In August of 2010, DePuy Orthopaedics, Inc., a division of Johnson & Johnson, issued a worldwide recall of its ASR XL Acetabular System and the ASR Hip Resurfacing System. The recall came after over 300 complaints were received describing device failure since 2008. Since then, a variety of lawsuits have been filed and many more are expected. The DePuy hip implant lawyers at Sullivan & Brill, LLP are currently representing individuals that have been implanted with this defective medical device after 2003.
The ASR XL Acetabular System is a metal on metal hip socket used in hip replacement surgeries since in 2003, while the ASR Hip Resurfacing System is a partial replacement involving a metal cap that is seated on the ball of the femur. It was not approved for use in the United States, but has been used abroad. The ASR XL was marketed to a younger more active user and promised to allow the patient to resume high impact activities, such as golf and tennis.
The recall was issued after the National Joint Registry of England and Wales revealed startling figures concerning the two devices. One in eight patients required "revision" surgery within five years of original implant surgery. Worse, officials at DePuy Orthopaedics knew about the defects for years. It seems the recall was only issued after reports started coming in, well after the manufacturer had become aware of the problems that could now potentially impact the 93,000 patients who were implanted with the recalled devices.
Patients implanted with the defective medical devices have complained of an array of problems that range from pain, swelling, difficulty walking, and flu like symptoms. Revision surgeries have revealed metallosis, a condition caused by the metal ions from the excessive wear of the devices which kills the soft tissue in the affected area. Patients have also been found to have excessive levels of the metals cobalt and chromium in their blood. The impact of this toxicity is not yet fully understood, but is being studied. Another tragic consequence of these early failures is that with each revision surgery, the useful life of these devices goes down. Thus, many of the relatively young people that DePuy marketed this device to may find themselves needing another revision in their late fifties or sixties, but not being eligible for one.
Federal lawsuits over the ASR Hip Implant have been filed in throughout the country and the cases will likely be transferred to one federal judge and joined for discovery and investigation in what is known as a multidistrict litigation. One lawsuit alleges that DePuy knew about the defect for years while many tens of thousands of patients were unwittingly implanted with the faulty device; another cites over 300 ASR hip failure reports received by DePuy; and another claims a plaintiff's body rejected the implant due to a flaw that enables metal on metal grinding. Other lawsuits involving faulty medical devices have led to huge settlements, including a $1 billion settlement agreed to by Sulzer AG in 2001 over its hip and knee implants manufactured by Sulzer Medica. As a result of the defect, nearly 3,000 patients required hip implant replacements and over 560 required knee implant replacements.
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The New York Times recently reported that pursuant to the Freedom of Information Act it obtained a letter that the Food and Drug Administration ("FDA") sent to DePuy Orthopaedics in August of 2009 requesting additional safety data on the ASR hip implant before it could approve DePuy's request to sell the device in the United States. The FDA found the data incomplete and inadequate to determine the devices safety and effectiveness. Rather than provide the information, a month later, DePuy decided to stop manufacturing the device and attempt to sell off its remaining inventory. It was not until a year later, after most of its inventory was sold off that DePuy recalled the DePuy ASR and ASR XL hip implants.
Prior to the recall, DePuy sold approximately 93,000 ASR and ASR XL hip implants, approximately one third of them in the United States. It began selling the ASR XL hip implants in the United States in 2003 (the ASR was never approved for sale in the United States) and, soon thereafter, data began to emerge indicating that the devices where failing at an unusually high rate. Within a year of implant, many patients began to experience pain, swelling and difficultly walking, and had to have a revision surgery to remove the defective implant and replace it. Lawyers began filing lawsuits alleging that the ASR XL and ARS where defectively designed in 2010 and in December of 2010 the lawsuits where consolidated into a multi-district litigation.
The price tag for defective metal-on-metal hip implants is adding up, say experts. With massive recalls, unexpectedly high failure rates, and a growing array of adverse health responses and other problems faced by patients, metal-on-metal hip implants are turning out to be much less than originally promised.
Thousands upon thousands of patients have been impacted globally in what the New York Times said is "the most widespread medical implant failure in decades." The failure is expected to cost billions of dollars to taxpayers, employers, Medicare, and insurance companies, a significant issue given the current economic climate. Complicating matters, the defect involves an array of companies and medical devices.
For instance, Johnson & Johnson's DePuy Orthopaedics Unit alone is facing over 550 lawsuits for one of its all-metal hip devices, the Pinnacle, and 3,500 lawsuits for another device recalled last year. The recalled DePuy ASR hip implant device was implanted in 40,000 patients in the United States, The Times pointed out.
Last month, the U.S. Food and Drug Administration (FDA) commissioned a hip implant study and discovered that new versions, such as the all-metal devices, offered no benefit over older devices. Worse, patients implanted with all-metal hips were likelier to need revision surgery versus patients implanted with older generation artificial hips.
Earlier this year, the agency mandated 21 all-metal hip implants makers-DePuy, Zimmer, Stryker, Biomet, and Wright Medical, to name a few-to carry out post-market device studies to ascertain if their devices were shedding metallic debris in patients, a problem which can lead to significant health issues.
Patients have complained of medical bills ranging from the tens of thousands into the hundreds of thousands of dollars above and beyond what insurance has covered. While some device makers have paid for some portions of their healthcare, substantial bills remain. And, notes The Times, with all-metal hip device lawsuits surpassing 5,000, insurers have said they will seek reimbursement of their costs from consumers who have won lawsuits and Medicare is also believed to attempt to recover its costs. The situation is only expected to worsen with tens of thousands more patients expected to suffer the effects of failed hip devices.
