Reflections on the Movement in California to Repeal the State’s Ban on Affirmative Action

VIKRAM DAVID AMAR

Illinois law dean and professor Vikram David Amar offers three observations on a measure recently approved by the California legislature that would, if approved by the voters, repeal Proposition 209, the voter initiative that has prohibited affirmative action by the state and its subdivisions since its passage in 1996. Amar praises the California legislature for seeking to repeal Prop 209 and for seeking to do so using the proper procedures, and he suggests that if Prop 209 is repealed, legal rationales for the use of race should be based not only on the value of diversity (as they have been for some time now), but also on the need to remedy past wrongs against Black Americans.

Read More

Immunex Corp v. Sandoz Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 20-1037

Opinion Date: July 1, 2020

Judge: O'Malley

Areas of Law: Drugs & Biotech, Intellectual Property, Patents

The patents at issue are directed to the fusion protein etanercept and methods of making the same. Etanercept is the active ingredient in Immunex’s biologic drug Enbrel®, which is primarily indicated for reducing the signs and symptoms of moderately to severely active rheumatoid arthritis, an autoimmune disorder. Sandoz filed an abbreviated Biologics License Application (aBLA), seeking approval to market Erelzi, a biosimilar version of Enbrel®. In a patent infringement suit under the Biologics Price Competition and Innovation Act, Sandoz stipulated to infringement of the asserted claims of the patents-in-suit. The district court held that Sandoz had failed to prove that the asserted claims of the patents-in-suit were invalid. The Federal Circuit affirmed, rejecting claims of obviousness-type double patenting; failure to meet the written description requirement; and obviousness.

Sharpe v. Secretary of Health and Human Services

Court: US Court of Appeals for the Federal Circuit

Docket: 19-1951

Opinion Date: July 1, 2020

Judge: Jimmie V. Reyna

Areas of Law: Drugs & Biotech, Health Law, Personal Injury, Public Benefits

In July 2010, L.M. was born at full-term and developed normally for six months. In February 2011, L.M. received childhood vaccines, including the diphtheria-tetanus-acellular pertussis vaccination. By that evening, L.M. had a fever, was lethargic, had poor muscle tone, and would not eat., Any disturbance caused L.M. to scream. L.M. began to have several seizures a day. At seven years of age, L.M. could crawl and walk with the assistance of a walker. She had a poorly coordinated grasp, suffered cortical visual impairments, and was nonverbal, though she could use a few signs to express ideas such as “yes,” and “no.” Testing revealed that L.M. had a genetic mutation. In a claim under the National Vaccine Injury Compensation Program, L.M. alleged that the vaccinations administered to L.M. in February 2011, significantly aggravated L.M.’s pre-existing condition under two alternative theories. The Special Master denied the petition, finding that L.M.’s genetic mutation was “the most compelling explanation for her predisposition to develop a seizure disorder.” The Federal Circuit affirmed the denial of an “on-table” claim, finding no support for an argument that most encephalopathies do not become acute until after vaccination. The court vacated and remanded the denial of an “off-table” claim, which requires determining whether the child’s receipt of vaccinations significantly aggravated her seizure disorder in the face of an underlying genetic mutation.

Mize v. Mentor Worldwide LLC

Court: California Courts of Appeal

Docket: B295829(Second Appellate District)

Opinion Date: July 2, 2020

Judge: Tangeman

Areas of Law: Drugs & Biotech, Personal Injury, Products Liability

Plaintiffs filed suit against Mentor, alleging causes of action for negligence and negligence per se based on Mentor's negligent failure to warn and negligent manufacturing of breast implants, strict products liability for failure to warn, and strict products liability for manufacturing defects. The Court of Appeal reversed the trial court's judgment and entered an order overruling the demurrer to the third amended complaint. The court held that the tort claims in this case survive preemption because they are premised on conduct that both violates the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act and would give rise to a recovery under state law even in the absence of the MDA. The court also held that plaintiffs pleaded the requisite causal connection between their injuries and Mentor's tortious acts to survive a demurrer. Finally, the trial court erroneously sustained Mentor's demurrer to the loss of consortium claim because it was derivative of the other claims.