News & Analysis as of

Adverse Events

Plaintiffs’ Causation Expert Renounces His Own Conclusions – and Withdraws – in Mirena IIH Litigation

by Reed Smith on

We have blogged before about the Mirena IUD litigation. Cases alleging injuries from device migration and uterine perforation were centralized in an MDL in the Southern District of New York but summary judgment was granted...more

Florida Supreme Court Rules That Hospital "Adverse Medical Incidents" Reported to a PSO Are Not Privileged From Discovery: Impact...

Southern Baptist Hospital of Florida (Hospital) was sued in a medical malpractice action in which the plaintiff sought to discover records relating to "adverse medical incidents" that occurred at the Hospital and involved any...more

Client Alert: Florida Supreme Court Broadens Patient Access to Adverse Incident Reports

A recent decision by the Florida Supreme Court has significant implications regarding certain adverse incident reports previously viewed as outside the scope of permitted discovery. Florida health care providers currently...more

FDA Outlines Substantially Revised ‘Possible Approach’ to the Regulation of Laboratory-Developed Tests

by McDermott Will & Emery on

On January 13, 2017, the US Food and Drug Administration (FDA) posted a “discussion paper” in which the agency outlines a substantially revised “possible approach” to the oversight of laboratory-developed tests (LDTs). The...more

FDA Adverse-Event Reports Go Public

Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable...more

FDA Increases Transparency of Adverse Event Data for Cosmetics and Foods

On December 6th, FDA announced that it is publicly releasing data received by the Agency’s Center for Food Safety and Applied Nutrition (CFSAN) about adverse events related to cosmetics and foods, including both conventional...more

Show Me, Show Me, Show Me: FDA to Post Adverse Event Report Data Associated With Certain Products

by Arnall Golden Gregory LLP on

On December 7, 2016, the Food and Drug Administration announced that it would post on its website adverse event reports from January 2004 to the present for food (including food additives, color additives, and dietary...more

FDA's Public Posting of Adverse Event Reports: Four Things to Know

by Faegre Baker Daniels on

As part of a new initiative, the U.S. Food and Drug Administration (FDA) will begin publicly posting all consumer reports of adverse events related to food, dietary supplements and cosmetics. Here are four things companies in...more

Hospital Adverse Event Reporting System To Be Integrated Into FDA NEST Program

Based on recent FDA statements, it looks as though the FDA would like to integrate hospital medical device reporting obligations into the National Evaluation System for health Technology (NEST) framework. The NEST system is a...more

FDA Examining Role of Hospitals in Medical Device Surveillance

by Ropes & Gray LLP on

On October 25, 2016, FDA announced an upcoming public workshop entitled, “The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance.” ...more

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

by King & Spalding on

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

PTSD Poses a Long-Term Health Risk for Workers

by Howard Ankin on

Traumatic events can cause severe psychological damage that can persist for years, even decades after the event transpired. A workers’ compensation lawyer in Illinois can help individuals file claims for the long-term damage...more

Developments in Compassionate Use and Right To Try Laws

by Reed Smith on

We blogged a couple of years ago about the beginnings of what has become a wave of state “Right to Try laws” – laws that purport to give terminal patients with no other medical options the right to seek investigational drugs...more

New Duty To Supply Decision

by Reed Smith on

Ever since we first waded into the issue of “duty to supply” back in 2007 in connection with the litigation that produced Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir....more

Is Overreporting Adverse Event Information Always In A Company’s Best Interest?

by Arnall Golden Gregory LLP on

Recently, we moderated a panel at the Food and Drug Law Institute’s Annual Conference, where a senior Food and Drug Administration official participated. The individual from the Center for Drug Evaluation and Research made an...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Heater-Cooler Devices Linked to Infections

Heater-cooler devices are used during cardiothoracic surgeries, and other medical and surgical procedures to warm or cool a patient. They include water tanks that provide temperature-controlled water to external heat...more

FDA Medical Device Safety Tracking System Reform

The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements, transvaginal meshes, and lead wires in heart defibrillators have been recalled. ...more

FDA Issues Draft Guidance on ‘Emerging Signals’

by Morgan Lewis on

New guidance could present liability concerns for device manufacturers. On December 31, 2015, the Food and Drug Administration (FDA or Agency) issued a Draft Guidance for Industry titled “Public Notification of Emerging...more

Federal Preemption and Peer Review - A New Frontier

by Reed Smith on

It’s not often that we get to blog about a new area of federal preemption, but we do so today. This isn’t a big area, otherwise we would have known about it before, but it is pertinent to drug and medical device product...more

Anything in the New Clinical Trial Rules of Interest to Product Liability? Not Really.

by Reed Smith on

An inter-agency taskforce is proposing a comprehensive overhaul of “Federal Policy for the Protection of Human Subjects” in today’s issue of the Federal Register (comments close on 12/7/2015). See 80 Fed. Reg. 53933 (Sept....more

Medical Liability Reform – Iowa’s Communication and Optimal Resolution (Candor) Bill Effective July 1, 2015

by Dorsey & Whitney LLP on

On July 1, 2015, the Iowa legislature rolled out what is being heralded as its most significant medical liability reform of the past decade: enabling confidential “open discussions” between health care providers and patients...more

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

by Morrison & Foerster LLP on

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

Grand Opening of openFDA.gov

Information is power, and as of this month, there’s a new power source of information about drug effects. openFDA.gov is an initiative of the U.S. Food and Drug Administration to expand access to and use of reports of...more

FDA Launches Huge Online Database of Adverse Events

by Faegre Baker Daniels on

As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more

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