$11 Million Verdict Against Gynecare Prolift Pelvic Floor Repair System Under Appeal

Ethicon Women’s Health & Urology, maker of the Gynecare Prolift Pelvic Floor Repair System, is appealing an $11 million verdict awarded to a South Dakota women injured by the defective mesh implant.

According to the company’s lawyers, the damages should be stricken because of the learned intermediary doctrine.

JNJIOffice2“It’s the physician’s job to advise the patient properly,” attorney Charles Lifland told the New Jersey Law Journal. “It is from the doctor that the patient is supposed to get the details.”

The case took place in Atlantic County, where a jury decided on $3.35 million in compensatory damages and $7.76 million in punitive damages to Linda Gross.

Gross’ attorney argued against the premise that the duty to warn a patient about a pharmaceutical is entirely that of the surgeon. Instead, the duty should fall on the manufacturer.

“The problems with the product were known from day one,” Adam Slater said in the journal story, titled “Appeals Court Hears Arguments Over $11M Pelvic Mesh Verdict.” “There was no learning curve, no ambiguity within the company.”

Slater is right. The Gynecare Prolift Pelvic Floor Repair System has been linked to a growing number of adverse events reported to the U.S. Food and Drug Administration. The device often is proscribed for pelvic organ prolapse, or POP, as well as urinary incontinence. Although minimally invasive (it is implanted through the vagina), the product leads to litany of problems including bleeding, infection and organ perforation caused by the erosion of the mesh over time.

Gross had 20 corrective surgeries to try to fix the damage.

“Her body has been decimated,” Slater said.

His defense: Officials at Ethicon Women’s Health & Urology knew about the defects and failed to adequately warn the public, and he strongly stated so in his litigation.

Mentor Case Time Barred

In 2004, North Carolina resident Melanie Cole was implanted with Mentor’s OB Tape, which is a sling device that is used to treat urinary incontinence.  Three weeks after the surgery, Ms. Cole visited her surgeon and complained that it was not working properly, and that her incontinence was worse.

Ms. Cole continued to have problems with incontinence and she experienced urinary tract infections.  In 2007, Ms. Cole visited her doctor, and her doctor removed sling.

In 2008, Ms. Cole visited another doctor because she believed that all of the device was not removed in her prior revision surgery.  The second doctor believes he told Ms. Cole that some of her pain came from inflammation caused by the OB tape and if the OB Tape could be removed, then most of the pain should go away. In January 2009, more of the device was removed.

BahnhofsuhrZuerich_RZIn June 2013, Ms. Cole sued Mentor in the U.S. Court for the District Court for the District of Minnesota.  Ms. Cole asserted claims for breach of warranty, negligence and strict liability (design defect, failure to warn).  The lawsuit was then transferred to the Mentor ObTape Transobturator Sling Product Liability Litigation, MDL No. 4: 08-2004.

The parties agreed that Minnesota law applied to Ms. Cole’s claims.  Mentor moved for summary judgment on the strict liability and warrant claims, arguing that they are time barred.

The District Court Judge agreed with Mentor that the breach of warranty claim was barred under Minnesota’s four year statute of limitations.  He held that “a cause of action accrues when the breach occurs, regardless of the aggrieved party’s lack of knowledge of the breach.  A breach of warranty occurs, regardless of the aggrieved party’s lack of knowledge of the breach.”  The Judge explained, “Except where a warranty explicitly extends to future performance of the goods and discovery of the breach must await the time of such performance.  The cause of action accrues when the breach is or should have been discovered.”

“Cole did not point to any evidence that any warranty made by Mentor explicitly extended to future performance, so her breach of warranty claim accrued in 2004, when her OBTabe was implanted,” Judge Land concluded.  “Cole did not bring her claim within four years, so her breach of warranty claim is time-barred”

Turning to the design defect claim, the Judge noted that under Minnesota law, “any action based on the strict liability of the defendant and arising from the manufacture, sale, use or consumption of a product shall be commenced within four years.”

Under Minnesota law, “a claim involving personal injuries allegedly caused by a defective product accrues when two elements are present: a cognizable physical manifestation of the disease or injury, and evidence of a causal connection between the injury or disease and the defendant’s product, act or omission,” Judge Land explained.

“Here, Cole does not deny that she knew by 2008 at the latest that her injuries- worsened incontinence, pain, and infections- were caused by ObTape,” the Judge determined.  “Cole argued, however, that her claims did not accrue until she knew that her injuries were caused by a defect in ObTape, Cole did not point to any Minnesota authority holding that a plaintiff must be on notice that her injuries were caused by the defect.  Rather, the precedent states that the plaintiff must be aware of an injury and a causal connection between the injury and the defendant’s product.”