An new study indicates that new generation, metal on metal and ceramic on ceramic, artificial hip devices might be linked to increased revision surgery rates and do not provide significant benefits over older generation devices.
Believed a better option over older devices, surgeons are using all metal and all ceramic devices with greater frequency; however, recent reports and recalls reveal that some newer devices fail at significantly higher rates than promised, leading to more revision surgeries. Revision involves removal of a faulty device and replacement with a new device, and is painful and complex and relies on reduced bone and tissue mass.
BMJ Group conducted a systematic review of clinical trials, observational studies, global registries, and pre- and post-market studies at the U.S. Food & Drug Administration (FDA) ensuring an extensive safety and efficacy review, that appropriate and thorough independent studies were reviewed and confirmed with criteria inclusion, and that comparative studies and qualitative data synthesis were completed. The research revealed some registries indicated that all metal and all ceramic devices were linked to increased revision reports versus older metal on polyethylene devices.
Metal on metal bearings presented the promise of reduced dislocation and better performance; however, the United Kingdom's Medicines and Healthcare Products Regulatory Agency exposed severe metallosis (metal ion accumulation in the tissues) linked to the devices' metal parts wearing on each other, releasing shavings into patients' bodies. In 2010 Johnson and Johnson's DePuy unit recalled over 93,000 of its metal-on-metal ASR implants and is facing a growing number of lawsuits over this and another similar device, the Pinnacle, over issues with metallosis, decreased ambulation, pain, swelling, masses, and joint dislocation, to name some.
Last week, we wrote that the president of DePuy Orthopaedics, maker of the recalled DePuy hip implants, is resigning to pursue other interests. David Floyd has been president of the Johnson & Johnson unit since 2007 and is stepping down at the end of this month. Now, Johnson & Johnson CEO, William Weldon is reportedly facing a nine-percent reduction in his total compensation for 2010, said the Journal Gazette, according to Becker's Orthopedic and Spine.
Johnson & Johnson saw a drop in revenue in both 2009 and 2010 following an unprecedented number of product recalls. Weldon's compensation package last year totaled $23.2 million; the prior year he received $25.6 million, noted Becker's. Weldon's package includes, said the Journal Gazette, salary, bonus, and other "rewards," noting that the information was disclosed in a Securities and Exchange Commission (SEC) filing.
Meanwhile, the significantly high failure rate of the DePuy ASR XL Modular Acetabular Cup System and the DePuy ASR Hip Resurfacing System, led to a massive global recall late last year. The implant can fail to remain in place, which causes a variety of adverse reactions, including pain, ambulation problems, and the shedding of dangerous metal debris into patients' bodies.
Now, according to the pharmaceutical advocacy firm U.S. Drug Watchdog "The makers of the recalled ASR DePuy hip implant have been writing recipients of this hip implant, and offering to pay their copays for the replacement of this hip implant-what an incredible insult.... In reality, recipients of the recalled ASR DePuy hip implant might be owed hundreds of thousands of dollars, or more, and we find this manufacturer's letter campaign to be nothing short of reprehensible. Offering to pay a copay when the victim could be handicapped, or crippled for life?" quoted News Junky Journal.
The significantly high failure rate of the DePuy ASR XL Modular Acetabular Cup System and the DePuy ASR Hip Resurfacing System, led to a massive global recall late last year. The implant can fail to remain in place, which causes a variety of adverse reactions, including pain, ambulation problems, and the shedding of dangerous metal debris into patients' bodies. The defective devices were manufactured by DePuy Orthopaedics, a unit of Johnson & Johnson.
The defect has led to hundreds of lawsuits over serious medical problems and monetary losses. Most recently, the first Connecticut lawsuit has been filed against Johnson & Johnson, DePuy Orthopaedics, and the hospital where the original surgery cited in that lawsuit occurred, the CT Post reported.
In this case, the female patient required revision surgery just three years after being implanted with the DePuy device, said the CT Post. The surgery was necessary following an infection in the patient's right hip and the detection of high metal concentrations in her blood, a health situation that can lead to serious health effects, including optic nerve atrophy and cardiomyopathy. The device had also fused to the patient's body, creating added challenges during the revision surgery, noted the CT Post.
The DePuy recall was prompted by release of information from England's and Wale's National Joint Registry that stated that about 12-to-13 percent of all patients fitted with the DePuy devices required revision surgery within the first five years of implantation. Most recently, the British Orthopaedic Association and the British Hip Society issued a two-page statement indicating that the failure rate for the devices could be much higher-up to 49 percent-than initially believed, four times greater than what DePuy stated at the time it issued its recall last year.
A Johnson & Johnson representative just announced that the president of DePuy Orthopaedics, maker of the recalled DePuy hip implants, is resigning to pursue other interests. David Floyd was president of the Johnson & Johnson unit since 2007, noted DrugWatch.
Facing some 600 lawsuits over its recalled hip devices, Johnson & Johnson-owned DePuy made headlines again last week for its failed ASR XL Acetabular hip replacement devices, which were recalled globally last year. Pulled from the market over significantly high failure rates, the devices are actually failing at a rate four times greater than what was initially revealed, according to the British Orthopaedic Association and the British Hip Society, which issued a two-page statement on the higher failure rates.
