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Status Updates - October 2014 #8

..Doctor in the mouse. What if you could input a list of your current symptoms to Google, and quickly be connected with a doctor for a brief consultation? For a limited trial period, Google seems to have set up such a system...more

Illinois Supreme Court Debates Automatic Revocation of Certain Health Professionals' Licenses

Our reports on the oral arguments of the May term of the Illinois Supreme Court conclude this morning with Consiglio v. Department of Financial and Professional Regulation. Consiglio involves a constitutional challenge to...more

Status Updates - June 2014 #4

..Are threats made on social media protected free speech, or potentially criminal acts? The U.S. Supreme Court has agreed to examine the constitutionality of a federal law making it a crime to transmit communications...more

New Reprint Guidance Maintains Bipartisan Status Quo

On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses. With minor textual revisions, this new Guidance essentially restates the safe...more

Health Reform + Related Health Policy News - January 2014, Issue 1

In This Issue: - Top News ..Congress Approves Budget Deal with Short-Term ‘Doc Fix' ..CMS “Two-Midnight” Rule delayed until March 31, 2014 ..Individuals with Canceled Insurance Policies May Apply for...more

Rodriguez Redux

Today, the Supreme Court of Canada granted leave to appeal in Carter v Canada (AG), which deals with the constitutionality of the assisted suicide provision of the Criminal Code. In 1993, in Rodriguez v British Columbia (AG),...more

Recent Cases of Interest to Regulators

Investigative Powers - Sazant v. College of Physicians and Surgeons of Ontario, 2013 CanLII 22324 (S.C.C.), dismissing leave to appeal of a decision in 2012 ONCA 727 - In Sazant, a physician faced both criminal...more

D.A.R.E. to Market Off-Label Uses of Prescription Drugs? Make Sure You are in the Second Circuit: United States v. Caronia and the...

Truthful, non-misleading off-label promotion of prescription drugs is not illegal. At least, not in the Second Circuit. This, despite the billions of dollars in civil and criminal penalties assessed against pharmaceutical...more

Miranda Eviscerated: How Your Silence During a Government Interview Could Be Used Against You

Can your silence be used against you in a criminal proceeding? Most of us would assume that it cannot because of the Fifth Amendment to the U.S. Constitution and case law interpreting it....more

Health Reform + Related Health Policy News - June 2013

In This Issue: - Top News ..CMS Finalizes MLR Rule for Plans, Maintaining Application to Part D Sponsors ..Early State Filings Show Premium Reductions under ACA ..HHS Received More Than 830 Letters of...more

Counties in California Can Learn a Few Lessons from State on Inmate Health Care - BB&K Health Care Attorney Shares Tips on...

Inmates in the Riverside County jails served a federal class-action lawsuit last month, claiming the county is subjecting them to cruel and unusual punishment by depriving them of basic medical and mental health care. A...more

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

White Collar Watch - February 2013

In This Issue: - New HIPAA “Megarule” Broadens Enforcement - Government Declines to Seek Rehearing of Landmark Off-Label Speech Decision - Seizure of Rothstein Ponzi Assets Highlights Tension Between...more

False Press Release Leads To Exclusion From Federal Programs

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

Legal links of interest for the week ending July 28

Attorney Steven Getman reports on a number of stories about the law and lawyers in the news this week: • Addressing threats to an independent judiciary • How colleges suppress free speech • Federal...more

Increased FDA Regulatory Action: The Current Landscape and Its Impact on Drug and Medical Device Litigation

The Food and Drug Administration (FDA) has a number of tools to enforce its laws and regulations. From warning and untitled letters to seizures, recalls, injunctions, monetary penalties and criminal prosecutions, its options...more

Bruce Carneil Webster: Will Mentally Retarded Man on Federal Death Row Be Executed?

This Monday, without comment, the United States Supreme Court denied the petition for writ of certiorari filed by Bruce Carneil Webster, who sets on the federal Death Row. Mr. Webster had sought the High Court’s relief,...more

The Regulate, Control and Tax Cannabis Act of 2010

Prop 19 - Copy of California Proposition 19 to Legalize Marijuana

Full text copy of California's Prop 19 initiative up for vote on November 2, 2010. If passed, Proposition 19 will in effect legalize marijuana in California. See text of the intiative for details. Includes following...more

Bedford v. Canada, 2010 ONSC 4264

Prostitution Law in Ontario

Ontario Superior Court of Justice ruling by Justice Susan G. Himel in Bedford v. Canada regarding the Criminal Code provisions over prostitution...more

Angel McClary Raich, et al. v. Alberto Gonzales, Attorney General, et al

Cato's Amicus Brief joined by the Reason Foundation,

In 2005, the Supreme Court decided Gonzales v. Raich, a case that pitted two sick women, who use medical cannabis, against the U.S. Department of Justice. The Justice Department asserted that the Commerce Clause gives federal...more

Alternative Sentencing Theory

Proposes a constitutional framework around which judges may sentence people charged with drug and alcohol-related crimes to faith-based programs rather than prison. Such a course of action, according to the author,...more

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