When this blogger hears “negligent undertaking,” my mind does not automatically turn to products liability – but rather to pre-teen children. Pre-teen children are at the age where they are asked (actually required) to “undertake” more and more duties and responsibilities. But often these duties are undertaken in a rather haphazard or lackadaisical way that some might say rise to the level of negligence. Dishes with food left on them put back in the cabinet. Wet laundry left in the dryer for more than a day. And as for cleaning up after the dog, well enough said. And as one of the two arbiters of whether such pre-teens have failed to act in good faith, I admit to guilt in an expanding definition of what constitutes negligent undertaking. The New Jersey courts fortunately have stricter and more precise guidelines than mood and level of tolerance on any given day to guide them and those rules led them to dismiss plaintiff’s negligent undertaking claim in Nelson v. Biogen Inc., 2017 WL 1382910 (D.N.J. Apr. 17, 2017).

The product at issue is Tysabri, a drug used to treat multiple sclerosis. Patients who test positive for anti-JC Virus antibodies were shown to be at an increased for developing a certain brain infection with use of the drug. Id. at *1. Plaintiff contracted the infection after being treated with the drug for three years.

It is worth pointing out some of the procedural history here to understand that his was a bit of a hail-Mary by the plaintiffs. Plaintiff’s initial and first amended complaints contained a claim for negligence that was dismissed because in New Jersey the sole remedy for products liability is the New Jersey Product Liability Act (NJPLA). Id. at *2. All products liability claims, except express warranty, are subsumed by the Act. So plaintiff’s second amended complaint alleged design defect and failure to warn under the NJPLA. Defendants moved to dismiss the design defect claim as preempted and plaintiff withdrew the claim before the court could rule on the motion. Id.   Which left plaintiff with only a failure to warn claim in his third amended complaint. After two years of discovery, plaintiff moved to amend his complaint for a fourth time, this time to add a negligent undertaking claim.

The basis for the claim, argued plaintiff, was that defendants had entered into a licensing agreement with the NIH to allow defendants to use the NIH’s JC virus antibody assay to develop the assay for commercial use. The assay would allow doctors to test for the antibodies to determine if their patients were at an increased risk for the brain infection. Id. The licensing agreement was entered into in 2006 and defendants released their JC virus antibody assay in 2012. Plaintiff alleges that when defendants entered into the licensing agreement, they were voluntarily undertaking the duty to develop the assay and that they failed to do so in a reasonable and timely manner. Id. at *3.

First, the court held that this negligent claim, like the negligence claim in plaintiff’s original complaint, was preempted by the exclusivity of the NJPLA. Plaintiff argued that negligent undertaking was different than other negligence claims because it is not based on a pre-existing duty. Not only did plaintiff have no New Jersey or other authority for this argument, it is a distinction without merit. As the court pointed out, “the application of the NJPLA is not premised on the timing of the duties incurred.” Id. at *4. Further, most duties (unlike those in my household) are at some point voluntarily assumed. “For example, before Defendants decided to develop, market, and sell Tysabri, they had no duty to do so. Once Defendants voluntarily decided to produce Tysabri, they then had a duty to act with reasonable care in doing so.” Id. Negligent undertaking is precluded by the NJPLA.

Second, the court found it would be an unprecedented expansion of liability to use negligent undertaking to create third-party negligence obligations to non-parties to the license, or indeed to any contract.  Plaintiff cited no cases in which a party who agreed to a license was held liable for negligent undertaking. Id. at *5. Acknowledging significant policy concerns, the court suggested that the more appropriate way to address issues of the type raised by plaintiff would be to deal with them specifically in the contract. The NIH could have included a time limit by when defendants should have developed the assay or the license would be revoked. Id.

Further, plaintiff failed to allege an essential element of negligent undertaking – reliance. Id. at *6. Plaintiff alleged that his status as a third-party beneficiary to the license agreement satisfied the reliance requirement, but he cited no authority for that proposition. So, closely adhering to the Erie doctrine, the court concluded that “If the courts of New Jersey believe that such an extension is appropriate, then they are in a better position to expand their own common law in the first instance.” Id.

