Sales Reps Denied Summary Judgment in Artificial Hip Case Despite Absence of Legal Duty to the Plaintiff
Once upon a time there was a federal judge . . . . When we were little, we liked it when our mom spun free-form fairy tales for us. We would contribute the object of the "was" ("Once upon a time there was a . . . bullfrog"), and she would make up the rest as she went along. Which is fine for mommies, but less so for federal judges, as today's (very short) case illustrates.
In Fay v. Depuy Orthopedics, Inc., et al, 2015 U.S. Dist. LEXIS 175344 (D.N.D. June 11, 2015), plaintiff's hip was replaced with a metal-on-metal hip system. The system consisted of various components, two of which were at issue: the femoral head and the acetabular cup. Both components come in various sizes, but, for the system to work correctly, matched sizes of the two components must be implanted in the patient.
In Fay, it was undisputed that Plaintiff received mismatched components and had to undergo revision surgery. One of the defendants was a distributor that marketed and sold the system. Plaintiff's surgeon testified that two specific sales reps employed by the distributor were always in the operating room when he implanted that particular hip system. According to the surgeon (who was not sued), the reps were responsible, based on a process called "templating" of the patient's x-rays, for placing an appropriate range of sizes of the two components on a table in the operating room before the surgeon arrived. From the prepared template, the surgeon would determine what size acetabular cup would be implanted, and would ask for that size cup and the correspondingly-sized femoral head. The sales reps were allegedly responsible for selecting the components from the implant table, verifying for both that they had pulled the size the surgeon requested, and handing the packaged components to the circulating nurse, who unpacked them and placed them in the sterile field. In the absence of sales reps, the circulating nurse would be responsible for selecting the correct sizes of components.
The distributor moved for summary judgment, arguing that there was no evidence that its sales reps were ever actually in the operating room on the day of the plaintiff's surgery, as the intraoperative report, in which the circulating nurse was responsible for recording the names of everyone in the operating room, omitted any mention of sales rep participation. Plaintiff argued that the nurse had simply forgotten to include the names of the sales reps, and the surgeon took an affidavit swearing that he never implanted this system without the assistance of his chosen reps.
But wait – under what legal doctrine could the plaintiff maintain a claim against a distributor based on conduct by its representatives? Plaintiff argued that it was the reps' "duty and responsibility to make sure proper implants [were] available for the case and that the proper implants [were] in fact what [were] opened and used at the time of surgery." Fay, 2015 U.S. Dist. LEXIS 175344 at *8 (internal punctuation and citation omitted). The distributor countered that it owed no such duty to the plaintiff. The court noted that the parties had "not directed the Court to any legal authority outlining the duty of an orthopedic sales representative in a case of this nature." Id. at *7-8. End of decision, right? If plaintiff could not cite authority for imposing a duty on the sales reps, then it didn't matter whether the reps were in the operating room or not, right? (Erie principle #1 – if there is no currently existing state-law duty, a federal court exercising diversity jurisdiction is not supposed to create one. We have law from every circuit (including the Eighth) for that proposition, here and here.)
Wrong. Glossing over the legal vacuum to (silently) superimpose an imaginary duty, the judge held that there was a genuine issue of material fact as to whether the reps were present for the surgery, and denied summary judgment. We shake our figurative head on several levels. First, call us old-fashioned, but we're pretty sure a plaintiff shouldn't be able to maintain a lawsuit when she has no legal claim, and that it wasn't the defense's burden to find precedent affirmatively rejecting nonexistent duties. Second, on a more personal level (we represent device manufacturers), we are horrified at the notion that a judge can "make up" a duty that could subject sales representatives to liability for a surgeon's conduct in an operating room. In any event, we can only hope that one federal judge in the District of North Dakota will come to his senses as the case progresses. And that all will live happily ever after.
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Breaking News – Learned Intermediary Mandates Dismissal of 31 of 32 New Jersey Accutane Plaintiffs
Still working on technical blog problems, so here's another email.
