If a medical device, drug or store-bought product injures you, there’s nothing frivolous about filing a claim. Why do we say this? Because sometimes, there’s no way to know about things like long-term side effects or defective medical device designs until it’s too late. We, the American public, should have high safety and effectiveness standards for drugs and medical device implants inside our bodies. Sadly, many manufacturers find ways to skirt these standards – and the U.S. Food and Drug Administration helps them do it. Below are four main reasons why you should feel good about filing a medical device or drug injury claim.
Reason #1: To Protect Others From Suffering Similar Drug & Medical Device Injuries In the Future
Today, everyone knows asbestos causes cancer. But in 1939’s The Wizard of Oz, the director used “fake snow” (asbestos fibers) extensively on set. This was a common practice until shortly after It’s a Wonderful Life (which also used asbestos snow!) came out in 1947. In fact, the first real research connecting asbestos to mesothelioma didn’t come out until 1964. Now, we know that asbestos is the only thing on Earth that causes mesothelioma, a rare (but always fatal) lung cancer. Because it takes 15-70 years to develop from asbestos exposure, this long-term effect wasn’t a concern for golden-era Hollywood films.
With so many new drugs and medical device implants entering the market today, it may take decades to learn all potential side effects.
Now that you know how long it took people to realize that asbestos exposure = fatal cancer, let’s go further. When did that hernia mesh your surgeon used during repair surgery come out? What about the heartburn pill you take whenever you have too many slices of pizza? Just how certain are you that the medical device or drug that hurt you is actually “safe” for long-term use? Sure, it’s possible that your injury isn’t normal. Maybe it’s an extremely rare side effect that only hurt a small handful of people. But chances are, if you have an unexpected health complication from a medical device, staying silent puts others at risk.
Reason #2: The FDA Requires Safety Testing On Just 1% of Medical Device Implants That Go Inside People’s Bodies for Life
Potentially millions of people face harm each year from medical device complications. Pelvic mesh, for example, is a medical device that’s currently inside millions of women. But 1 in 4 patients report chronic pain and other life-altering side effects, such as vaginal wall erosion. What’s scarier: Most transvaginal mesh (also known as pelvic mesh or TVM) didn’t undergo any real clinical safety tests. In fact, I couldn’t find a single TVM medical device that did undergo safety testing before entering the market. Instead, the first model — Boston Scientific’s ProtoGen Sling — entered the market in 1999 through the FDA’s 510(k) clearance program.
A 2011 JAMA study reports only 529 out of 50,189 medical device implants underwent clinical safety testing prior to market. The rest gained clearance through the 510(k) program I mentioned before, which isn’t remotely the same thing. The 510(k) program allows manufacturers to submit a letter saying their product is “substantially similar” to something else that’s currently sold. In my ProtoGen Sling example, doctors took large hernia mesh patches that became popular in the 1950s. They cut them into narrower strips, then sewed that mesh directly into women’s vaginal walls. This supposedly helped women with stress urinary incontinence (SUI) and pelvic organ prolapse (POP) symptoms. For 20 years, women suffered crippling pain from TVM medical device injuries. Finally, the FDA banned TVM in 2019.
Reason #3: To Recover Lost Wages, Medical Bills As Well As Any Future Expenses That Come From Your Unexpected Health Complications
If you develop a lifelong complication, who pays those bills? You do — unless you file a claim. There’s no other option to recover money spent on doctor’s bills, unpaid time off work, etc. Let’s look at how quickly those potential costs add up:
- Your surgeon puts in a Physiomesh patch during routine hernia repair surgery.
- Four months later, Johnson & Johnson issues a global Physiomesh recall in May 2016. They say the device is defective and has a very high recurrence rate, along with other reported injuries. Now what?
- After weeks of irritating stomach pain, your doctor says you do, in fact, have a hernia recurrence. That defective mesh must come out… but insurance won’t cover the surgery. Why? Because you can’t get two identical procedures in the same calendar year.
- You put off surgery until 2017 for insurance reasons. Your surgeon just needs to swap out the defective hernia patch for a “safer” one. Can you hold out?
- During your January repair procedure, your doctor finds intestinal loops embedded within the mesh. The surgery takes 10 hours and includes a nasty surprise. Your surgeon says you’ll need to a colostomy bag for life!
Who’s responsible for paying unexpected lifelong costs from faulty mesh? You are, unless you file a medical device injury claim. With good insurance, you’ll pay the out-of-pocket maximum and deductible. But the average hernia recurrence surgery cost is just over $21,000. In addition, you might need more surgical procedures down the road. Filing a claim means J&J, the medical device manufacturer, must cover those costs as a result. Damages can include expenses that won’t show up for years, such as ongoing doctor’s bills and scans.
Reason #4: Filing A Claim’s Easier, Faster & Cheaper Than Most People Think, Plus It Holds Big Pharma Accountable
Would you seek a cash settlement if it cost you nothing to file, but paid you thousands (or even millions)? Most people that file valid medical device and drug injury claims settle for less because it’s faster. But unless you file a claim, all those unexpected bills pile up quickly.
Filing a claim costs nothing until after you win your case. That’s because all medical device and drug injury attorneys work on contingency. Unless you win a cash settlement for substantial damages, you’ll owe the lawyer $0. And if your case wins, you’ll only pay a small, one-time fee. In fact, the attorney will simply deduct a preset percentage from your cash settlement. No fees will surprise you, because you must sign a fee agreement to retain that lawyer’s services. Not sure if filing a claim’s right for you? Consult a lawyer for free before deciding whether or not to move forward.
Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.