News & Analysis as of

Health Products Liability

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

Off-Label Marketing MDL Winds Down With Some Summary Judgment

by Reed Smith on

We have written extensively on the travesty of the Neurontin trilogy and noted how the plaintiffs’ efforts to fit cases based on alleged off-label promotion of the prescription SSRIs Celexa and Lexapro into the same rubric...more

E.D. Wash. Rejects Successor Liability in Hip Implant Case

by Reed Smith on

Our first stint in a law firm was on the transactional side. Yes, it sounds crazy even to us, but we spent our first 18 months in the profession pulling all-nighters on triple-tier financings of leveraged buyouts, doing...more

Massachusetts Launches New Online Breach Reporting Form

by Murtha Cullina on

On Monday, February 5, 2018, the Massachusetts Attorney General’s Office (AGO) sent an e-mail blast regarding their new online form for businesses needing to report breaches under Chapter 93H of the Massachusetts General...more

Only You Can Prevent….

by Reed Smith on

We’ve seen the latest affirmance of largely identical verdicts in a consolidated MDL trial in Campbell v. Boston Scientific Corp., ___ F.3d ___, 2018 WL 732371 (4th Cir. Feb. 6, 2018). We’re not discussing Campbell’s merits...more

Significant New York Drug and Device 2017 Product Liability Decisions

by Harris Beach PLLC on

To prepare the best product liability defense for pharmaceuticals and medical devices as well as anticipate and strategically plan for future challenges in the medical and life sciences legal world, it is often helpful to...more

Guest Post – The Federal Judicial Center’s Mandatory Initial Discovery Pilot Project Complicates Litigation In Adopting Districts

by Reed Smith on

Today’s guest post is by Reed Smith‘s Lisa Baird, who has written about her recent experience with mandatory initial discovery, as practiced in a “Pilot Project” in place in certain federal district courts. It was...more

Guest Post – Illinois Court Rejects Novel Claims Alleging Deficiencies In Post-Approval Studies

by Reed Smith on

Today we have a guest post from Reed Smith‘s Elizabeth Minerd discussing a PMA preemption case dealing with unusual “parallel claim” allegations involving the conduct of clinical trials. As always our guest posters are 100%...more

Federal Court Certifies Question to Utah Supreme Court of Whether Comment K Applies to Medical Devices

by Reed Smith on

Strict liability is not the same as absolute liability. We learned that truth in law school, but too many plaintiff lawyers and judges seem to have unlearned it along the way. The key separator between strict liability and...more

The Lawyer Full Employment Action of 2018

by Reed Smith on

On January 30, 2018, Judge Goodwin entered four case management orders in the Ethicon, Boston Scientific, Bard, and American Medical Systems mesh MDLS. These CMOs establish discovery and briefing deadlines for 13200, 6174,...more

Eleventh Circuit Affirms Summary Judgment for Defendants in Embrel Case

by Reed Smith on

This year’s Academy Award nominations came out last week. That means that we have spent the past few days setting a schedule for seeing all of the Best Picture nominees (well, most – we don’t do war movies and tend to opt out...more

A Client's Guide to FDA Recalls

Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more

Artificial Intelligence and Health Care—Key Regulatory Considerations for U.S. Operations

by Jones Day on

The Situation: Artificial intelligence is being used in innovative ways in the health care industry to drive down costs and improve clinical outcomes. The Issue: The health care industry, including the provision of health...more

Breaking News – MDL vs. MDL, FDA §510k Clearance Admissible in IVC Filter MDL

by Reed Smith on

As we demonstrated in a post back in 2013, FDA compliance evidence generally - and the fact of a medical device’s clearance as “substantially equivalent” in safety and effectiveness to a predicate device under §510k of the...more

More Legislation To Watch

by Reed Smith on

Like a lot of large firms, Reed Smith has a number of blogs. We don’t mention them much because, DDL has product liability pretty well covered, and the others mostly don’t overlap a lot with what we do. But occasionally…....more

More on BMS & Nationwide Class Actions

by Reed Smith on

Speed. Some things move faster than others. When we viewed last August’s solar eclipse, in Tennessee, the Moon’s shadow was moving along the Earth at a rate of about 1,450 miles per hour. Depending mostly on latitude, your...more

New Uniform Recall Procedure for Therapeutic Goods

by Dentons on

The new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) was published on 3 October 2017. This version replaces its 2004 predecessor. Sponsors were given a familiarisation period of three months and the...more

Pennsylvania Risperdal Decision Doesn’t Go As Far As Plaintiffs Suggest

by Reed Smith on

While the recent Pennsylvania Superior Court Risperdal decision is not a defense victory, it is certainly not as favorable for plaintiffs as they are making it out to be. While several issues were presented for appeal in...more

Applying the “Arising Out of or Relating to” Personal Jurisdiction Test

by Reed Smith on

Our careers have seen several major pro-defense trends in product liability litigation: Mainstreaming summary judgment: This happened when we were still young lawyers. A trilogy of United States Supreme Court cases...more

Dental Device Class Action Comes Back To Bite Plaintiffs

by Reed Smith on

You don’t see class actions going to trial very often, but that is what happened in Patricia A. Murray Dental Corp. v. Dentsply International, Inc., and the defendant device manufacturer came away with a defense verdict that...more

Guest Post – No Way For Non-Resident Plaintiffs To “MacGyver” Their Way Into Illinois Court Due To Forum Non Conveniens

by Reed Smith on

Today’s post is another guest post from Kevin Hara, of Reed Smith, who is on his way to becoming a semi-regular blog contributor. This post is about forum non conveniens, which is more discretionary, and less enforceable...more

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about...more

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

California Court of Appeal Limits Duty of Clinical Study Sponsor to Intervene in Treaters’ Care of Study Participants

by Reed Smith on

Last week, we took a short Western Caribbean cruise to celebrate a jarringly-advanced birthday. While the weather wasn’t an asset (it was 43 degrees when we departed Fort Lauderdale, and hovered in the 60s for most of the...more

FDA 2017 Year in Review

by McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more

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