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.

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 Messitte Decided To Sever Transvaginal Mash 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.”

Judge Denies C.R. Bard’s Request to Seal Documents in IVC Settlement

In August 2005, a patient was implanted with a Bard Recovery Filter System in order to catch blood clots or “thrombi” traveling from the lower portions of his body toward his heart and lungs. Unfortunately, the device failed and migrated to the patient’s heart, perforating the organs and requiring open heart surgery on April 30, 2010.

Was_soll_ich_werden,_56The patient sued C.R. Bard and Bard Peripheral Vascular Inc., in the United States District Court for the District of Nevada, accusing them of failing to conduct testing on the Recovery Filter Device and failing to recall the device. The patient also asserted claims of design defect, failure to warn, and manufacturing defect. Six days into the trial, the parties reached a confidential settlement. Following the settlement, C.R. Bard asked the Judge to seal certain trial exhibits and portions of the trial transcript.

This lawsuit was assigned to Judge Robert C. Jones. Judge Jones noted that a court may “make any order which justice requires to protect the party or person from annoyance, embarrassment, oppression or undue burden or expense” upon motion by a party from whom discovery is sought.” However, Judge Jones continued that “the mere fact that the production of records may lead to a litigant’s embarrassment, incrimination or exposure to further litigation will not, without more, compel the court to seal its records”, quoting Kamakana v. City & Cnty of Honolulu, 447 F.3d 1172, 1179, 9th Cir. 2006.

“There is a strong presumption towards public access to judicial records,” Judge Jones stated. He noted that “Under Kamakana, judicial records are separated into two groups, each with its own standard to be met if litigants wish to seal them. First, judicial records attached to dispositive motion must meet the compelling reasons’ standard in order for those documents to be sealed. Those compelling reasons must outweigh the competing interest of the public in gaining access to the judicial records and to understand the judicial process.”

In this case, Judge Jones held that “the only harm that could come to Defendant from the release of this information is the precipitation of further lawsuits against it..” He reasoned that “preventing lawsuits due to the release of inculpating information is not a compelling rdreason to seal otherwise pubic legal proceedings, Indeed, the exposure of the facts relevant to the material clams in a lawsuit is the purpose of a trial and these facts should remain public unless the harm likely to result from their release is unrelated to the nature of the claims. The information does not directly implicate trade secrets.”

Therefore, Judge Jones denied C.R. Bard’s motion to seal the materials, ruling that the reasons for sealing do not outweigh the public’s interest in gaining access to the judicial records. Also, C.R. Bard has waived the issue because it did not move to seal the exhibits or testimony at the public trial, the Judge noted.