Mesh News Desk, April 5, 2016 ~ Ethicon asks for new trial in the $3.27 million first TVT-O bellwether pelvic mesh case.
Jo and Allen Huskey
An appeal brief was filed March 28, in the Us Fourth Circuit Court of Appeals No. 15-2118, by attorneys for mesh-injured plaintiff, Jo Huskey in Huskey et al, v. Ethicon (2:12-cv-05201).
Jo and her husband Allen filed a product liability case against Ethicon, a division of Johnson & Johnson, over its TVT-O (transvaginal tape obturator). On September 5, 2014, the jury in the Charleston, WV federal court awarded the couple $3.27 million.
This was the in the first bellwether jury trial naming Ethicon in this multidistrict litigation before Judge Joseph Goodwin.
And it was also the first time a jury decided the TVT-O was defectively designed. See the background on the case here.
J&J appealed after the Huskey verdict, initially asking Judge Goodwin for a directed verdict in its favor, which he denied.
The team for Huskey was also denied the ability to seek punitive damages. See here .
J&J filed an appeal of the verdict.
Ed Wallace, attorney for Jo Huskey
TVT-O from beckenbodenzentrummuenster.de
Mrs. Huskey was implanted with a Johnson & Johnson, Ethicon TVT-O laser cut mesh to treat incontinence. TVT-O was first sold in 2004 and is considered a mid-urethral sling. Using trocars, or stainless steel curved end hooks, doctors will stab a woman’s thighs to pierce the obturator membrane. Then a strip of synthetic polypropylene (PP) mesh is pulled through the obturator foramen, a nerve-rich area of a woman’s body before it is placed midway under the urethra.
There are two types of TVT-O one that is laser cut and the other than mechanical cut. The plaintiff had a laser-cut mesh, thought to smooth out rough, exposed plastic ends.
Dr. Gretchen Byrkit, ob/gyn
Ms. Huskey had her TVT-O implanted by Dr. Gretchen Byrkit Feb 23. 2011. She experienced mesh erosion by March, also dyspareunia and she underwent a revision surgery where the doctor oversewed the exposed mesh. Another section was dissected but it retracted behind the public bone and it remains there today.
She is in pain,has dyspareunia, has been injected with countless drugs, and her SUI has reportedly returned.
At trial, the implanting physician also said she would likely not use TVT-O if it was contraindicated for athletic women and that information was contained in the product label or Instructions for Use (IFU).
Jo Huskey was an avid kayaker, liked to exercise, walk and work out regularly. At trial, Dr. Byrkit said if the warning was on the IFU label that TVT-O should not be used in athletic women, she would have reconsidered using it on Mrs. Huskey.
Dr. Jerry Blaivas
Dr. Jerry Blaivas, brought in as the expert to testify for Mrs. Huskey, testified that active women should not be implanted with a TVT-O.
The jury returned a verdict based on Illinois Pattern Jury Instructions since she is from Illinois. After a nine-day trial the jury returned a unanimous verdict in Plaintiffs’ favor on all four claims - strict liability design defect and failure to warn, negligent design and failure to warn.
The plaintiffs alleged there were six defects with the TVT-O:
* It’s made with Prolene mesh
* Prolene mesh undergoes oxidative degradation
* Prolene mesh shrinks
* Prolene mesh deforms
* Prolene mesh is too heavy and causes chronic foreign body reaction
* Prolene mesh is placed in the obturator space
* Prolene mesh was laser cut
Ethicon argued all of its surgical meshes the TVT and TVT-O are considered the standard of care, the “Gold Standard,” by medical industry organizations and therefore they cannot be defectively designed.
Ethicon relies on the learned intermediary, that is, the implanting physician as the end user. When a manufacturer of a drug or maker of a medical device gives adequate warning to physicians about the known dangers of such a product, that warning provides a shield from liability for the medical manufacturer under learned intermediary.
The plaintiffs’ brief says the exact nature of the dangers would have to be detailed to fully protect the seller.
