Articles Posted in DePuy Hip Implant Recall

Several years ago a medical device recall was issued that has grown into the largest and costliest such recall in history. In 2010, after months (perhaps even years) of pressure from safety groups, two versions of a hip implant system were recalled by a company called DePuy Orthopaedics. DePuy is owned by the largest medical products company in the world, Johnson & Johnson.

As we frequently discussed in the several years since the recall, various problems were identified with the metal-on-metal design of the systems. Metallic particles were suspected of flaking away and entering patient bloodstreams. All told. thousands of patients who received these products ultimately had them “fail.” Many of those patients required revision surgery and countless individuals suffered permanent damage as a result of defective devices.

Eventually, thousands of involved patients filed suit against the responsible company seeking accountability and redress for their losses. Over 11,000 such cases have since been filed.

DePuy hip implants trials and settlement negotiations are underway. Though, the legal ramifications of the defective hip implants will likely continue for a while into the future. That is because there are so many who have been affected, and because some patients may eventually be harmed in the future. The defective metal-on-metal hips designed by DePuy Orthopaedics were only recalled a pair of years ago, and ill-effects sometimes take several years to develop. That means that some patients may seem fine now, but suffer injury as a result of the defect down the road.

The DePuy lawsuits are obviously intended to ensure those harmed receive fair compensation for their losses, including medical bills, lost wages, pain and suffering. In addition, however, many DePuy injury lawyer are also working to ensure that lessons are learned from this situation so that fewer dangerous medical devices make their way into patient bodies in the future. One key aspect of that battle is fixing the current process by which those products are approved by federal regulators and become legal to use.

Altering the FDA Approval Process

Certain versions of metal-on-metal hip implants designed by DePuy Orthopaedics–a subsidiary of Johnson & Johnson–were recalled in August 2010. The recall came only after many concerned advocates raised questions about the potential harm caused by the product. Since then even more information has emerged about what company officials knew of the risks of the products and their awareness of the potential harm that they could cause to unsuspecting patients.

Since the recall thousands of patients have had their own DePuy hips fail, with varying damages and often requiring risky (and costly) revision surgery. Many of those patients have since filed Depuy recall lawsuits, now totalling nearly 11,000.

Considering the total number of affected patients, and the significant number of lawsuits already filed, it will be quite some time before these matters are completely resolved. That is especially true considering more patients are still coming in as their metal-on-metal hip implants begin failing and causing them harm.

Those who have been following along with the developments in the DePuy hip implant cases know that the first trial–of perhaps many–is now underway. The legal battle pits the orthopaedic company (and its parent Johnson & Johnson) against patients who were harmed after a certain type of its metal-on-metal hip implant system was installed in their body. The information that has come out over the course of this first trial is some of the first that provides an inside glimpse into what the company knew about the device risks while marketing it across the country.

The specific legal details surrounding these cases are somewhat complex, because they often implicate general negligence and product liability matters, with varying proof requirements and elements. At the most basic level it is important to know that what a plaintiff must show to recover in one of these cases–where a defective product is involved–is often different than when one is harmed by something else (i.e. a bad driver or a negligent doctor).

However, as in most cases related to medical conduct or medical products, one of the centerpieces is the testimony of experts. Because the jury is made up of a wide swath of society with most (or perhaps all) of its members without a medical background, experts are brought in to explain, in their own opinion, the detailed medical issues involved. Of course, each side will bring their own expert, and the two will essentially say the opposite thing. However, during cross examination it is often possible to bring up weak points regarding the experts’ claims or to suggest biases which might influence their testimony. In this way juries (or a judge) are best positioned to made a judgment about what side is likely correct. It is not foolproof but it is far and away the best system we have to make reasoned decisions about complex matters when parties vehemently disagree.

Patients who are harmed by medical malpractice often have to go through various stages of a lawsuit before finally getting straight answers about what happened in their case–or that of their loved one. Unfortunately, obfustication and attempting to cover up errors is far too common in the medical setting. It is obvious why individual professionals might want to cover up their own mistakes. But what makes things even more difficult is that colleagues or others with knowledge of the situation rarely speak up either. The result is that a code of silence permeates in some medical settings. That failure to speak up can prevent those harmed from learning about their situations. In other settings the silence may also allow more and more patients to be harmed.

The New York Times recently shared a story on this issue, using the metal-on-metal DePuy hip recall as an example.

DePuy Hip Recall Delayed

Certain metal hip implants from DePuy Orthopedics (a Johnson & Johnson company) were recalled in 2010. However, before the recall tens of thousands of patients received the products, including many in Chicago and throughout Illinois. Many legal challenges were eventually filed which sought accountability for the thousands of patients who subsequently suffered injury as a result of the dangerous products being surgically implanted into their bodies.

The first of those cases are now making their way to trial. In the lead-up to the courtroom some documents are being released publicly which shed light on what the company knew about the risks of the implants and when they knew it.

Internal Hip Implant Investigation Documents

All medical operations are somewhat delicate procedures. That is why it is obvious that the devices used in those procedures–from medical tools to implants–need to be safe and secure. Most medical patients assume that there are regulations in place so that not just any device is used when they go in for medical treatment or an operation. One assumes that there will be testing and trials for most products so medical professionals know that they are safe before they are used in a way which might harm thousands of patients.

Sadly, many of those assumptions are incorrect. Often is is not until a product causes significant harm that its lack of safety is verified. That was evidenced vividly over the last few years with the recall of thousands of metal-on-metal hip implants which were discovered to cause serious harm to thousands of patients. Readers are likely familiar with the two most high-profile cases, the Stryker hip implant recall and the Depuy recall. Our attorneys work with residents who were harmed by these products. Thousands of medical patients across the country, including in Illinois, were forced to endure painful revision surgeries and deal with other medical complications as a result of receiving these faulty devices.

The 501(k) Approval Process

Recently the American Association for Justice (AAJ) issued a letter explaining the latest developments in a case with implications for all those working on matters involving defective medical devices. The issue of preemption is invovled in the case related to state and federal rules for off-label promotion of the devices. In other words, this is a matter of a company violating rules in order to get its products used in ways that were not approved by regulators.

The Latest Case

The AAJ letter explains that the case, Sandager v. Medtronic, Inc. stems from complaints by a plaintiff that she was harmed by a bone-graft product as a result of that product’s illegal promotion. The device was not approved by the U.S. FDA for the use in the way that the plaintiff received it. These illegal marketing issues are quite common in many settings, including medical devices and pharmaceuticals.

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.

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.”
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