Many in the orthopedic community have long been issuing warnings on the faulty devices; however DePuy did not issue its recall until late 2010, noted DrugWatch, and then only because of information released from England's and Wale's National Joint Registry that stated that about 12-to-13 percent of all patients fitted with the DePuy devices required revision surgery within the first five years of implantation.
Reimplantation or revision surgery involves removal of the device and a surgical implantation with another device, a riskier procedure because of any number of problems including reduced bone surface area, devices being fused to bone, and increased chromium blood rates, a result of the metal-on-metal device disbursing chromium shavings into patients' bodies.
At 13 percent, the DePuy failure rate was considered quite significant. At up to nearly 50 percent, the issue is even that much more serious given that 93,000 patients-about one-third in the United States-were fitted with the faulty implants worldwide.
Two weeks we reported that lawsuit were beginning to mount against DePuy Orthopaedics in the United States and the United Kingdom and that Australia was expected to be the next country from which we would start seeing the trend. Last week, a class action involving eight people was filed in that country. DePuy Orthopaedics is a unit of embattled pharmaceutical giant, Johnson & Johnson.
A worldwide recall was issued for DePuy's ASR XL Acetabular Hip Replacement System following the release of information from England's and Wale's National Joint Registry that revealed that about 13 percent of all patients with the recalled medical devices required revision surgery within the first five years of implantation. The surgery involves removal of the device and reimplantation with another device on less bone, a longer, riskier procedure.
The unprecedented failure rate is a serious issue given that some 93,000 patients have been fitted with the implants globally.
About 30 percent of these patients are in the United States and approximately 6500 Australians were advised that their hip replacements could prove dangerous. Since, dozens of patients in Australia have reported toxic metal in their bloodstream, with at least one patient experiencing toxic cobalt levels so high that there was danger of significant morbidity. Also, about 10 percent of the patients in Australia who were notified of the problem have had to undergo revision surgery.
The defective devices have also led to other problems necessitating revision surgery such as pain, discomfort, problems with flexibility, and problems walking, which has left some unable to return to activities they previously enjoyed.
Lawsuits, individual and class actions, against DePuy Orthopaedics, a unit of Johnson & Johnson, have been filed in the United States and the United Kingdom. Now, lawsuits are expected from Australia, as well.
Following reports of medical discrepancies, some 6,500 Australians were advised that their hip replacements could prove dangerous. According to Adelaide Now, dozens of patients in South Australia are suffering from toxic metal in their bloodstream. In one case, the pathology report of a 58-year-old woman indicated that her blood cobalt levels were so high that even a small increase could have caused a "significant morbidity including deafness, blindness, and heart failure." The woman is now undergoing her second bilateral hip replacement and is expected to be out of work for five months.
This summer, DePuy hip implant devices-the ASR Hip Resurfacing System and the ASR XL Acetabular System-were recalled following numerous complaints from patients and doctors over pain, discomfort, flexibility issues, and ambulation problems. The devices were experiencing higher-than-normal failure rates, forcing patients to undergo removal of the defective implant and reimplantation with a different device in revision surgery procedures.
To date, about 10 percent of the 6500 Australians notified of the issues with the DePuy devices have already undergone revision surgery.
A design flaw in the metal hip cup is causing some of the problems, including that the metal-on-metal implants disburse shards that have left patients with masses in body tissue and increased blood cobalt levels, a potentially dangerous side effect.
This summer, DePuy hip implant devices-the ASR Hip Resurfacing System and the ASR XL Acetabular System-were recalled following numerous complaints of pain, discomfort, flexibility issues, and ambulation problems. The devices experience higher-than-normal failure rates that have forced patients to undergo removal of the defective implant and reimplantation with a different device in a revision surgery procedure.
We recently wrote that representatives of Johnson & Johnson's DePuy Orthopaedics unit have allegedly been attending revision surgeries to remove defective hip implants from surgical rooms. Some believe the implications of removing medical devices from surgical rooms points to an attempt to prevent evidence from being used in legal proceedings. Now, the pharmaceutical giant and lawyers suing J&J over recalled hip implants are working on a process to preserve and handle devices removed from patients' bodies.
Meanwhile, DePuy Orthopaedics, Inc. just announced that it received two 510(k) clearances from the U.S. Food and Drug Administration (FDA). This type of approval is described as a fast tracking of the traditional approval process used when a manufacturer claims its emerging product is substantially similar to a product or products already approved and on the market. Of note, the clearance enables a device maker to forego the human clinical trial process mandated when seeking to bring a new medical device to market.
The 501(k) approvals were granted for DePuy's GRIPTION® TF, a titanium foam to be used in the GRIPTION acetabular augmentation system (hip replacement) and GRIPTION cones (knee replacement) surgeries and for its RECLAIM Revision Femoral Hip System (cementless hip revision surgery). According to Mike Barker, the worldwide vice president of product development for DePuy, "This system has been studied extensively through analytic techniques and rigorous laboratory testing," quoted Ortho SuperSite. "The RECLAIM Hip System truly delivers a superb level of functionality and reproducibility for surgeons performing revision hip surgery," said David Floyd, worldwide president of DePuy. "We believe that the RECLAIM Hip Stem, in conjunction with our PINNACLE Acetabular Cup System, represents a meaningful advance in revision hip surgery," added Floyd, quoted Ortho SuperSite.
