As our loyal readers know, the Reed Smith side of the blog has been very interested in 3D printing, and particularly in its product liability implications. We recently shared with you the most comprehensive law review article to date on this subject (here) – authored by Bexis and Reed Smith associate (and sometimes guest blogger) Matt Jacobson – and we have posted about 3D printing here, here, here and here.

If you’ve found yourself equally fascinated by this new technology – and its potential impact on life sciences product liability – we’re pleased to announce that Bexis and Matt will be presenting a free 60-minute webinar on “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers” on May 8 at 12 p.m. ET.

This webinar is presumptively approved for 1.0 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. For lawyers licensed in New York, this course is eligible for 1.0 credit under New York’s Approved Jurisdiction Policy.

The program is free and open to anyone interested in tuning in, but you do have to sign up, which you can do here.

 

This post is from the Reed Smith side of the blog only.

For well over a year, now Reed Smith has been engaged in an “initiative” concerning the innovative technology, “3D printing,” also known as “additive manufacturing.”  We’ve tried to stay on the forefront of the legal implications of 3D printing, particularly the product liability implications, as we have posted about it here, here, here and here.

Blogging is a quick way to disseminate information, but it’s not the only way.  That’s why Bexis, sometimes guest poster Matt Jacobson, and a number of their Reed Smith colleagues have explored the legal ramifications of 3D printing in a more in-depth and traditional fashion.

Most recently, Bexis and Matt have authored the most comprehensive law review article to date on the product liability implications of 3D printing.  The article is called, “3D Printing:  What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers,” and it will appear in the Minnesota Journal of Law, Science & Technology at 18 Minn. J.L. Sci. & Tech. 143 (2017).  If there is anything better out there on this subject, we have not seen it.  It’s now on the law review’s site, and you can download directly a PDF of the article for free at this link.

The first part of this comprehensive article covers the nature of 3D printing and how this new technology works.  There follows an overview of traditional tort liability concepts, and of the gray area that occurs when a potentially revolutionary new technology that allows anyone to become a manufacturer meets legal doctrines, like strict liability and warranty, that turn on concepts like “manufacturer” and “seller” from a prior era.  The second part of the article focuses specifically on 3D printing’s impact on medical devices and health care and the product liability considerations that are specific to these highly technical and potentially life-saving products.

As 3D printing appears to be the next great chapter in the industrial revolution, with the technology often moving more rapidly than the law, this article is significant in that it comprehensively analyzes the current state of products liability law and the legal issues that arise from this body of law when 3D printing is involved.

Second, Reed Smith, again with Bexis and Matt co-authoring the tort liability chapter, has now released a second edition of its “white paper” on 3D printing legal issues:  “3D Printing of Manufactured Goods: An Updated Analysis.”  The paper includes chapters on the following topics:  (1) Constitutional Issues (regarding 3D printed guns); (2) Commercial Litigation; (3) Product Liability, (4) 3D Printing/Component Parts/Raw Materials, (5) Insurance Issues, (6) Intellectual Property Issues, (7) Data Privacy, and (8) Environmental Safety.

The second edition of the Reed Smith 3D printing white paper is available here. And for those who missed the first edition, it can be found here.

We on the Reed Smith side are committed to exploring this novel technology and the legal issues that come with it, especially when those issues involve products liability.  We will continue to post any new updates as products liability law changes (or does not change) as 3D printed products become more and more commonplace.

The FDA released its final Guidance on Postmarket Management of Cybersecurity in Medical Devices during the week between Christmas and New Year. You can link to a full copy here, and we gave you our detailed take on the draft Guidance here. You can also click here to see what our data privacy and security colleagues wrote about the final Guidance on Reed Smith’s Technology Law Dispatch, as they beat us to the presses.

The final Guidance resembles the draft, with a few refinements. We see two guiding principles in the final Guidance.  First, the final Guidance continues to follow a risk-based approach.  As we observed before, the FDA could not have taken a different tack.  Medical devices always present both benefits and risks, and the goal of regulators when it comes to cybersecurity is to assess and mitigate risks without overly compromising a device’s benefits.  Second, the FDA recognizes that managing medical device cybersecurity takes a village.  Or, in the Agency’s words, “FDA recognizes that medical device cybersecurity is a shared responsibility among stakeholders including health care facilities, patients, providers, and manufacturers of medical devices.”  Guidance, at 12.

The final Guidance therefore recommends the implementation of cybersecurity risk management programs.  Such  programs would include monitoring reported adverse events under current regulations.  The FDA also recommends incorporating elements consistent with the National Institute for Standards and Technology’s Framework for Improving Critical Infrastructure Cybersecurity.  Guidance, at 14.  We commented in our prior post that the FDA was combining familiar medical device elements with others borrowed from the cybersecurity world.  The citation to NIST’s Framework is a perfect example of the wedding between those two worlds.

More specifically, a cybersecurity risk management program would include:

  • Monitoring cybersecurity information sources for identification and detection of cybersecurity vulnerabilities and risk;
  • Maintaining robust software lifecycle processes;
  • Understanding, assessing and detecting presence and impact of a vulnerability;
  • Establishing and communicating processes for vulnerability intake and handling;
  • Using threat modeling to define clearly how to maintain safety and essential performance of a device by developing mitigations that protect, respond and recover from the cybersecurity risk;
  • Adopting a coordinated vulnerability disclosure policy and practice; and
  • Deploying mitigations that address cybersecurity risk early and prior to exploitation.

