Articles Posted in Decall Hip Recall

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It has been awhile since we’ve discussed the latest developments in the DePuy hip recall case. Many might remember that several years ago–in 2010–there was a large recall of DePuy ASR hip implant systems. At the time, over 90,000 such implants were on the market, with anywhere from 30-40% of them in the United States. DePuy Orthopaedics is an arm of the large business conglomerate Johnson & Johnson.

Over the past few years thousands of patients who received these products came forward sharing stories of complications which may have been caused by the faulty metal-on-metal design of the ball and socket device.

It was not long before those patients began using the civil justice system to demand accountability and redress. We reported a few months ago on the first resolution in trial where a jury returned a verdict for the plaintiff against Johnson & Johnson, awarding the injured party several million dollars for the harm caused by the defendant’s negligence.

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Over the past few weeks a trial was underway in the first case alleging harm caused by the now-recalled versions of the Depuy hip implants. As we have often discussed in the last two and a half years, several thousand similar claims have been made, all alleging various harm caused by lack of proper warning and prudent action by Depuy Orthopaedics (and parent company, Johnson & Johnson). The company has already set aside significant sums of money in anticipation of the litigation and eventual payouts to those affected.

It remains unclear how each individual case will be handled. However, the end of this first trial is a good indication of how these matters may ultimately play out.

Verdict for $8.3 Million

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Perhaps no major medical device recall has affected more seniors in recent years than the DePuy hip implants. Many local residents were convinced to have the implant surgery by their doctors who then used products of their choosing–sometimes certain metal-on-metal devices. It was only later that some of those seniors began having medical problems connected to the implant.

All of this eventually led to the recall of two version of DePuy metal-on-metal hip implants after the failure rate of the devices rose well beyond acceptable. The recall was a few years ago and since then thousands of patients who received the devices have filed suit seeking compensation for the significant harm caused by the products. The legal claims usually suggest that the products were defectively designed and that the company failed to properly warn consumers of the dangers of using them.

DePuy Trial

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Employees in most workplaces share a feeling of trust and sense of community. In some cases those feelings may actually persist across individual workplaces and thrive among all professionals in the same field. Lawyers are certainly not immune to this. While we may disagree vigorously in the courtroom, there exists a share of congeniality and shared experience among many attorneys. This is not surprising, considering that similar educational backgrounds, interests, strengths and knowledge makes it easy for bonds to be built.

All of this is a good thing in most cases, allowing workplaces and professional actions to run smoothly. Yet, there are some situations where a failure to speak out against colleagues or others in the same profession can cause real harm. That is perhaps most evident in the medical field. When the health of community members is on the line, then it is obviously critical that medical professionals place patient well-being above all else–even when it conflicts with professionals relationships or the status quo.

The New York Times recently shared a story on doctors who remain silent when presented with disturbing issues related to patient safety. The Depuy hip implant example is used to show how patients may be harmed seriously as a result of professionals’ unwillingness to speak out in a timely fashion, even if it may ruffle feathers.

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Many Chicago area seniors have had hip implants in the last few years. Unfortunately, some received dangerous “metal on metal” implants, including those designed and manufactured by DePuy Orthopedics–a subsidiary of Johnson & Johnson. Our hip implant injury lawyers are working with individuals who have been harmed by these products.

As most are now aware, the metal on metal implants have been shown in many models to have high failure rates. That means that the implants cause harm or break down at far too fast a rate. This often requires revision surgery and other treatments to try to deal with the complications.

It is important for families to know that these failures are not acceptable. In fact, evidence continues to mount that the company which designed and built the devices knew that the hips posed serious risks of harm.

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Over the last several years many seniors and their families were affected by problems with metal-on-metal hip implants that they received. From the Depuy hip recall to those affecting Stryker products, tens of thousands of residents faced the anxiety of potentially problematic medical devices installed in their bodies. Many had to undergo complex revisions surgeries and deal with serious medical complications.

In the aftermath of these high-profile problems, many began asking questions about the federal approval process for these products. After all, not just any device can be sold and used in medical procedures, right? Isn’t there a stringent safety process for these tools to ensure these very mass-recalls are prevented?

The truth is quite complicated, and a wake-up call for all consumers who assume that federal regulations protect them from inherently dangerous products. A recent New England Journal of Medicine (NEJM) article provides a comprehensive summary of the complex history behind the metal-on-metal hip implants and the Food and Drug Administration approval process. All those interested in these issues should check out the full article.

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Many seniors in Chicago and throughout Illinois face mobility problems. To help, full knee and hip replacements are often recommend by medical professionals to ease various ailments that affect those joints. When successful, the replacements can offer welcome relief to seniors who have spent years faced with pain and movement issues.

However, like all medical procedures, it is absolutely critical for community members to understand the risks of each operation. All medical treatment has some risk, and that is why it is critical for patients to be informed about their options before going forward. Of course, at the end of the day it is up to the patients to decide if they want to go ahead or not. But just because the patient has the ultimate say does not mean that doctors and medical professionals are not without some obligation to provide accurate information about those risks, taking them into account when making recommendations to the patient.

Failure to Identify Risks

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News about defective hip implants continued to roll in this week as it now appears that a U.S. Senate Special Committee on Aging will hear testimony today about the dangerous devices. Mass Device indicates that the hearing is connected to a large scale Senate investigation around the approval process currently available for medical devices and the effect of that process of patient safety. As the DePuy hip recall clearly showed, questions abound about the way in which devices are often rushed to market and harm unsuspecting medical patients.

The testimony in front of the subcommittee puts Johnson & Johnson-the conglomerate that owns DePuy-right in the middle of the federal investigation evaluating that medical device approval process. After the testimony of the Johnson & Johnson executives, the committee will hear from one of the victims of the recall-many Illinois nursing home residents have found themselves in circumstances just like the victim representative.

Following that personal appeal, a national researcher will touch on the broader issue and explain new data that reveals that devices that are approved through the 510(k) pre-market notification program usually include many more recalls than normal. This alternative approval process allows devices to reach consumers sooner, bypassing the Food and Drug Administration’s more comprehensive PMA protocol. This “short-cut” often has the effect of glossing over problems with involved devices.

“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,” said the Senate subcommittee, adding that “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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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.
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Many senior citizens face hip problems. A lifetime of work typically takes its toll on individual bones-joints are particularly susceptible to problems because of the continual movement and stress on the area. It is important for many nursing home residents to take special care that they avoid hip injury caused by slips and falls.

According to MedlinePlus there is even more reason for seniors to pay close attention to their hips-broken hips may increase the risk of stroke. A new study was just released which showed that patients with broken hips were 50% more likely to have a stroke within the next year. More research is to be conducted before the cause of the link is identified. One potential reason for the connection was the psychological distress and inactivity that comes with broken hips, which may increase the stroke potential.

It is information like this that makes the recent DePuy hip recall even more distressing. The consequences suffered by the victims of the defective hip implants may never be fully known.
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