(October 11, 2019) – Rex Medical sold an inferior vena cava filter (IVCF) – designed to allegedly stop blood clots from reaching the heart – despite a study showing the product was prone to failure. That’s what a jury heard during opening arguments Oct. 8 in a trial over injuries suffered by a woman implanted with one of the devices.
Attorney David Matthews of Matthews & Associates represents Tracy Reed-Brown in the first case to go to trial against Rex Medical over its Option IVC filter. Mr. Matthews told Philadelphia jurors that Rex Medical LP had pushed back against doctors who reported problems with the filter. Rex told doctors, he said, to rethink whether their patients’ complications during a clinical trial really stemmed from problems with the device.
“They were heavy-handed with the doctors and went and convinced them they didn’t have a problem, and that it was actually a clinical success,” said Mr. Matthews. It was only after a number of doctors withdrew their criticism of the devices, he said, that the FDA agreed to clear the filters for sale via the agency’s 510k process.
Mr. Matthews told jurors that instead of pressing forward with its bid for the FDA’s blessing, Rex should have seen the light in the development of the Option filter.
“They should have stopped when they flunked that test and had to change people’s opinions,” he said.
The trial is the first in Philadelphia over the controversial vein filters. They have been the subject of several multidistrict litigation programs and mass tort trials across the country. The trial is also the first of its kind in which the plaintiff’s filter remains inside her body.
IVC Filter Injuries from “Removable” Filter
Ms. Reed-Brown was first implanted with a “removable” Option filter in September 2010 after ‘ using blood thinning meds for nearly ten years to help fight her high risk of blood clots. Six years after she received the IVC filter implant, she returned to the hospital. Doctors soon discovered that the device had perforated the vein and was poking through into her pancreas, aorta, and renal vein.
“It perforated and punctured that vein over time and is now sticking into all of the organs around that vein,” said Mr. Matthews.
“This device was supposed to be a removable device, but now it’s stuck inside of Tracy Reed-Brown. They can’t get it out,” he said. “Not only is it stuck, it’s penetrating all of her organs, and each one of those organ penetrations is a medical disaster.”
A three-and-a-half-hour surgery she underwent in January 2017 to try and remove the device proved unsuccessful.
Rex Defense Responds
An attorney for Rex Medical, Pete Swayze, countered that Ms. Reed-Brown was a perfect candidate to receive a filter. He said the device was necessary to prevent her from experiencing a potentially fatal embolism.
“In some cases people only need blood thinners, but in some cases they need something else, and the evidence will clearly show that medication was not enough for Ms. Reed-Brown,” said Mr. Swayze. “It is undisputed in this case that Ms. Reed-Brown was an appropriate candidate for an IVC filter.”
Rex Medical Blames Doctor
Mr. Swayze said that any complications Ms. Reed-Brown experienced were a result of a faulty initial implantation procedure. He claimed the device had been placed just below the suggested implantation site.
He also said that Rex recommended IVC-implant patients be monitored for potential complications, but Ms. Reed-Brown received no follow-up care after her September 2010 implantation.
“It appears from the records,” he said, “that not one doctor and not one health care professional was following the status of her filter.”
Thousands of IVC Filter Cases
While Mr. Reed-Brown’s is the first case against Rex to go to trial, it is far from the first over the filters, and is only one of thousands of cases filed in state and federal courts.
Cases over devices manufactured by Cook Medical have played out as part of a multi-district litigation court (MDL) program in federal court in Indiana, while cases over C.R. Bard filters have been consolidated into another MDL in federal court in Arizona.
Meanwhile, cases over devices made by Cardinal Health Inc. unit Cordis have been consolidated into a mass tort program in California state court.
Six trials against Cook and C.R. Bard have resulted in inconsistent results so far. IVC filter makers have won two of the cases in trials – one was tossed by a judge on a summary judgment — and lost three others.
Cook’s record is 1-1 in Indiana. A jury ordered Cook to pay $3 million to a plaintiff in one case. In the other case, which Cook won, the IVC filter had been successfully removed and the plaintiff appeared to be healthy.
In a state course case against Cook in Texas in May 2018, a Houston jury ordered Cook to pay a plaintiff $1.2 million. In that case, a Houston-area fireman had an IVC filter successfully removed, but in a most obtrusive fashion. The filter is designed and promoted to slip out with a minimal incision, but the fireman’s filter was stuck and required a full open-chest procedure.
Bard has faced three trials so far as part of the federal multi-district litigation court set up in Arizona. Bard lost a $4 million verdict in April 2018, and then prevailed in two subsequent defense verdicts.
Ms. Reed-Brown is represented by and David Matthews of Matthews & Associates; Tim Goss of Freese & Goss; Rosemary Pinto of Feldman & Pinto.
Rex Medical is represented by Walter “Pete” Swayze and Megan Grossman of Lewis Brisbois Bisgaard & Smith LLP.
Rex Medical ignored IVC Filter Defects, Jury Told
The case is Tracy Reed-Brown v. Rex Medical LP et al., case number 170300241, in the Court of Common Pleas of Philadelphia County, Pennsylvania.