Posted On: January 31, 2011

Speculation Surrounding DePuy Kickbacks to Doctors Who Recommended Recalled Device

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 response to calls by watchdogs for greater transparency, the American Academy of Orthopaedic Surgeons mandated a disclosure system meant to shed light on potential conflicts of interest between doctors and medical manufacturers in 2010. According to the academy's website, such disclosure was necessary because of "increasing public and governmental scrutiny of the relationships between orthopaedic surgeons and industry." By exposing potentially dangerous relationships between doctors and manufacturers, the disclosure system can aid medical overseers in ensuring that doctors are not unduly influenced into giving patients faulty products, such as the recalled DePuy ASR hip implants.

While some payments exchanged between DePuy and physicians may have been for legitimate research purposes, the sheer amount of dollars spent by the company is nevertheless troubling. Given that DePuy had received reports about above-average failure rates in its hip implants for years leading up to the recall, one might speculate whether physician compensation was nothing more than a ploy by DePuy to encourage doctors to look the other way. As the discovery proceedings in DePuy lawsuits unfold, the answer to this question may eventually emerge.

Keep checking in with this blog for updates on the level of knowledge DePuy officials had while they continued to manufacture defective hip implants.

Posted On: January 29, 2011

Insurance Coverage for Lender Vehicles Affects Louisiana, Other Residents

Buying a car usually entails walking around a car dealership, spotting a car you potentially want to buy, and then test driving the car to see if satisfies what you are looking for in a vehicle. However, one aspect that you may not take into consideration, is what happens if you get into a car accident while driving the car dealership's vehicle? Who is is liable? Who ultimately has to pay? This all depends on the insurance contract the car dealership has, and whether or not you, as the test driver of the vehicle that has been damaged, is insured. Oftentimes, there is a limiting provision commonly found in insurance contracts called a "garage policy", it excludes customers of an automobile dealership unless the customer does not have liability insurance of his/her owner is statutorily uninsured. But what exactly does this mean?

A garage policy is a provision designed to limit coverage under certain circumstances. For instance, the recent case of Chretien v. Thomas, the Louisiana Second Circuit Court of Appeal explored garage policies in depth due to the existence of one in a service station's insurance policy. The course of events in the Chretien case involved the defendant, Thomas, bringing in a vehicle for repair. He was provided with a vehicle to drive while his vehicle was being serviced. Significantly, the car being serviced was his girlfriends and was listed as a covered vehicle under a policy issued by Allstate Insurance Company. The service station lent the vehicle to Thomas in hopes his employer would purchase the vehicle. The service station was insured by Stonington Insurance Company, which had the infamous garage coverage provision included in the insurance agreement. The garage policy excluded coverage for customers of the service station IF the customer had other insurance available. Shortly after being provided the "loaner" vehicle, Thomas was involved in an accident with the Plaintiff, who sued Thomas, the service station, as well as both insurance companies, Stonington and Allstate. The dilemma the court faced was determining who is ultimately responsible for coverage, and for how much. Under the garage policy, one would assume that Thomas would be responsible, since the vehicle he brought in for service was covered by insurance, thus, preventing him from relying on the service station's coverage. However, the issue is not so easily resolved.

Both insured parties have a burden to meet, and a burden to prove in order to avoid liability. When determining whether or not a policy affords coverage for an incident, it is the burden of the insured to prove the incident falls within the policy's terms. On the other hand, the insurer bears the burden of proving the applicability of an exclusionary clause within a policy, such as the "garage policy" provision found in Stonington's agreement with the service station. To begin with, an insurance policy is a contract, as such, the party's intent is reflected by the words of the policy, this determines the extent of the policy's coverage. When looking at the policy's language, one cannot read too much into the words, phrases and words are to be construed using their plain, ordinary, and generally prevailing meaning. Thus, interpretation or paraphrasing is not encouraged when exploring insurance policies, to put it simply, just look to the four corners of the document, and to nothing else, in order to understand what the policy means.

