Many people think filing a lawsuit against anyone that makes dangerous drugs, medical devices or products is “frivolous.” But did you know Big Pharma companies like Johnson & Johnson or Novartis build lawsuit costs into their quarterly budgets? What’s more, the U.S. Food and Drug Administration doesn’t safety-test most drugs or medical devices sold on the market today. We’ll debunk some myths that keep people from filing injury claims and explain why holding Big Pharma accountable matters below.
Reason #1: The FDA Approves Less Than 1% of All Medical Devices Inside Patients Today
A 2011 JAMA study found just 529 of 50,189 devices sold on the U.S. market were FDA-approved. The rest gained FDA clearance, which isn’t remotely the same thing. Only 529 devices went through the FDA’s strict pre-market approval (PMA) process. PMA means manufacturers conduct clinical safety trials and supply proof these devices are both safe and effective for human use. The FDA then reviews that data before granting approval for those medical devices to enter the U.S. market.
However, the other 49,660 devices sold on the U.S. market since 2003 entered through the FDA’s 510(k) clearance process. That means manufacturers submitted a letter to the FDA saying those products were “substantially similar” to other legally marketed devices. Here’s how that clearance process puts consumers like you at risk:
- Surgical mesh becomes popular for abdominal hernia repair in the 1950s.
- In 1996, the FDA clears Boston Scientific’s ProteGen Sling through its 510(k) program.
- The FDA clears other devices “substantially similar” to the ProteGen Sling until 1999. Doctors implant more than 100,000 mesh devices in women annually for POP, and another 260,000 for SUI repairs.
- FDA recalls ProteGen Sling in 1999 due to overwhelming severe injury reports.
- The 1999 recall doesn’t affect other meshes cleared through the FDA’s 510(k) program. In other words, devices “substantially similar” to the ProtoGen Sling are still available, harming several hundred thousand women.
- After tracking injury reports for 20 years, the FDA bans pelvic mesh in April 2019. As much as 1 in 4 women with mesh implants suffers severe, painful side effects for life. These include not being able to sit or urinate without severe pain, chronic infections and vaginal wall erosion.
Reason #2: A Lawsuit Is the Only Way to Recover Lost Wages & Medical Bills As Well As Any Future Expenses
If you develop a lifelong health problem from taking prescription drugs, who pays that cost? You do — unless you file a lawsuit. There’s literally no other way to get back money spent on doctor’s visits, missing work and other potential damages. Let’s look at how quickly that can add up:
- Your doctor prescribes Invokana to treat your type 2 diabetes.
- You take it as directed, but throw the warning insert into the trash. All blood sugar drugs have similar side effects, right?
- After six months, your blood sugar’s great… but you notice a weird bump on your foot. Maybe you rubbed a blister on your heel during a coworker’s wedding?
- One month later, your doctor says it’s badly infected and admits you to the hospital.
- Your doctor says that foot must come off. Only then does your doctor say Invokana doubles your risk for foot amputations!
Who’s responsible for your foot surgery costs? You are. If you’re lucky and have good insurance, you’ll pay the out-of-pocket maximum and deductible. But costs can range from $20-$60k, plus ongoing expenses from a missing limb. A lawsuit can help you get back all money spent treating unexpected side effects. Damages can include anything from doctor’s bills, pain and suffering as well as lost wages and estimated future costs.
Reason #3: Your Lawsuit May Protect Others From Suffering Similar Problems In the Future
Now you know the FDA isn’t the consumer safety watchdog you thought, and doctors may not explain every side effect. Filing a lawsuit is the best way to hold Big Pharma accountable for putting their profits above patient safety. Your lawsuit may grab headlines, so more patients find out they’re at risk. With enough lawsuit filings, a federal judge panel may consolidate all claims under a multidistrict litigation (MDL). If that happens, your case gets heard faster and you’re more likely to receive a cash settlement.
Once enough injured people file a lawsuit, TV commercials appear warning the public about their risks. Amplify this message enough, and the FDA may pull that device, drug or product off U.S. shelves. You don’t want loved ones, friends or kids suffering the same problems you did, or paying the cost. A lawsuit is the fastest, most effective way to ensure Big Pharma puts patients’ safety first every time.
Reason #4: Filing A Lawsuit Is Easier, Faster & Cheaper Than You Might Think
Would you file a claim if it cost you nothing, but could pay thousands (or even millions) in settlement cash? It’s true that most people with valid claims settle for much less than that. But if you don’t file a lawsuit, you must pay all those unexpected medical bills on your own.
Let’s say you got hernia repair surgery two years ago. Since then, the FDA recalled the mesh patch your surgeon used to fix it. It’s defective, and 3 in 4 patients need surgery to fix another hernia recurrence within 18 months. You noticed some stomach problems and pain a few months back, but tried to ignore it. You can’t take time off for surgery again without losing your new job. So, what should you do? Unless you have a second (expensive) surgery and take more time off, you may suffer worse health problems!
Filing a lawsuit costs nothing now, since mass tort attorneys work on contingency. You won’t pay anything, ever, unless you win damages. And if you do win, you’ll only pay a small, one-time fee. Not sure how to find an experienced mass tort lawyer that can help you? DrugJustice can match you with the closest one near you today! Just answer a few brief questions first to check your eligibility, then tell us what happened to you. Once you’ve submitted your current contact info, an attorney will call right away to discuss your case. You can talk to this lawyer for free and get answers to all your questions. Then, only you decide whether you’re ready to file a lawsuit (or not). In fact, your free case evaluation and consultation don’t obligate you to do anything else.
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.