Articles Posted in Defective Medical Device

The DePuy metal-on-metal hip replacements have affected many citizens and often left them with serious and life-threatening complications. These implants suffer an extremely high failure rate, which is projected to be around 80% at just 8 years after surgery. The complications of a metal-on-metal hip replacement can be extremely severe. Problems after surgery range from pain, swelling, limited mobility, trouble walking, and dislocation, to a very serious disease called metallosis. The grinding that occurs between parts of the hip replacement can release metal debris into the body and bloodstream, causing the blood levels of chromium and cobalt to become dangerously high. This metal poisoning in the blood can cause cardiovascular, neurological, thyroid and renal issues in the body as well as destroying muscle, tissue, and bone. There have already been thousands of lawsuits filed citing the disastrous results of a DePuy metal-on-metal hip implant.

DePuy, a Johnson & Johnson company, issued a recall on these products in August of 2010. Due to Texas’ 2 year statute of limitations law, clients will no longer be able to file lawsuits against DePuy metal-on-metal hip replacements after August 23, 2012. A statue of limitations law is intended to put a specific length of time on certain lawsuits, so that future filings cannot be extended indefinitely. While this can help avoid clogging in the justice system, it may also leave many victims incapable of receiving compensation for their suffering.

If you or a loved one has been adversely affected by a DePuy metal-on-metal hip replacement, don’t let the sun set on your filing rights. Every patient should be entitled to proper care and certainly proper medical device implants. If you fail to file a lawsuit by the August 23 deadline, your claim could be lost forever. No one should have to live with life-altering complications from a defective medical device without retribution, so make sure you are one of the ones to have your voice heard. Contact Borchardt Law Firm now for a consultation about your case.

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The Stryker Corporation is a leading manufacturer of medical devices. However, even Stryker could not avoid blame in the ongoing metal-on-metal hip replacement issue. Earlier this month, Stryker stated that it is issuing a voluntary recall of two of its hip replacement products: the Rejuvenate Modular hip replacement and the ABG II Modular-Neck hip stem. While neither is strictly a metal-on-metal hip implant, both contain metal-on-metal components that may cause the same disastrous complications seen in the DePuy case. Both defective products can lead to metallosis and other serious damage.

After reports of trouble with Stryker hip implants began to mount, the FDA launched an investigation into one of its manufacturing facilities. The disappointing findings included inadequate quality control measures and even the presence of the Staphylococcus bacteria. In 2007, the FDA warned Stryker to rectify these problems immediately or face very detrimental consequences. These deficiencies are independent of the serious structural problems that plague the two recalled implants. The friction of its metal parts can lead to, according to Stryker, “…a potential for fretting and corrosion at the modular neck junction which may lead to adverse local tissue reactions.” Such reactions include unbearable pain, swelling, and the development of metallosis. These products suffer from a very high early failure rate as well, working directly against their original marketing as a more long-lasting product for younger patients. Often patients implanted with defective devices must consequently undergo extremely costly and painful revision surgeries to correct the trouble.

Overall, the problems associated with these products warrant their immediate removal from the market and widespread public concern for patient safety, especially those patients who are still implanted with such devices and remain at risk for developing very severe complications. These medical devices can be extremely harmful, and no patient should have to carry such a risk.

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Although the recall on Johnson & Johnson’s metal-on-metal DePuy hip replacement was in August of 2010, the problems are far from over. Johnson & Johnson created the Pinnacle hip replacement as a second generation of DePuy, and it has already begun suffering similar results to its predecessor. According to Fox News, it is estimated that over 10% of Pinnacle hip replacements will fail within the next 2-3 years. At Borchardt Law Firm, we have seen many cases protesting the hazards of DePuy’s metal-on-metal hip replacement surgery, and it seems that litigation over this defective medical device still has a long road ahead.

