Published by If you or a loved one experienced serious complications, infections, or hernia recurrence following AlloDerm skin graft surgery, you may be entitled to pursue compensation.
At Schmidt & Clark, LLP, we are dedicated to helping individuals who have suffered due to defective medical products.
Our experienced legal team is here to guide you through the process and fight for the compensation you deserve. Contact Schmidt & Clark, LLP today for a free, no-obligation consultation.
AlloDerm Lawsuit Overview
AlloDerm lawsuits target LifeCell Corporation for producing allegedly defective skin grafts that have caused serious complications in hernia repair patients.
These legal actions claim the company aggressively marketed the product off-label for hernia surgery despite high failure rates.
Over 300 lawsuits have been filed in New Jersey state court alone, with nearly 10% filed within a 45-day period.
Patients report requiring painful revision surgeries after experiencing hernia recurrence, infections, and other serious complications.
Latest AlloDerm Lawsuit Updates
- January 2025 – The number of lawsuits filed in New Jersey state court over LifeCell Corporation's controversial AlloDerm product has surpassed 300, with nearly 10% of the complaints entered in just 45 days. The litigation continues to expand as more patients report complications.
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2014 – A Virginia federal jury awarded LifeNet Health $34.7 million in damages after determining that LifeCell's AlloDerm and related products infringed on LifeNet Health’s patent concerning tissue graft preservation. The verdict underscored ongoing legal challenges tied to the use and development of AlloDerm products [1].
- 2013 – In a significant development, New Jersey courts saw rapid growth in AlloDerm litigation, with the case count exceeding 300. Almost 10% of these complaints were filed within a 45-day period, highlighting the increasing recognition of problems associated with the product.
- September 2005 – The FDA announced that LifeCell had issued a recall of certain AlloDerm, Repliform, and GraftJacket products from the U.S. marketplace.
The recall was initiated when internal quality processes raised questions about the donor documentation received from a tissue recovery organization called Biomedical Tissue Services (BTS).
According to reports, there had been allegations that BTS was harvesting tissue from cadavers without first obtaining the proper documentation.
FDA Reports and Statistics
Between 2007 and 2009, at least 29 adverse event reports involving AlloDerm hernia patches were reported to the FDA. These reports highlighted serious complications requiring medical intervention.
In a clinical study involving 70 test subjects who received AlloDerm patches for hernia repair, researchers documented one case of rejection, two infections, and 14 hernia recurrences – indicating a 20% complication rate in the study population [2].
Another study revealed that almost 10 percent of AlloDerm recipients required additional revision surgery to remove defective grafts, suggesting a significant rate of product failure necessitating further medical procedures.
The Medical Product Safety Network (MedSun) has received numerous reports documenting a pattern of serious complications associated with AlloDerm when used for hernia repair, particularly noting that studies of patients with AlloDerm implants show the shortest follow-up period and highest overall failure rate compared to other products.
AlloDerm Injuries & Side Effects
AlloDerm skin grafts have been linked to numerous serious complications, particularly when used in hernia repair procedures.
Recent studies show an extremely high rate of hernia recurrence in patients whose abdominal hernias were repaired with these grafts.
- Hernia Recurrence: Studies show AlloDerm has a higher failure rate than alternative products, with one study reporting 20% of patients experiencing hernia recurrence
- Infections: Potentially life-threatening infections have been reported, requiring additional medical intervention
- Development of Abscesses: Painful collections of pus that may require surgical drainage
- Graft Failure: Including tearing, perforation, and explant of the mesh patch
- Tissue Damage: Injury to organs, blood vessels, and other tissues near the patched area
- Adhesion Failure: Improper healing of surgical incisions and failure of the graft to adhere
- Mesh Erosion: Breakdown of the mesh material causing additional complications
- Post-Operative Issues: Including inflammation, swelling, bulging, pain, and extreme discomfort
Do You Qualify for an AlloDerm Lawsuit?
You may qualify for an AlloDerm lawsuit if:
- You received an AlloDerm skin graft, particularly for hernia repair.
- You experienced serious complications such as hernia recurrence, infection, or required revision surgery.
- Your complications required additional medical treatment or hospitalization.
- You can provide medical documentation linking your injuries to the AlloDerm product.
Evidence Required for an AlloDerm Lawsuit
To build a strong case for your AlloDerm lawsuit, you should gather:
- Medical Records: Documentation of your original surgery, complications, and any revision procedures.
- Product Information: Proof that AlloDerm was used in your procedure.
- Physician Statements: Documentation from healthcare providers linking your complications to the AlloDerm graft.
- Treatment History: Records of additional treatments, hospitalizations, or medications required due to complications.