DePuy Orthopaedics, Inc. just announced that it received two 510(k) clearances from the U.S. Food and Drug Administration (FDA). One for the use of GRIPTION® TF, a "commercially pure titanium foam (TF)" meant for two of its new implant systems which Medical News Today described as "complex joint replacement procedures."
Ortho SuperSite, citing a press release issued by DePuy, wrote that the medical device maker also announced it received 510(k) clearance for its RECLAIM Revision Femoral Hip System, a cementless hip revision surgery. Orthopaedic and Spine explained that GRIPTION titanium foam implants will be used in the GRIPTION acetabular augmentation system for hip replacement and GRIPTION cones for knee replacement surgeries.
510(k) approval is a so-called "fast-tracked" approval process used when a manufacturer claims its emerging product is substantially similar to a product or products already approved and on the market. Such fast-tracked approvals enable a device maker to forego the human clinical trial process mandated when seeking to bring a new medical device to market.
This summer, DePuy hip implant devices-the ASR Hip Resurfacing System and the ASR XL Acetabular System-were recalled following numerous complaints from patients and doctors over pain, discomfort, flexibility issues, and ambulation problems. The devices were experiencing higher-than-normal failure rates that have forced patients to undergo removal of the defective implant and reimplantation with a different device in revision surgery procedures.
A design flaw in the metal hip cup is causing some of the problems and physicians have noted that the metal-on-metal implants disburse shards that have left patients with masses in body tissue and increased blood cobalt levels, a potentially dangerous side effect.
The US Drug Watchdog recently announced that, "the number of potential U.S. victims of the now recalled ASR DePuy hip implant is close to 100,000; nearly enough to fill the famed Rose Bowl." This August, DePuy hip implant devices-the ASR Hip Resurfacing System and the ASR XL Acetabular System-were recalled following many patient and doctor reports of pain, discomfort, and flexibility and ambulation problems. The devices' higher-than-normal failure rates have forced patients to undergo defective implant removal and reimplantation with a different device in so-called revision or explant surgeries.
DePuy said it wrote to hospitals and surgeons "...with information about preserving explanted ASR Hip Systems," said DePuy spokeswoman Mindy Tinsley. "DePuy is committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary.... DePuy will also pay for reasonable expenses related to receiving care, such as lost wages and travel costs," quoted Bloomberg.com.
DePuy hired third-party claim administrator, Broadspire Service Inc., "to ensure that reimbursements are handled as efficiently and smoothly as possible," Tinsley said. J&J lawyer, Susan Sharko said patients who go to Broadspire are not waiving their legal rights, reported Bloomberg.com.
Close to 100,000 U.S. citizens who received an ASR DePuy hip implant between 2005 and early 2010, could be impacted, said advocacy group, The U.S. Drug Watchdog. Hip implant failure symptoms include, said the group, hip area pain and swelling, flexibility issues, discomfort, problems or pain when walking, or being unable to walk. The devices can loosen, misalign, dislocate and/or fracture, which can send metal debris to the hip socket and surrounding tissue, with excess metal leading to significant inflammation, life-threatening blood problems, and serious health issues.
We recently wrote that representatives of Johnson & Johnson's DePuy Orthopaedics unit have allegedly been attending revision surgeries to remove defective hip implants from surgical rooms. Some believe the implications of removing medical devices from surgical rooms points to an attempt to prevent evidence being used in legal proceedings. Now, the pharmaceutical giant and lawyers suing J&J over recalled hip implants are working on a process to preserve and handle devices removed from patients' bodies.
This summer, DePuy hip implant devices-the ASR Hip Resurfacing System and the ASR XL Acetabular System-were recalled following numerous complaints from patients and doctors over pain, discomfort, flexibility issues, and ambulation problems. The devices were experiencing higher-than-normal failure rates that have forced patients to undergo removal of the defective implant and reimplantation with a different device in revision surgery procedures.
A design flaw in the metal hip cup is causing some of the problems. Also, physicians have noted that the metal-on-metal implants disburse shards that have left patients with masses in body tissue and increased blood cobalt levels. According to Bloomberg.com, 37,000 ASR XL Acetabular Systems, alone, have been implanted.
Attorneys for DePuy and the plaintiffs are collaborating on how to deal with hips and area body tissue removed in surgical procedures. The cobalt and chromium debris released to the body from the defective metal-on-metal implants can lead to tissue death, bone fracture, and other adverse reactions. Surgically removed devices can indicate how much metal debris was released from the devices.
While plaintiff attorneys are hoping for a process in which to ensure capture of the devices immediately following surgery, Mindy Tinsley, a spokeswoman for DePuy argues that the so-called explants are the property of the patient and "the patient's surgeon should take appropriate steps to preserve" the removed device. In September, DePuy wrote to hospitals and surgeons, providing information on how to preserve explanted, or removed, ASR Hip Systems, said Tinsley, added Bloomberg.com.
A recent Canadian class action lawsuit against defective hip device maker DePuy, a unit of Johnson & Johnson, alleges that DePuy "...consistently failed to disclose or warn Canadian patients of the significant risk of failure of the DePuy implants." Reports about the growing problems with the devices started surfacing in 2007. At that time, the Australian Joint Registry, the second largest such registry in the world, issued seven reports to DePuy.
In late 2009, the ASR system was withdrawn from the Australian market, but it took until March 2010 for DePuy to admit that its device was subject to early failure, and until August for DePuy to recall the ASR System internationally. The DePuy recall involved a massive 93,000 hip replacements impacting patients world-wide. Still, many patients remain unaware of the recalls and that they could be implanted with a device that has or could, potentially, fail.