“The learned intermediary doctrine does not shield Ethicon from liability because the warnings in the instructions for use were inadequate.” ~ appeal brief for Jo Huskey
What was missing? Information about mesh degrading, cracking becoming embrittled or stiffening; mesh contracting and shrinking; mesh complications increasing with the more mesh used; more complications with the TVT-O; chronic or permanent pelvic pain; the potential for multiple surgeries, among other things not included in the IFU (Instructions for Use).
David Robinson, former Medical Dir. Ethicon
Ethicon’s own Associate Medical Director, Dr. Meng Chen, testified at trial Ethicon was aware of many adverse events which were being called into the company and she told Ethicon “These complications are not transitory.” Yet they did not make it to the IFU.
Dr. David Robinson, Ethicon’s Worldwide Medical Director, outlined many complications Ethicon never warned about including lifelong complications relating to foreign body reaction. He said the company was telling doctors the opposite, that there was no foreign body reaction.
And Ethicon did not warn that TVT-O was contraindicated in active women.
Illinois law does not require the plaintiff to show what the doctor would or would not have done if she had been adequately warned. The plaintiff is from Illinois.
Don’t you love a double negative? An unavoidably unsafe product is one that has a benefit that far outweighs its known risks…. Like the rabies vaccine, says the appeal, which is quite incapable of being made safe (though one could always refuse the vaccine so is it really unavoidable?).
And if you are a trained lawyer, you have been schooled in something called comment k.
Comment k says that a product is not defective or unreasonably dangerous if you are properly warned about them. It comes from prescription medicines that were dangerous but had some value when used only by prescription in the right hands. Should that doctor be legally liable for a dangerous product? Comment k says it should be used as a defense of strict liability, or in other words, a shield to protect the company. See Illinois law here:
Ethicon argued that TVT-O falls under the protection of comment k (unavoidably unsafe). Judge Goodwin had decided comment k was not applicable because Ethicon had not met its burden to show that TVT-O was “unavoidably safe.” In fact the opposite, at trial, Ethicon claimed TVT-O was perfectly safe.
It’s difficult to have it both ways.
Ethicon says the plaintiff was required to identify what about the TVT-O was defective and what caused her pain. The plaintiff says that is not required under Illinois law, in fact, Illinois law does not require a plaintiff to pinpoint a specific defect in a product to recover under strict liability.
Meanwhile at trial Dr. Blaivas testified Ms. Huskey had the TVT-O removed because of chronic inflammation and a doctor who attempted a removal (Dr Siddique) testified that surgeries both implanting and attempting to remove the mesh were the probable cause of her pain. Dr. Guelcher testified that polypropylene in the T VT-O degrades in the body and the oxidative process changes the structure of the mesh, the amount of mesh used affects foreign body response and that continues until the mesh is removed. Degradation of the mesh causes the mesh to become stiff, embrittled and crack and cause pain.
Dr. Rosenzweig from Rush University testified the placement of the TVT-O in the adductor muscles can irritate the obturator nerve resulting in pain. He also said that the heavyweight laser-cut mesh in the TVT-O led to mesh shrinkage and contraction and foreign body response near muscles and nerves - all contributing to chronic pain.
Christy Jones, Dave Thomas, atnys for J&J
Ethicon in its appeal asked for a new trial based on the omission of FDA related evidence. The fact that the FDA uses a 510(K) approval process was not included in the Huskey trial, just as it’s been omitted from the majority of these pelvic mesh trials (Cisson for example), which are on a tight time budget (the Huskey case was 9 days).
Ethicon never sought to have that admitted at trial, says the plaintiffs.
Ethicon also argues that comment k instructions should have been given to the jury and that the regulatory history of Prolene sutures, cleared by the FDA, should have been presented to the jurors.
Prolene sutures, approved by the FDA under the New Drug Application process in 1969, are not the same product as a boxed mesh kit containing the TVT-O, argued plaintiff attorneys.
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