Illinois Medical Malpractice Blog

In August of 2010, DePuy Orthopedics, a division of Johnson & Johnson, issued a recall for two of its widely used hip replacement products, ASR™ XL Acetabular Hip System and the DePuy ASR™ Hip Resurfacing System, after it was determined that the metal-on-metal design of the prosthetic hip could be harmful to the individual recipients. The metal-on-metal devices have caused issues for thousands of recipients because of the deterioration of the metal once implanted in a patient’s body. The metal-on-metal design can lead to the release of small metal particles into the recipient’s body. This can lead to a slew of health problems including infection, necrosis, allergic problems or even heart and neurological system problems.

The company estimated that between 2003 and 2009 over 90,000 patients received one of the now recalled DePuy hip replacement systems. Research has shown that nearly one in eight recipients of a DePuy Hip Replacement required a revision surgery to correct the issues associated with the faulty hip replacements.

With approximately 90,000 faulty hip replacements used and a one in eight chance of issues occurring, it is safe to assume that well over 11,000 patients will require a revision surgery to correct the problems suffered because of the faulty metal-on-metal design. “Anyone who received a recalled DePuy hip implant may be eligible to receive compensation for these defective products, even if they have not yet experienced pain or symptoms,” said attorney Steven Levin of Levin & Perconti.

With the large number of potential claimants DePuy is expected to face an increased amount of litigation.

The Chicago hip implant attorneys at Levin and Perconti believe that the number of claims already filed against DePuy may only be the tip of the iceberg. It is impossible to know whether the tens of thousands DePuy hip replacement recipients that have not yet incurred problems will in the future.

The almost year-long saga involving defective hip implants continues unabated as a U.S. Senate Special Committee on Aging will soon hear testimony related to the issue. According to Mass Device, the hearing will come as part of a bigger investigation into the patient safety approval process currently available for medical devices. As the DePuy hip recall made clear, many questions remain about the safety of devices rushed to market and given to unsuspecting medical patients.

Reports indicate today’s testimony will place the Johnson & Johnson company in the middle of the federal investigation evaluating that medical device approval process. After representatives from the large medical company testify, the committee will then hear from one of the victims of the recall—many Illinois medical patients found themselves in a similar circumstance to the victim who will speak to the committee.

In addition, a national researcher will explain data that indicates that there are more recalls of devices that are approved through the 510(k) pre-market notification program. This alternative approval process allows devices to reach consumers sooner without the stringent testing required by the Food and Drug Administration’s more comprehensive PMA protocol.

The subcommittee holding the hearing explained, “Internal reviews by FDA officials and other outside sources have found troubling lapses in the procedures by which a number of medical devices were approved. The results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months.”

Continue reading "United States Senate Begins Probe Into Defective DePuy Hip Replacements" »

As we’ve previously reported, the problem with the DePuy hip implants was uncovered last year, prompting the official recall in August of 2010. However, complaints about the devices go back to 2005. Nearly 100,000 patients received the specific metal-on-metal implant in question in the six years it was used. At least 12,000 of those patients will likely face severe complications as the device fails, requiring corrective surgery. Many of those patients may not be aware of their risk.

The failure of the devices caused metallic particles to be released in patient bodies. The particles then may enter the bloodstream ultimately risking a range of problems from deafness and dementia to heart failure. The consequences cannot be overstated.

Just this week WHEC News reported on even more DePuy hip recall lawsuits. Seven people have recently filed suit against the manufacturer of the defective hip implants, DePuy Orthopaedics. One of the victims had the cobalt and chromium implant that began dispelling metal shaving into his body. Those shavings eventually made their way into the man’s bloodstream, causing extreme inflammation. Only a year and a half later, he needed replacement surgery.

His story is the same one faced by many other victims. One attorney explained the conduct of the business responsible for the problem, “this company had basically wanted to continue to make money off of these implants as long as they could, and as a result a lot of people have been. [will]…have multiple surgeries.”

Continue reading "DePuy Hip Recall Lawsuits Continue To Mount" »

About Lawsuits reported on the latest developments related to the DePuy hip recall lawsuits. Johnson & Johnson, the company that owns the orthopedic business that created the defective hips, recently released financial information that sets aside money it expects to pay because of the problematic medical devices.

Specifically, the business set aside nearly $1 billion to cover costs related to the defective hip implants. It is yet unclear what percentage of that figure is expected to be spent on litigation defense, payouts to victims and other costs.

Experts admit that the overall total cost to the business will rise well above $1billion. Frequent blog readers are aware of the growing number of lawsuits filed on behalf of the many victims--including many in Illinois . Thousands of lawsuits are expected to be filed, with more victims stepping forward every day. Many of these victims have suffered a variety of severe complications because of their receipt of hip implants that failed at an unacceptable rate.

Initially the fail rate was revealed to be a high 12-13% of all implants. The continued monitoring of patients has led many doctors to believe the total fail rate will ultimately prove to be much higher.

