FDA Updates Exactech Hip Implant Recall

The U.S. Food and Drug Administration prompted medical-implant manufacturer Exactech to expand its voluntary hip implant recall to all models, not just some of them.

Exactech joint replacement devices are used to replace painful, arthritic joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and loss of normal structure and function in adults.

These devices are also used to improve previously failed joint replacement devices with adequate bone and soft tissue. All Exactech joint replacement devices contain a plastic component which should be in packaging that contains multiple oxygen-barrier layers as indicated in the package specification. The recalled devices were packaged in defective bags that were missing one of the oxygen barrier layers that protect devices from oxidation.

The FDA continues to work with Exactech to assess whether any of its other joint implants that contain polyethylene components packaged in defective bags may result in increased oxidation and similar risks. 

Voluntary Hip Implant Recalls

A hip implant or other product recall is like closing the barn doors after the horses run off. When the FDA recalls a dangerous medical device, people have already been hurt or at least put at unnecessary risk for serious injury. Furthermore, a recall does not compensate these survivors for their economic losses (medical bills) and noneconomic losses (pain and suffering). Only an experienced defective-medical-implant lawyer can help victims get the justice the deserve.

If you or a loved one has been harmed by a defective Exactech hip implant, call us today for a free consultation (1-800-967-8529). If you have a case, we will help you get the justice you deserve

Additionally, an FDA “recall” is not exactly what most people would think of a “recall.” By law, the Food and Drug Administration cannot unilaterally recall products, no matter how dangerous they are. In a few cases, FDA bureaucrats can limit marketing activities or unilaterally take another action that is not particularly effective. But in most cases, the FDA can only publicly pressure companies to voluntarily recall their own products.

Even then, a product recall is usually a sales modification. The company adds a warning to a dangerous product and keeps selling it. Warning labels, especially in defective hip implant cases, create several legal issues. More on that below.

Exactech Hip Implant Issues

Metal-on-metal hip implants have a long and unsafe history. Most of these defective hip implants have design or manufacturing defects. However, Exactech’s defective implants have packaging issues. Therefore, the product is defective before a doctor even implants it.

Once upon a time, hip implant durability was not an issue. Most hip implant recipients were semi-retired people who were not physically active. Then, in the late 1990s into the early 2000s, people in their fifties and even forties started getting replacements. To cash in on this uptick, manufacturers began taking shortcuts.

But we are getting a little ahead of ourselves. Some metal-on-metal hip implants were defective before they reached consumers. The hip is basically a cup-and-socket joint. When the all-metal parts grind together, the friction releases tiny metal fragments into the body and causes metallosis (metal poisoning). 

Most manufacturers addressed this design defect by replacing some of the metal parts with ceramic parts. But the design defect was only part of the problem.

To cope with the increased demand, many hip implant manufacturers bought inexpensive parts from China and other overseas countries. These countries often have lax or nonexistent product safety laws. Therefore, many imported implant parts had high levels of mercury, cadmium, and other dangerous heavy metals.

The human body cannot process these toxic particles in unnatural amounts, so they accumulate in the body and cause a host of serious health problems.

Exactech hip implants, however, have a unique problem. The packaging does not properly prevent oxidation. A loaf of bread gets stale if you do not tie it up properly to keep the air out. Similarly, hip implants degrade if they are not tied up properly to keep the air out.

These defects lead to premature device failure. While routine, implants are still an invasive surgery, especially on older individuals. Once the device fails after implantation, a surgeon must fish the broken device out of the body and replace it with a new device—yet another invasive procedure. These multiple surgeries usually rob survivors of what little mobility they have left, assuming they are candidates for such risky procedures in the first place.

Your Legal Options

Survivors need and deserve financial compensation for device failure and other injuries. Additionally, the manufacturers who sold such products should accept responsibility for causing such problems in the first place. If a personal injury attorney files a legal action, that filing kills two birds with one stone. Defective implant survivors receive compensation. At the same time, companies face financial and reputational consequences.

