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Health Consumer Protection

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Proposed Law Would Criminalize Failures to Report Data Breaches

A draft bill recently introduced in the U.S. Senate serves as a good reminder that compliance with data breach reporting requirements is critical. This bill follows significant, high-profile data breaches by Uber and Equifax,...more

Update on Florida's Emergency Generator Rules

by Baker Ober Health Law on

On September 15, 2017, Florida Governor Rick Scott directed that by November 15, 2017, all nursing homes and assisted living facilities in the state were to install generators capable of powering air conditioning systems for...more

Innovator Liability – A Word to the Wise

by Reed Smith on

A lot of us attended the annual ACI Drug & Medical Device Litigation Conference in New York City last week. One of the messages sent loud and clear from the initial client round table panel is that our clients don’t like...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Democrat Chris Mattei Announces Campaign for Connecticut Attorney General- Democrat Chris Mattei announced his candidacy for Connecticut AG in 2018, switching statewide races and forgoing a previously...more

Still No “Newly Acquired Information,” Eliquis Claims Still Preempted

by Reed Smith on

The defendants in the Eliquis MDL have turned somewhat of a preemption hat trick. The latest order is In re Eliquis (Apixaban) Prods. Liab. Litig., No 17-md-2754 (S.D.N.Y. Nov. 29, 2017), where the district court dismissed...more

Window on Washington - Vol. 1, Issue 37

by Clark Hill PLC on

House Majority Leader McCarthy informed members on Thursday that they should be ready to vote this evening on a motion to go to conference with the Senate on tax legislation, despite the House not scheduled to be in session....more

Soy Vey! FDA May Revoke Soy’s Heart Health-Claim

by Reed Smith on

The FDA has called into question its health claim finding a link between consumption of soy protein and reduced risk of heart disease. Since 1999, the FDA has allowed manufacturers and advertisers to label soy products with...more

Unavoidably Unsafe PMA Medical Devices

by Reed Smith on

When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely reasonable, given the many decisions that preempt state-law design-related...more

PMA Preemption & Fraud by Omission/Concealment

by Reed Smith on

As our PMA preemption scorecard makes clear, warning claims are preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the preemptive language, “different from or in addition to,” precludes plaintiffs from...more

Competing Cosmetic Safety Bills Would Each Expand FDA Regulatory Authority

by Beveridge & Diamond PC on

On October 25, 2017, Senator Orin Hatch (R-UT) introduced S. 2003, the “FDA Cosmetic Safety and Modernization Act.” The proposed legislation would amend the Federal Food, Drug and Cosmetic Act of 1938 (“FFDCA”) and allow the...more

The Opioid Epidemic – What Kind of a Problem Is It?

by Reed Smith on

We know that our blogposts are carried by legal aggregating services, such as Lexology and JDSupra. Some of you may even be reading this post via one of these services. In addition to writing for them, we actually read...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Democrat Justin Nelson Launches Campaign for Texas Attorney General- Democrat Justin Nelson declared his candidacy for Texas AG seeking to unseat incumbent Republican AG Ken Paxton, who is running for...more

C.D. Cal. Excludes Three Plaintiff Experts in Breast Implant Case

by Reed Smith on

It is not as if we are delighted to see efforts to resuscitate breast implant litigation, but we won’t groan when the rulings are as good as they are in Laux v. Mentor Worldwide, LLC, No. 2:16-cv-01026-ODW(AGR) (C.D. Cal....more

Non-News: Warnings Claims For A Generic Drug Preempted (Still)

by Reed Smith on

We can be inundated with news. Old news. New news. Fake news. Breaking news. News that makes you want to break something. News that makes you want to go back to bed. In trying to be discerning consumers of the news, it...more

FCC Closes Loopholes and Expands Telephone Consumer Protection Act “TCPA” Consumer Protections in Declaratory Ruling and Order

by Womble Bond Dickinson on

On July 10, 2015, the Federal Communications Commission (“FCC” or “Commission”) released a Telephone Consumer Protection Act (“TCPA”) Declaratory Ruling and Order (“TCPA Declaratory Ruling and Order” or “Order”) offering...more

No Voluntary Dismissal for Plaintiffs, and a Summary Judgment Win for Defendants, in Central District of California Risperdal Case

by Reed Smith on

In the mass torts world in which we find ourselves, glimmers of jurisprudential light can seem few and far between. Two things we love are good warnings causation decisions and sneaky plaintiffs getting caught at their own...more

ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria

by McDermott Will & Emery on

In September, the Office of the National Coordinator for Health Information Technology (ONC) announced that it is scaling back requirements for third-party certification of criteria related to certified electronic health...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Democrat Renato Mariotti Declares Bid for Illinois Attorney General- Democrat Renato Mariotti, a cable news commentator and a former Assistant U.S. Attorney in the U.S. Attorney’s Office in Chicago,...more

FDA Warns Companies Marketing Unsubstantiated Marijuana-Derived Products That Claim to Treat or Cure Cancer

Earlier this week, the U.S. Food and Drug Administration (FDA or the Agency) issued Warning Letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers...more

Recent Webinar Focused on Hot Topics in Safety and Health Law

by Nexsen Pruet, PLLC on

The Oct. 11, 2017, webinar in our Workplaces that Win certificate series consisted of a safety and health update. During the event, we discussed topics that included: New developments at the Occupational Safety and Health...more

Guest Post – Accutane Amici Say: Relax Somewhere Else – Expert Testimony in New Jersey Should Be Held to a Higher Standard

by Reed Smith on

The Accutane litigation in New Jersey has been covered closely by this Blog for its duration. The Blog’s most recent Accutane post evaluated the Appellate Division’s decision to reverse the trial court’s order excluding...more

Florida's Emergency Generator Rules Invalidated

by Baker Ober Health Law on

On Friday, Judge Garnett W. Chisenhall, a duly-designated administrative law judge of the Florida Division of Administrative Hearings, issued a ruling invalidating emergency rules requiring all Florida nursing homes and...more

Communities in Crisis: Local Responses to Behavioral Health Challenges

As the opioid and mental health crises continue to gain national attention, local leaders are stepping up to implement programs to address the prevalence and impact of untreated serious mental illness (SMI) and substance use...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more

Declaration of Public Health Emergency Changes Remote Prescribing Requirements but Creates Many Questions Waiting to Be Answered

by McDermott Will & Emery on

President Trump declared the opioid addiction epidemic a public health emergency on October 25, 2017. The White House made it clear that this declaration would allow officials to remove barriers to the prescribing of...more

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