Damages You Can Recover
Victims of AlloDerm complications may be eligible to recover:
- Medical Expenses: Costs for additional surgeries, treatments, medications, and hospital stays.
- Lost Wages: Compensation for time missed from work due to complications and recovery.
- Pain and Suffering: Damages for physical pain and emotional distress.
- Punitive Damages: In cases of gross negligence or willful misconduct by the manufacturer.
AlloDerm Recall Information
In September 2005, the FDA announced that LifeCell had issued a recall of certain AlloDerm, Repliform, and GraftJacket products from the U.S. marketplace.
The recall was initiated due to concerns about donor documentation received from a tissue recovery organization called Biomedical Tissue Services (BTS).
According to reports, there had been allegations that BTS was harvesting tissue from cadavers without first obtaining the proper documentation.
Before tissue can be legally harvested, permission must be obtained by the donor while he or she is still alive or from the immediate family after death.
This improper documentation not only caused distress for surviving family members but also raised serious concerns about the safety and screening of the tissue used in AlloDerm products. Many patients were forced to undergo additional revision surgeries to remove and replace the recalled products.
Statute of Limitations for AlloDerm Lawsuits
Time limits for filing an AlloDerm lawsuit vary by state, typically ranging from 1-3 years from the date when complications were discovered or should have been discovered.
These statutes of limitations make it crucial to consult with an attorney as soon as possible after experiencing complications.
Some states may apply the "discovery rule," which means the statute of limitations begins when you discovered or reasonably should have discovered that your injury was related to the AlloDerm product. However, this varies significantly by jurisdiction, making prompt legal consultation essential.
Also read: Hernia Mesh Patch Suit
Check out our website to find out which medical device lawsuits our lawyers are currently accepting.
FAQs
1. What Is AlloDerm and How Is It Used?
AlloDerm is a type of skin graft made from acellular cadaveric dermal matrix, meaning skin cells harvested from cadavers are processed and used as grafts. Originally developed in 1994, it was initially used for treating burn patients but later marketed for hernia repairs, dental procedures, and breast reconstruction following mastectomies.
2. Why Was AlloDerm Approved by the FDA?
During pre-approval development, the FDA weighs potential benefits against risks. Even if side effects exist, approval may be granted if benefits are thought to outweigh risks. However, FDA approval does not guarantee product safety, as post-market use often reveals a higher prevalence of complications than estimated during testing.
3. How Common Are Complications with AlloDerm?
Studies have shown concerning complication rates. In one study of 70 patients with AlloDerm hernia repairs, researchers documented one rejection, two infections, and 14 hernia recurrences (20% complication rate). Another study found nearly 10% of recipients required revision surgery to remove defective grafts.
4. What Should I Do If I've Had an AlloDerm Graft and Am Experiencing Problems?
If you're experiencing complications after receiving an AlloDerm graft, seek immediate medical attention to address your symptoms and document the issues. Then, consult with an attorney experienced in medical device litigation to evaluate your potential legal claim and options.
5. Can I File a Lawsuit If My AlloDerm Graft Is Out Of Warranty?
Yes, you can still file a lawsuit if your AlloDerm graft is out of warranty, especially if the issues are related to inherent defects or safety failures. An attorney can help determine if you have a valid claim regardless of warranty status.
6. What Evidence Is Needed To Support My AlloDerm Lawsuit?
Essential evidence includes medical records documenting your complications, records of any additional surgeries, proof of the AlloDerm graft, and expert testimony linking the graft to your health issues. Preserving all medical documents related to your original procedure and subsequent treatments is crucial.
7. Can I Seek Punitive Damages In The AlloDerm Lawsuit?
In cases of gross negligence or willful misconduct by the manufacturer, you may be eligible to seek punitive damages in addition to compensatory damages. These are intended to punish the defendant and deter similar behavior in the future.
Get Your Free AlloDerm Lawsuit Evaluation From Our Lawyers
Time is limited to pursue legal action for AlloDerm complications. Many states restrict the filing period to just 1-3 years from the date of injury discovery, after which your right to compensation may be permanently lost.
Our specialized legal team at Schmidt & Clark, LLP offers:
- Free, confidential case evaluations to determine your eligibility
- No upfront costs or fees for representation
- Payment only if we secure compensation for you
- Experienced representation against major medical device manufacturers
Don't delay seeking the justice and compensation you deserve. The number of AlloDerm lawsuits continues to grow as more patients discover complications related to these products.
Reference:
- https://www.lifenethealth.org/news/lifenet-health-successfully-defends-patent-wins-347m-verdict#:~:text=VIRGINIA%20BEACH%2C%20VA%2C%20NOVEMBER%2019,that%20the%20patent%20was%20invalid.
- https://www.sciencedirect.com/science/article/abs/pii/S1072751507007648