Articles Posted in Product Defect

In parts 1 and 2 of a three-part interview with client Eugene O’Neal (name changed to protect attorney-client privilege), Eugene communicated to readers the menacing effects a failed DePuy ASR hip implant can impose on a person. Not only is the required revision surgery physically taxing, but it generates emotional uncertainty and psychological anxiety as well. For Eugene and the thousands like him, the fallout from the nationwide recall of DePuy ASR hip implants carries with it very real, very human consequences.

When Eugene realized his defective hip had been recalled, he turned to the Berniard Law Firm for guidance. Immediately, attorney Jeffrey Berniard and his staff gave Eugene vital legal advice and connected him to medical professionals who could explain in plain language how the defective hip implants were adversely affecting his body and causing pain.

As previously reported by this blog, Mr. Berniard is using his legal expertise to assist those like Eugene everyday. As he has for years before, Berniard is filing lawsuits for those affected by the inappropriate actions of a large company; in this case, our firm has filed on behalf of patients who have suffered before the recall. Lead attorney Jeffrey Berniard has sought to centralize DePuy litigation to Lousiana and, although his motion was not granted, he is very happy with the selection of the Northern District of Ohio as the transferee forum. Mr. Berniard has also applied to the Honorable Judge Katz in the transferee court for a leadership position with the Plaintiff’s Steering Committee. If granted the position, he would be responsible for directing the strategic direction of national DePuy litigation. However, even if Mr. Berniard is not selected as a member of the Plaintiff’s Steering Committee he will continue to be a part of the litigation as a valuable member of one of the junior committees.

This is the second installment of Berniard Law Firm’s interview with client Eugene O’Neal (name changed to protect attorney-client privilege). In the first installment, it was revealed that Eugene’s DePuy hip implant had failed and he now requires revision surgery to remedy the problem. Below, Eugene shares his thoughts on having to endure hip replacement surgery for a second time as a direct result of DePuy’s faulty manufacturing techniques.

In addition to fear, Eugene possesses frustration at the weeks upon weeks of rehabilitation he will be forced to undertake in order to recover from his upcoming revision surgery. Following the original implantation of his ASR hip implant in 2008, Eugene endured sixteen weeks of physical therapy before he got to the point where he could adequately walk again. “After they saw your femur off, your body takes a lot of pounding,” Eugene explains. “During the first week of rehab, you have to learn to use your leg all over again. You just stare at your leg and tell it to move. But it won’t move. Your toes move, but your leg doesn’t.” When asked for his thoughts at the prospect of enduring a similar round of rigorous rehabilitation within the next few weeks, Eugene puts it tersely: “It will be a major disruption.”

Eugene makes no secret of his antipathy toward DePuy and its faulty manufacturing practices. “I can’t understand how they’d put a medical product on the market that deteriorates or comes apart in such a short amount of time. To have to get a replacement is just crazy.” Because of the company’s mistake, Eugene believes he’s paying the largest price. “I’m putting my life on the line,” he says, referring to the serious risks of revision surgery. When asked what DePuy owes him, Eugene explains that his ability to earn an income for his family is likely ruined. What’s more, the possible consequences of surgery make him worry about his family. He notes “you can’t put a price on my life, but if something happens to my family because of what DePuy did, they are responsible. I want my wife and kids to be taken care of if something happens to me because of this.”

To document the struggles of those encountering difficulties with defective DePuy hip implants, the Berniard Law Firm presents an interview with one of its clients. While the client’s name in the following article has been changed to protect attorney-client privilege, his story is true and, unfortunately, all too common for many others suffering from undue pain and hardship due to defects recently identified in recalled DePuy ASR hip implant units.

“Eugene O’Neil” never envisioned he’d once again face the pain and anxiety associated with hip replacement surgery. Only two years ago, Eugene was fitted with a DePuy ASR Hip Implant. At the time, his surgeon maintained the artificial joint would last 15 to 20 years before showing any signs of deterioration. For Eugene, his DePuy-manufactured hip implant lasted just a little over two years before completely failing. The warehouse worker from Georgia must now undergo revision surgery to replace his failed hip unit with a functional one.

