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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

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This is our vacation week, so it’s time once again to play the game of “Where in the World is Stevie Mac?”　 Last year, we wanted to visit a place with nice sights, great beer, and, most of all, zero chance of terrorism.　 We chose Belgium.　 Let that sink in for a moment.　 This year should be easier.　 The animating factors in 2016 — fear of jet-lag, fear of poverty, and, yet again, fear of terrorism – conspired to keep us fear-ly close to home.　 Enjoy these hints:

  • Hello misnomer!
  • It never ratified the 18th amendment (prohibition – so, yes, this is our kind of place).
  • There is a specific law against biting off someone’s leg.　 (The legislators here have obviously gotten a little too into The Walking Dead.)
  • The first American ever jailed for driving his car too fast earned that distinction by going a rip-roaring 15 mph here in 1904.
  • Cap guns are illegal in this state.
  • You will be fined if you throw pickle juice on a public trolley.　 That rule will frustrate the DDL Son to no end.
  • Finally, our all-time favorite basketball player, Marvin Barnes, hailed from these parts.　　 Barnes (nicknamed “Bad News”) was part of a gang of high schoolers arrested for robbing a bus.　 The victim had no trouble identifying Barnes, who had been wearing a letter jacket with his name embroidered on it.　 That brush with the law did not stop Bad News (later shortened to “News”) from having a remarkable hoops career.　 Barnes began his professional career with the ABA’s St. Louis Spirits.　 Once upon a time, his team was scheduled to fly home from Louisville at 8 o’clock.　 Because of the East-to-Central time zone change, the flight was scheduled to arrive in St. Louis at 7:56.　 Barnes refused to board the flight.　 In his immortal words, “I ain’t getting on no time machine.”　 Instead, he rented a car and drove home.　 Sadly, Barnes died way too young (62) a couple of years ago.　 Let’s pour out a little White Ship Lovecraft IPA in his honor this week.

Continue Reading DDL Summer Vacation: Another Sequel

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Here’s another guest post, this time from Reed Smith‘s Elizabeth Graham Minerd.  This post concerns PMA preemption, and a second opinion largely getting rid of a case that we blogged about before.  As always, Elizabeth deserves all the credit, and any blame, for what follows.  Without further ado:

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In the recent decision of Marion v. Smith & Nephew, Inc., 2016 WL 4098608 (D. Utah July 27, 2016), the Court dismissed all but one of the plaintiffs’ claims relating to a premarket approved medical device from the amended complaint.  This was the Court’s second time finding the plaintiffs’ pleading largely deficient.  This blog previously discussed the Court’s first order dismissing plaintiffs’ original complaint with leave to amend here.  In that order, the Court provided the plaintiffs with a road map to navigating the “Scylla and Charybdis” of pleading a legally viable claim related to a premarket approved device.  But even with a road map, the plaintiffs were only able to navigate one of their nine claims through Scylla and Charybdis and that one claim did not escape unscathed.

In Marion, the plaintiff was implanted with the defendant’s hip resurfacing device—a device that received premarket approval a little over a year prior to the plaintiff’s surgery.  2016 WL 4098608, at *1.  After six years, the device allegedly failed and the plaintiff had it surgically removed. Id. The plaintiffs filed a lawsuit asserting various claims against the defendant for the device’s purported failure. Id.

The Court dismissed the plaintiffs’ original complaint, but granted the plaintiffs leave to amend. Id. In doing so, the Court provided “clear guidance” regarding the three issues that the plaintiffs would need to address in the amended complaint in order to state a parallel claim that would survive both preemption and Twombly/Iqbal [editorial note: regular bloggers call this “TwIqbal“]:

First the court required the [plaintiffs] to identify with specificity the federal law requirements that parallel the state law claims. Second, the court required the [plaintiffs] to identify with specificity the state law duties that existed prior to but allegedly parallel the requirements for the [device] under federal law.  Finally, the [plaintiffs] were required to plead adequate facts to make their parallel state law claims plausible on their face.

