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Posts Tagged ‘FDA’

FDA Approves First Drug Made by 3D Printing

Posted on: September 1st, 2015

By: Mike Bruyere

Additive manufacturing, or 3D printing, reached a significant milestone this month when the FDA approved the production of an epilepsy medication that will be marketed under the name Spritam.  The new drug, developed by Aprecia, controls seizures brought on by epilepsy, and is the first drug produced by a 3D printer to receive the FDA’s imprimatur.

3D printing was invented over thirty years ago by a brilliant engineer, Chuck Hull. At its most fundamental level, 3D printing began as the modification of an ink printer to utilize various materials as the “ink” or powder to build vertical levels of a design. In successive passes of the build process, the printing jet is slightly raised and the printed material is added onto the previous layers.

3D printing enables medical providers to rapidly produce devices like customized artificial limbs, dental devices, and exterior bracing (such as braces used to treat scoliosis).  Accordingly, the availability of high-quality and low-cost devices is spreading geographically and throughout the health care industry. 3D printing applications are currently in use or development for pumps, stents, coils, surgical guides and a host of orthopedic applications.

As with myriad other applications in the life sciences industry, 3D printing of medicines brings the manufacturing process much closer to the patient, but it also raises potential issues concerning who is considered the actual manufacturer of the drug from a products liability standpoint.  For example, is Aprecia considered the manufacturer, or are other entities involved in the design, testing, manufacturing (such as the manufacture of the 3D printer), and distribution of the drug also at risk?  Additionally, while life sciences advances such as Spritam hold the promise of lower health care costs and more readily available drugs, the implications for misuse of this technology, particularly in the area of illegal designer drugs, cannot be understated.



A Rose By Any Other Name: Alabama Supreme Court Denies Creating Tort of Innovator Liability for Brand-Name Drug Manufacturers, But Its Decision Creates A Pathway for Innovator Liability for Brand-Name Drug Manufacturers

Posted on: August 21st, 2014

By: Michael P. Bruyere and Michael J. Eshman

After the U.S. Supreme Court’s decision in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011) holding that a generic drug manufacturer generally cannot be liable for a failure-to-warn state law claim because of its duty of sameness – to match the warning provided by the brand-name drug manufacturer – we anticipated that this would lead to creative theories of liability from plaintiffs’ lawyers representing people who allege injuries from ingestion of a generic drug.  One such theory, the innovator liability theory, which seeks to hold a brand-name manufacturer liable for the alleged injuries produced by ingestion of a generic drug, has routinely been rejected by courts across the country because there is no relationship between the brand-name drug manufacturer and the person alleging injury.  See e.g. Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013) (applying Florida law).

This past week, the Alabama Supreme Court gave new life to innovator liability claims in that state.  See Wyeth, Inc. v. Weeks, 2014 WL 4055813 (Ala. Sup. Ct., August 15, 2014) (Westlaw).  The court held that a brand-name drug manufacturer could be liable based on fraud or misrepresentation for injuries allegedly caused by ingestion of a generic version of its drug.  The court based its ruling on the unique federal regulations in the prescription drug industry that prevent a generic drug manufacturer from altering the warning provided by the brand-name drug manufacturer.  The court indicated that it did not intend to create a new tort of “innovator liability,” but its decision creates a pathway for just that in the prescription drug context.  The court may not have created a new tort, but it created a pathway for consumers of generic drugs who have never ingested the brand-name drug to recover against brand-name drug manufacturers.  The net result is that innovator liability against brand-name drug manufacturers is alive and well in Alabama, for the time being.

We expect there will be reactions to this decision from other courts and potentially the FDA and/or Congress.  In the interim, we expect an increase in claims against brand-name drug manufacturers by people who never ingested their drugs, based on the adequacy of the warnings that accompanied the generic drugs they actually ingested.