All Matters FDA Conference

SAVE The DATE: March 21, 2018 from 1pm-4pm 

The Annual FDA Matters Conference at the Delaware Law School, Wilmington DE 

Learn from seasoned professionals from FDA, FBI and the U. S. Office of the Attorney General

Focus: Opioids, Medical Devices, Food Safety, Dietary Supplements, Criminal Cases and Other Matters FDA—Year in Review, Top Notables, and Looking Forward

In Brief : This “All Matters FDA” promises to be informative and related to the Food and Drug Administration’s top accomplishments across the food and drug law spectrum.

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Death Wish Coffee Co. Announces Recall of Nitro Cold Brew Cans From Retailers, Online Sales

Company Recall of Nitro Cold Brew

The following is from the FDA website which posts the company’s announcement as a public service.

“Death Wish Coffee Co. (“Death Wish”), the Round Lake, N.Y.-based Coffee producer known for producing the ‘World’s Strongest Coffee’, has initiated a recall its 11-oz Death Wish Nitro Cold Brew cans.”

“Death Wish in conjunction with an outside Process Authority has determined that the current process could lead to the growth and production of the deadly toxin, botulin, in low acid foods commercialized in reduced oxygen packaging.”

$57.1 Million Verdict Pelvic Mesh Implants Against J&J’s Ethicon, Inc.

Mesh Implant Verdict

A Pennsylvania jury awarded $57.1 million in the allegedly defective pelvic mesh lawsuit against J&J’s Ethicon, Inc. The award includes $50 million in punitive damages and $7.1 million in compensatory damages. The trial was held in the Philadelphia County Court of Common Pleas mass tort program over allegedly defective pelvic mesh implants which were sold by Ethicon Inc. Stay tuned for the appeal by J&J.

Ebaugh et al. v. Ethicon Inc et al., (Ct. Common Pleas Phila., PA, No. 130700866, 9/07/2017). http://reut.rs/2gQR7Lr

Pink Slime – Beef Products Inc. v. ABC Defamation Lawsuit Settled Mid-trial

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.

Biosimilars Sandoz Inc. v. Amgen Inc.

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).