Emphatically rejecting post-trial defense arguments, a Philadelphia Judge upheld a $13.7 million verdict against Ethicon, a Johnson & Johnson subsidiary, for the defective design of Tension-free Vaginal Tape (TVT) that brought multiple surgeries and a lifetime of pain to a New Jersey woman.
Philadelphia Court of Common Pleas Judge Kenneth J. Powell, Jr. ruled in Sharon Carlino and Charles Carlino v. Ethicon, Inc., Case Nos. 1129 EDA 2016 and 1294 EDA 2016, upholding the Feb. 10, 2016, award of $3.25 million in compensatory damages for Mrs. Carlino, $250,000 to Mr. Carlino for loss of consortium, punitive damages of $10 million, plus $239,119 in delay damages.
Kline & Specter PC attorney Shanin Specter represented The Carlinos. Ethicon faces 164 lawsuits in the Philadelphia courts, as well as 31,630 lawsuits in Ethicon, Inc., Pelvic Repair System Products Liability Litigation consolidated before U.S. District Judge Joseph R. Goodwin in MDL 2327 in the Southern District of West Virginia.
The Philadelphia court ruled:
- The Court does have personal jurisdiction under Pennsylvania law over Ethicon, headquartered in New Jersey, because the corporation carries on a “continuous and systematic part of its general business within this Commonwealth.” Parent company Johnson Johnson has 16 subsidiaries in the state.
- State-law design-defect claims are not preempted by federal law because Ethicon used the 510(k) shortcut to get FDA approval for the TVT, which merely verifies that a medical device is “substantially equivalent” to an already-approved device. “The United States Supreme Court has determined that the Food, Drug, and Cosmetic Act’s preemption provision does not apply to products liability claims regarding medical devices that underwent 510(k) clearance rather than the premarket approval process. Medtronic, Inc. v. Lohr, 518 U.S. 470, 501-02, I 16 S. Ct. 2240 (1996),” the court ruled.
- The lawsuit is not time-barred, even though Mrs. Carlino was prescribed TVT in August 2005 and did not file suit until June 2013, and there is a two-year statute of limitations. She underwent revision surgeries in 2007 and 2010 to remove the TVT that was pushing through her flesh, but “[i]n cases of complex medical causation, it is not at all self-evident that the cause of injury was the fault of a third party,” the court said. Under the “discovery rule,” the statute did not begin to run until she saw a TV commercial that described transvaginal mesh products as defective.
- The punitive damage award is constitutional, especially because a key element is “the degree of reprehensibility of the defendant’s misconduct.” The 4-to-1 ratio between compensatory and punitive damages is within the limitations of the US Supreme Court ruling in State Farm Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408,416 (2003).
Ethicon was deceptive
The court blasted Ethicon because it “deceptively withheld important information about the risks of undergoing a TVT implant procedure,” and that “the jury was free to determine that Ethicon provided warnings so deliberately misleading as to warrant the imposition of punitive damages.”
Three Ethicon executives testified that Ethicon knew of the risks but gave no warnings about it.
- Piet Hinoul, M.D., Ethicon worldwide medical director admitted that the TVT product has a number of serious complications, including erosion, pain, scarring, mesh contracture, pain during intercourse, and the potential necessity of subsequent surgeries to remove mesh that was malfunctioning or causing harm. He also confirmed that these risks were known to Ethicon at the time they launched the TVT product.
- Dr. Martin Weisberg, Ethicon’s Medical Director, testified that the company did not warn in the TVT Instructions For Use or patient brochures that there was a risk of the following complications even though they knew about them when the TVT was released: multiple surgeries to repair erosions, severe and chronic inflammation, mesh extrusion, exposure extrusion into the vagina or other structures or organs, chronic pain, pain with intercourse, neuromuscular problems including acute and/or chronic pain in the groin, thigh, leg pelvic and/or abdominal area, surgical treatment or revision surgeries, excessive contraction or shrinkage of the tissue surrounding the mesh and urinary frequency.
- Dr. David Robinson, the former Ethicon Medical Director, testified that that there is lifelong risk of erosion as long as the foreign body remains in place, but that Ethicon did not warn of the lifelong risk of erosion, the possibility of multiple surgeries, or permanent painful sexual intercourse in the Instructions for Use or patient brochure.
The case is on appeal to the Superior Court of Pennsylvania.