This means plaintiff is back to his third amended complaint – failure to warn only. And as we just reported last week, there is good precedent on the adequacy of the Tysabri warnings and on Wyeth v. Levine preemption. And precedent has much more bearing in the courtroom than in the laundry room – where when prior rulings are cited to the judges they can be summarily ignored with a simple – “that was then, and I’ve changed my mind.”

 

I hope to see many of you at the 2017 DRI Drug and Medical Device Seminar on May 10-12th in New Orleans.  The meeting will feature its usual stellar lineup of presentations by in-house and outside counsel, a federal judge, deans of the drug and device defense bar, and – this is new – the US Chamber Litigation Center.  This seminar is the foremost educational and networking opportunity for practitioners in the pharmaceutical and medical device defense space. Connect with clients and colleagues and learn from cutting-edge presentations. We hope you join us in New Orleans!

If you want to chat, I’ll be in my usual front and center seat.

If you want to register, do it here

Regular readers of this blog know that we have a pretty jaded view of many MDLs. Obviously consolidation makes sense, at least on paper, in terms of efficiency and the best use of scarce court resources.  But, in practice, many MDLs promote a litigation “mob mentality,” in which the merits of individual cases are not important at the outset and, in the world of “settlement inventories” and “mass settlements,” may never draw the scrutiny of the judge or anyone else.   Though we continue to hope that “Lone Pine” orders will burgeon and raise the standards for plaintiffs seeking to fly under the radar and await settlement, many MDLs remain “safe havens” for plaintiffs who can’t satisfy the burden of proving their claims.

And a recent decision from the hip implant MDL does nothing to disturb this reality. In that MDL, a longstanding “Explant Preservation Order” requires preservation of hip implant devices removed from plaintiffs during explant surgeries.  The order requires plaintiffs to “make good faith efforts to ensure that [medical facilities] preserve” explanted devices and provides options for plaintiffs’ counsel to claim devices within 60 days of explant or, in the alternative, for the devices to be sent to the defendants.  It  requires all parties to handle explanted devices in accordance with a written protocol or consistent  with “methods and practices accepted by those in the field of inspection and testing of orthopedic devices,” to notify each other of devices in their possession before the date of the order, and to make devices available to each other after inspection and testing.   All of this, obviously, ensures that the critical evidence in this product liability MDL is preserved and handled in a fair and consistent manner.

In Marquis v. Biomet, Inc., et al., 2017 U.S. Dist. LEXIS 28465 (N.D. Ind.  Mar. 1, 2017), the defendants moved for summary judgment against six plaintiffs.  Five of these plaintiffs had had their devices explanted before they filed suit, or after they filed suit but before their cases were transferred into the MDL, and did not know what happened to their devices after they were explanted.  The sixth plaintiff had several revision surgeries.  During the first, the femoral head of her hip implant was replaced, and she asked for the explanted femoral head.   She explained, “I figured I paid for it.  I wanted it.”  She kept the femoral head in her closet, didn’t disclose on her fact sheet that she had kept it, and didn’t tell anyone she had it until her deposition.  The devices explanted during her subsequent surgeries were not preserved.

Continue Reading Hip Implant MDL Denies Summary Judgment on Claims of Plaintiffs Who Failed to Preserve Explanted Devices

Our weekly search for new drug/medical device cases for 1/13/17 turned up something unusual – not of particular substantive significance, but unusual. Two of the opinions included citations to Wikipedia.

Wikipedia?  You mean the comprehensive online encyclopedia that is crowd-sourced, so that anybody – even us – can edit/alter the information contained on the entries (at least, most of them)?  That’s it.  Since the provenance of the information on Wikipedia is unknown, as lawyers we’ve been taught never, ever to cite to it as authoritative in filed papers (we often cite to it on the blog).  After all, given the high stakes of most of our litigation, an attorney citing to Wikipedia could have just added the information to which s/he is citing.