Additionally, a purpose of a policy is to afford coverage. Thus, when analyzing insurance policies, they should be construed to effect and not to deny coverage. With the existence of the garage policy, the purpose of such provision is to narrow the insurer's obligation, and unless this would be considered against public policy, such restrictions are allowed. The limiting provision in the commercial garage policy excludes customers of a car dealership (or service station as is the instant case) in its definition of an insured, unless the customer does not have liability insurance of his/her own or is statutorily underinsured. Putting this into perspective, if the insurance coverage did afford protection to every individual who test drove or were provided a "lender vehicle," any accident that may occur would force the insurance company to be responsible, regardless of whether or not the test driver/borrower had their own coverage or not. This presumably, would be against public policy, affording test drivers an "upper hand" in avoiding responsibility through their own insurance companies and instead, relying on the dealership's insurance company. Thus, one can see the logic in the garage policy provision included in many dealership and service station's policy agreements.

However, the caveat in the Chretien case was the fact the designation of "customer" applied to Thomas and not the owner of the vehicle brought in for service. Thomas brought in his girlfriend's vehicle, was listed on the billing for services, and paid for such services performed on the vehicle. As such, only individuals defined as "customers" may rely on the dealerships insurance coverage if they are in an accident in the "lender" vehicle. Thus, even though the vehicle brought in for service was insured under and through his girlfriend, Thomas himself was not insured or named on the insurance of the vehicle brought in for service. Thus, as a customer, who is not insured, he did not fall into the prevention of protection designed by the garage policy. Therefore, the court held that he was covered by the service station's insurance, as he was a customer and he did not have insurance coverage.

Therefore, when you walk onto a car lot, searching for that "perfect car" to buy, be careful if you are allowed to test drive it. If you have insurance, any accident that may occur may be your insurance company's responsibility and not the car dealership or service stations. Garage policies are designed to prevent car dealerships and service stations from incurring huge liability from customers; however, they may not escape liability if their customer is uninsured. This is an interesting note to take into consideration the next time you are behind the wheel of a lender vehicle or are test driving a potential new car.

Posted On: January 27, 2011

Lake Charles Payment Delays Cost Insurer in Court

Lake Charles resident Ginger Hinch Durio sued her Insurer, Horace Mann, over the extent of payments she received for the damages she sustained during Hurricane Rita. Durio's house was severely damaged, including her garage where her family's belongings were being stored while they were in talks to sell the house. The ceiling inside the garage collapsed onto their stored belongings. Additionally, an engineering report obtained by Durio four months after the hurricane indicated the structural and mechanical integrity of the house was compromised, and the HVAC, electrical, and plumbing systems had failed.

Durio's policy with Horace Mann provided for several categories of damages for which the Insurer would pay her up to their respective policy limits: Structure ($173,300), Adjacent Structures ($17,330), Contents ($103,980), and Additional Living Expenses ($103,980). After Durio submitted a claim in September of 2005, Horace Mann made several payments to her that fell far below the category policy limits. Despite Durio's submission of re-evaluation materials, Horace Mann ultimately honored in full only her Contents claim (for all the belongings contained in the garage) of $47,061.44. This, however, was after the Insurer issued her a "sarcastic" check for $6.90 for a broken flowerpot.

The Third Circuit Court of Appeal affirmed the damages awarded by the Trial Court for a total in excess of $1.5 million. Durio received Contractual damages for the difference between what she was paid by Horace Mann and the policy limits for Structure and Adjacent Structure damages. In addition, the Court affirmed an award of $39,000 for thirty-eight months of living expenses based on Durio's own estimation for the period in which the Insurer worked on the claim.

Beyond Contractual damages, the Court affirmed the award of General and Special damages, including compensation for Durio's mental anguish and the egregious conduct of Horace Mann. The Insurer was found to have handled the claim in a "... dilatory and non-customer service fashion," including the facetious flowerpot check, the assignment of eight different adjustors to the claim, and their failure to actually inspect the premises (Horace Mann relied on photographs and the notes of an adjustor).

Durio was found to have sustained damages of $3,000 a month from mental anguish, but this amount was cut in half after the Court considered other factors in her life like family, job, and other financial pressures as equally responsible for her mental and stress-related symptoms. The award for 38 months was adjusted to $57,000. Additionally, Durio was awarded $110,333 to compensate her for lost wages and lost future retirement benefits for the period when she was unable to work due to her symptoms.

Moreover, the Court upheld the award of Attorney Fees and Penalties, which together amplify Durio's damages to the sum of $1.5 million. Durio was awarded one-third of the total amount in Attorney Fees based on a statutory amendment passed after her initial claim was made. Though Horace Mann objected, the Court upheld the award, reasoning that the Insurer has a "... continuing duty of good faith and fair dealing" during the entire litigation period. The Penalties award - calculated as two-times the damages for general, special, and contractual damages - was upheld because the Court found that Horace Mann received satisfactory proof of Durio's loss and arbitrarily, capriciously, or without cause, failed to make payment within 30 days.