Continue reading "Illinois DePuy Lawsuits Likely Part of Over $1 Billion in Projected Settlements" »

The Food and Drug Administration recently rejected a proposed rule change that sought to ensure the safety of all medical devices. As reported in DrugWatch the proposal would have eliminated the loophole that allows certain medical devices, like hip implants, from undergoing clinical trials. The mandate for more testing of devices before their mass use would catch potentially defective products before they are capable of injuring patients.

The chaos surrounding the DePuy hip implant recall was the impetus for the proposal. As blog readers are aware, over 93,000 implants were recalled at the end of August this year after the metal-on-metal hip implant system was discovered to fail at a much higher rate than usual. The malfunction caused metallic particles to enter the patient’s body, leading to bone and tissue problems. The defect requires a painful and risky revision surgery. As a result, anyone who has had a hip implant with the DePuy ASR XL Acetabular System and ASR Hip Resurfacing Systems may have a legal claim against the company for the problem with the medical device.

However, had the proposed rule been in place, the clinical trials would likely have caught the problem with the DePuy implants before thousands of patients suffered.

Continue reading "DePuy Hip Recall Update: Stricter Implant Requirements Rejected by FDA" »

We have frequently updated readers on the latest news related to the DePuy hip implant recall. The impact of the defective product continues to have effects close to home. Several Chicago patients recently filed a lawsuit for their suffering due to the hip device.

According to ABC News, the Chicago DePuy lawsuit includes five patients who are accusing the company of ignoring the clear evidence that the devices being implanted posed too high a risk of failure and complications. Failure to act reasonably led to an unnecessary delay in the recall.

The husband of one of the victim explains of his wife, “She can’t walk. She can’t do anything. [She’s] in deep pain.”

These victims represent only five out of thousands who suffered because of defective DePuy hip implants. Nearly 100,000 of the implants were recalled by the company in August after evidence mounted even higher showing the extreme danger the product presented to patients. Many of the patients who have suffered complications from the product may have suffered irreparable harm to their bodies. Each time a join is redone some bone is lost.

Perhaps even more frustrating is the lack of clear answers on why the product was even defective in the first place and how the company allowed so many patients to face complications. Also concerning is the fact that there is no standardized tracking system in the United States for joint implants—other countries require such tracking. Those nations have seen the rates for revision surgeries drop by as much as ten percent as the lists allow defective devices to be identified much earlier.

Continue reading "New DePuy Hip Implant Lawsuit Filed in Chicago" »

Since the official August recall of certain DePuy hip implants, thousands of patients have taken steps to check the safety of their own devices. In the Chicago area many individuals who had hip implants in the last several years have discovered that their device was defective and in need of replacement. The problems with the device vary, with some patients suffering extreme complications shortly after their surgery and others experiencing difficulties only much later. In all cases, however, the cause of the hip concerns lie squarely at the feet of the DePuy officials who made the defective product and continued to push for its use after concerns about it arose.

New data from the National Joint Registry and republished in Drug Watch suggests that woman are more likely than men to suffer problems with their DePuy hip implant. Specifically, patients with small hips (those with femoral heads below 50mm in diameter) were more likely to need revision surgery. Women have hips more frequently smaller than men, leading them to suffer more complications from the defective hips.

Over 93,000 patients have undergone surgery using the problematic implants since 2004. The recall was issued in August after much higher than average failure rates. Patients suffered a variety of maladies including bone fractures near the implant sight, implant dislocation, and metallosis. Metallosis is caused when fragment of metal break from the device and enter the body.

Continue reading "DePuy Hip Implants May Fail More Frequently in Women" »

Word of the problem with hip implants made by DePuy Orthopaedics continues to spread, as ABC News recently reported again on the recall developments.

The investigators talked with one patient who had the recalled device implanted. Only five months after the implant she recalls suffering from severe pain. She explains of the problem, “I’m angry…patients or consumer rely on our doctors, we rely on the products that they use.”

As we’ve previously reported, the problem with the DePuy product was uncovered earlier this year, prompting the official recall in August. However, complaints about the devices go back to 2005. Nearly 100,000 patients received the specific metal-on-metal implant in question in the six years it was used. At least 12,000 of those patients will likely face severe complications as the device fails, requiring corrective surgery. Many of those patients may not be aware of their risk.

The failure of the devices caused metallic particles to be released in patient bodies. The particles then may enter the bloodstream ultimately risking a range of problems from deafness and dementia to heart failure. The consequences cannot be overstated.

New investigations into the cause of the problem are shedding light on the troubling reality of the product and its regulation. For one thing, the device was cleared by the Food and Drug Administration without any clinical trials to test its safety. This was made possible by a little known regulation that allows short-cutting the regulations if a new device is substantially similar to one already in use. In addition, no medical registry exists to track the performance of these medical devices. In that way, it is often difficult to uncover patterns of failure and complications. The delay in uncovering problematic devices means s that more patients receive the product before it is finally pulled.

Continue reading "Hip Implant Patients Continue to Report Problems with DePuy Devices" »

My Fox Chicago recently shared more information with its readers about the “junk joints” made by DePuy that continue to affect thousands of patients who underwent joint replacement surgery.

