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Did Your Pelvic Mesh Come With a Warranty?

In January 2013, yet another (!) lawsuit was filed in a Minnesota district court on behalf of a woman who received a pelvic mesh implant manufactured by Boston Scientific. This by itself is hardly news; litigation over pelvic slings has just gotten started. It's worth looking at the specific grounds of her lawsuit, however.

The complaint alleges negligence, failure to warn and defective design – as well as breach of “express” and “implied” warranties.

An “express” warranty is just what it sounds like. It is “expressed” in writing by the manufacturer or seller, assuring the buyer that the device (in this case) will perform to certain standards in the manner the buyer expects.

Sometimes, a manufacturer does not provide an “express” warranty. This brings us to the “implied warranty,” or “warranty of merchantability.” This means that the product must perform to the buyer's expectations, even if there is no written (“express”) warranty. In some cases, the seller can negate an implied warranty by stating that the product in question is sold “as is” or “with all faults.”

This was not the case with Boston Scientific's  pelvic mesh, however. When a patient has a device surgically implanted into his or her body, s/he has every reasonable expectation that it will do what it is supposed to do – right?

This brings up another issue, however – which is, to whom was the “implied warranty” made? After all, an ordinary person cannot simply purchase a medical device and implant it into themselves. S/he relies on what is known as a “learned intermediary” - in this case, the doctor.  This means that the patient may not be able to claim “breach of implied warranty.” In a 2011 California case against Stryker Medical, the court ruled that because the plaintiff (the patient) had relied on her physician's knowledge and had “no direct relationship” with Stryker Medical, she had no grounds to sue for breach of implied warranty.

Although this was a California case, most jurisdictions appear to rule similarly when a patient has relied on his or her doctor's professional judgment.  This does not preclude the plaintiff from holding the company liable for manufacturing defects and failure to warn, and the defendant may still be liable for breach of any written warranty. When it comes to civil litigation, tangible evidence and demonstrable direct relationships between the parties make for stronger cases.

Sources

Beck, Jim. “The Learned Intermediary and Implied Warranties.” Drug and Device Blog, 10 November 2013. Available at http://druganddevicelaw.blogspot.com/2011/11/learned-intermediary-and-implied.html.

Larkin, Perry. “Vaginal Mesh Lawsuit Filed in Minnesota.” Injury Lawyer News,  5 February 2013. Available at http://injurylawyer-news.com/2013/02/vaginal-mesh-lawsuit-filed-in-minnesota/

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