Meanwhile, lawsuits nationwide are beginning to mount and Canada has recently reported a number of class action and individual actions against the defective device maker. In Canada, an existing plaintiff is looking to bring a class action against DePuy alleging that she is "concerned about the possibility of an early revision surgery and her blood ion levels as a result of her DePuy hip implant," according to the existing action.
A design flaw in the metal hip cup is responsible for some of DePuy's problems, but another growing problem some physicians have noted is that the metal-on-metal implants disburse metal shards that have left patients with masses in their body's tissues and increased blood cobalt levels. Periprosthetic metallosis-release of metal debris into the body-can create increased risks in revision surgery and can lead to a number of adverse and serious reactions that include tinnitus, irritability, vertigo, cardiomyopathy, blindness, fatigue, and deafness, to name just some.
As predicted, the number of lawsuits being filed against DePuy Orthopaedics is growing and the trend is expected to continue. DePuy is the hip implant manufacturer that is a unit of pharmaceutical giant, Johnson & Johnson.
Just last week, a woman in Arizona implanted with a defective DePuy device filed a lawsuit against the beleaguered device maker and, earlier in the month, someone dozen residents from Tennessee also filed against DePuy. The lawsuit filed in California and originating with the Arizona resident alleges that DePuy sold its recalled ASR TM XL Acetabular System for more than five year while receiving and concealing repeated warnings of significantly high failure rates.
The device maker recalled its ASR TM XL Acetabular System hip replacement last summer following a report published in the United Kingdom that stated that an unusually large amount of patients required corrective surgery-known as revision surgery-within just five years of being implanted with the devices. Such devices are meant to be effective for between 15 and 20 years.
In the United States, the Food and Drug Administration (FDA) started receiving reports about the defective DePuy devices in 2008. Now, experts say that the device's hip replacement cup is not deep to accommodate the hip joint, which is creating implantation problems versus other hip replacement systems.
Meanwhile, DePuy is facing three recently-filed class-actions lawsuits in Canada. At least one claim includes allegations that DePuy and Johnson & Johnson knew about the defective hip devices for at least two years and were aware of the significantly high and early failure rates that cause serious harm to patients, but that the device maker failed to act on the growing reports, allowing patients to continue to be implanted with defective devices.
Under current U.S. Food and Drug Administration (FDA) mandates, medical device makers can introduce new products without having to go through testing if the device is substantially the same as an already approved device. This regulatory loophole is what enabled the defective DePuy hip implant to be introduced to the United States market in 2003. While many have argued for more stringent legislation to be considered in light of a number of recent device recalls, the FDA just opted against these efforts, allowing the legal loophole-Section 510(k)-to continue.
The DePuy's ASR hip implant contains a critical and new component that did not receive FDA approval: The implant's cup, noted DrugWatch. The faulty design of this component is what experts believe has led to complications that call for revision surgery to remove and replace defective implants.
The defective product can lead to the implant loosening; causing pain, discomfort, and tissue damage; resulting in problems ambulating; and leading to the development of masses near the implant site from metal shards loosening into body areas, as well as increased cobalt levels believed to be from those metal shards.
According to US Recall News, the tissue damage from periprosthetic metallosis-release of metal debris into the body-caused by the faulty metal-on-metal hip devices can create increased risks in revision arthroplasty. In addition to replacing a device on a body area that now has less bone to work with, increased blood cobalt levels - or cobaltism - can lead to a number of adverse and serious reactions that range from irritability and fatigue to tinnitus and deafness to vertigo, blindness, and cardiomyopathy, to name just some.
This summer, DePuy hip implant devices-the ASR Hip Resurfacing System and the ASR XL Acetabular System-were recalled following numerous complaints from both patients and doctors over pain, discomfort, flexibility issues, and ambulation problems. The defective devices were manufactured by DePuy Orthopaedics, a unit of beleaguered pharmaceutical giant, Johnson & Johnson.
DePuy has been making headlines for its devices' higher-than-normal failure rates that have forced patients to undergo both removal of the defective implant and reimplantation with a different device-so called revision surgery. Most recently, DePuy was reported as being one of five implantable medical device makers reaching a $310 million agreement to settle charges it paid kickbacks to physicians in exchange for using its products.
A design flaw in the metal hip cup is responsible for some of DePuy's problems, but another growing problem includes that some physicians have noted that the metal-on-metal implants disburse metal shards that have left patients with masses in their body's tissues and increased blood cobalt levels.
Recent news also includes reports of negligent record-keeping, which has left nearly half of all DePuy implant patients unaware that the devices have been recalled. Also, it seems that representatives of the device maker have allegedly been attending revision surgeries to remove defective hip implant devices from surgical rooms. The implications of removing medical devices from surgical rooms points to an attempt to prevent some evidence being used in legal proceedings.
Now, Drug Watch reports that amid the growing DePuy debacle, the U.S. Food and Drug Administration (FDA)-the agency responsible for oversight of medical devices and drugs-has passed on a proposal meant to enhance and ensure medical device safety and to put in place stronger mandates on medical device makers.
In addition to defect issues, poor record-keeping, and having representatives attend revision surgery to allegedly remove defective hip implant devices from surgical rooms, DePuy Orthopaedics, a unit of beleaguered pharmaceutical giant, Johnson & Johnson, recently settled accusations that it paid kickbacks to doctors to use its products. It's not surprising that lawsuits are mounting against the device maker.
