News & Analysis as of

Black Box Warnings Food and Drug Administration (FDA)

Patrick Malone & Associates P.C. | DC Injury...

Women will receive more disclosures about risks of breast implants

Federal regulators have toughened the requirements for surgeons and medical device makers to inform women in detail about rising risks associated with breast implants, which also now will carry the government’s sternest...more

Baker Donelson

OIG Okays Assistance Arrangement Offered to Drug Patients in Advisory Opinion 20-02

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In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more

Wilson Sonsini Goodrich & Rosati

CMS Makes CAR T-Cell Cancer Therapy Available to Medicare Beneficiaries Nationwide

Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more

Patrick Malone & Associates P.C. | DC Injury...

Big Pharma executives convicted of criminal racketeering with opioid sales

Even as more felony charges may follow in drug epidemic, sleep med warning suggests pill popping stays too popular - Five top executives at a major drug maker have been convicted of criminal racketeering for their...more

Morrison & Foerster LLP

Another Step Toward Reasonable Preemption Case Law

Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th...more

Foley & Lardner LLP

Four Distinct Federal and State Policies Addressing Prescription Opioid Abuse

Foley & Lardner LLP on

The first quarter of 2016 has witnessed a great deal of attention in government to the problem of opioid-related overdose and death in the United States. In just the past few weeks, the Senate passed prescription drug...more

BakerHostetler

FDA Investigates Children’s Cough and Cold Medication With Codeine Amid Safety Concerns

BakerHostetler on

In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s...more

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