Most attorneys file negligent failure to warn legal actions in these cases. Companies pride themselves on quality control measures. These companies are fully aware that the products they sell are defective. They just hope that if survivors file legal actions, they can beat those legal actions in court. These legal actions have basically four components:

  • Duty: Exactech and other companies have a duty to identify device safety issues—such as improper oxidation protection—and a duty to warn customers about them. This warning must be proportionate to the risk.
  • Breach: Exactech and other companies breach their duty of care when they do not warn customers or do not adequately warn them (e.g., placing a device failure warning on a long list of mild side effects). A personal injury lawyer typically partners with an industry expert who establishes the standard of care and testifies about the breach of care.
  • Cause: In most states, survivors must prove, by a preponderance of the evidence (more likely than not), that the failure to warn substantially caused their injuries. The standard is slightly different in some states. Plaintiffs must also establish foreseeability (possibility) of injury.
  • Damages: Device failure causes physical injuries. Device failure also causes emotional injuries. Compensation is available for both.

Assumption of the risk is one of the most common defenses in weak-warning cases. Companies like Exactech include serious side-effect warnings in the fine print. These warnings could reduce compensation in the case if the survivor saw the warning, could read the warning, and could understand what the warning meant.

In most states, jurors must divide injury responsibility on a percentage basis. For example, jurors might conclude, based on the evidence, that the company was 80% at fault for using defective packaging, and the survivor was 20% at fault for not heeding the warning.

Work with a Compassionate Defective Exactech Implant Lawyer

If you or a loved one had a defective Exactech hip implant removed after suffering harm, you may have a case, and The Yost Legal Group wants to help you seek justice. Injury victims are entitled to significant compensation for the harms they suffered. Call today: 1-800-967-8529.

Allergan Breast Implant Recall: What You Need to Know

In 2019 Allergan issued a voluntary worldwide recall of their Biocell textured breast implants and tissue expanders. This came amid reports of women with Biocell implants and expanders developing breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma that brutally attacks the immune system.

Allergan Breast Implant Warranty Will Not Cover Operative Costs

Allergan announced that they will work with harmed parties by replacing defective textured implants with smooth implants under the BIOCELL replacement warranty, although they will not be providing or assisting with operative costs or fees. This means the only cost covered is for the product alone, not the operation or any other associated costs.

What is BIA-ALC?

Specifically linked with Allergan Biocell textured breast implants and tissue expanders, breast implant associated anaplastic large cell lymphoma (BIA- ALCL) is not a type of breast cancer. BIA-ALCL is a very rare and slow-moving blood cancer that attacks the immune system.

Typically, ruptured blood cells secrete seromas – pockets of fluid – which build up within the fibrous scar capsule encompassing the implant where the BIA-ALCL cultivates. An extraction of that fluid should be tested for a protein called CD30 which is found in “higher than normal” amounts on lymphoma cells. It is reported to take seven to 10 years to progress and present itself, so it is highly recommended that women who have undergone reconstructive surgery are screened regularly for cancer growth.

How Common is it?

Reports in the US alone total an alarming 355 confirmed cases between July 2019 and January 2021 of the 733 confirmed cases worldwide. Since then, the FDA announced over 35 women had died as a result of contracting BIA-ALCL.

What Can I Do?

No studies show how to prevent this disease, but if you acquire any symptoms such as breast pain, lumps or swelling you should contact your doctor immediately to discuss all concerns. The good news is that BIA-ALCL is completely treatable when found early, by performing an “en bloc capsulectomy” in which the implant and any surrounding scar tissue are completely removed.

What about the BIOCELL replacement Warranty?

Currently the BIOCELL replacement warranty only covers the cost of the implants that are ruptured, defective, or deflated. In November of 2021, they updated their warranty to pay up to $7500 for revision surgery required after developing cancer from their product. It is important to note- this offer is only available to those who have received a BIA-ALCL diagnosis. In exchange, you must waive your right to legal action in the future. Additionally, the warranty does not cover the costs associated with pain management, treatment, and additional appointments required because of the cancer or other complications.

Prior to signing any agreements with Allergan, call for a free consultation- you may be entitled to compensation beyond just the cost of revision surgery.

Do I Have A Case?