A design flaw in how the metal hip cup was created is responsible for some of DePuy's problems. Some physicians have noted that the metal-on-metal implants were disbursing metal shards into patients' bodies that, in addition to leading to the development of masses in the body's tissues, could increase blood cobalt levels.
Excessive cobalt levels, known as cobaltism, is a serious condition that can lead to a variety of adverse reactions including "irritability, fatigue, ringing in the ears (tinnitus), hearing loss, headaches, loss of coordination, cognitive decline, and depression... blindness, convulsions, nerve damage, and disease of the heart muscle (cardiomyopathy) ...and tissue damage that can complicate future revision surgeries intended to replace the damaged metal implant," explained Drug Watch. When cobaltism occurs as a result of this type of medical implant, the condition is referred to as arthroprosthetic cobaltism.
DePuy not maintaining accurate records for patients implanted with their faulty devices has contributed to nearly half of all DePuy hip replacement patients never receiving notification of the recall, which means these patients may be unaware that they require revision surgery and that, with their movements, they are releasing metal shavings into their bodies.
Citing the New York Times, Drug Watch reported that surgeons had reported this problem to DePuy, but with minimal response. Today, the device maker has been condemned for not acting sooner to advise consumers about its devices' risks.
DePuy hip implant devices-the ASR Hip Resurfacing System and the ASR XL Acetabular System manufactured by DePuy Orthopaedics, a Johnson & Johnson unit-were recalled in August 2010 following scores of complaints from patients and physicians reporting pain, discomfort, loss of flexibility, and problems walking. Now, DePuy is one of five implantable medical device makers that just reached a $310 million agreement that also includes ongoing monitoring to settle charges they paid kickbacks to physicians.
"This investigation uncovered evidence that health care decisions were being made based on a doctor's wallet and not on a patient's well-being," said Weysan Dun, the agent in charge of the FBI's New Jersey division, quoted the Associated Press. DePuy will pay $84.7 million of the total agreement amount.
DePuy has been making headlines in recent months for its devices' higher-than-normal failure rates that have resulted in patients requiring revision surgery. Revision surgery involves removal of the defective DePuy implant and reimplantation with a different device in a surgical procedure that is considered risky because the reimplantation takes longer than a first implantation and must be done while working with less bone surface area than the original surgery.
A design flaw in how the metal hip cup was created, in which the interior is insufficient to hold the hip's femoral portion, appears to be to blame, potentially impacting tens of thousands of patient. The recalled devices have been implanted in about 93,000 patients. Meanwhile, lawsuits are mounting, a Multidistrict litigation has been organized before Judge Katz in the United States District Court for the Northern District of Ohio, and numerous state actions have been filed.
Lawsuits against DePuy Orthopaedics, Inc., a unit of Johnson & Johnson Inc., are being filed and many more are expected.
DePuy hip articular surface replacement (ASR) implant devices-the ASR Hip Resurfacing System and the ASR XL Acetabular System-which have been implanted in about 93,000 patients, were recalled in August 2010 following very high failure rates and ongoing reports of patients experiencing pain, discomfort, and problems with flexibility and walking. A design flaw in how the metal hip cup was created, in which the interior is insufficient to hold the hip's femoral portion, appears to be to blame.
"The defendants were aware of many complaints made to the Food and Drug Administration in the United States and Health Canada regarding the failure of the DePuy implants. These complaints included component loosening, misalignment, dislocation and fracture, and the creation of abnormal or excessive metal debris in the hip socket. This metal debris could spread to surrounding tissue, causing severe inflammation and damage. The failure of the DePuy implants often requires complicated, expensive and painful revision surgery to correct," alleged one Canadian plaintiff, Jo-Anne Scharf, in her lawsuit against the device maker, quoted the Chronicle Herald.
In addition to defect issues, DePuy did not maintain appropriate records of patients implanted with their faulty devices and, worse, has recently been found to be attending revision surgeries, possibly taking removed devices from operating rooms. Meanwhile, nearly half of all DePuy hip replacement patients have not been contacted by their surgeons, which means that many patients may be suffering the effects of defective implants unaware they may require revision surgery, a long and dangerous reimplantation on a joint that has less bone to work with due to what was removed for the original surgery.
Lawsuits are beginning to make the news in the debacle involving pharmaceutical giant Johnson & Johnson Inc.'s subsidiary, DePuy Orthopaedics, Inc. As a matter-of-fact, says the Chronicle Herald, at least one plaintiff is seeking certification of a class action against both entities.
Plaintiff Jo-Anne Scharf said, "For at least two years, the defendants knew, contrary to their marketing campaigns, that a disproportionately high number of DePuy implants were failing and causing harm to patients," quoted the Chronicle Herald. Scharf's claim was just made public in Nova Scotia Supreme Court.
ABC Local also recently wrote that five patients located in the Chicago area have filed a lawsuit against DePuy. Many more lawsuits are expected to be filed against the device maker and its parent company.
DrugWatch noted that DePuy lawsuits have been increasing in numbers in recent weeks following a U.S. judicial panel's finding that all DePuy lawsuits, nationwide, should be consolidated and filed under Judge David A. Katz. Judge Katz presides over a U.S. district court in Ohio, said DrugWatch. Initially, seven cases were transferred; scores more have come in, and many more individual suits have been filed against DePuy, DrugWatch pointed out. Presently, there are 103 lawsuits consolidated before Judge Katz.