After a costly $3 billion dollar recall on the DePuy product, Johnson & Johnson could still pay $5 billion dollars to cover revision surgeries for affected patients. There are 1600 lawsuits filed with the U.S. District Court for Northern Texas alone. The statistics on DePuy failure rates continue to look very grim. It is currently believed that DePuy will see a 49% failure rate after just 6 years, a number that is four times what DePuy cited when it decided to recall the product. Additionally, this failure rate is expected to rise to 80% at 8 years after surgery.

The complications of a metal-on-metal hip replacement can be extremely severe. Problems after surgery range from pain, swelling, limited mobility, trouble walking, and dislocation, to a very serious disease called metallosis. The grinding that occurs between parts of the hip replacement can release metal debris into the body and bloodstream, causing the blood levels of chromium and cobalt to become dangerously high. This metal poisoning in the blood can cause cardiovascular, neurological, thyroid and renal issues in the body as well as destroying muscle, tissue, and bone.

In light of the current situation, the FDA has recently stated that they see no reason to continue the usage of metal-on-metal products in hip replacement surgeries. Many doctors have begun to refuse using them altogether, because the extreme risk of exposure to dangerous substances can render any proposed benefits negligible. Ultimately, it has been proven that the DePuy hip replacement and other metal-on-metal systems can be very unsafe and potentially life-threatening to patients, warranting deep concern over the continuing presence of such products on the market and concern that manufacturers and physicians take responsibility for exposing patients to danger.

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The FDA has recently proposed a new method of identifying and tracking medical devices. Under this system, most medical devices would be inscribed with a “unique device identifier”, or UDI. This code would contain product information including manufacturer, expiration and other device specifics. High risk medical devices are the first priority to receive UDI codes, whereas some less risky devices or over-the-counter devices may be exempt from the ruling. This information could be held in a database that is available to the public, greatly improving the transparency and accessibility of medical device implants.

The FDA is optimistic that continued post-market surveillance will help the medical community identify, isolate, and inform consumers about problematic devices. This proposal will be open to public comments for the next 120 days, and has already garnered much support for its potential to increase the safety of medical device implants.

This system will help manufacturers and hospitals to discern the problems of a given product faster and implement more efficient recalls. It is also suggested that UDI codes will make it easier to prevent counterfeit products from entering the market. This could greatly improve patient safety by limiting the amount of defective devices available and making it easier for consumers to learn when their safety may be at risk. FDA Commissioner Margaret A. Hamburg, M.D. is quoted in the Star Tribune: “The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.”

Overall, this proposal may hold great promise to increase consumer safety and medical accountability. Medical device disasters like metal hip implants and transvaginal mesh could have been mitigated by a system that made recognizing and recalling dangerous products more effective. Consumers deserve accurate and timely information regarding their well-being and the well-being of any device implants they may have received.

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Transvaginal mesh is a surgically implanted device designed to help with problems of organ prolapse (or “falling out”) and bladder incontinence. This mesh is a synthetic material which acts as a reinforcing sling around the intended organs. Such mesh has been used with some success in other surgeries, but has proven especially problematic in the female pelvic region due to the increased number of organs involved, the very small area, and possibility of erosion from movement. According to the American Association for Justice, in 2010, approximately 300,000 transvaginal mesh devices were implanted in American women.

Surgeries involving transvaginal mesh have proven the risk for disastrous consequences. Some side effects include organ perforation, extreme pain, infection, bleeding, urinary problems, mesh contraction and mesh erosion through the vagina. After such complications ensue, multiple surgeries are often required to remove the device and reconstruct any damage it caused. A patient may suffer for years after their original surgery from debilitating pain and discomfort.

If transvaginal mesh is such a problem, why is it on the market? The answer lies in the FDA’s 501(k) approval process. If a device is considered low to moderate risk or if it can prove it is sufficiently similar to another device that has already gained approval, then there are very few requirements necessary to begin marketing and selling a product. Most transvaginal mesh devices have been approved in this manner, meaning they did not have to prove rigorous clinical testing to the FDA before they began selling the devices. In fact, very few studies have even been conducted that aim to assess the safety of transvaginal mesh. However, those studies that have been conducted provide conclusive evidence that transvaginal mesh is neither safer nor more beneficial than traditional methods of surgery. Transvaginal mesh devices were approved because they are similar to the forms of mesh used in other surgeries without consideration of the fact that they are intended to be used in a totally different procedure. The FDA has since recognized the extreme risks involved and issued a statement recognizing that serious complications are not rare in these procedures.

