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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

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

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

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

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

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

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

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

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

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

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

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