DePuy hip implant devices, the ASR Hip Resurfacing System and the ASR XL Acetabular System, were recalled in August 2010 and have been implanted in some 93,000 patients. The devices are experiencing a higher-than-average failure rate and have left many patients in pain and, in some cases, unable to ambulate. Also, many patients require revision surgery, in which the defective implants must be removed and a new device implanted.
If you or someone you know has been implanted with one of these defective devices, you should seek the advice of an attorney familiar with the litigation against DePuy Orthopaedics.
DePuy hip implant devices-ASR Hip Resurfacing System and ASR XL Acetabular System-recently popular for the news being made due to their high failure rate, have been implanted in some 93,000 patients. Among other issues, DePuy-a subsidiary of pharmaceutical giant Johnson & Johnson-did not maintain appropriate records of patients implanted with their faulty devices.
With more than 40 percent of DePuy hip replacement patients not having been contacted by their surgeons, many patients may be suffering the effects of defective implants unaware that they may require "revision surgery," a procedure in which the defective implant is removed and a new device is implanted.
Because of DePuy's inadequate record keeping and because a large percentage of surgeons have not advised patients of the recalled device, tens of thousands of patients are not aware of the DePuy ASR recall. The onus has been left to the patient to determine if they have been implanted with a defective device and require revision surgery.
Of note, revision surgery is long and dangerous and involves reimplantation on a joint that has less bone to work with due to what was removed for the original surgery.
According to the Wall Street Journal, some patients have reported pain and significantly increased blood levels of cobalt ions. Also, said the Journal, some surgeons who have conducted the replacement surgery have reported finding dead tissue masses near the patients' thighs.
The ASR was meant to last at least 15 years, but is failing at very high rates after a few years. Now, one in eight patients needs revision surgery within the first five years of the original surgery. Not unsurprisingly, the lawsuits against the defective hip replacement manufacturer are mounting.
Patients implanted with either the recalled DePuy ASR Hip Resurfacing System or the recalled DePuy ASR XL Acetabular System have been experiencing problems that include pain, swelling, and problems walking, with symptoms developing after the surgery and continuing long after healing should have occurred. These issues point to significant problems with the device such as loosening or dislocation of the implant, or fracturing of the remaining bone.
Some patients not experiencing these symptoms might be at risk for other problems. These implants, which are metal-on-metal, could be releasing metal shards as they wear into the patients' bodies. The particles could result in a condition called metallosis in which fluid builds into the joint and muscle, leading to pain, swelling, and damage to nerves, bone, and muscle.
According to Drug Watch, citing information from the National Joint Registry of England and Wales, women are likelier to require revision surgery versus men after having received a DePuy Hip Device. Based on a University of Adelaide, Australia, study, hip size impacts how soon revision surgery is needed, with the risk higher in patients with ASR femoral head sizes less than 50 mm in diameters, a typically female trait.
If you have received a hip implant from DePuy, be aware of the symptoms of implant failure such as swelling and pain, even problems walking. Any of these symptoms should not be ignored and, if present after the original surgery should have healed, could be a result of the implant becoming depositing metal ions into the surrounding tissue, becoming loose, having detached, fracturing the surrounding bone, or dislocating the implant. The device, manufactured by DePuy Orthopaedics, which is a unit of Johnson & Johnson, is called the Articular Surface Replacement or ASR.
Emerging data issued by the National Joint Registry (NJR) of England and Wales indicates a five-year revision rate of about 12 percent for the hip resurfacing system and about 13 percent for the acetabular system, both manufactured by DePuy.
All of the DePuy ASR hip devices have been recalled. If you have been implanted with this device, you should see the advice of an attorney familiar with the hip implant litigation against DePuy and the injuries suffered by those that have been implanted with this defective device.
DePuy devices have long been making headlines for having a significantly high failure rate, which has led many patients to undergo so-called "revision" surgery. This means removing the defective implant and undergoing surgery to implant a new device on a joint that has less bone due what was removed from the original surgery.
Revision surgery can be long, complex, and more likely to result in complications. Even worse, experts say that patients undergoing this type of revision surgery experience an astounding four-fold increased likelihood of suffering from a dislocated hip.
According to the San Francisco Gate, the effects of the ASR defect can be severely painful and devastating. Sadly, DePuy was apparently aware, had even been receiving warnings for some time, that there were problems with the device, but continued to tout the ASR, all while doctors were ditching use of the ASR in their patients, noted the SF Gate.
With 93,000 ASR devices recalled, the implications are staggering.
The recently recalled Articular Surface Replacement-ASR-artificial hip made by DePuy Orthopaedics, Inc., a unit of beleaguered pharmaceutical giant, Johnson and Johnson, is being faulted for its high failure rate worldwide.
The ASR system, which is supposed to last for at least15 years, is failing in patients after five years. With the potential of up to 100,000 patients being implanted with this device since 2005, the potential for revision surgery is staggering.
The metal-on-metal device can shed metal shards inside the patient's body, leading to discomfort, pain, and the need for revision surgery that is painful, long, and dangerous, especially given that there is, as the SF Gate pointed out, significantly less bone to work with because of the bone lost in the original surgery. What's more, the revision surgery is likelier to result in complications than the original surgery, said the SF Gate.
