7 On Your Side: If a medical device hurts you, why can't you sue?

Women protest to help patients injured by medical implant devices, Monday, Sept. 25, 2017 (ABC7)

If a medical device hurts you, why can't you sue? Well, you can, but it's very, very tough.

"Even the breast implant women, who developed lymphoma from textured breast implants, are having a difficult time getting lawyers to discuss their cases," Jamee Cook told 7 On Your Side. "And that should be a given."

Cook blames her auto-immune disease on her implants. Angie Firmalino claims Essure, a permanent birth control, caused her severe problems. (She is supported by the famous whistleblower, Erin Brockovich). Lisa Zak said three implantable devices: a bladder mesh, a nerve stimulator, and breast implants, have made her life "pure hell."

"Antibiotics after antibiotics," said Zak. "ER visits. Pain non-stop. It's a very hard life to live."

There are more than 157 Class III medical devices on the market today. According to the U.S. Food and Drug Administration, "these devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury."

They're supposed to get the FDA's highest level of scrutiny for patient protection. But the manufacturers enjoy broad liability protection, thanks to the 2008 Supreme Court case, Riegel v Medtronic , which had the effect of making it difficult for patients to sue.

"I think that's unjust and unfair," said Firmalino. "That doesn't apply to any other consumer product, so why for 157 devices?"

Among those devices, hip implants, cochlear implants, defibrillators, cardiac stents, pacemakers, and so on. Since 2008, there has been a six-fold increase in death and injury reports submitted to the FDA. Already this year, of patients with Class III devices, 3,614 have died, and 86,234 claim injury.

A spokeswoman for the FDA, Deborah Kotz, explained the increase in numbers this way: "The FDA has worked to enhance adverse event reporting and the overall volume of adverse event reports has increased since 2008 across all device classes. It is important to consider that the number of products entering the market place and in use, as well as the number of adverse event reports received in general by FDA increase each year."

The women are taking those statistics, and their red t-shirts that read "SUPPORT THE MEDICAL DEVICE SAFETY ACT" to the halls of Congress this week with a tiny, two-page bill, with hopes of accomplishing one big thing: getting their day in court.

But they are Davids facing the Goliath of medical manufacturing, an industry that saves millions lives worldwide.

"The FDA represents the gold standard when it comes to providing safe and effective medical technologies for patients and providers," said Mark Leahey, President and CEO of the Medical Device Manufacturers Association. 7 On Your Side asked him for a response to the proposed legislation.

"Replacing the expert opinions of scientists, physicians, engineers and the trained professionals at the FDA who have dedicated their careers to patient safety with the lay opinion of a jury is simply not prudent," said Leahey.

This story has been updated, Tuesday, Sept. 26, 2017

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