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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

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

Building a Health App? Part 6: HIPAA and Other Privacy and Security Considerations

Consumers are increasingly turning to health apps for a variety of medical and wellness-related purposes. This has in turn caused greater amounts of data—including highly sensitive information—to flow through these apps....more

M.D. PA Declines to Dismiss Monitoring/Declaratory Judgment Action vs.  Blood Temperature Regulation Device

by Reed Smith on

We thought we were on a winning streak on medical monitoring. In August, we blogged about plaintiff lawyers stumbling in their efforts to walk the not-quite-yet-injury line. In September, we blogged about a denial of a...more

Staying The Course In A Mississippi Drug Case

by Reed Smith on

Defense hacks. Homers. Biased. These are just a few of the labels we have applied to the authors of this Blog. While we recognize our leanings and strive to offer something more than just cheering a decision for the defense...more

FDA Approves Companion Dx for PD-1 Inhibitor

by Foley & Lardner LLP on

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung...more

JAMA: Cybersecurity Concerns and Medical Devices – Lessons from a Pacemaker Advisory

Interesting viewpoints from this Journal of the American Medical Association article on FDA’s August 2017 notice re: cyber security issues with certain pacemakers, including:... ...more

Cybersecurity 2018 – The Year in Preview: HIPAA Compliance

Like many things in Washington, the HIPAA landscape in 2018 will be shaped by the shifting priorities of President Trump’s new administration. Early signs point to less funding for the Office of Civil Rights (“OCR”) within...more

Building a Health App? Part 4: Avoiding an FTC Enforcement Action

The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter...more

Security Vulnerabilities Identified In Wireless Syringe Infusion Pumps

The U.S. Department of Homeland Security (DHS) recently issued a warning that Smiths Medical Medfusion 4000 wireless syringe infusion pumps contain a security vulnerability that can be exploited by hackers to alter the...more

Off-Label Marketing Case Tossed

by Reed Smith on

Implied Preemption. Off-label promotion. TwIqbal. They make up a core of our posts, yet we never seem to tire of them. Maybe our readers, especially interlopers from the other side of the v., tire of reading about them,...more

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

by Baker Ober Health Law on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

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