Ethicon is a subsidiary of Johnson & Johnson and a manufacturer of hernia mesh systems and products. Many of these products, however, cause serious injuries to patients. Lawsuits over the failed hernia mesh devices have been filed in pursuit of compensation. If you have been injured by an Ethicon hernia implant, you may be eligible for compensation as well.
- 1. Why are hernia repair patients filing lawsuits against Ethicon?
- 2. What is the status of current lawsuits against Ethicon?
- 3. What is the timeline of Ethicon’s hernia mesh product line?
- 4. How do I know if I qualify to file a lawsuit against Ethicon for the defective hernia mesh product used in my hernia repair surgery?
1. Why are hernia repair patients filing lawsuits against Ethicon?
Hernia repair patients who have had an Ethicon hernia mesh implant, like the Physiomesh, Proceed mesh, or Prolene mesh, are filing lawsuits alleging:
- Defective mesh design, and
- Failure to warn patients and physicians about the risks to patients.
1.1 What is the defective design and associated risks of the Physiomesh?
The Physiomesh has a unique design where five layers are incorporated into one mesh:
- Two layers of poliglecaprone-25 film that covers
- Two underlying layers of polydioxanone film that coats
- One polypropylene mesh.
Plaintiffs contend this five-layer approach actually prevented incorporation of the mesh once implanted and contributed to serious complications, like:
- Hernia recurrence
- Additional surgeries
- Inadequate repair
- Bowel obstruction
- Sepsis, and even
It is believed the coating on both sides of the mesh did not allow the product to incorporate with the host tissue. The polypropylene portion of the mesh was also insufficient to withstand the hernia. Cases of herniation through the mesh and deformation of the mesh have been reported to the U.S. Food and Drug Administration (FDA). 1
1.2 What is the defective design and associated risks of the Proceed?
The Proceed is a light-weight polypropylene hernia mesh product coated with an Oxidized Regenerated Cellulose (ORC) fabric. There are several primary problems associated with the design of this product:
- The polypropylene disintegrates or breaks after implantation. This disintegration causes bowel complications. Numerous adverse reports stating the same have been submitted to the FDA with the first sent in February 2007. 2
- The mesh is prone to shrinking and contracting. The Proceed is sterilized with radiation, and this process causes the product to shrink in a shorter period of time. When the polypropylene degrades and shrinks, it can then migrate. Migration causes serious injuries, including but not limited to organ perforation, infection, adhesion, and bowel obstruction. The first adverse report was sent to the FDA in May 2009.3
- The implant is prone to tearing. This mesh is light-weight, made of a soft polypropylene material. The material, however, is prone to ripping or tearing easily. This makes handling the device difficult during surgery. The first complaints or adverse reports were filed with the FDA in February 2007. 4
- Proceed is prone to blow outs. The light-weight mesh is not strong enough to hold up against the bowel or other tissues. Eventually a hole is made through the mesh whereby the mesh becomes herniated, too. The first adverse report was made to the FDA in February 2007. 5
- The ORC fabric is defective. The ORC layer is prone to delamination and, thus, ineffectively protects the organs from the polypropylene mesh. The first reports of the same began in January 2008. 6 When the ORC layer deteriorates, the propylene is exposed and causes injuries like pain, adhesion, and organ perforation.
1.3 What is the defective design and associated risks of the Prolene?
The Prolene is a heavy-weight polypropylene mesh plug combined with a polypropylene onlay. Due to the combination design and material, this plug and only system cause:
- Debilitating pain
- Chronic pain
- Nerve damage
- Sexual dysfunction, sometimes leading to testicle removal.
Many adverse reports have been provided to the FDA stating the severe complications. 7
2. What is the status of current lawsuits against Ethicon?
There are thousands of lawsuits pending against Ethicon today. Most are related to the Physiomesh but some lawsuits are directed at the Proceed and Prolene hernia systems. 8 Lawsuits related to the Physiomesh have been consolidated into multidistrict litigation.
2.1 What is Ethicon’s Physiomesh multidistrict litigation?
There are more than 1,000 Physiomesh lawsuits filed throughout the United States in federal court. On June 2, 2017, the Judicial Panel on Multidistrict Litigation consolidated these cases into the Ethicon Multidistrict Litigation (MDL):
- 17-md-2782; In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, MDL No. 2782 (Judge Richard W. Story, US District Court, Northern District of Georgia)
Other cases, however, are still pending in the NJ State court — New Jersey is home to both Ethicon and Johnson & Johnson. Depending on the facts of each specific case, you may join the hernia mesh MDL or you may file separately in state court.
2.2 Must you join the multidistrict litigation?
If the questions of fact are the same when compared to those of the MDL, then your case — if filed in a state court — will be moved for diversity reasons to a district court at which time it will be moved to the MDL by the Judicial Panel. The same happens if your attorney files your lawsuit in a district court — the Judicial Panel will remove it to the MDL.
On the other hand, your attorney can — if questions of fact are the same — file your lawsuit directly with the MDL. In the end, if you join the MDL is dependent primarily on the questions of fact.
3. How do I know if I qualify to file a lawsuit against Ethicon for the defective hernia mesh product used in my hernia repair surgery?
The basic elements of this type of medical device/product liability lawsuit include:
- Having hernia repair surgery
- Used with an Ethicon mesh product
- That was defective, and
- That caused injury
- That is monetarily quantifiable.
If these apply to you, then you may be eligible to file a lawsuit for compensation. The best way to determine what your options are is to contact experienced personal injury attorneys who have specific mass tort experience in medical malpractice and/or product liability.
Indeed, if you or a loved one have suffered serious complications due to an Ethicon mesh product, you should seek legal counsel immediately. Time is of the essence due to statute of limitations, which varies depending on the state or jurisdiction of your lawsuit.
Our personal injury and product liability attorneys are currently taking hernia mesh cases now. We have offices locally throughout California but accept these types of cases throughout the United States. Call our office today or complete our online form. We will review your case and your options with you.
- FDA. Adverse Reports on Ethicon’s Physiomesh.
- FDA. Adverse Reports on Ethicon’s Proceed Ventral Mesh.
- FDA. Adverse Reports on Ethicon’s Prolene Hernia System.
- See, e.g., Complaint, Cheryl Lecza v. Johnson & Johnson and Ethicon, Inc., BER-L-004559-18, June 20, 2018.