News & Analysis as of

Health Consumer Protection

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

FDA Proposes to Delay Off-Label “Intended Use” Rule

by Reed Smith on

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and...more

No Old Kentucky Home for Parallel FDCA-Based Tort Claims

by Reed Smith on

Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following: "In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the...more

Second Circuit Holds Flu Shot Reminder Did Not Violate the TCPA

The Second Circuit has affirmed a lower court decision that a flu shot reminder sent by text message by a medical provider did not violate the Telephone Consumer Protection Act (the “TCPA”). The decision is important because...more

FDA to step up enforcement of homeopathic medicine

by Thompson Coburn LLP on

Homeopathic medicine has long occupied a niche in American culture. Since 1988, with the issuance of the Compliance Policy Guide, § 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed,” the FDA has had a...more

Antitrust enforcement priorities for 2018

by Bricker & Eckler LLP on

Health care antitrust in 2017 saw governmental agencies successfully pursue a number of enforcement actions. Examining these actions provides insight and guidance as to what might happen in antitrust enforcement in 2018 and...more

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

by McDermott Will & Emery on

Introduction - Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more

Where To Find Our Research 3.0

by Reed Smith on

Happy New Year! - It’s been 3 ½ years since we last updated our index to our online research resources. That’s almost ? of the total life of the blog, which started in way back in 2006. We’ve been blogging now for well...more

Court Finds Calls Regarding Medicaid Coverage Not Telemarketing

A Nevada federal court granted summary judgment in favor of a Telephone Consumer Protection Act (TCPA) defendant after concluding that the plaintiff granted prior express consent to be contacted when she provided her phone...more

The Highs - Celebrating the Ten Best Prescription Drug/Medical Device Decisions of 2017

by Reed Smith on

Ending the year on a high note is one thing that the blog tries to do – with the top ten drug/device product liability decisions of the year. Occasionally, a court will do something that ruins the party, with an eleventh-hour...more

Breaking News: TH v. Novartis – California Supreme Court Recognizes New Tort Duties as Traditional Limits Slide into the Sea

by Reed Smith on

We posted our 2017 “Worst 10 decisions” list a day too soon, because the California Supreme Court issued its anticipated decision in TH v. Novartis, No. S233898, slip op. (Cal. Dec. 22, 2017) today, and if it is not the worst...more

Bah, Humbug! HIPAA Compliance Isn’t Getting Any Easier

As we look back on 2017, one message is clear: don’t be a Scrooge when it comes to HIPAA compliance. With ever-evolving security threats and unrelenting enforcement, regulated entities must maintain a spirit of compliance...more

OIG Report Reveals HHS Cybersecurity Vulnerabilities

On December 19, the US Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) released a report indicating continued cybersecurity vulnerabilities among HHS’ four operating divisions based on FY...more

The Lows - Mourning the Worst Prescription Drug/Medical Device Decisions of 2017

by Reed Smith on

The second most successful college basketball coach of all time (in terms of NCAA Division 1 national championships) has said “All of life is peaks and valleys. Don’t let the peaks get too high and the valleys too low.” ...more

FTC Granted Preliminary Injunction to Block Physician Practice Acquisition

On December 13, 2017 a magistrate judge in the U.S. District Court for the District of North Dakota granted a request of the Federal Trade Commission (FTC) and North Dakota Attorney General to preliminarily enjoin Sanford...more

FDA Considers Approval Pathway for Medical Devices to Unilaterally Cross-Reference Marketed Drug Products

by King & Spalding on

Would Not Require Collaboration by the Drug Sponsor; FDA Requests Comments on Potential Approach - The Food and Drug Administration (FDA) requests comment on a potential approval pathway for “ devices referencing drugs”...more

Cannabis Podcast — A New Jersey Update

by Pepper Hamilton LLP on

The New Jersey Compassionate Use Medical Marijuana Act was passed in 2010, legalizing marijuana use for patients with certain approved debilitating medical conditions. In the 2017 election for New Jersey’s next governor,...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Republican Todd Atwater Announces Bid for South Carolina Attorney General- Republican state Representative Todd Atwater has declared his candidacy for South Carolina AG in 2018. ...more

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

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