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Medical Injury FAQ

How Do Dangerous Medical Devices Reach the Market?

When a medical device requires clearance from the FDA, there are two ways for the medical devices to get on the market:

  • To gain premarket approval, the medical device manufacturer must demonstrate through clinical trials that the device can be safely used for intended purposes.
  • Premarket notification, on the other hand, allows for clearance of device that is shown to be "substantially equivalent" in safety and effectiveness to another device that has already been cleared for the market by the FDA. This is commonly called the 510(k) process.

Problems arise when medical device manufacturers withhold certain negative results in clinical trials that would undermine their claims that their device is safe and effective, or when the manufacturer misrepresents the actual intended use for their product in a bid to get it to market quickly through the 510(k) process. This is often referred to as "off-label" usage.

Off-label usage may also include the marketing of the product for a use it was not intended for which, in effect, causes serious medical harm to its recipients. Sometimes pharmaceutical manufacturers include side effects on their labels, but downplay the severity of them.

There are many ways in which drug manufacturers can manipulate the system to get their product on the market, and the motivation is almost always money at the expense of safety. This type of corporate misconduct cannot be tolerated. Negligent or reckless medical device manufacturers must be held accountable when they put profits above patient safety. Fortunately, state and federal law provides relief for those who have been harmed by products that should never have been allowed to go on the medical device market.

Get more information and the answers you deserve by scheduling your free consultation with Arnold & Itkin. Call (888) 493-1629 today!

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  • $8 Billion Top 3 Largest Jury Verdict in U.S. History Arnold & Itkin LLP tried a Risperdal case against Johnson & Johnson for failing to warn about one of the drug’s most damaging side effects: gynecomastia. Our skill, hard work, and dedication resulted in the third-largest jury verdict ever obtained ...
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  • $205 Million Confidential Settlement Obtained for Numerous Clients Arnold & Itkin reached a record $205,000,000 settlement on behalf of clients after several years of hard-fought litigation. The case settled just before trial was set to begin.
  • $171 Million One of the Largest Confidential Settlements in History Arnold & Itkin worked over the course of several years to represent clients in a case that many other law firms turned down. In the end, we were able to obtain a record-setting confidential settlement of $171 million.
  • $117 Million Largest Single-Event Personal Injury Verdict in Louisiana History Arnold & Itkin represented a pregnant woman who experienced stomach pain and called Acadian Ambulance. The driver of the ambulance drove the ambulance into the back of a sugar cane truck causing the plaintiff's spine to be severed at T4 and for her ...
  • $116 Million Confidential Settlement Arnold & Itkin LLP negotiated a massive nine figure settlement on behalf of their clients after several years of hard fought litigation.
  • $110 Million Record Settlement Achieved for Victims of Defective Products Arnold & Itkin obtained a record settlement for individuals harmed by defective, dangerous products. The result exemplifies our commitment to clients and justice for those seriously injured by the conduct of others.
  • $105 Million Record Settlement for Dangerous Product Victims Arnold & Itkin’s legal team helped represent those harmed by dangerous products. We were successful in recovering a $105 million settlement.
  • $97 Million Massive Settlement Secured for Refinery Workers Arnold & Itkin is proud to share that after months of preparation for trial, our firm was able to secure a huge settlement for clients who were injured in a refinery fire. Find out more now.
  • $92.7 Million Record Settlement for Burn Injury Victim Arnold & Itkin LLP secured a substantial settlement for a man who suffered severe burns in an accident at his job. The settlement set a new record statewide for workers with similar injuries.
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