Boston Scientific Prevails in North Carolina Mesh Case

The Uphold Vaginal Support System is a transvaginal mesh product used to treat pelvic organ prolapse (“POP”).  Marta Carlson sued Boston Scientific Corporation (“Boston Scientific”), the maker of the Uphold Vaginal Support System, and asserted that the device caused her to suffer chronic vaginal pain, difficulty during intercourse and incontinence. Ms. Carlson sued Boston Scientific for claims of breach of implied warranty, negligent design and strict liability failure to warn.

Boston Scientific claimed that Uphold device did not cause Ms. Carlson’s injuries and it helped to treat her POP. Boston Scientific alleged that had Ms. Carlson not been implanted with the device, her POP would have continued progressing.

uphold vaginal meshMs. Carlson’s lawsuit was transferred to the multidistrict litigation (“MDL”) which is pending in the Southern District of West Virginia (In re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, MDL No. 2326). On April 29, 2015, the MDL Judge granted a summary judgment against Ms. Carlson’s on her claims of strict liability failure to warn. However, the MDL judge allowed the claims of negligent design and breach of implied warranty to proceed to trial. The case was then remanded to the Western District of North Carolina for trial.

A North Carolina jury found in favor of Boston Scientific following a 10 day trial, the jury found that Boston Scientific did not act unreasonable in designing the Uphold device and did not breach the implied warranty of merchantability.

Manufacturing Defect, Misrepresentation and Concealment Claims Will Proceed in Mesh Case

In 2004, a Georgia resident was diagnosed with stress urinary incontinence. On July 16, 2004, she was implanted with a Mentor transobturator sling. In December 2010, she began experiencing pain in her thigh and saw an orthopedic surgeon, who diagnosed her with a groin strain. In March 2011, she experienced severe pain in her right leg, along with vaginal discharge. She was diagnosed with an abscess due to an erosion of the Mentor transobturator sling. In April 2011, Dr. Mygayy and Dr. Kyburz performed an excision surgery to remedy the situation.

Lady JusticeIn September 2011, the plaintiff sued Mentor, the maker of the transobturator sling, in the Northern District of Georgia. The plaintiff asserted claims of duty to warn, manufacturing defect, misrepresentation and concealment. Mentor moved for summary judgment on the claims of duty to warn, manufacturing defect, misrepresentation and concealment.

Judge Land first addressed the manufacturing defect claim noting it is based on evidence that Mentor’s product specifically called for pores measuring between 40 and 100 microns, and tests of sling samples revealed “non-uniform pores, some of which are closed-ended pores and the vast majority of which are smaller than 40 microns.” As to the manufacturing defect claim, the Judge concluded that genuine issues of fact surround this claim and, as such, it should proceed.

In her misrepresentation and concealment claims, the plaintiff asserted that she elected to undergo the sling procedure after consulting with her doctor and that Mentor provided the doctor with materials that led him to recommend the transobturator sling to the plaintiff. The plaintiff asserts that those materials either misrepresented or concealed an accurate complication rate for sling, the severity of known transobturator sling (“ObTape”) complications, and true information about sling’s physical characteristic.

Mentor contended that the plaintiff cannot prove that she relied on any misrepresentation by Mentor because it is undisputed that it did not make any representation directly to the patient. Mentor communicated exclusively with her doctors. Judge Land concluded that a genuine fact dispute exists on the justifiable reliance element and as such, Mentor is not entitled to summary judgment on the misrepresentation and concealment claims.

The Judge held that: “In general, a fraudulent or negligent misrepresentation claim ‘must be based upon a misrepresentation made to the defrauded party, and relied upon by the defrauded party,'” the Judge stated. “Here, [Plaintiff] asserts that Mentor, intending to defraud her and induce her to undergo the ObTape procedure, made misrepresentations to Dr. Mygatt and induced him to recommend ObTape to [the plaintiff]. [The plaintiff] relied on Dr. Mygatt in deciding to proceed with the ObTape procedure.”

Therefore, the Judge denied the summary judgment as to the plaintiff’s manufacturing defect claim and her claims for fraudulent misrepresentation, fraudulent concealment and negligent misrepresentation.

Summary Judgment Upheld in Boston Scientific Vaginal Mesh Case

On February 9, 2009, a North Carolina resident was implanted with the Obtryx Transobturator Mid-Urethral sling. This patient filed suit against the maker of her vaginal mesh, Boston Scientific (“Boston”), asserting claims of breach of express and implied warranties, negligence, punitive damages, and strict liability (design defect, failure to warn, and manufacturing defect). She asserts that she experienced multiple complications as a result of the mesh including difficulty during intercourse and vaginal pain.

