You’re the Lab Animal Testing Your Medical Device’s Safety

You expect a medical device recommended by your physician and approved by the Federal Drug Administration (FDA) to be safe and effective. That may be showing too much faith in how our system of medical device approvals works. A device you expect to keep you alive or improve your quality of life may have undergone little or no safety testing before it was surgically implanted.

Satterley & Kelley, PLLC helps people victimized by defective medical devices that severely harmed them. We also represent families of those killed by these devices in wrongful death legal actions. If you want to learn more, contact us at 855-385-9532.

Insulin Pump Causes Problems for Thousands of Users

One such device is a Medtronic portable insulin pump, featured in an article by KFF Health News. People with diabetes use it. The pump is supposed to push insulin from a reservoir into the user when needed.

One user was Carlton Gautney, Jr., of Alabama. He died in 2020 when he was 59, and his family is suing Medtronic in a wrongful death lawsuit. They claim the device is defective and gave him a fatal insulin dose.

What he used was one of about 200,000 Medtronic insulin pumps that were recalled in 2019 because a part was defective and could “lead to an over or under delivery of insulin,” which could “be life threatening or may result in death.” The recall was expanded two years later.

During an inspection at a Medtronic plant, FDA personnel discovered the company received more than 74,000 complaints about the part from 2016 to the November 2019 recall. More than 800 of them weren’t investigated by the company.

Medtronic faces more than 60 lawsuits by injured patients and their families. Last August Medtronic stated in a Securities and Exchange Commission that they expect thousands more of these legal claims.

A Loophole in Federal Law Allows Products to Bypass Safety Testing

It sounds good on paper. If a device is substantially equivalent to one the FDA has already approved, why incur another $500,000 in costs to sell it? This process was part of legislation passed in 1976, known as 510(k) clearance.

A 2011 Institute of Medicine report stated this was “not intended to evaluate the safety and effectiveness of medical devices.” It stated, “(A) move away from the 510(k) clearance process should occur as soon as reasonably possible.” That advice has yet to be heeded.

The FDA now approves about 3,000 what are considered low- to moderate-risk devices annually through the 510(k) review process. That’s a hundred times as many as the roughly 30 annual approvals through the agency’s stricter premarketing requirements. Many doctors and patients don’t know devices that may mean the difference between life and death (like the one used by Carlton Gautney, Jr.) haven’t undergone clinical trials to prove they’re safe.

The FDA can convince a company to fix defective devices or force them to do so through a recall. However, a critical part of that step is for companies to investigate complaints and tell the FDA about them. Several medical device companies have been found to have kept bad news to themselves and didn’t tell the agency about complaints.

New and Improved But Substantially Equivalent to Something Approved in the Past?

Are these devices truly equivalent to what’s been approved in the past? Rochester Institute of Technology researcher Sandra Rothenberg told KFF, “We can’t get detailed data…It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems.”

While companies take advantage of the safety shortcut, they also market the same devices as having new and exciting features.

Defective Products are Impacting Patients

Two Medtronic sales executives turned whistleblowers exposed problems with one machine that got 510(k) FDA approval. The Puritan Bennett 980, or PB 980, is a ventilator approved in 2014 based on the company’s claim it was substantially equivalent to an older mechanical ventilator, the PB 840, made by a Medtronic subsidiary.

Though the PB 980 works differently, Medtronic claimed it was substantially equivalent. For years, the PB 980 ventilator suffered many dangerous malfunctions before it was recalled in 2021 because of a “manufacturing assembly error” that, according to the company, may cause it to become “inoperable.”

The whistleblowers claim that:

• Smoke billowed out of one ventilator in an intensive care unit
• The ventilator cart’s wheels may fall off during transport
• Batteries could fail without warning, forcing staff to suddenly try to keep patients alive manually
• Monitor screens would freeze repeatedly or otherwise break
• Alarm bells warning of an emergency rang constantly and were only stopped when the unit was unplugged from a wall socket and the batteries removed

Medtronic denies the PB 980 is defective.

Schedule A Free Consultation — Contact Us Today

If medical device producers are selling dangerously defective products and the FDA is unwilling or unable to stop them, a product liability lawsuit can hold responsible parties accountable if you or a loved one are injured while using one. You may be awarded compensation for the pain, suffering, medical bills, and lost income you’ve endured.

Schedule a free initial consultation with a Satterley & Kelly, PLLC attorney, to discuss what happened, why the device may have caused the injury, and how Kentucky law may apply to your situation. To reach our Louisville office, call toll-free at 855-385-9532 or contact us online.