Many lawsuits have already been filed against transvaginal mesh manufacturers. Most patients are horrified to find that the procedures they have undergone with the assumption that they are safe have, in fact, been approved without sufficient attention to safety. Widespread concern and litigation has prompted Johnson & Johnson to remove their transvaginal mesh device from the market. However, there are other manufacturers producing these devices. Every patient deserves assurance that their intended surgery is safe and effective. It should be the responsibility of the medical community and the FDA to ensure the safety of U.S. consumers of medical devices.

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The Medtronic Infuse Bone Graft is a bone growth stimulator used during surgery. “Infuse” is a bone morphogenetic protein, a genetically engineered form of a naturally occurring protein. It is applied in liquid form via sponge; it is meant to grow into bone in order to facilitate re-growth and replace damage. It was originally marketed as an alternative to the traditional procedure of harvesting bone grafts from the hip. The Infuse Bone Graft was approved by the FDA in 2002. But, there’s a catch: it was only approved for a very limited set of surgical procedures. The trouble with the Infuse Bone Graft is when it is used for off-label procedures for which it is not approved. A number of lawsuits have already been filed for botched surgeries that used the Infuse Bone Graft for operations it was not intended for.

Off-label usage of the Infuse Bone Graft has been linked with many serious complications. It has been known to cause difficulty breathing, swallowing or speaking, airway compression, respiratory depression, nerve damage, unwanted bone growth, and even death. Despite the FDA’s warning of the potential dangers of off-label Infuse procedures, usage of this system has not waned. It is alleged that Medtronic actually encouraged doctors to pursue the Infuse Bone Graft for cervical spine surgeries, a purpose for which Infuse has not received approval. Medtronic subsequently received a 3 billion dollar payday as a result of this questionable tactic. The Wall Street Journal also alleges that Medtronic paid a physician to falsify a study that produced positive results from Infuse’s off-label use in the cervical area.

One recent lawsuit involves a woman who still suffers disabling complications after an Infuse spinal surgery in 2006, according to The Courier-Journal. The extensive nerve damage incurred during the procedure has left her barely able to walk or sit up, and simple tasks such as tying shoes and shaving legs are impossible without assistance. It is argued that this surgery was an off-label usage of Infuse carried out without the patient’s consent. This lawsuit is only one of multiple similar suits citing debilitating results of an Infuse Bone Graft. Such extreme side effects should be cause for much stricter enforcement of the Infuse Bone Graft’s usage in only approved procedures. No one should be the victim of a practice that has intentionally hidden the truth from those it affects. Moreover, medical device companies must be held to a higher standard of transparency and legitimate concern for patient outcomes, instead of profit margins.

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Intuitive Surgical, Inc.’s da Vinci Surgical System is the target of several recent lawsuits beginning in Alabama, Mississippi and New York. This device was cleared by the FDA in 2000 and claims to be a much-desired minimally invasive alternative to traditional surgery. The da Vinci robot performs surgery through a remote-controlled robotic arm with powerful electricity at the tip, meant to “burn” away specified tissue. According to the Los Angeles Times, use of the da Vinci robotic surgery “…has quadrupled in the last four years, and the machine now helps with incisions and sutures in 2,000 hospitals around the world.”

Though this system was once touted as a great achievement of modern innovation, its problems may outweigh the technological benefits. For instance, the da Vinci robot uses very powerful electrical energy in order to cauterize the desired tissue, effectively “burning” away the tissue that a surgeon would cut for an incision or remove if infected. This electrical current is concentrated at the tip of the robotic arm. However, it has been found that, due to repeated use, insulation on the robotic arm may degrade over time, allowing electricity to flow into unintended surrounding tissue. This defect can cause serious burns and life-threatening complications.

