Case Updates

Neuroscience

• United States v. Semrau

  Issue: Whether fMRI-evidence is admissible for the purpose of lie-detection in criminal cases.
  Status: Panel decision in the U.S. Court of Appeals for the Sixth Circuit
  Holding: fMRI evidence is not admissible for the purpose of lie-detection in criminal cases. The district court was correct in refusing to admit such evidence. The defendant's conviction for healthcare fraud is affirmed.

• Maryland v. Smith

  Issue: Whether fMRI-evidence is admissible for the purpose of lie-detection in criminal cases.
  Status: Panel decision in the Court of Appeals of Maryland; new trial granted; defendant convicted on new trial; sentenced to twenty years. 
  Holding: fMRI evidence is not admissible for the purpose of lie-detection in criminal cases. The district court erred on other grounds.

Genetics

• Haskell v. Harris

  Issue: Whether mandatory collection under California statute of DNA samples for persons arrested but not (yet) convicted violates the Fourth Amendment.
  Status: Panel decision in the U.S. Court of Appeals for the Ninth Circuit; en banc submission deferred in light of Maryland v. King.
  Holding: Panel upheld constitutionality of California DNA collection statute.

• People v. Buza

  Issue: Whether mandatory collection under California statute of DNA samples for persons arrested but not (yet) convicted violates the Fourth Amendment.
  Status: Currently before the Supreme Court of California; fully briefed; argument date not yet set.
  Holding: Lower appellate court struck down California statute on constitutional grounds as violating the Fourth Amendment.

• Maryland v. King

  Issue: Whether mandatory collection under Maryland statute of DNA samples for persons arrested but not yet convicted violates the Fourth Amendment.
  Status: Currently before the U.S. Supreme Court; certiorari granted; argument date not yet set.
  Holding: Maryland Court of Appeals had struck down its state's DNA collection statute as violating the Fourth Amendment.

Stem Cells

• Sherley v. Sebelius

  Issue: Whether federal funding for human embryonic stem cell research violates the Dickey-Wicker Rider, 5 U.S.C. § 706(2)(A).
  Status: Panel opinion by the U.S. Court of Appeals for the D.C. Circuit
  Holding: The district court did not committ error by dismissing the lawsuit.

• United States v. Regenerative Sciences, LLC

  Issue: Whether autologous mesenchymal stem cells used in treatment are “drugs” under the FDA’s jurisdiction.
  Status: Before the U.S. Court of Appeals for the D.C. Circuit
  Holding: Stems cells, as used in the contested procedure, are "drugs," for purposes of FDA oversight.

Intellectual Property

• Association for Molecular Pathology v. Myriad Genetics

  Issue: Whether genetic medical diagnostic tests are patentable subject matter.
  Status: Certiorari filed before the U.S. Supreme Court.
  Holding: The U.S. Court of Appeals for the Federal Circuit concluded that genetic medical diagnostic tests are patentable subject matter; some genetic probes used in such tests are not.

• Sequenom, Inc. v. Natera Inc.

  Issue: Whether the defendants' use of prenatal genetic tests for down syndrome infringes the plaintiff's patents.
  Status: In litigation.

• Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc.

  Issue: Whether the performances of patented tests done in connection with the submission of information to the FDA is safe from allegations of infringement under the "safe harbor provision" in 35 U.S.C. § 271(e).
  Status: Panel opinion by the U.S. Court of Appeals for the Federal Circuit.
  Holding: Such tests do come under the "safe harbor provision" and are immune from allegations of infringement.

• In re K-Dur Antitrust Litigation

  Issues: Whether payments made to generic pharmaceutical makers by pioneer drug manufacturers, as part of litigation settlements, presumptively violate the antitrust laws.
  Status: Panel opinion in the U.S. Court of Appeals for the Third Circuit
  Holding: The "rule of reason" applies to such analyses; the case is remanded to the district court for further proceedings.
   

First Amendment

• R.J. Reynolds Tobacco Co. v. FDA

  Issue: Whether government-required graphic warnings on cigarette packages violate the First Amendment
  Status: Panel opinion by U.S. Court of Appeals for the D.C. Circuit
  Holding: The warnings are unconstitutional.

• Par Pharmaceutical, Inc. v. United States

  Issue: Whether prohibitions on off-label drug promotion violate pharmaceutical companies’ First Amendment rights, and whether the FDA’s policies regarding off-label promotion are inconsistent with the Food, Drug, and Cosmetic Act.
  Status: Pending before the U.S. District Court for the District of Columbia
  Holding: Stayed untill December 14, 2012.

• United States v. Caronia

  Issue: Whether a pharmaceutical rep's criminal conviction for promoting a drug for off-label uses violates the First Amendment.
  Status: Opinion by U.S. Court of Appeals for the Second Circuit
  Holding: “[W]e construe the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.” The court vacated the criminal conviction of drug rep for promoting a drug off-label.