Schoenbrod: SCOTUS Ruling Helps EPA Deal With a "Stupid Statute"
A More Perfect Union: Why Punish Russia for Crimea?
Jail Time for Revenge Porn Offenses?
End Game in the Fight Over Same Sex Marriage?
Is Punishment Dead in America?
Bill on Bankruptcy: Detroit Falls Short on Good-Faith Test
Bill on Bankruptcy: Madoff Victims Rooting for Stanford Victory
Bill on Bankruptcy: Listening in the Dark at the NCBJ
Health Care Antitrust & the Supreme Court – Interview with Bruce Sokler, Member, Mintz Levin
Bill on Bankruptcy: Detroit Shows Need for Amending Bankruptcy Law
Bill on Bankruptcy: Detroit Judge Might Lose Grip on the Case
PennDOT to Increase Number of Pennsylvania Bridges with Weight Restrictions
Harvey Miller: Detroit Will Be In Bankruptcy "For A Long Time"
Grayson: Only 1 Agency Should Regulate Wall Street
Bill on Bankruptcy: Supreme Court Cases Will Have Wide Impact
Coyle: Robert's SCOTUS Doesn't Respect Congress
Goldstein: Expect More Litigation in Wake of Myriad Gene Patent Decision
What's So Funny About The U.S. Constitution? Colin Quinn's Unconstitutional: Off-Broadway
S&C's Cohen: Brown-Vitter Punishes Banks For Being Big
Cohen: Cyprus Is Not A Template For Future Restructurings
It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more
A professor at the University of Texas Health Science Center has petitioned the U.S. Supreme Court to determine the standard for imposing liability on state universities (and their related entities, such as hospitals and...more
Last month in its decision in In re Sci. Applications Int’l Corp. (SAIC) Backup Tape Data Theft Litigation, 2014 U.S. Dist. LEXIS 64125, the United States District Court for the District of Columbia dismissed all but two...more
The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more
On June 6, 2014, the Food and Drug Administration (“FDA”) issued two documents that reflect the agency’s ongoing effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical...more
The U.S. Supreme Court’s decision in Clapper v. Amnesty International USA again has been relied on by a federal district court to hold that the “mere loss of data” in a data breach case does not constitute an injury...more
On April 18, 2014, California Clinical Laboratory Association (“CCLA”) and “Jane Doe” (collectively, “Plaintiffs”) filed a lawsuit against HHS for equitable relief in the United States District Court for the District of...more
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
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
Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more
Relying in part on the recent United States Supreme Court’s ruling in Clapper v. Amnesty International, a federal judge in New Jersey dismissed a putative data breach class action against three healthcare entities and a...more
On November 27, 2013, the Drug Quality and Security Act was signed into law. This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new...more
On October 8, 2013, Reliance Medical Systems, LLC (“Reliance”) filed a Complaint against the HHS OIG in the United States District Court for the Central District of California. The Complaint alleges that OIG’s assertion in a...more
On August 28, 2013, the U.S. District Court for the Northern District of California issued an order upholding Alameda County's Safe Drug Disposal Ordinance as constitutional. The ordinance, passed in July 2012 by the Alameda...more
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
On September 11, 2013, HHS stated in a joint motion filed in the case of Adheris, Inc. v. Sebelius, No. 1:13-cv-1342 (D.D.C.), that it plans to issue guidance on a HIPAA regulation related to prescription drug refill...more
In This Issue:
- Top News
..Obama Administration Delays Employer Mandate One Year
..House Energy and Commerce Committee Releases Draft Legislation for SGR Fix
..CMS Proposes Payment Changes for Medicare...more
Full text copy of the unanimous U.S. Supreme Court ruling in Association for Molecular Pathology v. Myriad Genetics that human genes may not be patented because they occur naturally in nature.
From Greg Stohr writing for...more
The Patient Protection and Affordable Care Act (“ACA”) generates very few areas of agreement. However, in recent months, proposals to repeal one of the most visible and controversial provisions of the...more
On April 5, 2013, Judge Edward R. Korman of the United States District Court for the Eastern District of New York found that the Secretary of Health and Human Service’s (“HHS”) decision to limit over-the-counter (“OTC”)...more
On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more
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
Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more
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
In This Issue:
- Top News
..CMS Announces Round 2 Competitive Bidding Single Payment Amounts
..CBO Lowers SGR Repeal Cost by $100 Billion
..Republicans Press HRSA on 340B Audits
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