In this post, we continue our review of transvaginal mesh cases. We look at one (remarkable) jury verdict and one partial summary judgment decision in favor of the defendant from 2015. Many other cases are moving to trial. Going forward, I will keep you updated on jury verdicts and other key court decisions as they happen.
Barba v. Boston Scientific Corp. (Delaware Superior Court)
Products: Pinnacle Pelvic Floor Repair Kit Transvaginal Mesh and Advantage Fit Mid-Urethral Sling System
Jury Award: $100,000,000.00.
Date of Jury Verdict: May 28, 2015
Key Takeaway: A huge verdict for the plaintiff, Deborah Barba. This case was remarkable for the very high money award: one hundred million dollars, to a single woman.
Deborah Barba was implanted with the Pinnacle Pelvic Floor Repair Kit TVM and Advantage Fit Mid-Urethral Sling System prior to 2011. These medical devices were implanted to treat Ms. Barba’s pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Like the other TVM plaintiffs I’ve written about on this site, following implantation Ms. Barba suffered severe pain, infections, sexual dysfunction, incontinence, prolapse, and vaginal wall erosion. She was forced to undergo corrective surgeries to fix the problems caused by the transvaginal mesh products. Apparently the surgeons were not able to remove all the TVM product, and parts of it were left inside Ms. Barba permanently.
Barba sued Boston Scientific in 2011, alleging failure to warn of the risks involved in the TVM, negligent manufacturing of the product, negligent design, breach of warranties, fraud, and punitive damages. Her case made it to trial on May 11, 2015.
The jury found that Boston Scientific Corporation negligently designed and manufactured the Pinnacle TVM and the Advantage TVM, and failed to warn doctors and patients of the risks involved in the implantation of the TVM products. The jury then awarded $25,000,000.00 in compensatory damages and a staggering $75,000,000.00 in punitive damages.
Of course, Boston Scientific has appealed the verdict. I will keep you posted on this appeal.
Frankum v. Boston Scientific Corp. (Western District Federal Court, North Carolina)
Product: Obtryx Transobturator Mid-Urethral Sling System TVM
Summary Judgment: Federal judge in North Carolina upheld prior MDL decision of partial summary judgment as to the failure to warn claim in favor of Boston Scientific.
Date of Decision: June 4, 2015
Key Takeaway: The Defense of the Learned Intermediary Doctrine
Quick back story: Bertie Frankum was implanted with the Obtryx TVM in 2009. She later suffered vaginal pain, pain during sexual intercourse, and bleeding. Ms. Frankum sued Boston Scientific in federal court in North Carolina for the usual claims: failure to warn of the risks of the medical device, negligence, manufacturing and design defects, and punitive damages. The case was moved to the multi-district litigation (MDL) venue for transvaginal mesh in West Virginia.
Once in the MDL, Boston Scientific brought a motion for summary judgment. Summary judgment is a tool for the lawyer to resolve a case in the client’s favor without going to trial. Essentially the motion asks the court for a judgment because there is no “dispute of material fact” and that the party should be awarded judgment as a matter of law. Thus, the lawyer will argue, “look judge, if you take all the facts we’ve gathered in this case in a light most favorable to the other side, my client still wins the case.”
Summary judgment can dispose of all claims, or it can dispose of some claims (known as partial summary judgment).
The MDL reviewed the motion for summary judgment and awarded judgment in favor of Boston Scientific on the failure to warn claim.
Summary judgment was awarded to the transvaginal mesh manufacturer based in large part on a legal defense known as the “learned intermediary doctrine.” It goes like this: a manufacturer (like Boston Scientific) cannot be liable for negligence if it provides all necessary information to a “learned intermediary” (in this case the implanting surgeon), who then has the duty to communicate with the patient about the benefits, risks, etc. The surgeon in Ms. Frankum’s case admitted that he failed to read the directions for use (DFU) with the Obtryx TVM product. This is what is known in the world of litigation as a “bad fact.”
Ms. Frankum therefore lost her claim for failure to warn. Fortunately she still has other claims that are moving forward against Boston Scientific.
Ms. Frankum then asked a federal judge in North Carolina to review the award of partial summary judgment. That judge upheld partial summary judgment as to the failure to warn claim. So Ms. Frankum now moves forward with her lawsuit against Boston Scientific, but without the failure to warn claim.
Key takeaway from decision: The learned intermediary doctrine can be a valid defense for medical device manufacturers like Boston Scientific. Always ask your doctor about the known risks for any medical product being implanted in your body, whether it is transvaginal mesh, an artificial hip, knee, or other device.
Note: Nothing in these posts should be construed as legal advice.