Ultimately, Horace Mann's poor processing of their Insured's claim cost them over $928,000 in damages and penalties, in addition to over $379,000 in Durio's Attorney Fees. These figures each dwarf the Court's finding of only around $210,000 in Contractual damages. The standard below which an Insurer like Horace Mann falls can therefore impose a costly consequence for such deficient conduct.

Posted On: January 25, 2011

Depuy Litigation Hip Replacement Surgery Claimant Interview Part 3

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.

Mr. Berniard continues to accept new clients for the DePuy matter, and he maintains this blog which informs the public about the legal consequences of the DePuy ASR Hip Implant Recall. Mr. Berniard is a sought out expert in this matter and has educated other attorneys on the complexities of the Hip Recall litigation and will continue to lecture on this topic. Ultimately, Mr. Berniard and his legal team are concerned with achieving the best possible recovery for each and every one of their clients. At the time of this writing, Eugene's case against DePuy is moving steadily forward due to the resources provided to him by Berniard Law Firm. The same can be said for all of the clients the firm is serving.

If you or someone you know has been affected by the defective hip implants manufactured by DePuy, please contact the Berniard Law Firm today for a free consultation. As Eugene's story showcases, the human toll of the DePuy recall can be staggering without an advocate fighting for you.

Posted On: January 23, 2011

ASR Defective Hip Recall Surgery Claimant Interview Part 2

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."

Despite the ongoing struggles produced by DePuy's suspect manufacturing processes, Eugene manages to maintain his resolve. "My mother told me that God doesn't give a person more than they can handle." He mentions that his wife supports him and has helped make efforts to return Eugene to a normal life. When expounding on whether he ever thought he’d be in his current situation following the original implantation of the DePuy unit, Eugene summons a chuckle. "I thought I’d have a pretty nice golf game by now," he muses.

Stay tuned to this blog for information on how the Berniard Law Firm has assisted Eugene, and those like him, in attempts to reclaim a normal life following the massive August 2010 DePuy ASR hip implant recall.

Posted On: January 21, 2011

Interview with Depuy Hip Replacement Claimant Requiring Revision Surgery - Part 1

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.

Coaching and participating in athletics in his free time, Eugene was healthy and active throughout much of his early life. Once he began to suffer from arthritis, however, he opted for hip replacement surgery to regain his lost mobility and mitigate resulting pain. But several months after the operation Eugene continued to experience pain in his hip region, although it was a vastly different sensation than he had ever felt before. "It felt like little toothpicks poking me," he recalls. "It was sharper than the pain from the arthritis, and it kept getting worse." As Eugene's artificial hip joint continued to deteriorate, he steadily continued to lose much of his mobility. At one point, he was relegated to using the local malls' hand railing in order to remain upright, even though he was walking on a flat surface.

In August 2010, Eugene's surgeon informed him that his hip implant had been recalled. Yet when Eugene went to the doctor for an evaluation, the surgeon did not notice any correlation between the recalled implant and the pain Eugene reported. It was only after Eugene sought the second opinion of another surgeon that the source of Eugene’s pain was identified as a direct consequence of a failed DePuy hip implant. Accordingly, the second surgeon ordered a revision surgery as soon as possible to prevent further symptoms.

With the date for his revision surgery imminent, Eugene expresses apprehension at the thought of going under the knife a second time. The potential for surgical mistakes and other medical hazards scares him to say the least. "Two friends of mine have died following knee surgery," he says. "Hip replacement surgery is higher risk than knee surgery." Eugene confesses, "It puts me on edge to think that once I go under for this second surgery I may never wake up... I'm numb thinking about it..."

The second part of this interview will appear in the next few days.

Posted On: January 19, 2011

Darvon and Darvocet Recall Has Serious Health, Legal Implications

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.

Lawsuits filed against the drug manufacturer, Xanodyne Pharmaceuticals, and Eli Lilly (the pioneer of the drug) are beginning to grow steadily as individuals learn about the danger they have been relegated to by taking such harmful prescription drugs. The suits claim strict liability and negligence. Strict liability for products liability type cases such as this, will involve the injured party proving that the item was defective, that the defect proximately caused the injury, and that the defect rendered the product unreasonably dangerous. A plaintiff, under this cause of action, may recover damages even if the seller has exercised all possible care in the preparation of the sale of the product. Another important aspect of liability is to protect the public against harm that may result from a specific product, such as the drug here, propoxyphene.