The demise of the New Jersey Accutane litigation under the new mass tort judge continues apace. Today 31 more Accutane cases were dismissed for failure to establish warning causation under the learned intermediary rule. The order is here, but the actual opinion is about halfway through the PDF, so keep looking, you'll find it.
It's worth looking for, too.
This round of dismissals is all about the learned intermediary rule. The court recites six bases for the rule: (1) prescription drugs have risks that require a prescription in the first place; (2) prescription drugs are complex, requiring a doctor to make patient-specific assessments; (3) direct warnings to patients are impracticable' (4) medical ethics require the physician to act as intermediary; (5) patients can't be expected to evaluate technical information; and (6) not to put too fine a point on it – plaintiffs tend to lie once they get into litigation ("human nature is what it is"). In re Accutane Litigation, No. 271, slip op. at 7 (N.J. Super. Law Div. Jan. 29, 2016). In these 32 cases:
In each claim, there was a "willing patient" who only thought differently upon acquiring new information via the litigation process. Because the doctors, in each and every instance, testified that even with a different warning they still would have prescribed the medicine, the manufacturer's duty is fulfilled. Because the warning is directed to the prescribing physician, she/he is afforded the opportunity to engage in "hindsight" and opine on what they would have done had they known then what they knew at the time of their deposition, Plaintiffs are not afforded an opportunity at "hindsight."
Slip op. at 9. In only one case was summary judgment denied, without prejudice, because a deposition hadn't been completed. Id. at 11-12.
Choice of law was no obstacle. These plaintiffs all chose to come to New Jersey and asked for New Jersey law, so they got what they asked for. Id. at 9-10. Ask for a New Jersey mass tort, and you get New Jersey law. Next time, plaintiffs, be more careful what you ask for. But since the learned intermediary rule is virtually universal, even under other states' law (Kansas, Louisiana, California, Texas) the result is the same. Page after page of the slip opinion (pp. 11-36) consist of minor variants on the theme of no change in prescribing behavior equals no causation.
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The Shape of (Discovery) Things To Come
We assume that all of our readers by now know that significant changes to the federal discovery rules went into effect on December 1, 2015. We've posted about them frequently. We're not going to bore you by describing the changes for the umpteenth time. There are a couple of new developments, though, that are worth noting. First, on December 31, 2015, the Supreme Court, per Chief Justice Roberts, issued its "2015 Year-End Report on the Federal Judiciary," available here. Coming hard on the heels of the rules changes going into effect, the 2015 Report is the best indicator of how the Court contemporaneously intended these rules changes to be applied. To the extent that the other side is trying to pooh-pooh these changes as not changing much of anything, the 2015 Report suggests that they are quite wrong:
- "Many rules amendments are modest and technical, even persnickety, but the 2015 amendments to the Federal Rules of Civil Procedure are different. Those amendments . . . address the most serious impediments to just, speedy, and efficient resolution of civil disputes." 2015 Report at 4.
- The amendments "focus discovery − the process of obtaining information within the control of the opposing party − on what is truly necessary to resolve the case" and "address serious new problems associated with vast amounts of electronically stored information." Id. at 5.
- "The amended rules . . . mark significant change, for both lawyers and judges, in the future conduct of civil trials. Id.
- "The amendments may not look like a big deal at first glance, but they are. That is one reason I have chosen to highlight them in this report." Id.
- "Rule 26(b)(1) crystalizes the concept of reasonable limits on discovery through increased reliance on the common-sense concept of proportionality. . . . The amended rule states, as a fundamental principle, that lawyers must size and shape their discovery requests to the requisites of a case. Specifically, the pretrial process must provide parties with efficient access to what is needed to prove a claim or defense, but eliminate unnecessary or wasteful discovery." Id. at 6-7 (block quote from Rule 26(b)(1) omitted).
- "The 2015 civil rules amendments are a major stride toward a better federal court system. But they will achieve the goal of Rule 1 . . . only if the entire legal community, including the bench, bar, and legal academy, step up to the challenge of making real change." Id. at 9.