Id. at *3.

Continue Reading Guest Post − Marion − Even with a Road Map, Only One Dubious Claim Navigates Preemption

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This is from the non-Reed Smith side of the blog.

Looking back at our posts on innovator liability, it’s becoming more and more difficult to title them. According to the DDL blog, innovator liability has been rejected, abolished, denied, refused, disallowed. You get the idea. With the news from earlier this summer that the California Supreme Court is going to consider the issue – which will hopefully spell the demise of Conte – we may be nearing the end of the chapter on innovator liability. In the meantime, we’ll keep bringing you the wins as they stack up.

Today’s case was actually decided right around the time the California Supreme Court decided to take on the issue. Gillette v. Boehringer Ingelheim Pharm., Inc., 2016 WL 4217758 (Mag. D. Minn. Jun. 16, 2016). The decision didn’t come to our attention, however, until the magistrate’s report and recommendation was adopted last week. See 2016 WL 4203422 (D. Minn. Aug. 9, 2016).

The Gillette decision comes out of the Mirapex MDL and involves the application of Indiana law. Indiana products liability claims are governed by the Indiana Products Liability Act (“IPLA”) which provides a single cause of action subsuming all common law strict liability and negligence claims, as well as tort based warranty claims. Gillette, 2016 WL 4217758 at *3-4, *6. So, plaintiff in this case had one cause of action based on her allegations that her use of Mirapex caused her to gamble compulsively.

But was it Mirapex that plaintiff was taking at the time she suffered her injuries? According to her pharmacy records, plaintiff was prescribed Mirapex from 2001 until 2015. Id. at *1-2. It appears that from 2001 until April 2010, plaintiff’s pharmacy filled her prescriptions with brand name Mirapex. In April 2010, when her prescribing physician increased plaintiff’s dosage, her pharmacy began filling her Mirapex prescriptions with its generic equivalent – pramipexole dihydrochloride. Id. at *1. From April 2010 until late 2015, plaintiff received the generic version of the drug manufactured by a succession of four different generic drug manufacturers. Id. at *1-2.

Continue Reading Brand Defendants Thwart Another Innovator Liability Claim

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Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison v. Biogen Idec Inc., No. 2:11-CV-01140-DN-DBP, slip op. (D. Utah Aug. 5, 2016).  With respect to preemption and innovator drug warnings, these cases provide further support to an emerging, common-sense bright line in the otherwise all-too-murky world of “clear evidence” – that a warning change rejected by the FDA for lack of scientific evidence must be “clear evidence” that this change would have also been rejected at any earlier date.  The logic is inescapable that, if there was insufficient scientific evidence at moment X, there is no more, and usually less, evidence on the same issue at any time before X.

Looking at our cheat sheet, the first case to so hold appears to be In re Fosamax (Alendronate Sodium) Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. 2013). Fosamax involved the FDA’s partial rejection of a prior approval supplement after the date of the plaintiff’s injury.  Id. at 703 (FDA rejection occurred “approximately one month after” plaintiff’s injury).  The label change failed because “the data that FDA has reviewed have not shown a clear connection” between the drug and the risk at issue.  Id. at 699.

[C]lear evidence exists that the FDA would not have approved a label change to the Precautions section of the [drug] label prior to [plaintiff’s] fracture because Defendant submitted a label change and the FDA rejected it, and the FDA never required Defendant to submit new language or change the label, which demonstrates that the FDA did not think that the label should have been changed at that time.

Id. at 703-04. See In re Fosamax Alendronate Sodium Products Liability Litigation, 2014 WL 1266994, at *11 (D.N.J. March 26, 2014) (applying this ruling “to those Plaintiffs’ whose injuries occurred prior to [the FDA rejection date], without allowing additional discovery”).

