Federal Lawsuit Against C.R. Bard says Mesh is Not Inert
July 30, 2012 ~ This is a brief synopsis of the lawsuit that has been filed against C.R. Bard, a synthetic vaginal mesh manufacturer. You may see your mesh mentioned as they are all here. Summary provided by a non-lawyer so it’s best to read the actual case which is here.
Final Master Complaint in the Federal Court in the Southern District of West Virginia, MDL #2187.
The Defendant is C.R. Bard, a mesh manufacturer based in New Jersey, as well as Sofradim Production SAS, a French company, and Tissue Science Laboratories Limited, a British company. The Plaintiffs are women who had one of more of the mesh products implanted to treat pelvic organ prolapse or stress urinary incontinence.
a. The Align Urethral Support System;
b. The Align TO Urethral Support System;
c. The Avaulta Anterior BioSynthetic Support System;
d. The Avaulta Posterior BioSynthetic Support System;
e. The Avaulta Plus Anterior BioSynthetic Support System;
f. The Avaulta Plus Posterior BioSynthetic Support System;
g. The Avaulta Solo Anterior Synthetic Support System;
h. The Avaulta Solo Posterior Synthetic Support System;
i. The InnerLace BioUrethral Support System;
j. The Pelvicol Acellular Collagen Matrix;
k. The PelviLace BioUrethral Support System;
l. The PelviLace TO Trans-obturator BioUrethral Support System;
m. The PelviSoft Acellular Collagen BioMesh;
n. The Pelvitex Polypropylene Mesh;
o. The Uretex SUP Pubourethral Sling;
p. The Uretex TO Trans-obturator Urethral Support System;
q. The Uretex TO2 Trans-obturator Urethral Support System; and
r. The Uretex TO3 Trans-obturator Urethral Support System.
Bard designed, made, packaged, labeled, marketed and sold the Align and Align TO Urethral Support Systems as well as the Avaulta Plus Anterior and Posterior BioSynthetic Support Systems.; the Avaulta Solo Anterior and Posterior BioSynthetic Support System.
Bard had an arrangement with those two companies that they would design and manufacture, label and package the products which Bard would then sell and distribute.
The meshes made by Sofradim but sold by Bard include: Avaulta Anterior and Posterior BioSynthetic Support Systems; Pelvitex Polypropylene Mesh; the Uretex SUP Pubourethral Sling and Uretex TO, TO2, TO3 Trans-obturator Urethral Support Systems.
The meshes made by TSL but sold by Bard include: the InnerLace BioUrethral Support System; the Pelvicol Acellular Collagen Matrix; Pelvilace and PelviLace TO Trans-obturator BioUrethral Support Systems; the PelviSoft Acellular Collagen BioMesh.
The Plaintiffs claim that the polypropylene mesh (monofilament) is not inert, meaning it does not lie dormant in the body and is biologically incompatible with human tissue. In a subset of the population, an immune response is noted in the form of inflammation of the pelvic tissue and severe adverse reactions including, but not limited to, hyper-inflammatory responses, chronic pain and fibrotic reaction. Collagen products can also cause adverse tissue reactions and “are casually related to infection as the collagen is a foreign organic material from animals. Cross linked collagen is harsh upon the female pelvic tissue. It hardens in the body. When mesh is inserted in the female body according to the manufacturers’ instructions, it creates a non-anatomic condition in the pelvis leading to chronic pain and functional disabilities.”
Here is the rest of the complaint. It says in a nutshell:
- Mesh was approved under the 510(k) FDA approval process
- July 13, 2011 the FDA Safety Communication said mesh complications for repair of POP are “not rare”
- FDA also said mesh shrinkage, previously unidentified, has been reported in the scientific literature
- December 2011, a joint opinion from two organizations, the American College of Obstetricians and Gynecologists (ACOG), and the American Urogynecologic Society (AUGS) acknowledged some women have serious complications associated with mesh
- AUGS and ACOG recommended pelvic organ prolapse repair with mesh should be reserved for high-risk individuals “in whom the benefit of mesh placement may justify the risk.”
- An FDA communication said the benefits of mesh may not outweigh the risks
- An FDA White Paper states “these products are associated with serious adverse events”
Defendants should have known the above.
Count I Negligence – in failing to take reasonable care in designing, making and selling the products
Count II Design Defect (strict liability) – the products were defective in their design
Count III Manufacturing Defect – the mesh products were made unsafe for their intended use
Count IV. Strict Liability- Failure to Warn – the Defendant didn’t warn about shrinkage, degradation, fragmentation, improper mating with the pelvic floor, mesh erosion and extrusion, the risk of chronic inflammation and infections, pelvic scarring, pain, the need for revision surgery, among other things.
Count V. Breach of Express Warranty – Defendants assured the doctors and hospitals and general public the products were safe and effective.
Count VI. – Breach of Implied Warranty – Defendant warranted that the product was fit for its intended purpose.
Count VII. – Loss of Consortium – the woman is so injured the husband has lost her consortium, companionship, affection etc.
Count VIII. Punitive Damages – in simple terms the award is requested that punishes the Defendant for the above actions and for continuing to promote and misrepresent an unsafe product it knew or should have known would cause injury.
The Plaintiffs demand a trial by jury.