- "[T]he 2015 civil rules amendments provide a concrete opportunity for actually getting something done." Id. at 11.
The Chief Justice's 2015 Report was among the authorities cited in Kissing Camels Surgery Center, LLC v. Centura Health Corp., 2016 WL 277721 (Mag. D. Colo. Jan. 22, 2016), medically-related (but not drug/device) litigation involving claims – and counterclaims – between four surgical centers and some of the largest health insurers in Colorado. The lead plaintiff, Kissing Camels, is located in Colorado Springs, which accounts for the unusual name (a rock formation). Very briefly, the subject matter of the lawsuit involves health insurance reimbursements, which vary depending on whether the health care provider is in the insurer's network.
But we don't care about that today. We're interested in the court's take on post-new rules discovery disputes in this long-running litigation. Basically, the court decided that both sides need to shape up. "[T]he new amendments to the Federal Rules of Civil Procedure, effective December 1, 2015, refocus the court and the Parties on their respective obligations in discovery." 2016 WL 277721, at *1
The first issue was proportionality. The new rules, having emphasized this issue, "require this court to address issues of proportionality of discovery." Id. at *2. Litigation "mired in continuous disputes over the appropriateness of discovery served and the adequacy of responses" for some "six months . . . is not what the Federal Rules intended." Id. Proportionality did not permit the defendants' "omnibus requests," which were "improper on their face." Id. The court gave an example:
All documents relating to any meeting, discussion, or conversation (whether in person, by telephone, or via e-mail) between you and [a third-party defendant] in which a payor, including [defendants], is directly or indirectly mentioned or referenced.
Id. The "definitions" accompanying this request only made things worse – "including, without limitation, any [long list], or any other person(s) acting or purporting to act with or on behalf of the foregoing." This kind of scattershot approach doesn't cut it any longer. "[T]here appears to be no attempt by Defendants to tailor the discovery request to issues arising from this case." Id.
On the other hand, the plaintiffs' objections to this discovery were "no better."
Boilerplate objections are improper. The responding party has the obligation to explain and support its objections. As far as this court can tell, Plaintiffs fail to provide any specificity to their objections, including their objection that they have already produced responsive documents. Rather, it appears that Plaintiffs' response simply points generally to the production of 1 terabyte of information − conservatively, millions of pages − without providing any type of guidance to Defendants as to where in the production such responsive documents are to be found.
Id. (footnote omitted). The court held that, with respect to ESI (electronically stored information – if you haven't yet learned this acronym, learn it now), a party cannot rest on Fed. R. Civ. P. 34(b)(2)(E)(i), validating production of hard copies as "kept in the usual course of business." Rather:
This distinction between a party's obligations with respect to ESI and traditional, hard copy documents permeates the Rules. . . . ESI, and therefore, its treatment, is distinct from hard copy documents. The newly amended Rule 37(e) also distinguishes ESI from other discoverable information.
2016 WL 277721, at *3 (citations omitted). "[P]arties, by mutually agreeing to transmit discovery in ESI format, had chosen to have Rule 34(b)(2)(E)(ii) govern the production." Id. "[P]arties requesting ESI [are] able to organize it themselves − in their own way, to their own satisfactory level of thoroughness, and at their own expense. Id. at *4 (citation and quotation marks omitted).
Here, however, the plaintiffs' vague "already produced" objections were not sufficient. The court ordered them to "provide additional information about where in the production Defendants may find certain information." Id. In so holding, the court took into account case-specific circumstances, here:
the volume of the document production to date, the asymmetry of information regarding the production between Plaintiffs . . ., the duration of time during which this case has been pending, and the fact that the Parties suggest that additional discovery must be conducted as to [new] claims.
Id. The court would not require page-specific designations "for every Request for Production" because of the gross overbreadth of those requests. Instead, proportionality required prioritization. Defendants could "identify ten limited categories of documents" that had been subject to the boilerplate "already produced" objections. Id. For those ten categories only, "Plaintiffs must identify bates ranges of responsive documents." Id.