The common element between Darvon and Darvocet, propoxyphene, may not be safe if taken at any level. Even when the drugs are taken at "safe" and prescribed levels, studies show the drug still causes the individual to have an irregular heartbeat. Whereas the irregularity will stop in some individuals, others are not so lucky. Despite the declaration by the pharmaceutical companies that causation will be hard to prove, the studies performed by the pharmaceutical companies themselves and the FDA, illustrate the causal link between the painkillers with the common element drug, and the serious heart conditions that result.

If you have taken either Darvon and/or Darvocet, and want to know your legal rights please call The Berniard Law Firm. We are here to answer your questions and guide you through the legal process while protecting your legal rights along the way. Call Toll Free The Berniard Law Firm at 1-866-574-8005. Our attorneys will protect your legal rights every step of the way.

Posted On: January 17, 2011

Court of Appeals Awards Bad Faith Damages Against Insurance Company Who Refused to Pay

For the family of someone killed in a tragic car accident faced with mounting medical bills there is nothing worse than learning that the driver at fault for the accident did not have insurance. Luckily, when that happens, you should be protected by the uninsured or underinsured motorist (UM) coverage on your vehicle. For the Jones Family, however, their UM provider refused to tender the policy limits even after undisputed evidence was provided that damages exceeded that amount. This nightmare happens to far too many families and is a sad reality during a time in which insurance companies try to limit payouts in any way possible.

Thomas Jones was severely injured when his motorcycle was hit by a vehicle driven by Bertha Johnson, and his wife Mary was killed. Johnson was entirely at fault for the accident but neither she, nor the owner of the car she was driving, had insurance coverage at the time. The Jones' sought their policy limits of $100,000 per person/$300,000 per accident from their UM insurance and at one point the parties agreed that $200,000 would be paid. However the amount was not tendered due to disputes regarding liens from the Jones' healthcare providers and the company's concern regarding future claims.

Luckily the Jones had redress when their UM provider refused to pay. The Jones' brought an additional claim against their insurer, the Markel American Insurance Company, and were awarded $100,000 in (additional) penalties as well as $10,000 in attorneys' fees. In a recent decision (available here: 45,847-CA) the Louisiana Court of Appeals upheld that ruling.

Under La. R.S. 22:1892, insurance providers can be forced to pay penalties and attorneys' fees if there is proof that their action in refusing to tender policy limits was arbitrary and capricious and without probable cause. This statute derives from another Louisiana Law, La.R.S. 22:1973(A) that states that insurance companies own a duty of good faith and fair dealing to their policyholders; an affirmative duty to adjust claims fairly and promptly and make reasonable efforts to settle. Before a policy holder can collect on a bad-faith action, however, they must first prove that the insurer received satisfactory proof of loss and then show that the failure to pay was arbitrary and capricious.

Courts have interpreted proof of loss in an UM claim to require review by the insured of four elements:

1. The uninsured or underinsured status of the the owner or operator of the other vehicle in the accident. 2. The fault of that other owner or operator. 3. That damages resulted from that fault. 4. The extent of the damages.

Here, Markel argued that the extent of the damages was not proven due to liens asserted against whatever the Jones' were entitled to under the policy, also arguing that the amount of liens kept changing.

The Trial Court and Court of Appeals rejected this argument. Even though the amount asserted by lienholders was not exact, it was undisputed that the Jones' had incurred substantial medical expenses in excess of their policy limits. In addition, Markel could have protected themselves from future claims from lienholders by tendering $200,000 into the Registry of the Court and then holding a concursus proceeding to determine who was entitled to what, and they chose not to do so.

Beyond proving that Markel had proof of loss, the Jones' also had to prove Markel's actions were arbitrary and capricious. "Arbitrary" and "capricious" are legal terms of art that mean vexatious--that the refusal to pay is unjustified and without excuse; not based on any good faith defense. Here, because Markel was clearly required by law to tender the policy limits, had no good faith defense, and did not dispute the amount they were obligated to pay, the court found that criteria satisfied.

