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Medical Monitoring Class Certification Fails

by Reed Smith on

Normally, when we think of decisions relating to medical monitoring, the issue is whether a state will recognize medical monitoring for uninjured people as a separate claim or relief that can be sought under an existing...more

Northern District of New York (Quickly!) Holds that the MDA Expressly Preempts Essure Suit

by Reed Smith on

A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity. That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from...more

Congressional Task Force Issues Report on Cybersecurity in the Health Care Industry

by Polsinelli on

Recently, the Health Care Industry Cybersecurity Task Force (the “Task Force”) issued its Report on Improving Cybersecurity in the Health Care Industry (the “Report”). The Task Force, which was created by Congress as part of...more

Better Healthcare Newsletter from Patrick Malone - September 2017

Deflating the hype and exposing the risks of stem-cell treatments - Stem cells and regenerative medicine—a promising and complex field that has been a preoccupation of no less than popes, presidents, and top health policy...more

FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more

Guest Post – Before the Flood: Fifth Circuit Oral Argument on Writ of Mandamus From Pinnacle Hip Implant MDL

by Reed Smith on

Today’s guest post is by Reed Smith Houston office associate Curtis Waldo. Given the Noachic weather down there recently, one might ask “where’s Waldo?” The answer is safe and sound, if not quite high and dry. Curt is...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Three)

Even though the GDPR is a general regulation, some provisions are expressly addressing the specificities of the processing of personal data in the healthcare/life science sectors....more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part One)

The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation (“the GDPR”) will apply in all Member States of the European Union (“EU”) and will replace the Directive 95/46/CE...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Two)

New General Features of the GDPR - Some of the GDPR general features may be of particular interest for companies in the healthcare/life science sectors....more

D.C. Circuit Moves Data Breach Suit Forward

The U.S. Court of Appeals, D.C. Circuit issued a decidedly pro-consumer opinion recently in addressing what is required to establish standing for a data breach class action....more

Recent HHS Activity Following International Cyber Attacks

by Steptoe & Johnson PLLC on

Following recent international cyber attacks, the U.S. Department of Health and Human Services (HHS) has issued warnings to healthcare organizations, provided a cyber attack checklist, and launched its revised HIPAA Breach...more

New Favorable Risperdal Decisions

by Reed Smith on

Risperdal, an antipsychotic drug prescribed to treat serious mental conditions – schizophrenia, manic depression, and autism – allegedly causes some male users to develop abnormal breast tissue growth. Particularly when...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

Corporate Law & Governance Update - August 2017

by McDermott Will & Emery on

A new article published in the Harvard Business Review confirms that the preservation of reputation continues to be a significant motivating concern for individual board members. This is a factor that should be taken...more

FDA Clarifies Consent Requirements for Certain Minimal Risk Clinical Investigations

by Morgan Lewis on

FDA’s guidance, which permits institutional review boards to waive informed consent for certain clinical investigations, may facilitate valuable personalized medicine research....more

Comment K and Non-Implanted Medical Devices

by Reed Smith on

About two years ago, in our post “How Does a Bad Idea Get Implanted,” we discussed what at the time seemed a California peculiar argument that the “unavoidably unsafe” product doctrine epitomized by Restatement (Second) of...more

PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine

by Reed Smith on

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use...more

Rx IP Update - July 2017

by Smart & Biggar on

Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Artificial Intelligence and Learned Intermediaries

by Reed Smith on

In the July 7, 2017, “Artificial Intelligence” issue of Science, we were intrigued by a short piece in the “Insights” section on “Artificial Intelligence in Research” that discussed the future use of autonomous robots in...more

A Sometimes Overlooked Fact About Express Warranty

by Reed Smith on

The warranty is “express.” Before you say, “Well, duh,” this sometimes actually does matter. Here’s how. Most complaints in product liability actions involving prescription medical products that include express warranty...more

HIPAA in the Age of Ransomware

According to a recent US Government Interagency report, ransomware is the fastest growing malware threat, targeting users of all types, including health care facilities. This past spring, for example, the WannaCry ransomware...more

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

DeepMind Deal with NHS Trust Reveals Privacy Concerns

Back in 2015, DeepMind, a Google company, signed a deal with the Royal Free NHS Foundation Trust. The deal allowed DeepMind access to 1.6 million patients health information as well as the ability to develop an app called...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more

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