Back in 2012 Beef Beef Products Inc. brought a lawsuit against ABC in a multibillion-dollar defamation claim.
According to the lawsuit, the product, described by Beef Products Inc. as “lean finely textured beef,” was described by ABC as “pink slime” numerous times. The trial started June 5, 2017. The complaint had alleged damages of $1.9 billion dollars. Under South Dakota’s Agricultural Food Products Disparagement Act, this amount could have been tripled to $5.7 billion. The terms of the settlement are confidential.
Here is the United States Supreme Court June 19, 2017 Opinion in
BRISTOL-MYERS SQUIBB CO. v. SUPERIOR COURT OF CALIFORNIA, SAN FRANCISCO COUNTY, ET AL.
or shortened link below
Commercial Marketing notice prior to obtaining a license. Here is the link to the official U. S. Supreme Court opinion https://www.supremecourt.gov/opinions/16pdf/15-1039_1b8e.pdf
Held: An applicant may provide notice of commercial marketing before obtaining a license/approval from FDA.
The Biologics Price Competition and Innovation Act of 2009 (BPCIA or Act) provides an abbreviated pathway for obtaining Food and Drug Administration (FDA) approval of a drug that is biosimilar to a licensed biological product known as the reference product.
Section 262(l)(8)(A) of the (BPCIA or Act) states that the applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the bio-logical product licensed under subsection (k).” See 42 U. S. C. §262(k).