While there are manufacturers producing implants other than Allergan or McGhan, there are no current litigations currently linking BIA-ALCL with other styles. Because the evidence of scientific studies currently show BIA-ALCL is not as common in other implants, for now we are only pursuing Allergan and McGhan textured implants. As time goes on, things may change regarding the correlation between other implants and BIA-ALCL. If you have any questions about your eligibility, please contact us for a free consultation.

The Time to Act is Now.

If you or a loved one have been diagnosed with BIA-ALCL after a breast implant surgery, you do not have to go through this process alone. Please contact our experienced attorneys at The Yost Legal Group for a free case evaluation. We can be reached by email or phone at info@yostlaw.com or 1-800-YOST-LAW, or you can fill out our web inquiry form and we will respond to you as soon as possible.  We will investigate the circumstances of your individual case, answer any questions you have, and fight to get you the compensation you deserve.

Allergan Breast Implants Linked to Rare Cancer

In an informative new video brought to you by The Yost Legal Group, Founding Attorney Tom Yost explains the alarming, established link between Allergan’s popular texturized breast implants and tissue expanders and a rare form of non-Hodgkin’s Lymphoma. This type of cancer is called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Allergan failed to warn women of their products’ link to cancer, and due to their negligence, hundreds of thousands of women are at risk of developing cancer.

Allergan Did Not Complete FDA-Required Studies, Did Not Warn Women About Link to Cancer

Allergan had been required by the FDA to complete safety studies after their product went on the market as a condition of FDA approval. However, they did not complete these tests. When their products’ link to BIA-ALCL was made apparent, Allergan withheld this information and did not inform women of this serious risk.

Instead, patients were offered the Confidence Plus Warranty Program, which would offer free Allergan replacement breast implants. However, in exchange for this warranty program, patients were asked to sign a release of all claims against Allergan. Many patients were unaware of the relinquishment of their rights.

Allergan Breast Implants Responsible for Majority of Reported Breast-Implant Related Cancers

 Due to Allergan withholding information about the link to cancer, hundreds of thousands of women are at risk of developing BIA-ALCL. In fact, Allergan products are responsible for more than 80% of reported breast implant-related cancers.

What Are The Symptoms of BIA-ALCL?

  • Breast pain and swelling
  • Fluid accumulation at the implant site
  • Skin rashes
  • Lumps or masses

How Long After Surgery Does it Take for BIA-ALCL to Manifest?

It can take years after implant surgery for cancer to develop. It is reported that it can take on average 9 years after the implant surgery for BIA-ALCL to manifest.

What Should You Do if You Have Allergan Implants or Tissue Expanders?

Those with Allergan implants are advised to have continued and frequent cancer screenings. The FDA has advised recipients of these implants against removal surgery unless they have been diagnosed with this cancer or are experiencing symptoms.

The Skilled Defective Products Attorneys at The Yost Legal Group Are Here to Help

If you have received Allergan textured breast implants or tissue expanders and developed BIA-ALCL or have since had them surgically removed, you may be entitled to compensation. At The Yost Legal Group, our team of attorneys will provide you with answers and help recover the best possible compensation for your experience. Contact us today by submitting a contact form online or calling our office toll-free at 800-YOST-LAW today for a free legal consultation.

RoundUp Lawsuit

As Monsanto’s flagship product, the weed killer Roundup generates approximately $5 billion in annual sales for the company. In March of 2015, the International Agency for Research on Cancer (IARC), part of the highly respected World Health Organization, reported that Roundup contains a probable cancer causing chemical called glyphosate. Cases of persons suffering from the cancer known as non-Hodgkin lymphoma caused by exposure to Roundup have been filed and consolidated in a federal court Multi-District Litigation (MDL) in San Francisco. Documents produced in the MDL show that Monsanto desperately tried to hide information about the dangers of Roundup from the public in the form of falsified studies and protection from government agencies.

