September 21, 2018

The Impact of 3-D Printing on Pharmaceutical Products Liability

Elizabeth Christen authored an article for The MedLaw Update titled “The Impact of 3-D Printing on Pharmaceutical Products Liability.” The article discussed recent advancement in 3-D printed medicines and its intersection with traditional medical regulations and the law.

The medical industry has used 3-D technology for medical devices such as prosthetic limbs, dental implants and surgical screws, and the Food and Drug Administration has approved more than 100 3-D printed medical devices. Pharmaceutical companies are exploring 3D-printed medications and the FDA approved the first, and currently only, 3-D printed medication in 2015. Elizabeth examined the current regulatory climate and potential liability concerns for pharmaceutical manufacturers.

“Regarding potential tort liability, 3-D medical printing brings about a plethora of new considerations,” she said. “Legal questions undoubtedly will include what is a ‘product,’ who is the ‘manufacturer,’ what is the ‘marketplace,’ and who should be liable for a defective 3-D printed medication.”

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