News & Analysis as of

National Geographic Considers Technology and Its Threat to Humanity

Progress, and faith in progress to improve human lives, has been a cornerstone belief in American civilization (and, indeed, Western civilization generally, at least since St Augustine argued that Christ's death put an arrow...more

No False Claims Act Case Where There is No False Claim – DNJ Throws Out Qui Tam Action Against Genentech

Halloween has come and gone. The Drug and Device Law Little Dogs stayed in their costumes (Batgirl and a rabbi) long enough to be photographed for (unsuccessful) entries for a pet costume contest. There was ample candy –...more

Nanotechnology Startup Challenge for Cancer Will Bring Nanotechnology Inventions to Market

On October 29, 2015, the White House Office of Science and Technology Policy (OSTP) published a blog item concerning the Nanotechnology Startup Challenge for Cancer (NSC2), “an open-innovation competition designed by the...more

Can the California A.G. limit those incessant Prop 65 lawsuits?

The California Attorney General has proposed amendments to California’s Proposition 65 regulations governing enforcement actions brought by a “private person in the public interest.”...more

Merck Sharp & Dohme Corp. v. Sandoz Inc.

Case Name: Merck Sharp & Dohme Corp. v. Sandoz Inc., Civ. No. 3:12-cv-03289-PGS-LHG, 2015 U.S. Dist. LEXIS 113710 (D.N.J. Aug. 27, 2015) (Sheridan, J.) - Drug Product and Patent(s)-in-Suit: Emend® (fosaprepitant...more

Plaintiffs Allege GSK Hid Risk of Birth Defects

The Food and Drug Administration approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy. The two women have sued GlaxoSmithKline (GSK), the maker of Zofran, accusing it of promoting...more

DAP Products Sued By EEOC For Disability Discrimination

Construction Products Manufacturer Fired Capable Worker Because of Cancer, Federal Agency Charged - DALLAS - DAP Products, Inc., a Dallas-based business and a leading manufacturer of home repair and construction...more

What impact will the Australian Myriad decision have on patent eligibility of diagnostic tests?

By now most will know that: (a) Australia’s final appeal Court has made adverse findings against Myriad’s patent for utilising the BRCA1 locus to diagnose breast cancer; (b) the rejected claims are only those that...more

Government Finally Investigating Power Morcellators

Patients undergoing medical treatments expect that their physicians will utilize tools that will assist in the treatment without causing undue harm or damage to their bodies. One of these tools, a power morcellator which is...more

Plaintiffs Ask JPML to Transfer Power Morcellator Lawsuits to Kansas

Laparoscopic power morcellators are electronically powered tools that use a bladed feature to shred uterine fibroids and other tissue so that they may be easily removed through small incision in the abdomen. The process has...more

Plaintiff’s Mere Presence in Area Where Asbestos is Present Insufficient to Establish Bystander Exposure

In Schiffer v. CBS Corporation (filed 9/9/15; modified 9/30/15), the California Court of Appeal, First Appellate District, affirmed summary judgment in favor of the defendant asbestos insulation manufacturer finding...more

A Legislative El Niño for California?: New 2016 Employment Laws for the State’s Private Sector Employers

Experts are predicting a 95% chance of heavier-than-usual seasonal rainfall this year in Southern California based on the phenomenon known as “El Niño.”  Did the California Legislature and its Governor produce a comparable...more

High Court of Australia determines isolated BRCA1 gene not patentable in Australia

The High Court of Australia has unanimously overturned previous decisions from lower courts and has held that certain claims to Myriad's patent for isolated BRCA1 nucleic acid molecules are not patentable in Australia...more

Cancel My Reservation! Pennsylvania Sows Confusion Over Consent-to-Settle Clauses

This summer, the Supreme Court of Pennsylvania addressed an important question that has divided other courts: if an insurer defends a claim subject to a reservation of rights, may the insured settle the claim without the...more

Precision Medicine - Even Medicare Will Pay for It!

President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. "Precision Medicine"...more

Products Liability – Raw Material Supplier – Consumer Expectations Test

David Johnson, et al. v. United States Steel Corporation - Court of Appeal, First District (September 1, 2015) - In a products liability case, a plaintiff may seek recovery on theories of both negligence and...more

Alabama CON Report

I. SHPDA Administrative Report - AL2015-022, Gulf Health Hospitals, d/b/a Thomas Hospital, Daphne, AL: Proposes to establish a freestanding emergency department (FED). The project was approved with stipulation of...more

OIG Approves Limited, Free Drug Program

On August 12, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-11, approving two pharmaceutical manufacturers’ free starter drug program. Citing the limited scope...more

OIG Issues Advisory Opinion Regarding Pharmaceutical Manufacturers’ Program to Provide Free Limited Drugs to Beneficiaries When...

On August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health...more

OIG Will Not Impose Sanctions on Entities for Program That Provides Free Drugs to Patients Experiencing Delayed Insurance...

On August 5, 2015, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG) issued Advisory Opinion No. 15-11 (the “Opinion”) in response to a request by pharmaceutical manufacturers that...more

When Cancer Strikes: When Happens AFTER You Run Out of Paid Time Off

I’d much rather write about a legal topic than a personal one, but before I talk about the logistics of handling an employee who has exhausted their paid time off, I wanted to share a brief personal update. Last...more

2015 Florida Legislative Post-Session Report

Carlton Fields Jorden Burt’s Government Law and Consulting Practice Group released its 2015 Florida Legislative Post-Session Report detailing significant bills that passed during the 2015 Regular Session of the Florida...more

Hidden Costs of Common Beauty Treatments?

The “toxic trio” is a foreboding name some associate with common and seemingly innocuous manicures and pedicures. Salon workers suffer higher-than-average rates of birth defects, miscarriages, cancers, and skin afflictions...more

Health Alert (Australia) - July 6, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Victoria. 26 June 2015 - Northern Health v Kuipers [2015] VSCA 172 - The Victorian Supreme Court has allowed an appeal...more

Regulators' Actions Against Charities that Swindled $187 Million from Donors Serve as Compliance Reminder

On May 18, 2015, the Federal Trade Commission (FTC) and 58 agencies from all 50 states and the District of Columbia filed a complaint charging four cancer charities and the individuals controlling them with allegedly...more

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