Continue Reading Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

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The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016) (“NYCAL”), was not too good for asbestos defendants – as it permitted, under certain circumstances, non-manufacturers to be sued for failure to warn of a risk that the product they manufactured didn’t have (exposure to asbestos), where they “encourage[ed]” the use of products containing that risk with their products and thereby benefitted economically:

[A] manufacturer’s duty to warn of combined use of its product with another product depends in part on whether the manufacturer’s product can function without the other product, as it would be unfair to allow a manufacturer to avoid the minimal cost of including a warning about the perils of the joint use of the products when the manufacturer knows that the combined use is both necessary and dangerous. And, the justification for a duty to warn becomes particularly strong if the manufacturer intends that customers engage in the hazardous combined use of the products at issue.

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[W]here a manufacturer creates a product that cannot be used without another product as a result of the design of the product, the mechanics of the product or the absence of economically feasible alternative means of enabling the product to function as intended, the manufacturer has a substantial, albeit indirect, role in placing the third-party product in the stream of commerce. . . .  Specifically, when the manufacturer produces a product that requires another product to function, the manufacturer naturally opens up a profitable market for that essential component, thereby encouraging the other company to make that related product and place it in the stream of commerce.

NYCAL, 2016 WL 3495191, at *__ (for some reason there is no Westlaw star paging at the moment).  This opinion is very bad news for the affected companies, who are now sucked into the maw of interminable asbestos litigation on the basis of products they didn’t even make, but it should not open the door to innovator liability type claims against our medical product manufacturer clients, and it’s good on causation, too.

Here’s why.

Continue Reading New York Decision Not Good For Asbestos, But Not Bad For Drug/Device

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Not everyone sees eye to eye on federal preemption, including judges. Take for example the conflicting opinions from the California Court of Appeal applying the express preemption provision of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (“2003 Medicare Act”).  The statute governs Medicare benefits—a topic not usually within our bailiwick.  But we know and appreciate preemption, and we can see pretty clearly in these cases where two Appellate Districts got it wrong and a third got it right.

First the one that got it right. In Roberts v. United Healthcare Services, Inc., No. B266393, 2016 WL 4150703 (Cal. Ct. App. Aug. 4, 2016), the plaintiff enrolled in a private health plan offering benefits under the federally funded Medicare Advantage program.  The long and the short of it was that the plan advertised that it was “made up of local doctors,” but when the plaintiff needed urgent care, it turned out there was no urgent care center anywhere in California. Id. That resulted in an out-of-network co-pay ($20 more than the in-network co-pay) and a class action lawsuit asserting that the plan engaged in misleading conduct and unfair competition, among other state-law claims. Id.

The main issue was preemption, specifically express preemption because of the Act’s express preemption provision:

The standards established [by regulation] shall supersede any State law or regulation (other than State licensing laws or State law relating to plan solvency) with respect to [Medicare Advantage] plans which are offered by [Medicare Advantage] organizations under [Part C].

Id. (citing 42 U.S.C. § 1395w-26(b)(3). This is not exactly the same as the “different from or in addition to” language we see in the Medical Device Amendments’ express preemption provision, but it is close, and the idea is the same.  State requirements give way to federal requirements established under the authority of the Act.

Continue Reading California Court Clears The Way For Express Preemption

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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

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This is a guest post, by Jaimee Farrer, an associate at Reed Smith.  We’re always looking for new twists that can help in efforts to remove cases to federal court, and the case Jaimee describes does that, relying on an MDL standing severance order to short circuit what might have been lengthy and complex joinder arguments.  As always, our guest posters should get full credit (and any blame) for their analyses.  With that said, take it away Jaimee.

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We’re used to seeing judges split the baby when it comes to ruling on Daubert motions, for example.  Courts frequently allow an expert to testify about some of his/her opinions while excluding his/her other opinions, thereby giving both sides a little of what they want.  But remand decisions are usually black and white with a clear winner and a clear loser.  Either a case gets to remain in federal court and the defendants are the happy victors or the case gets remanded to state court, leaving the defendants to sulk and bemoan their fate.  But in today’s opinion, In Re Benicar (Olmesartan) Products Liability Litigation, 2016 WL 4059650 (D.N.J. July 27, 2016), which comes courtesy of the Benicar MDL Court, both scenarios happened simultaneously . . . well at least sort of.