[I]f Wikipedia were regarded as an authoritative source, an unscrupulous lawyer (or client) could edit the Web site entry to frame the facts in a light favorable to the client’s cause. Likewise, an opposing lawyer critical of the Wikipedia reference could edit the entry, reframing the facts and creating the appearance that the first lawyer was misrepresenting or falsifying the source’s content.

Peoples, “The Citation of Wikipedia in Judicial Opinions,” 12 Yale J. L. & Tech. 1, 24 (2010) (quoting Richards, “Courting Wikipedia,” Trial, at  (April 2008)).  Obviously, that kind of bootstrapping oneself into authority isn’t allowed.  If lawyers want to cite ourselves, we should at least have to write law review articles.

So we thought it would be fun to see what we could find in the way of Wikipedia references in judicial opinions involving product liability litigation or prescription medical products, and even both. This post details what we found.

First, courts (or masters) have gotten in trouble for excessive reliance on Wikipedia.  In a Vaccine Act case, a special master declined to hold a hearing, and instead relied on internet sources such as Wikipedia.  That produced a reversal.  As to Wikipedia, the court stated:

[T]he exhibit introduced by the Special Master indicates that its information was drawn from Wikipedia.com, a website that allows virtually anyone to upload an article into what is essentially a free, online encyclopedia. A review of the Wikipedia website reveals a pervasive and, for our purposes, disturbing series of disclaimers, among them, that:  (i) any given Wikipedia article “may be, at any given moment, in a bad state: for example it could be in the middle of a large edit or it could have been recently vandalized;” (ii) Wikipedia articles are “also subject to remarkable oversights and omissions;” (iii) “Wikipedia articles (or series of related articles) are liable to be incomplete in ways that would be less usual in a more tightly controlled reference work;” (iv) “[a]nother problem with a lot of content on Wikipedia is that many contributors do not cite their sources, something that makes it hard for the reader to judge the credibility of what is written;” and (v) “many articles commence their lives as partisan drafts” and may be “caught up in a heavily unbalanced viewpoint.”

Campbell v. Sec’y HHS, 69 Fed. Cl. 775, 781 (2006). But see Keeler v. Colvin, 2014 WL 4394467, at *3 (D. Colo. Sept. 4, 2014) (allowing administrative law judge to cite Wikipedia in vaccine case; “[t]his Court finds no per se prohibition on citing Wikipedia in judicial opinions”).

Continue Reading Pitfalls Of Judges, Lawyers, And Experts Citing Wikipedia

These past two weeks, our loyal readers have descended into “The Pits” and then climbed to “The Peaks” with us as we reviewed the 10 worst and 10 best cases of 2016.

If you found yourself wanting more information on these cases and their impact – perhaps with a side of CLE credit – we’re pleased to announce that three of your bloggers (Bexis, Eric Alexander, and Steven Boranian) will be presenting a free 90-minute webinar on “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device Decisions of 2016” on January 18 at 12 p.m. EST.

The webinar is presumptively approved for 1.5 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. (For lawyers licensed in New York, it’s eligible for 1.5 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.

Ponder the following:  A man attends an exercise class at a facility run by a local religious institution.  Assume that he belonged to this facility, wanted to attend an exercise class because his fitness was less than optimal, and was informed of the need to get medical advice before starting a new and potentially demanding exercise program.  He had a heart attack and collapsed right after leaving the class.  Assume that the heart attack was not a total surprise given his health, but that he had not had a heart attack before and had not informed the people running the class of any particular risk.  The class instructor rushed to the man’s aid while others called 911.  The instructor was certified in cardiopulmonary resuscitation (“CPR”) and did her best to help the man.  When paramedics arrived, they assumed care of the man, but he died despite their best efforts.

Based on these facts and assumptions, answer this question:

Who should the man’s estate sue over his death?

A) Nobody.  B) The class instructor.  C) The religious institution.  D) The entities that operate the 911/EMT system.

If you answered other than “A,” then you might need to examine your propensity to blame others.

Add in the following to the scenario presented above:  The class instructor tending to the man did not utilize an automated external defibrillator (“AED”) that she knew was present and was certified in using.  She brought the AED to the man’s side, but elected not to use it because, in her judgment, he was having a seizure and not a heart attack.