Three lawsuits have already been filed citing the da Vinci system’s defects. All three suits stem from hysterectomy surgeries, in which two serious injuries and one death have been directly linked to the da Vinci robot. Two women continue to suffer from internal burns on surrounding organs that were meant to be untouched. Both have been forced to undergo extensive, expensive and ineffective corrective surgery to fix these mistakes. One woman died following surgery because the da Vinci robot inadvertently burned a pelvic artery; she hemorrhaged internally and died within two weeks.

The lawsuits also claim that Intuitive Surgical practiced questionable marketing and business techniques in order to sell its da Vinci robots. The company reportedly suppressed complaints and the actual rate of complications and errors in its marketing campaign. It is also argued that Intuitive Surgical employed intimidation tactics in order to persuade hospitals into purchasing the equipment, causing hospitals to fear the loss of business if they did not buy the robots. The company has been accused of fraud for misrepresentation of facts and competition risks.

The Intuitive Surgical case has highlighted the problem of medical communities choosing profit over patient safety. Medical device companies like Intuitive Surgical can be more concerned with keeping products like the da Vinci robots in service than considering any potential health risks. The FDA and organized medicine must take greater steps to protect the public from defective medical devices.

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The FDA has recently been receiving a lot of attention for something other than a recall or warning; the health experts are facing pressure on approving medical devices at a faster rate. The majority of approvals can take years, and when life threatening or extremely painful health problems are at risk, that wait can be too long. However, other health experts and administrations fear that a faster approval rate of medical devices could also decrease the safety of the devices.

An article from the Huffington Post states the possible new agreement hopes to “double the user fees paid by device makers to the Food and Drug Administration; the fees help fund the agency’s review of their products. In exchange, the industry wants to speed up the approval process, claiming that crucial devices to help treat suffering patients are being needlessly delayed in FDA bureaucracy.” (read full article)

However, this agreement is not supported by all. Many health experts are arguing that administrations need to focus on the high number of medical device recalls just in 2011, the average number of recalls was doubled compared to previous years. Adjusting to a faster approval rate would only spike those numbers even more. Looking back at the thousands of DePuy Hip System recalls and the several vaginal mesh lawsuits, the idea that devices would be approved even quicker only frightens patients, lawyers and doctors. After thousands of patients suffered from severe pain and multiple revision surgeries due to failed medical devices, patients are very hesitant on devices being approved faster. Many of them believe health experts and administrations need to put more focus on approving the devices, rather than speeding up the process.

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Metal-on-metal hip replacement systems continue to receive criticism as experts across the world encourage doctors to stop using these defective systems. Due to the full metal design of these replacement systems, the implant is known to shed tiny pieces of metallic ions that lead to a high risk of causing permanent tissue, muscle and bone damage. Though all orthopedic implants shed debris after a few years, the metal-on-metal poses a much higher threat that can cause severe lifelong problems.

Recalls and lawsuits began piling up in August of 2010 after one of the most commonly used metal-on-metal hip replacement system was recalled. The DePuy ASR XL Acetabular was recalled due to unusually high rates of hip implant failure within only a few years of surgery. DePuy estimated the failure rate to be about 12-13 percent and was designed to last up to 15 years. However, results showed otherwise. Several patients ended up in constant pain resulting in several costly revision surgeries only a few years after the implant.

The decreasing use of metal-on-metal hip replacements has spread world wide. Recently, British experts at one of the world’s largest artificial joint registry’s have told doctors metal-on-metal hip replacements are prone to being fixed or replaced more often then other non metal-on-metal system. According to the Huffington Post, a recent study shows that “experts analyzed data for more than 400,000 hip replacements from the National Joint Registry of England and Wales between 2003 and 2011. More than 31,000 of those were metal-on-metal devices. After five years, about 6 percent of people with the metal-on-metal variety needed surgery to fix or replace them. That compares with just 1.7 to 2.3 percent of people who had ceramic or plastic joints.” (read full story)

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