Seventy-nine plaintiffs joined in filing a Complaint in the Circuit Court of the City of St. Louis, Missouri, against five defendants, two Daiichi Sankyo affiliates and three Forest Laboratories affiliates.  2016 WL 4059650 at *1-2.  In their Complaint, the plaintiffs alleged generally that they were injured by drugs developed and marketed by the defendants. Id. at *1.  The defendants removed the action to the Eastern District of Missouri, claiming diversity jurisdiction. Id.  The defendants concurrently moved to stay the case pending MDL transfer, which was granted. Id.  Plaintiffs predictably moved to remand, arguing lack of complete diversity. Id.  There things stood for several months while MDL transfer occurred. Id. at 2.  After the transfer, the stay was lifted, allowing the District of New Jersey to rule on the plaintiffs’ remand motion. Id.

At this point, in a multi-plaintiff case, we usually see arguments about fraudulent joinder, fraudulent misjoinder, or alternatively about personal jurisdiction. See here and here, for examples.  Not this time.  In ruling on remand, the Court conducted a cursory analysis of the citizenship of the parties and determined that thirty-five of the seventy-nine plaintiffs were citizens of the same state where at least one of the defendants has its principal place of business or is incorporated. Id. at *2.  That’s usually bad news for defendants.

Continue Reading Guest Post – Benicar MDL Court: An Unconventional, but Relatively Simple, Remand Decision

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We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory position in light of repeated governmental First Amendment losses in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011); Thompson v. Western States Medical Center, 535 U.S. 357 (2002); United States v. Caronia, 703 F.3d 149 (2d Cir. 2012); and Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015), to name the most notable.  The FDA has promised action on a number of occasions, but has never delivered.  This stonewalling has even caused the Pharmaceutical Research & Manufacturers of America (“PhRMA”) to force the issue by filing amicus curiae briefs in litigation, as we discussed here a couple of years ago.

The longstanding disconnect remains. What the FDA purports to prohibit, and what the First Amendment actually allows, in terms of truthful communications by regulated manufacturers about off-label uses are two very different things.  So PhRMA, joined this time by the Biotechnology Innovation Organization (“BIO”), is charging once more unto the breach, this time with its own industry-practice “principles” concerning off-label communications.  Here’s a link to the document itself, which is called “Principles on Responsible Sharing of Truthful & Non-Misleading Information about Medicines with Health Care Professionals and Payers.”  That’s a mouthful, so we’ll just call it “Industry Principles” in this post.

Essentially, these industry organizations are drawing a line in the FDA’s regulatory sand – telling the Agency, and their own members, that they will fill the gap caused by administrative dithering themselves. Notably, since PhRMA has already shown its willingness to litigate First Amendment issues against the FDA, we would not be surprised to see these guidelines form the basis of industry’s First Amendment position in future court challenges.

The Principles’ introduction first states the reason off-label communication is needed: “Scientific knowledge and new findings go far beyond . . . clinical trials, often are outside the scope of [FDA] parameters . . ., and often outdate the FDA-approved labeling.”  Industry Principles, at 1.  The introduction then explains why the industry cares so much.  “Biopharmaceutical companies are uniquely positioned to help health care professionals achieve the best outcomes for patients, because companies can provide timely, accurate, and comprehensive information about both approved and unapproved uses of [their] medications.” Id. Finally, it states what the industry is doing about it from this day forward.

These Principles are intended to form the basis for defining new and clear regulatory standards governing responsible, truthful and non-misleading communications to inform health care professionals about the safe and effective use of medicines.

Id. In other words, in default of FDA action, industry will set its own standards for off-label communications (including those that the FDA calls “promotion”), and will defend them in whatever fora are necessary, including in court.

Continue Reading Off-Label Marketing – Industry Groups Step into the Breach

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