Symptoms of a failed DePuy hip implant include swelling, pain, and problems walking and can suggest an implant that has loosened or has detached, fracture of the bone surrounding the implant, or the implant's components dislocating, noted the SF Gate. According to the New York Times, surgeons conducting revision procedures have noticed dead tissue near the implants of some patients. Some patients also have high cobalt and chromium ion levels in their blood.
Meanwhile, nearly half of all DePuy hip replacement patients have not been contacted by their surgeons regarding the recall, meaning tens of thousands of people remain unaware that they have been implanted with a defective device and are at risk. Worse, because DePuy did not keep a list of implant patients, the onus is now on the patient to figure out of he/she has been implanted with a defective DePuy ASR.
DePuy Orthopaedics, a division of beleaguered pharmaceutical Johnson & Johnson, and maker of the recalled ASR XL Acetabular and ASR Hip Resurfacing Systems, paid hefty fees to physicians to market its devices.
DePuy paid out an astounding $80.8 million since last year to fund about 200 doctors in the United States for promotion, research, and so-called consulting fees, according to The New Haven Independent: Nearly $48 million in 2009 and close to $33 million from January to September 2010.
DePuy provides information on these payments on its website at www.depuy.com/corporate-information/depuy-divisions/depuy-orthopaedics/find-surgeon. There are no yearly totals; however, information is broken down by physician. Some physicians were paid over $1 million and some payments were being made as issues were surfacing about the defective DePuy ASR Systems. DePuy finally issued a global recall of its ASR XL Acetabular and ASR Hip Resurfacing Systems this August.
Meanwhile, DePuy was one of four medical device makers that were the focus of a Justice Department criminal complaint alleging that kickbacks were paid to surgeons for use of these systems. Ultimately, DePuy paid an $84.7 million fee and agreed to only pay doctors for legitimate consulting services.
The implants were failing at higher-that-typical rates versus other, similar devices and, according to DePuy, approximately 13 percent of patients had to endure revision surgery after only five years. Traditionally, replacement surgeries are needed after 15 years.
Both recalled DePuy devices are constructed of metal-on-metal elements. As these components rub against each other, metal pieces are released into the body, which can accumulate, leading to significant health issues. According to an editorial in a recent issue of The Journal of Arthroplasty, authored by three key physicians in the field, metal hip implants "do not show any clinical advantage," but "are producing a new series of complications," quoted Drug Watch.
Lawsuits continue to mount against DePuy.
On December 4, 2010, the Judicial Panel on Multidistrict Litigation issued a decision organizing litigation over the recalled DePuy ASR XL hip implants into a multidistrict litigation ("MDL") and transferred all pending federal court cases to Judge David A. Katz in the Northern District of Ohio. The MDL was assigned number 2197 and all cases subsequently filed in federal district court will be transfer to Judge Katz for coordinated and consolidated pre-trial proceedings. Click here to read the decision.
On October 29, 2010, the Journal of Bone and Joint Surgery reported two cases of Cobaltism in patient implanted with the recalled DePuy hip replacement implant. Cobaltism is a metal poisoning that can damage multiple organs and has been associated manifested itself in vertigo, blindness, hypothyroidism, optic nerve atrophy, convulsions, headaches, tinnitus, deafness, peripheral neuropathy, and cardiomyopathy.
The authors note that "A normal serum cobalt level is 0.19 ug/L, and 95% of those who are unexposed to cobalt have a value of <0.41 ug/L5. A serum cobalt level of >1 ug/L indicates excessive cobalt exposure, and levels of >5 ug/L are considered toxic." The patients in the study both had cobalt levels in excess of 60 ug/L and presented with symptoms of deafness, blindness, cognitive decline, headaches, convulsions, fatigue, weakness, peripheral neuropathy, heart failure, and hypothyroidism.
They also presented with periprosthetic metallosis, a disease of the tissue surrounding the implant caused by the metal shavings release into the tissue and blood stream as the metal-on-metal device wears out. Periprosthetic metallosis destroys the tissue in the hip area and can make subsequent hip replacements impossible.
If you have been implanted with the recalled DePuy ASR Acetabular System, you should see your physician and have your whole serum cobalt and chromium levels checked. You should also be sure to make your physician aware of any pain, swelling, clicking or other unusual symptom in your hip, as well as any of the symptoms associated with Cobaltism that you are experiencing.
You should also seek legal counsel as you may be entitled to compensation in excess of the reasonable medical expenses that DePuy is offering to cover.
On November 18, 2010, a hearing was held before the Judicial Panel on Multidistrict Litigation ("JPMDL") to decide whether the numerous lawsuits filed by attorneys for injured individuals against DePuy Orthopaedics regarding its defective hip implants should be consolidated for discovery before a single federal judge.
The JPMDL is a panel of seven sitting federal judges, who are charged with (1) determining whether civil actions pending in different federal districts courts involve one or more common questions of fact such that the actions should be transferred to one federal district for coordinated or consolidated pretrial proceedings; and (2) selecting the judge or judges and court assigned to conduct such proceedings.
The purposes of the transfer or "centralization" process are to avoid duplication of discovery, to prevent inconsistent pretrial rulings, and to conserve the resources of the parties, their counsel and the judiciary. Transferred actions not terminated in the transferee district are remanded to their originating transferor districts by the Panel at or before the conclusion of centralized pretrial proceedings.
If you have received a defective implant from DePuy, contact Sullivan & Brill, LLP today. We expect that the panel will decide to consolidate the cases in New Jersey, Ohio or Illinois. Its decision should be issued shortly.
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