Eugene’s story is not unique. After DePuy, a division of Johnson & Johnson, announced in August 2010 that it was recalling hundreds of thousands of its defective ASR hip implants from the American marketplace, swarms of patients suddenly realized that the intense pain and lack of mobility they had experienced following their own hip replacement surgeries were not an isolated phenomenon. At the moment, thousands of lawsuits are pending against the manufacturer for billions in dollars of pain, suffering, lost wages, and medical expenses. Revision surgery remains the only viable medical remedy for the alleviation of pain in those patients who have experienced complications from the recalled units. Like most other major surgeries, revision surgery carries with it an inherent risk of serious complications including further injury, or even death.

Two of the most highly prescribed painkillers, Darvon and Darvocet, have recently been pulled off the market as a result of the health risk they pose to individuals. Dangerous heart side effects plagued the painkiller for years; however, it was not until November of 2010 that the FDA recommended the painkillers be withdrawn from the market completely. The estimated amount of individuals who have been prescribed such medications is in the millions, especially since Darvocet has been prescribed for over sixty years. The actual amount of people who have been prescribed or have taken either or both of these painkillers may lead to an astounding number, which no one can quite quantify as of yet. While it is sad that a prescription that is supposed to ease the pain of individuals may lead to a person suffering fatal consequences, the legal ramifications of the drug causing these problems is important to understand.

Both types of painkillers have been criticized heavily for over thirty years, without any change or modification until now by the FDA. The common dangers element that exists in both Darvocet and Darvon is the fact they both contain propoxyphene. In fact, the Public Citizen group petitioned the FDA to ban the drug in 1978 and again in 2006. Within that time period, millions of individuals every year were being newly prescribed the painkillers or were continuing to take them, relying on their physicians assurance that the drug was safe and would help ease their pain and discomfort. Yet, in July 2009, an FDA expert advisory committee voted 14-12 to ban the drug as a result of its dangerous side effect.

The FDA overruled the panel, instead conducting more research on the prescriptions dangerous effects. The director of the FDA’s office of new drugs at the Center for Drug Evaluation and Research, John Jenkins, MD, stated, “The drug puts patients at risk of abnormal or even fatal heart rhythm abnormalities.” Further, Jenkins admitted that it is hard to determine exactly how many individuals have passed away due to taking these painkillers, yet, the FDA study shows that more deaths are linked to the drug than to either of two alterative opioid painkillers, tramadol and hydrocodone.

This blog has noted several times that DePuy knew of the likely failure rates of its ASR hip implants several years before the medical device manufacturer issued its 2010 recall of the product. In light of this knowledge, DePuy nevertheless waited years before it decided to remedy the dangerous situation caused by its defective hip implants. Instead, it chose to shift the blame for reported problems elsewhere before finally initiating the recall.

New evidence has been uncovered showing that DePuy had received credible notification of its ASR hip implant failure rates as far back as 2007. According to The Independent, the Australian joint registry, the second largest registry of its kind in the world, informed DePuy of identified problems in seven separate reports. One of the most striking findings made by the registry was the higher than usual amount of revision surgeries needed to replace previously-implanted ASR hip units. DePuy sat on this knowledge until 2009, when the company finally withdrew the ASR hip implants from the Australian marketplace, citing “commercial reasons.” DePuy initially blamed the Australian joint registry findings on “imprecise surgical techniques” by doctors, but was forced to retreat from that position in response to the multiple reports of problems sent the company’s way.

Director of the Australian joint registry, Stephen Graves, has since stated DePuy behaved “irresponsibly and very badly.” Graves warns, “This is why regulators should not rely so heavily on manufacturer data. It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people.”

The A.S.R., or Aritcular Surface Replacement, artificial hip was promoted by Johnson and Johnson as a breakthrough in design that would last 15 years or more and provide patients with more natural movement. Now, the device has been recalled due to patients developing inexplicable pain and surgeons discovering mysterious masses of dead tissue in patients who are having the device replaced. DePuy Orthopedics, the Johnson and Johnson unit responsible for the hip and the largest maker of replacement hips worldwide, maintained that the hip was working for a long time despite warnings that it was a failure.