If you are seriously injured or lose a loved one in a car accident that was not your fault and later learn that the driver to blame did not have insurance, you should be able to collect from your UM carrier to cover the costs of damages arising from the accident. However, if your provider argues they do not have to pay for some reason, it is paramount you have a good attorney on your side to make sure the requirements of your policy are followed and will not hesitate to use laws like the one utilized here to not only collect damages but also penalties and attorneys' fees to which you are entitled.

Posted On: January 13, 2011

DePuy Had Time to Recall Device, Chose to Not Notify Public

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."

British officials have also noted that the ASR hip implant recall is not the first time DePuy has recalled one of its products. In 2003, the company had to issue a recall for its Hylamer hip and shoulder components in British markets. Similarly, during the summer of 2009, DePuy-manufactured knee components were withdrawn because of aluminum leakage into the bodily tissue of British patients.

In the United States, DePuy began issuing letters to physicians in March 2010, notifying them of the high failure rate of its hip implants. Nevertheless, the implants remained in the American marketplace for nearly half a year until the American recall was announced in August 2010. Moreover, by March 2010, DePuy was aware that patients with smaller bones were the highest at risk for failures, yet the company continued to market the hip implants to those very patients until the recall.

Based on the reports cited above, it is apparent DePuy had scientifically-backed data illustrating the propensity of its ASR hip implants to fail. Furthermore, the company's track record of recalling other implant products elsewhere shows DePuy has a tendency to forego consumer safety in exchange for maintaining its profit margins. Had DePuy acted responsibly in 2007, and removed the defective hip implants from the marketplace, thousands of patients would have been spared the pain, suffering, and economic damages they've experienced as a result of the medical problems the ASR implants create.

The attorneys at Berniard Law Firm will continue to make efforts to uncover reports DePuy ignored when it continued to market the hip implants to the American public. If you have received a hip implant since 2003 and are interested in knowing whether your legal rights have been impacted, feel free to contact Berniard Law Firm today.

Posted On: January 11, 2011

Artificial Hip Recall Shows Dangers of a Broken Medical Implant System

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."
DePuy does not know how many patients received the faulty device but estimated that about one third of 93,000 patients worldwide who received the implant were in the United States. This lack of exact numbers or documentation brings up another problem: the lack of an independent monitoring system in this country to track implant failures. If the U.S. had a database like those used elsewhere, doctors may have been clued into the problem a lot sooner.

Some doctors did try to get the word out about the problem but were rebuffed by DePuy. In fact, according to the director of Austrailia's orthopedic database, data showed that the A.S.R. was failing earlier and at a higher rate than other devices all the way back in 2008.

Patients who have a defective A.S.R. require additional painful surgery to replace the device. Worse yet, some are permanently disabled due to damage to their bone, muscles, and nerves. Suffering patients often do not even know that the hip component that caused their disability is part of another device the FDA never approved.

DePuy initially developed the A.S.R as a "resurfacing implant," composed of a cup and thigh component, used in a procedure where less of a patient's thigh bone is removed compared to a standard hip replacement. However, because the resurfacing was a new procedure, the FDA required that implant be tested in a clinical trial before it could be sold in the US. So, in 2005, the FDA allowed DePuy to sell another version of the same device, a modified standard hip replacement containing the same cup found in the resurfacing device, thus, getting around the clinical trial requirement. Current rules do not even require producers to notify the FDA when they bundle components from approved and unapproved devices.

According to British doctor Antoni Nargol, in 2007 his A.S.R. patients started complaining of groin pain. Nargol claims he told DePuy officials that he found an explanation for why the device was failing. However, the company did not stop selling it, or even issue a warning. Instead, the company blamed the failures on the doctor's surgical technique. At first, Dr. Nargol thought surgical technique could have been the problem. However, another orthopedic resident, Dr. Langton was not so sure so he began taking blood samples of patients using the A.S.R. and a competing device who were not experiencing pain. The tests showed elevated levels of cobalt and chromium in A.S.R. patients (used in the device) and soon proved that placement error was not the problem. As doctors in Britain and other countries operated on patients to remove the device, they found metallic debris shed by the device was causing a chemical reaction that destroyed muscle and bone. By early 2009, more testing revealed that the cup that the FDA had allowed to be sold without testing was the heart of the problem due to an interior surface that was too shallow.

This case is not the first time that problems with orthopedic implants emerged in registries outside the U.S. well before doctors here stopped using defective devices. Device companies, rather than doctors, patients, or regulators determine when safety alerts are issued or products are withdrawn from the market. DePuy actually did issue a safety alert about the A.S.R., a year after data revealed it was dangerous, and even then it was still on the market.