This will ensure that Defendants prioritize their requests regarding location of responsive documents within the 1 terabyte of data, and will limit Plaintiffs' obligation to sort through the production on Defendants' behalf and correlate every Request for Production to specific bates ranges.
Id.
Moral of story: The new rules require courts to confine discovery "within a proper scope," but producing parties must likewise facilitate that process with "objections [that] are appropriate" and not boilerplate. Id.
Kissing Camels is thus the second case we're aware of that, since the amended rules became effective, has actually restricted discovery due to proportionality concerns. See also State Farm Fire & Casualty Co. v. Gates, Shields & Ferguson, P.A., 2015 WL 8492030, at *4-5, 7 (Mag. D. Kans. Dec. 10, 2015) (contract action between insurer and law firm).
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[DK GreenRoots] Might be of interest: renewable electricity future highly affordable
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DDLaw blog post - The Other Shoe Drops in Estes
Here is another jerry-rigged email to bring you, our most loyal subscribers, the latest. Also, here's a convenient link to the blog itself if you want to visit for any reason.
Last month, we discussed Estes v. Lanx, Inc., 2015 WL 9462964 (N.D. Miss. Dec. 23, 2015), and mentioned that the court had left a bit of unfinished business behind – having raised sua sponte the question of whether the plaintiff's assertions that the device lacked proper FDA clearance was preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).
A lot of you were interested. That post has received over 1000 hits.
The other shoe has now dropped.
In Estes v. Lanx, Inc., 2016 WL 211691 (N.D. Miss. Jan. 14, 2016), the court held that, yes indeed, a product liability claim grounded in an attack on the validity of the FDA's §510k device clearance is barred under Buckman. Buckman, of course, interposed implied preemption against claims that are nothing more than attempts to enforce purported Food, Drug & Cosmetic Act ("FDCA") "violations," because the statute limited enforcement to the United States government. 531 U.S. at 549 n.4 (citing 21 U.S.C. §337(a)). Buckman then distinguished the "parallel claim" concept enunciated in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996):
[Lohr's] claims arose from the manufacturer's alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements. In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.
531 U.S. at 532-33 (Lohr citation omitted) (emphasis original). "The conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted." Estes, 2016 WL 211691, at *1 (citation and quotation marks omitted).
Buckman thus killed the Estes improper FDA clearance claim. Whatever else one can say about that claim, if the FDCA didn't exist, there wouldn't be any requirement of FDA clearance for the defendant allegedly to have violated. Therefore, that claim "exist[ed] solely by virtue of the FDCA":
Plaintiff's claims here are premised on [defendant's] failure to submit a standalone 510(k) premarket notification. . . . [Plaintiff] contends that the [product] should not have been available for use because it was not cleared by the FDA, and that [defendant] was negligent in releasing the system without proper FDA clearance or fraudulently concealed that fact. . . . Accordingly, Plaintiff's fraud claim is based and premised on [defendant's] alleged violation of the FDCA. Plaintiff's fraud claim solely arises out of the alleged violation of the FDCA, not state substantive law. Thus, Plaintiff's claims are preempted.
Id. at *2 (citations omitted). That's about as straightforward as one can get. If, when the FDCA is removed from the picture, the basis for the state-law claim goes away as well, then there never was any claim to start with. Buckman sees to that.
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[DK GreenRoots] Civil Disobedience - First hand account
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Winter Storm Jonas wrecking your weekend? Pass the time catching up on DDLaw blogposts
This isn't how you normally expect to receive our Drug and Device Law blogposts, but we have technical glitches (that we're still trying to work through), and those glitches mean that our new posts have not been distributed to our subscribers since January 14th. We apologize profusely for that. Until we've straightened this out, you may want to visit the blog itself to get our daily new content. As a stopgap we've captured our most recent posts here to make sure you received them. If you can take the time to catch up – especially those of you in the Eastern part of the U.S., who are likely homebound for the next 24-48 hours, be our guest. We hope to have the blog issues worked out by next week (fingers crossed), but until that happens, you may receive the occasional email from us. We appreciate your patience as we work through these issues.
