A federal judge in Indiana has refused to dismiss tort claims against Coloplast Corp. after a patient filed a lawsuit claiming he was implanted with a defective urethral sling device, one year after the FDA warned about complications the mesh was causing women.
The U.S. District Court for the Southern District of Indiana’s court ruled that Coloplast was aware of the U.S. Food and Drug Administration’s (FDA’s) warning in 2008, suggesting that there could be a defect in the product’s design. Despite this, the company continued marketing the Virtue Ventral Urethral Elevation Sling System device, which allegedly caused the victim to suffer serious, painful injuries following implantation of this device in 2009 for his urinary incontinence.
The victim claims that he received the device without his consent or knowledge. He had given consent to a well-proven sling, not this one. Five months following implantation of the Virtue Sling, and months of continued, intolerable pain, as well as continued incontinence, a reconstructive surgeon removed a portion of the Virtue sling mesh and implanted an Advance Sling in the operating room.
Following this corrective surgery, the victim sued Coloplast in a 10-count complaint, alleging that the device should not have been used on him to treat his incontinence and that the company failed to warn him and his doctors of the risks associated with the mesh products.
Several months prior to his surgery, the FDA issued a warning regarding complications of mesh devices used in the treatment of female incontinence, specifically a kit manufactured by Mentor Corp., using the same material used in the Virtue device. Mentor Corp. sold its surgical, urological, clinical and consumer healthcare business to Coloplast in 2006.
If the company was aware in late 2008 that the FDA had issued a warning for the very same mesh used for a very similar, almost exact, purpose as that the victim had received, why did they continue to sell this product in 2009 without disclosing the risks involved? They were very much aware that the Virtue sling had caused serious problems for many individuals who were previously implanted with this device.
Not only did the company fail to warn customers or train and educate physicians about the Virtue device following the potential problems with this sling, or qualify the claims for failure to provide proper warnings or instructions under the Indiana Products Liability Act (IPLA), it is also alleged that the company marketed the Virtue sling for non-FDA-approved purposes.
Because the IPLA follows strict liability guidelines against manufacturers, the victim was not required to plead plausible allegations of negligence.
Both the victim and Coloplast agreed that several of his claims should be merged into one under the Indiana Products Liability Act, with the victim requesting that the negligence, defective design and failure to warn allegations all be combined.
For the remaining counts, those will likely be handled in the merged IPLA claim going forward. No punitive damages or attorneys fees were granted.
Once again, these big companies put their profits before patient safety. Do you think the manufacturers of the Virtue Sling should be held accountable for implanting a device that they knew had potential risks? Especially when they hid the fact that the FDA issued warnings regarding complications of the same mesh used in their products?
Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).