Articles Posted in DePuy ASR Hip Implants

Lead Attorney Jeffrey Berniard of the Berniard Law Firm participated in a recent status conference called by U.S. District Judge David A. Katz of Ohio. The conference was a coordination hearing, and it was the first of several that will be held to determine the strategic direction of DePuy litigation. At the conference, Judge Katz listened to several attorneys argue for a position on the Plaintiffs Steering Committee. Berniard previously submitted his application for a position on the Plaintiff’s Steering Committee, and even if he is not picked as a member, he looks forward to being an active participant in the litigation on the Plaintiffs’ behalf. Judge Katz will consider all applicants, and he will announce the committee selection at a later time.

Jeffrey Berniad is pleased that Judge Katz was ultimately chosen by the Judicial Panel on Multi-District Litigation to preside over the DePuy pretrial matters. Because the Berniard Law Firm represents clients nationwide, Jeffrey Berniard is accustomed to practicing in front of judges located throughout the country. Indeed, Berniard has indicated that Judge Katz is a remarkable judge with a great reputation and that he is happy to be working with him.

As Judge Katz considers the various DePuy matters pending in front of him, including applications to the Steering Committee, Berniard continues to work diligently to achieve justice for those clients who have been harmed by defective DePuy hip implants. In August 2010, DePuy announced a nationwide recall of hundreds of thousands of its ASR hip implant devices due to abnormally high failure rates and structural breakdowns. Hundreds of thousands of patients who received the implants have experienced serious injuries, such as pain and suffering, as a result. Since day one of the recall, Berniard, along with other attorneys, have been seeking recovery on their behalf through the filing of lawsuits with various district courts on a near daily basis.

The New Haven Independent reported in December 2010 that DePuy, the company responsible for manufacturing thousands of defective hip implants, spent millions of dollars in attempts to woo doctors toward the use of its products on patients. DePuy, a division of Johnson & Johnson, recalled hundreds of thousands of the hip implant devices it had manufactured after a serious design defect was discovered in August 2010. Just as many patients are currently faced with potential complications or the prospect of revision surgery. Some question whether patients could have been saved from these consequences had doctors not been prompted, via kickbacks, to surgically implant DePuy devices into hip replacement patients.

DePuy discloses payments to doctors on its website, but it categorizes such pay as “product royalty payments, “compensation for research,” “meals,” “airfare,” and other expenses. DePuy paid nearly $50 million to surgeons in 2009, with some physicians receiving as much as $1 million from the company. Even if doctors in good faith believe that payments from DePuy do not compromise their medical judgment, health consumer advocates disagree. “…[T]he reality is, it’s human beings,” Jean Rexford, executive director of the Connecticut Center for Patient Safety, said. “We are influenced. If somebody does something nice for me, I’m nicer to them than someone who hasn’t done something nice to me.”

Another expert, Gregory E. Demske, an assistant inspector general, testified before the Senate that “…[I]n an environment where physicians routinely receive substantial compensation from medical device companies through stock options, royalty agreements, consulting agreements, research grants and fellowships, evidence suggests that there is a significant risk that such payments will improperly influence medical decision-making.”

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.

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.”

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.

Continue reading

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.

Contact Information