Based on these additional facts, answer these questions:

1.  Who should the man’s estate sue over his death?

A) Nobody.  B) The class instructor.  C) The religious institution.  D) The entities that operate the 911/EMT system.  E) The company that sold the AED and offered training to purchasers.

2.  If the man’s estate already sued the religious institution over his death, who should the defendant bring in via third-party complaint?

A)  Nobody.  B)  The class instructor.  C) The entities that operate the 911/EMT system.  D) The company that sold the AED and offered training to purchasers.

In Wallis v. Brainerd Baptist Church, No. E2015-01827-SC-R11-CV, 2016 Tenn. LEXIS 920 (Tenn. Dec. 22, 2016), the estate sued the church that ran the gym and then both turned their attention to the seller of the medical device that was not used.  It is often said that bad cases make bad law, but sometimes egregiously over-reaching cases can make good law.  Ultimately, Wallis fits into the latter category.  A contrary result, which would have allowed a negligence or contract claim against the seller of a device that was not used with the decedent, would have been bad, maybe bad enough to have been mentioned in our bottom ten post last week.

Continue Reading Decision Limiting Duties regarding Automated External Defibrillators Does Not Shock The Conscience

Last week, along with many of you, we attended the ACI Drug and Medical Device Conference in New York City. The quality of the presentations was uniformly high, and the collegiality and camaraderie were welcome, refreshing, and a lot of fun.  There was plenty to drink.  There was lots of food.  Oh, and we got to see Hamilton!  We should preface our comments by pointing out that we were skeptics – we knew how pricey (really, really pricey) tickets are, and we weren’t even positive we would enjoy this immensely innovative rap musical.  To wit, one of our best beloved musicals of recent years was the wonderful, if short-lived, revival of Finian’s Rainbow that played the Great White Way a couple of years ago.  We go for the traditional stuff, and had neither resources nor plans to spring for Hamilton.

But we got very lucky. A generous friend had bought four tickets a full year earlier in anticipation of the annual conference.  And there was a last-minute cancellation.  And we got to go.  And it was worth all of the hype (and all of the money, if you have it).   We enjoyed it so much that we came home and researched ticket availability to return with the Drug and Device Law Long-Suffering Companion.  Tickets are on sale for next year, and we thought that we could avoid the crazy street prices by planning way ahead.   Not so – even this far in advance, tickets (from official ticket sources, not ticket agencies) are way out of the reach of normal consumers.  Sometimes, the early bird does not get the worm (or the greatest financial benefit).

And, with just a bit of creativity, we can glean the same message (among others) from today’s case. Dobbs v. DePuy Orthopedics, — F.3d —, 2016 WL 7015648 (Seventh Cir. Dec. 1, 2016), is an appeal of an attorney’s fee decision from the United States District Court for the Northern District of Illinois.  (We’ll explain how it got there in a minute.)  The plaintiff/appellant had direct-filed a product liability claim in the Hip Implant MDL in the Northern District of Ohio.  Believing that the promised compensation was too low, he opted out of the global settlement and fired his lawyers, who had advised him to accept the global settlement, which included a 35% attorneys’ fee.   (The global settlement provided one level of payment for unrepresented plaintiffs, and a second level, 35% higher, for represented plaintiffs.)

Less than two months after his lawyers withdrew their appearance, the plaintiff accepted the global settlement. Because he was considered “represented” for purposes of the settlement, he was paid the larger amount.  (Not clear why he was considered “represented” when his lawyers had been fired.)  His former lawyers asserted a lien on the award and sought to recover attorney’s fees.  The MDL judge tried unsuccessfully to mediate the fee dispute in the Northern District of Ohio then transferred the case to the Northern District of Illinois, where the case would have been filed if the MDL had not been pending.

Continue Reading Court of Appeals Applies Law of Would-Be Filing Court in Fee Dispute in Hip Implant Case Filed Directly Into MDL

What follows is a guest post by John Feldman, a partner in Reed Smith’s Entertainment and Media Industry Group.  John closely follows all things Federal Trade Commission and approached us when he saw the FTC weighing in a group of products that falls under the first word of our title.  We have weighed in before on FDA’s regulation of homeopathic drugs, but FDA is not the only regulator in town.