IARC’s report exposing Roundup’s glyphosate as a probable cause of cancer was supported by numerous scientific research studies. In particular, research studies, including one conducted as early as 2002, found an association between glyphosate and the cancer known as non-Hodgkin lymphoma. Faced with the damning evidence published by IARC, Monsanto struck back with a vengeance. Monsanto approached various regulatory departments of United States governmental agencies for the purpose of keeping information about its cancer causing Roundup a secret. Documents produced in the federal court MDL show that the Environmental Protection Agency (EPA) and the Department Health and Human Services conspired with Monsanto to hide Roundup’s glyphosate connection with causing cancer. Additionally, Monsanto conducted fraudulent studies designed to deceive governmental agencies and the public into concluding that Roundup’s glyphosate is safe and does not cause cancer. Monsanto submitted its phony studies to the EPA. Based on these studies, the EPA initially reported that Roundup’s glyphosate was “not likely to be carcinogenic,” but were later forced to remove this unsupported statement from the EPA website.

Monsanto’s dishonest effort to keep their carcinogenic product Roundup on the market displays a clear disregard for human life. Roundup constitutes one third of Monsanto’s sales revenues, leaving little doubt as to the motive for their shameful behavior. However, despite its power as a big corporation, Monsanto’s day of reckoning may not be far off. To date, more than 50 cases have been filed against Monsanto for cancer caused by Roundup in state and federal courts. The federal cases have all been consolidated into one Multi-district Litigation in San Francisco. The Monsanto Roundup litigation continues to grow, as lawsuit filings are increasing. It is anticipated that this litigation will ultimately grow to include thousands of cases and they will collectively hold Monsanto responsible for destroying countless lives for the sake of profit.

Roundup remains on the market as a product commonly used by many Americans, including farmers, landscapers, and gardeners. While the use of this toxic herbicide product remains common, its lesser known cancer causing risks are quickly coming to light.

If you or a loved one has non-Hodgins lymphoma cancer that may have been caused by exposure to Roundup, the experienced Mass Tort lawyers at The Yost Legal Group are here to help. Call The Yost Legal Group today at 1-800-YOST-LAW (967-8529) for a FREE, confidential, no-obligation consultation. At The Yost Legal Group, there is no fee or expense unless you recover.

Hip Replacement Manufacturer To Pay Over $1 Billion in Major Settlement

Stryker Corp, a major manufacturer of artificial hip implants, announced on Monday, November 3rd that it has reached a settlement agreement with the thousands of patients that were harmed by their all-metal Rejuvenate and ABG II hip-replacement models.

Stryker, a subsidiary of the DePuy division of Johnson & Johnson, originally recalled these models in July of 2012, citing numerous complaints by patients and medical professionals alike that the metal-on-metal construction caused serious complications. In almost all cases, the all-metal artificial joints corroded quickly, causing inflammation in the tissue surrounding the implants, as well as elevated levels of dangerous metals in the blood.

This settlement deal will cost Stryker over 1 billion dollars, making this agreement one of the largest sums paid by an implant manufacturer in the last year. An estimated 250,000 hip replacement procedures take place around the country every year, and metal-on-metal devices once accounted for nearly two out of every three of these procedures.

This number has plummeted since the original Stryker recall, with physicians now recommending hip replacement devices that use a combination of plastic, ceramic and metal materials.

The defective product and medical malpractice attorneys of The Yost Legal Group have a proven track record of standing up to big manufacturers and securing the maximum compensation for our clients that have suffered due to negligent or defective medical devices. If you or a loved one have experienced any of the following symptoms due to a metal-on-metal hip implant, contact the experienced attorneys at The Yost Legal Group immediately:

  • Osteolysis, or bone dissolution
  • Synovitis, or inflammation of the synovial membrane in joints
  • Pseudo-tumors
  • Joint fluid
  • Tissue or bone necrosis
  • Hypersensitivity to metal

Medical devices are designed to reduce pain and increase mobility and longevity. When these procedures instead cause pain, complications and unforeseen expenses, it is important to have an experienced attorney on your side. The caring product liability attorneys at The Yost Legal Group will speak with you for free to discuss your situation and help you understand your rights.

Cal 1-800-YOST-LAW (1-800-967-8529) now for a free confidential consultation.

The Yost Legal Group, Experienced Lawyers Dedicated to Protecting your Rights.