Why Do Some Individuals Not Qualify?

Product liability lawsuits involving drugs and medical devices are extremely complex, and involve taking on large corporations with almost limitless financial resources. As such, the criteria for filing a claim are often very strict, and some individuals may not qualify.

What Do I Need to Prove to Prevail in a Lawsuit?

In order to win any product liability lawsuit, including those involving drugs and medical devices, plaintiffs must prove the following:

  • The product involved was defective. There are three types of defects that might qualify for a lawsuit: Manufacturing defect, design defect, and failure-to –warn.
  • The defect was the direct and proximate cause of their injury.
  • The plaintiff actually sustained an injury.
  • The seller or manufacture must owe a duty to manufacture or sell a safe product.

Statute of Limitations

Prospective plaintiffs are barred from filing a lawsuit if the filing falls outside of their state’s statute of limitations, or SOL. In most states, the SOL  on product liability claims doesn’t begin tolling until the person who was injured discovered or should have discovered the injury. However, some states begin this time period when the injury actually occurred.

Once you contact an attorney, he or she will immediately research the SOL issues affecting your case. Unfortunately, you will be time-barred from pursuing the lawsuit if your state’s deadline has expired.

Generic Drug Lawsuits

Unfortunately, two U.S. Supreme Court ruling have made it extremely difficult for plaintiffs to pursue product liability lawsuits against generic drug makers. In 2013, the Court ruled in Pliva vs. Mensing that generic manufacturers could not be held liable for failing to warn about a drug’s dangers because they have no control over the contents of product labels. Two years later, in a case called Mutual Medical vs. Bartlett, the Court found that generic manufacturers can’t be held responsible for medications that are defectively designed, as federal law requires that their products be exact copies of the name-brand counterparts.  Read More

Preempted Medical Device Lawsuits

In a 2008 case called Reigel vs. Meditronic, the U.S. Supreme Court ruled that medical device lawsuits are preempted in cases where the device in question has gone through the U.S. Food & Drug Administration’s (FDA) stringent premarket approval process. However, medical device lawsuits can still be filed over products cleared via the agency’s 510(k) protocols. This “fast-track” approval process does not require device makers to conduct human clinical trials if they can show that a product is substantially equivalent to another device previously approved by the FDA. Read More

Other Eligibility

Every drug and device lawsuit involves very specific criteria prospective plaintiffs must meet in order to ensure that they have a strong case. For example, certain pre-existing conditions might make it impossible for a plaintiff to prove that a medication or device actually caused their injury. Because each case is unique, it’s important to obtain a legal consult with a qualified attorney before you move forward.

Bernstein Liebhard LLP offers free, no-obligation legal reviews to individuals who may have been harmed by defective drugs and medical devices. To find out if you qualify to file a lawsuit, please call (888) 994-5118.

  1. New York Times (2013) “In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs” http://www.nytimes.com/2013/06/25/business/justices-rule-generic-makers-not-liable-for-drugs-design.html?_r=0
  2. Washington Post (2008) “Supreme Court Shields Medical-Device Makers” http://www.washingtonpost.com/wp-dyn/content/article/2008/02/20/AR2008022001140.html
Last Modified: June 2, 2016

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