This episode has led to a wave of litigation around the world. In addition, officials have renewed there efforts to begin an orthopedic registry in the US. Many believe that such a system will only be effective if the federal government mandates reporting of data as a condition of payment of taxpayer funded programs like Medicare. The FDA has recently proposed rules that could require implanted devices to undergo more thorough testing before they are approved for sale, however, the fate of the proposals is unclear and receiving opposition from the device industry.

Posted On: January 6, 2011

Court Rules that Survival Suits Exists Against Insurance Company of a Dissolved Corporation

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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Posted On: January 4, 2011

Firm's Lead Attorney Submits Application for Plaintiff's Steering Committee in DePuy Litigation

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.

Whether or not Berniard is appointed to the Plaintiff's Steering Committee by Judge Katz, Berniard says he will remain tirelessly committed to guiding victims of DePuy's defective hip implants to the verdicts and settlements they are entitled to. In fact, Berniard continues to accept new clients who have experienced damage from DePuy's faulty medical products, and he has filed many suits against the manufacturer already. And like the past cases he has previously been complimented for, Berniard intends on representing his clients with the same selflessness and tireless vigor he has been credited with doing before.

Continue to check this blog periodically for updates on attorney Jeff Berniard's efforts in representing plaintiffs in their ongoing class action against DePuy Orthopaedics.

Posted On: January 2, 2011

Louisiana Legislature Extends Period to Bring Suit in Home Fire Damage Cases

While Louisiana law has not always been a beneficial reliance for residents to fall back on, changes in the last 5 years have helped change that and make financial recovery in the wake of a disaster possible. The previous law in Louisiana stated that, after a fire to a home, the homeowner had 12 months in which to bring a case against the insurance company. A new law passed in mid-2007 extended the period to 24 months. This is a break for many families who felt the impact of such a disastrous event. It will give these individuals and families more time to figure out whether the insurance company's offer is sufficient. As with every time a new law is passed, there are certain questions that remained to be answered as the situations arise. One such question is how the new legislation impacts those whose claim arose prior to the enactment of the law and had not expired by the time the law was enacted.

In Eric Holt vs. State Farm Fire Casualty Co., such a situation arose for Mr. Holt (Holt). In January 2007, Holt's home was damaged in a fire. He was insured by State Farm Casualty Co. (State Farm). State Farm refused to pay for any of the damages under the policy. In February of 2008, Holt sued State Farm due to dissatisfaction with its ultimate decision. State Farm filed for summary judgment arguing that (1) the claim was barred because state law, at the time the claim arose, allowed only 12 months in which the claim could be filed for fire damage to a home and (2) the claim was barred because the policy stated that any claim must be filed within 12 months. State Farm argued that because of these two reasons, and the fact that the claim was filed more than 12 months after the fire, the claim is barred by the prescriptive period. The trial court refused to grant summary judgment and State Farm appealed.

In terms of State Farm's claim that the policy between it and Holt barred any claim beyond a 12 month period, the policy also states that if the policy conflicts with state law, state law will control the issue. The appellate court then had to figure what state law governed the issue at hand. Act 43 of 2007 was enacted On August 15, 2007. The act increased the time in which to bring a home damage claim, including fire damage, from 12 months to 24 months. State Farm argued that because the act was enacted after the damage to Holt's home, the act did not apply to Holt. Under Louisiana law, the difference comes down to (1) whether the legislature clearly identified if an act will apply retrospectively and (2) if the act does not clearly so state, if the act is substantive in nature, meaning that it creates or impacts a cause of action, it will only apply proscriptively, on the other hand, if the act is procedural in nature, meaning it impacts only how a cause of action can be brought, it can apply retrospectively.

Act 43 does not clearly state whether it applied retrospectively. The Appellate Court concluded that because the act only increased the time in which to bring a claim, and not the type of claim or any elements of the claim, that the act was procedural in nature. Under Louisiana law, it is a well settled issue that procedural acts can be applied retrospectively. The only exceptions to this are that if applying an act retrosepctively (1) impacts a vested cause of action, or (2) revives an already expired cause of action, the retrospective application would violate constitutional rights and would be unjust to apply. However, neither of these exceptions apply in the application of the law in Holt's case. Therefore, the Court decided that Holt's claim was not time barred by the prescriptive period.

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 .

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