(Reuters) – A lawyer representing 4 women in Miami federal court who say they were injured by Boston Scientific‘s (NYSE:BSX) transvaginal mesh yesterday accused the company of ignoring patient safety in its haste to get the devices on the market.
"They set a priority that should never exist inside a medical device company – speed as No. 1," said plaintiffs’ lawyer Jim Perdue during opening arguments in the trial, which is 1 of 2 that began yesterday.
Perdue is representing 4 women implanted with the company’s Pinnacle device to treat pelvic organ prolapse. During his opening statement, he said the company fast-tracked the device without performing any human or animal testing and used materials that it had been warned weren’t meant to be permanently implanted in human bodies, all in an effort to keep up with competitors.
A lawyer for Boston Scientific, Molly Craig, said similar mesh products had been used successfully in a variety of medical applications for decades. Each woman suffered from serious problems and, along with their doctors, was well aware of the risks that went along with the device, Craig said.
"Just because a complication occurs does not mean a product is defective and doesn’t mean a person or company is at fault," Craig told the 9-member jury.
The cases are among more than 23,000 that have been filed against Boston Scientific over its mesh devices in U.S. federal and state courts. Other device makers, including C.R. Bard (NYSE:BCR) and Johnson & Johnson‘s (NYSE:JNJ) Ethicon Inc, also face thousands of mesh cases.
Plaintiffs generally allege the devices are defectively made from a substandard material, causing injuries ranging from bleeding and infection to nerve damage and pain during sex. The company has said in previous statements that it has made patient safety a top priority and stands by the devices as an important treatment option for women.
Boston Scientific has faced 3 trials over the devices so far, all in state court. The first 2, in Massachusetts, ended in wins for the company. The 3rd, in Texas, ended with a $73 million verdict for the plaintiff, which was later reduced to $34 million under a state damages cap.
Judge Joseph Goodwin, who is overseeing more than 66,000 mesh lawsuits against 7 companies that make the device, is presiding over the trial in Miami, which he said he expected to last roughly 10 days.
It’s 1 of the first federal suits to go to trial against Boston Scientific over the devices. The other also began yesterday in West Virginia federal court involving claims from 4 women who say they were injured by the company’s Obtryx device, which is used to treat stress urinary incontinence.