As pointed out in a recent New York Times article, the trouble with the hip is an indicator of a bigger problem: a piecemeal, broken medical implant system. Critical implants are sold without going through medical trials and testing or gaining FDA approval if the device resembles an implant that has already been approved. Theoretically, this allows manufacturers to make small changes to devices without having to jump through approval hoops; however, according to experts, it has also created a loophole that allows manufacturers to bundle an unapproved component into an existing design and sell it with minimal testing.

This is what happened with the A.S.R. as DePuy announced late last year that it was phasing the device out. However, the company blamed lagging sales rather than safety issues. In a recent statement an official stated that, “We believe we made the appropriate decision to recall at the appropriate time given the available information.”

The death of a loved one can obviously be a hard time for a family. Families have to deal with many issues after the death of one of its members, and the financial implication of the death is a hard to handle issue. Many times financial issues may take a long time to materialize. When the death of a loved one is due to an accident or an effect from something on the job, many families have to sift through the complex legal system to see if they have any rights against the employer, or any third-party. Many people in the past have been impacted by exposure to asbestos. Many illnesses can occur due to this exposure, icluding malignant mesothelioma. Many families attempt to bring survival suits against employers when their loved one was exposed to asbestos during employment. The impact of asbestos exposure may not manifest itself for many years, or decades in the future. What if the corporation has changed hands? What if the corporation no longer exists? This last question was answered in a recent decision by the Appeals Court of Louisianna, Fourth District.

In Marcel vs. Delta Shipbulding Co.(Delta), the plaintiffs were survivors of a man who died due to malignant mesothelioma after exposure to asbestos while working for Delta. The plaintiffs were suing Delta’s insurance company, Continental Insurance Co.(Continental). The issue in the case was that the company went out of business in 1969. The employee worked there between 1948 and 1949. Continental argued that there could be no cause of action because the corporation was no longer in business. In trial court, Continental was able to successfully argue that due to today’s law, which states that all suits against a corporation are null and void three years after the dissolution of the corporation, the cause of action did not exist as a matter of law. Plaintiffs took their case to the appellate court arguing that the trial court was wrong to conclude that there was no cause of action.

The appellate court took the case as a matter of first impression. The Court had never dealt with a case where the corporation had went out of business prior to the enactment of legislation creating a cause of action in such circumstances. The new legislation was passed in 1969. The Court stated that the cause of action accrues in a long-latency occupational disease case when the tortious exposures are significant, such that they will later result in the manifestation of the disease. This meant that the cause of action accrued when the exposure occured back in 1948-49. The Court cited a Louisiana Supreme Court case for the proposition that a survival action accrues simultaneously with the tort, i.e. the exposure, and is transmitted to the heirs of the victim upon death. Based on this, the Court found that the appropriate law was the law that existed at the time of exposure, not the law that exists as it stands today. The statute in effect at that time was act 128. This act discussed the procedure of bringing an action against a dissolved corporation, but it did not discuss causes of action. Although the current law, which states that after three years a cause of action is barred against a dissolved corporation, would have barred this case, the law as it existed at the time of exposure would not bar the current suit, and that law is the law that applied to the current case. Continental brought forth case history that stated that any case against a dissolved corporation is abated at the time of dissolution. The Court was quick to state that even if that law would bar a case against Delta, it does not extend to parties other than the dissolved corporation like Continental. Therefore, the survivial action is not terminated due to Delta’s dissolved status.

In hard times, the last thing anyone wants to deal with is a difficult legal question regarding one’s rights. However, it is pertinent that potential legal issues be discussed with a lawyer as soon as possible. Each case has a time period in which it can be brought. It is essential that if you have a claim, or your think you have a claim, you should seek the advice of legal counsel as soon as possible so that time does not run out on your ability to take any kind of action on your claim.

For more information on asbestos exposure and mesothelioma, feel free to browse our blog dedicated to the topic.

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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.

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