Continue Reading What You Need To Know About the FDA’s Guidance on Postmarket Cybersecurity

Bexis recently attended the “Emerging Issues in Mass-Tort MDLs Conference” sponsored by Duke Law School (those of us from Philly remember Duke as part of “Black Saturday” back in 1979).  Several panels discussed various issues relating to MDLs including using early, issue-specific fact sheets, which Bexis advocated be considered amended pleadings subject to Rule 8 and TwIqbal, as a winnowing tool against the hordes of meritless plaintiffs that persist for years in MDLs involving prescription medical products.  Another discussion, about Lone Pine orders, produced (among other things) a great deal of disagreement as to what exactly a “Lone Pine order” actually requires.

By the end of it all, Bexis was moved to make a modest proposal. A lot of the problem – both with the use of plaintiff questionnaires/fact sheets and with Lone Pine orders – is definitional.  There is no set standard for either of these supplemental discovery procedures.  What’s really needed is the type of clarity that can only be brought about by an actual rule of civil procedure.  Thus, Bexis proposed (and proposes here) creation of a new Federal Rule of Civil Procedure governing “optional discovery methods” that allow judges to use defined procedures for party questionnaires/fact sheets (not necessarily plaintiffs in all cases) and Lone Pine orders would set standards, as well as several other discovery techniques that we think should be defined and allowed by a formal rule.

The other techniques Bexis would include in a new rule are: (1) authorizations for release and production of medical and other relevant records in the hands of third-parties; (2) informal interviews with treating physicians; (3) predictive coding in ediscovery; and (4) provision of blood or tissue sampling for genetic testing.  The first two are traditional discovery techniques that suffer (like Lone Pine and questionnaires) from wildly divergent standards and could benefit from the uniformity imposed by a rule – as well as a leveling of the plaintiff/defendant playing field.  The latter two are innovative discovery techniques that are driven by technological advances.  Predictive coding (as we discussed in the links above) could both cheapen and sharpen electronic discovery.  Genetic testing, reliant on DNA and other molecular sequencing techniques that have become dramatically cheaper and more accurate over the past decade, will become more and more necessary in toxic exposure cases of all kinds as causation of more and more medical conditions, such as mesothelioma and other cancers, is determined to vary by individualized genetic differences (also discussed in our prior link).

As illustrious as the attendees of the (invitation only) Duke Conference are, that is not the forum for actually amending the Federal Rules of Civil Procedure. That honor goes to Discovery Subcommittee of the Federal Judicial Conference’s Standing Committee on Rules of Practice and Procedure.  Having successfully completed its project on scope and sanctions that resulted in the amendments that became final in December, 2015, that Subcommittee might be looking for something else to do.  Maybe it could see fit to take up some or all of Bexis’ modest proposal.

If you represented a large corporation or a wealthy individual, wouldn’t you want to know if your prospective jurors were campaigning for Bernie Sanders on Facebook? Or how about criminal prosecutors who might want to know if members of their jury panel had posted strong feelings on police conduct?  If you were adverse to a drug or medical device company, maybe you would want to know if a prospective juror wrote for the Drug and Device Law Blog (although we can guarantee that you will find no more thoughtful and impartial jurors than the seven individuals who make up the collective “we”).

Millions of potential jurors make information like this (and much more) publicly available on the Internet through social media or otherwise, and what trial advocate would not want to uncover it? We got to thinking about this topic a few months ago when we read a unique order that came out of the Northern District of California in Oracle America, Inc. v. Google Inc., ___ F. Supp.3d ___, 2016 WL 1252794 (N.D. Cal. Mar. 25, 2016).  The district judge in Oracle v. Google asked the parties in a high-stakes copyright action to abstain voluntarily from searching the jury panel’s social media.  If the parties would not agree to a complete ban, then the court would impose specific limitations.

We’ll get to the details in a minute. But first, we set out to see if there are any rules that govern searching jurors’ social media (with research assistance from Reed Smith attorney David Chang).  It turns out there are, mainly within the rules of ethics and professional conduct.  The first rules obviously are our duties of competence and diligence.  They are among the first duties listed under the ABA’s Model Rules and probably the rules governing lawyers in most every state. See Model Rules of Professional Conduct, Rules 1.1, 1.3.  If there is publicly available information that would help us identify jurors with potential biases, a competent and diligent trial advocate needs to consider gaining access to it.

There are, however, countervailing considerations. On April 14, 2014, the ABA’s Standing Committee on Ethics and Professional Responsibility published “Formal Opinion 466, Lawyer Reviewing Jurors’ Internet Presence.”  The ABA committee’s opinion came on the heels of an opinion from the Association of the Bar of the City of New York—“Formal Opinion 2012-2, Jury Research and Social Media.”  These are not the only publications on the topic, but they were at the cutting edge, and they cover the major considerations.

Continue Reading Did You Search Your Jurors’ Social Media? There Are Rules

This is one of those stories you simply cannot make up.

We were using technology to get some ideas about technology. That is, we were surfing around the internet to find descriptions of the successful use of technology in litigation. Our eyes grew weary as we scrolled from screen to screen. There was a lot of same-old-same-old. Then we found an article in the Legal Times from 2005 entitled, “Jurors, Watch the Screen.” You can see the article here. Even as far back as 2005 it was becoming clear that one could use snazzy technology without suffering from the Goliath effect – the perception that your client must have deep pockets. After all, both sides at trials and depositions were using PowerPoints, videos, and arresting graphics. Jurors had come to understand that anyone with a laptop could put on a multi-media show. (Lawyers used to talk about a trial-in-a-box. But by 2005, we went up against a plaintiff lawyer who had a trial-in-a-laptop. He was smooth. He was impressive. He lost.)

Continue Reading Seen on the Screen