Boston moved for summary judgment on all of the claims. Applying North Carolina law, the Multidistrict Litigation (“MDL”) court denied Boston’s motion as to the negligent design claim, ruling that a genuine issue of fact exists as to whether Boston acted unreasonably in designing the Obtryx. The judge ruled that an issue of fact also existed as to whether Boston unreasonably failed to adopt a safer, practical, feasible, and otherwise reasonable alternative design, or whether the design or formulation of the product was so unreasonable that a reasonable person, aware of the relevant facts, would not use it. The MDL court also denied Boston’s summary judgment on the claim of breach of implied warranty of merchantability, explaining that because a reasonable juror could likewise find that Boston breached the implied warranty of merchantability.

vaginal mesh gavel

The MDL court also awarded Boston’s summary judgment on the negligent manufacturing claim, finding the record “is devoid of any evidence regarding Boston’s manufacturing process, much less any negligent action or omission that occurred during those processes.”

In addition, the MDL court awarded Boston’s summary judgment on the breach of expressed warranty, finding the record contains no evidence suggesting that any express warranties were provided to her surgeon. At the conclusion of pretrial proceedings, the MDL court transferred the plaintiff’s action to the Western District of North Carolina.

Motion for Reconsideration

The plaintiff filed a motion for reconsideration, where she argued that the MDL court improperly weighed contradictory evidence, failed to construe the evidence and reasonable inferences in a light most favorable to the Plaintiff, and made a determination on an issue that should have gone to the jury. The plaintiff asked the North Carolina Court to set aside that ruling as clearly erroneous and resulting in a “manifest injustice.”

On June 4, 2015, Judge Max O. Cogburn Jr. of the United States District Court for the Western District of North Carolina explained that the MDL court properly relied on the implanting surgeon’s admission that he did not read the device’s directions for use. Judge Cogburn found that the plaintiff’s request is simply an attempt to have the District Court “rethink” the merits of the MDL court’s decision, which is not a valid ground for reconsideration.

Judge Severs Transvaginal Mesh Lawsuit

In November 2011, a Maryland woman underwent surgery at Calvert Memorial Hospital in Maryland where Dr. Jeffrey Welgoss implanted her with a sling manufactured by Ethicon. The patient asserts that she continued to experience pain and discomfort after the removal of the sling and that her Ethicon TVT sling has also caused her to suffer pain and discomfort. She sued Calvert Memorial, Dr. Welgoss and his surgical team in the Calvert Circuit Court in Maryland asserting claims of medical negligence and a product liability claims against Ethicon and its parent company, Johnson & Johnson (collectively the “Ethicon Defendants”).

empty steel chairEthicon defendants removed the action to federal court and the case was assigned to Judge Messitte. Ethicon defendants moved to sever the product liability claims from the medical negligence claim. They argued that the healthcare defendants are not necessary parties to the claim against the Ethicon defendants, or alternately, that the claims against the healthcare defendants have been fraudulently misjoined.

The plaintiff opposed the motion and moved to remand the case to state court. She asserts that the healthcare defendants are necessary and proper parties to the claims against the Ethicon Defendants because if the medical negligence and products liability claims were tried separately, each set of defendants could use the “empty chair” defense and blame her injuries on the actions of the missing group of defendants.

Judge Messitte found that severance is particularly appropriate in this case because if would allow for the transfer of the plaintiff’s claims against the non-healthcare defendants to the transvaginal mesh multidistrict litigation pending in the Southern District of West Virginia.

The Judge stated, “[Plaintiff’s] medical negligence claims against the Maryland healthcare Defendants hinge on whether they deviated from the standard of care of healthcare professionals in selecting the sling and implanting during surgery. Her products liability claim against the Ethicon defendants turn on whether those defendants, at an earlier point in time, improperly designed, manufactured, tested, advertised, and gave directions regarding use of the sling. These standards of care and the deviation from same are different and distinct from one another. As a result, the Court has the authority to sever the claims against the two groups of defendants.”

Judge Messitte held: “Whatever inconvenience [plaintiff] might suffer from her having to litigate her claims in two separate forums, that inconvenience is far exceeded by the prejudice of requiring the manufacturer of a TVT to defendant on ‘many more than just two fronts.’” The Judge further stated, “Forcing the Ethicon defendants to litigate TVT claim in state court throughout the country whenever and wherever the claims might be joined to claims against healthcare providers that installed the device would defeat the entire purpose of the MDL.”