The story profiles one particularly young victim. The 43-year old man decided to have a metal hip implanted in his body after suffering sharp pains every time he bent over. As a lifetime sports addict, his body had been punished over the years—it had finally caught with him. However, while the doctor told him that the implant was supposed to last at least 15 years, he began having trouble with the hip implant within one year. He was struggling to move the hip and was in extreme pain.

Eventually his doctor discovered that his newly installed hip implant was defective. He was forced to have another risky surgery to replace it.

Thousands of other patients have a similar story to share. The article also discussed a female patient whose implant began flaking metal particles. The particles traveled into her bloodstream, leading to pain and swelling. After two corrective surgeries and a four day stint in the hospital, the ordeal was still not over. She suffered complications following the surgery. In one particular harrowing ordeal her whole body began to swell and turn black and blue. She was rushed to the emergency room where it was discovered that she had contracted a dangerous staph infection caused by pneumonia. She is lucky to have survived.

These victims represent only two out of thousands who suffered tremendously because of defective DePuy hip implants. As we have discussed often on this blog, nearly 100,000 of the implants were recalled by the company in August after evidence continued to mount regarding the extreme danger the product presented to patients. Many of the patients who have suffered complications from the product likely have irreparable harm to their bodies. Each time a join is redone some bone is lost.

Perhaps even more frustrating is the lack of clear answers on why the product was been defective in the first place and how the company allowed so many patients to face complications. Also concerning is the fact that there is no standardized tracking system in the United States for joint implants—other countries require such tracking. Those nations have seen the rates for revision surgeries drop by as much as ten percent as the lists allow defective devices to be identified much earlier.

One surgeon explains the problem, “If Maytag can track their washing machines…we should have the ability to track all major orthopedic implants, where they go and when they’re removed.”

Continue reading "Defective DePuy Joint Implants Continue Harming Patients" »

A newsletter that follows the latest happenings in the world of mass torts and product liability problems recently discussed the litigation surrounding the DePuy hip implant recall. Our Chicago product liability attorneys have been following the developments closely, because many patients in our area may have been affected by the recall.

Over 93,000 implants were recalled at the end of August this year after its metal-on-metal hip implant system was discovered to fail at a much higher rate than usual. The malfunction caused metallic particles to enter the patient’s body, leading to bone and tissue problems. The problem requires a painful and risky revision surgery. As a result, anyone who has had a hip implant with the DePuy ASR XL Acetabular System and ASR Hip Resurfacing Systems may have a legal claim against the company for the problem with the medical device.

However, the company is attempting to limit its payment and gain the upper hand in legal matters by having patients unsuspectingly sign consent forms which provide the corporation with valuable information about a patient’s case before the lawsuit is even filed. The company has sent letters to orthopedic surgeons who then pass along the consent form to the patient. The letter asks patients to contact DePuy to receive a claim number. In the most egregious cases, the surgeon has appeared to require patients to call DePuy before scheduling the follow-up appointment.

This misleading attempt to obtain patient information in order to get the upper hand in litigation should be rejected. Any patient who has already signed the consent form can waive the consent at any time by writing to the organization or person to whom they gave consent. The group asking for the consent may be “Broadspire,” an organization working with DePuy to send out the consent forms.

In short, if you have had a hip implant and have been contacted in any form similar to that described here, be sure not to sign away important rights. The consent forms essentially give away private patient rights for little to nothing in return. Be sure to contact a product liability lawyer to ask all questions you may have about the DePuy recall.

A new lawsuit has recently been filed in Illinois courts alleging that many medical patients have suffered following defective metal-on-metal hip implants made by DePuy Orthopaedics, reports AboutLawsuits.com.

Thirteen former patients have alleged that ASR hip implants made by the company were defectively designed and had to be replaced. Specifically, the challenged devices include the ASR Acetabular System implants and DePuy ASR Hip Resurfacing System implants. Over 93,000 of these implants were recalled by the company after startling data revealed that one out of eight recipients of the defective DePuy hip implants experience problems within five years of the surgical implant. Many of those victims eventually require a risky hip revision procedure to completely replace the defective DePuy product.

This new lawsuit filed by over a dozens of those victims claim that the company failed to appropriately test the metal-on-metal system, and even after realizing the problem, the company delayed in calling for the full recall. In particular, there were early concerns about problems with the part of the device known as the acetabular cup. The cup on the DePuy device was much shallower than on cups made by other orthopedic companies. The shallowness has consequently been shown to pose more risks for those receiving the implant.

The metal-on-metal his replacement system has been questioned repeatedly in the five years that it has been used. Medical device safety advocates explain that the product can shed metal materials into the body which in turn pose severe risk to soft tissues. The metal particles also pose risk of instigating inflammatory reactions and causing bone loss.

Our Chicago medical product liability lawyers at Levin & Perconti believe that no patient should suffer at the hands of defective and downright dangerous products like this type of hip implant. With the severity of the possible complications, it is vital for you to contact a product liability attorney as soon as possible if you may have been implanted with one of these problematic devices.