As always, our guest posters are entitled to all of the credit, and any blame, for their efforts.

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“Eye of newt, and toe of frog. For a charm of powerful trouble, Like a hell-broth boil and bubble.”  Hey, if it works for you, more power to ya.

That’s the FTC’s attitude toward homeopathic drugs.  Following up on a homeopathic drug workshop in conducted in 2015, the staff at the FTC is apparently convinced that generally there is no medical basis for most claims on homeopathic drug labels and marketing materials.  The FTC recognizes that thousands if not millions of people use and find value in homeopathic drugs.  And it may be that many if not most of the users of such products know that the science underpinning the products is shaky at best and possibly non-existent, but the FTC believes that many people purchasing homeopathic drugs do not even understand what homeopathy is.

Enter: The FTC Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs.

Continue Reading Guest Post — Do It If It Makes You Feel Good: FTC’s Report on Homeopathic Medicine Advertising

What follows is a guest post by Cara DeCataldo, a Reed Smith associate, who gamely stepped up to the plate to research one of a number of blogging topics that have been hanging fire for some time now.  This topic is a type of “no good deed goes unpunished” liability – whether a defendant whose internal policies aspire to a degree of care that exceeds legal requirements can be sued solely because it allegedly failed to live up to those high aspirations.  The two most common theories that purportedly support such a result are negligence per se and negligent undertaking.  Thankfully, Cara’s research indicates that such liability is not recognized.

As always, our guest posters are entitled to all of the credit, and any blame, for their efforts.

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Clearly articulated company policies imposing heightened safety standards on a company and its employees can’t be a bad thing, right?  But what happens when a Plaintiff attempts to use a company’s alleged failure to comply with its own corporate aspirations as the basis for a lawsuit?  There is an inherent tension between a company’s desire to set high standards for employee conduct and/or its products, and the fear of liability if those standards are not met.  With this in mind, we thought it would be a worthwhile to take an in-depth look at whether internal company policies that exceed what the law requires, can also pose the risk of creating a legal duty.

For those companies seeking to hold employees and/or products to ambitious standards of care, the news is largely good.  Most courts to address the issue support these endeavors and recognize the value of encouraging companies to maintain high voluntary standards.  They also recognize the potential negative impact if those goals were misused to create legal duties to the public.  Negligence per se claims consistently fail when citing various official pronouncements that encourage, but do not mandate, conduct, such as company credos, internal agency manuals, protocols, policy statements, and the like, as relevant evidence of the alleged negligence. Many states take matters a step further and bar the admission of company policies even as evidence of negligence. The most frequently applied rationale barring the admission of internal policies is that to the extent internal rules and regulations exceed the standard of care, then they are not admissible.

Continue Reading Guest Post – Tis Better to Try and Fail, Then to Have Never Tried At All: Internal Corporate Policies Do Not Create a Heightened Legal Duty

We wanted to take a moment to let you know about the Drug and Device Defense Forum coming up on December 13th   It’s a bit of a shameless plug because several of our bloggers will be speaking, not to mention Michelle Yeary is co-chairing the event for the third year.  First a reminder that this conference is only open to the folks on the defense side.  That means the presenters will be able to discuss things that we don’t talk about on the blog because we don’t want to give the other side any bright ideas.  There will be presentations by numerous in-house counsel from major pharmaceutical and device companies, and a bunch of defense side DDL experts.

Eric Alexander is among the group kicking off the morning talking about hot topics in the DDL world.  Then just before lunch hear Bexis and McConnell talk about the continuing battle on preemption.

The agenda also includes topics such as the risk management in the early litigation stage, trial prep strategies, a closer look at voir and jury selection, the new FDA guidance for device manufacturers, and protecting confidential information.  And plenty of CLE credits, including ethics, to be had!

Here is the link for more information and to register.  Still some free seats available for corporate counsel.  Look forward to seeing you there.