WILMINGTON, Del. (Legal Newsline) — A Delaware Superior Court judge has dismissed a lawsuit against Astrazeneca Pharmaceuticals, LP in a case that alleged personal injury from a woman who had taken their drug Farxiga to treat Type 2 diabetes.
Judge Sheldon K. Rennie filed the order dismissing the case for failing to state a claim on March 2.
AstraZeneca filed its motion to dismiss back in January. The company argued that plaintiff Viola Kumaritakis' allegation of the company's failure to warn was invalid because by law the FDA-approved warnings for Farxiga were sufficient, her negligence claim was based on a defective design theory, and that she wasn't entitled to damages.
Kumaritikis filed her initial complaint in October 2019, after she had taken Farxiga from October 2017 to May of 2019. She initially said she suffered personal injury because of taking Farxiga, but filed an amended complaint the next month in response to Astrazeneca's motion to dismiss. In it, she raised three counts, which included negligence, strict product liability for failure to warn, and punitive damages.
The court found Kumaritikis did not bring forward any arguments or exceptions to the law that would prove the FDA-warning label wasn't adequate. Judge Rennie also said she didn't argue the drug was not properly prepared, just "unreasonably dangerous" since it's label didn't warn of the risk of causing her harm.
There is another element for the defective design, which is that a safer alternative is already existent. But the court ruled it's prevented by federal law since under the law the company is forbidden from changing the design of the drug without getting FDA approval before doing so.
The court also found her failure to test theory under the defective design liability was not supported by evidence.