owners, the Pasternack family. The Pasternack family sold the property in June 1999 and, after several conveyances, the property was owned by the Wagoners when the lawsuit was commenced. Still, the Pasternacks reserved their mineral interests in the land. Eventually, the Wagoners discovered that the subsurface of their property was contaminated with exploration and production waste, particularly through the use of unlined pits. As a result, they filed suit in August 2008, claiming that their property was contaminated by the oil and gas exploration and production activities of Defendants.

Through a complex timeline, Chevron leased and conducted oil and gas operations on the property from 1945 to 1992. Throughout the years, the lease was assigned to several entities including Devon, Merit, LSJ Exploration and Oil & Ale LSJ, Smith Operating and Management Company. Beginning in 2004, McGowan Working Partners leased and operated the shallow oil–producing subsurfaces beneath the property while the deeper subsurfaces were leased and operated by Denbury Onshore after 2004. Numerous exceptions were filed by various Defendants and the trial judge sustained the following exceptions filed or adopted by all Defendants: (A) Vagueness; (B) No Cause of Action for Strict Liability for Nuisance; (C) No Cause of Action for Strict Liability for Garde or Custody; (D) No Cause of Action for Abnormally Dangerous or Ultrahazardous Activity; (E) No Cause of Action for Breach of Contract or Warranty; (F) No Cause of Action for Punitive Damages; (G) No Cause of Action for Unjust Enrichment; and (H) No Cause of Action for Civil Fruits.

The Court of Appeals of Louisiana, First Circuit, recently defined the way in which the Court would look at implied permission for the use of ones car. Depending on the terms of the auto insurance policy, the policy may provide protection for damages that even extend to the passenger in a vehicle driven by someone who has permission to drive the vehicle. This means that if the passenger died in the car accident, the passenger’s family may be able to collect by filing a petition for damages against the insurance of the actual owner of the car, not just the actual driver at the time of the accident.

In Hartzo v. American National Property and Causualty Insurance Company, the driver of a Ford Taurus crashed into a Toyota Tacoma. The driver and passenger of the Taurus were killed in the accident. The driver of the Taurus was the brother of the owner of the vehicle. The family of the passenger filed a petition for damages against American National Property and Casualty Insurance Company (ANPAC) and another insurance company. The insurance policy through ANPAC had provisions that extended such benefits if the driver of the vehicle had express or implied permission to drive the vehicle.

ANPAC thought that they had a good argument that the driver of the Taurus had no permission to drive the vehicle. The Court of Appeal looked at the facts and the policy that the owner of the vehicle had. The Court found that deciding whether there was express permission would not dispose of the case. The Court spent its time analyzing what factors they would look to in order to find implied permission. The Court stated that “the issue of implied permission involves a balancing of legal and public policy issues and must be inferred from the totality of the facts and the relationships involved.” With this statement the Court seems to be saying that both customary use and relationship can be used to find implied permission. The Court of Appeal later stated that the following factors were indicative of implied permission: (1) At the time of the accident the driver and owner of the vehicle were living in the same household, (2) On the day of the accident, the driver of the vehicle had already driven the vehicle with the knowledge of the owner, (3) In the past, the driver had driven the Taurus on many occasions. Therefore, the Court looked at both the relationship involved (i.e. the fact that driver and owner lived under the same roof) and the custom between the parties (i.e. the fact that the driver had driven the car on many occasions). Thus, ANPAC was liable under the petition of damages.

It is very important to clearly understand your insurance policy. The policy may be confusing and many different, and what may seem insignificant factors, can change the entire outcome of a litigation. It is essential that prior to settling any issues with your insurance company, that you seek the advice of competent legal counsel to help you maneuver through complex insurance policy determinations.

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It was recently announced that the pretrial filings for DePuy ASR hip replacement lawsuits have been consolidated to the Northern District of Ohio. The lawsuits have been assigned to the Honorable David A. Katz for supervision during the early stages of the litigation. Judge Katz is based in Toledo, Ohio, and he will be responsible for overseeing discovery efforts and pretrial motions made by DePuy ASR hip implant litigants.

With over 150 federal lawsuits pending against DePuy, it was necessary to consolidate the DePuy ASR hip replacement pretrial actions to just one judicial district in the interests of simplicity and judicial economy. According to the U.S. Judicial Panel on Multidistrict Litigation, these numerous federal lawsuits all contain common issues of fact and law. Therefore, the pretrial actions only need to be considered in one consolidated court proceeding.

Once the pretrial phases of these lawsuits are completed, the U.S. Judicial Panel on Multidistrict Litigation will transfer the actions back to the federal court districts they originated from for further litigation in the plaintiffs’ respective home districts.
The consolidation of DePuy hip implant pretrial litigation will streamline the exchange of evidence between the multiple plaintiffs and DePuy. Because some commentators predict that thousands of plaintiffs may end up filing suits against DePuy for complications experienced as a result of receiving a defective DePuy ASR hip implant unit, it is critical that redundancies and duplications of evidence and motions are avoided in the earliest phases. Consolidation to the Northern District of Ohio should facilitate this goal.

DePuy, a division of Johnson & Johnson, announced a nationwide recall of its ASR hip implants in August 2010 after a significant number of patients were forced to endure revision surgery to correct complications suffered from defective ASR units, including metallosis and loss of mobility. As many as 12-13% of patients were adversely affected. Experts estimate that billions of dollars in damages are at stake. Consequently, complex litigation and negotiations are expected in order to justly compensate plaintiffs’ claims for the pain and suffering they’ve experienced. And because product liability litigation is only just beginning against DePuy, the recent consolidation action will set the foundation for future litigants and forthcoming litigation.

This blog will continue to keep you posted on legal developments surrounding the DePuy hip implant recall as they materialize.

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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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