Without further delay, here are the posts you may have missed (starting with the most recent):
· Jan. 22: Medical Device Cybersecurity: FDA's New Draft Guidance
· Jan. 21: Breaking News – High Wattage Reasoning – Arizona Adopts Learned Intermediary
· Jan. 21: Guest Post -- It's No Crime: Ninth Circuit Gets Crime-Fraud Exception Case Mostly Right
· Jan. 19: Louisiana Medmal Removals – It Ain't Over 'Til It's Over
· Jan. 18: The New One-Two Is Back
· Jan. 15: First Amendment Follow-Up
Happy reading and those affected by the storm, stay warm!
James M. Beck (bio)
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[Drug and Device Law] Mississippi Plaintiff Defeated By Improper Construction of "Amend As A Matter Of Course" Rule
We spent the past weekend in Cleveland, visiting a dear law school friend of whom we see much too little. Cleveland deserves more press as a travel destination. It boasts beautiful architecture, (including spectacular bridges, like the Detroit-Superior Bridge over the Cuyahoga River), reasonable prices, and the Cleveland Clinic. It is also home to the world-class Cleveland Symphony and the renowned Cleveland Museum of Art. But (not surprisingly, for regular readers of our posts) our most memorable afternoon was spent in that mecca of popular culture, the Rock and Roll Hall of Fame. We had to be dragged away from the continuous loop of induction ceremony highlights. We gleefully donned headphones and entered a simulated recording booth, where we “laid down the harmony track” over a melody line sung by a popular artist. We stared at Elvis’s army uniform and the sheet of paper on which Neil Young first jotted the lyrics for “Heart of Gold.” But we were most captivated by a room-size exhibit devoted to one of our personal idols, Graham Nash, a two-time Hall inductee (with the Hollies and with Crosby, Stills and Nash), onetime Joni Mitchell cohabitant, and author of a song in serious contention to be our all-time favorite, the folk-y classic “Teach Your Children.” (In a minute, we will find a way to tie this, however tenuously, to something legal. We make no such attempt with this link to a lovely moment from the 2007 American Idol finale, on which Nash sat on a stool with an acoustic guitar and performed this song with an Idol finalist.)
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Posted By Rachel B. Weil to Drug and Device Law at 1/14/2016 04:15:00 PM --
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[Drug and Device Law] Breaking News -- Cisson Plaintiff's Verdict Affirmed
This post is not from the Reed Smith side because they are too involved in the mesh litigation to comment. Here is a link to today’s opinion in Cisson v. C.R. Bard, Inc., No. 15-1102 (4th Cir. Jan. 14, 2016). The plaintiff’s verdict in Cisson was affirmed.
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Posted By Michelle Yeary to Drug and Device Law at 1/14/2016 01:53:00 PM
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[Drug and Device Law] Latest First Amendment Off-Label Notes - Has DoJ Finally Come Around?
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Posted By Bexis to Drug and Device Law at 1/13/2016 03:59:00 PM --
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[Drug and Device Law] Off-Label Promotion Not Dispositive in Qui Tam Action
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Posted By Michelle Yeary to Drug and Device Law at 1/12/2016 03:10:00 PM --
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[Drug and Device Law] California Supreme Court - Presumption Against Preemption Still Around
Last month, in Quesada v. Herb Thyme Farms, Inc., 361 P.3d 868 (Cal. 2015), the California Supreme Court did to “organic” foods what it had done to most other foods in Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008) – which is to expose them to still more garbage class actions over labeling that complies with federal government standards. As we discussed here, in the Salmon cases the court had to work reasonably hard to come up with an (uncodified) food-related exception to the general ban on private enforcement of the Food, Drug & Cosmetic Act (“FDCA”).
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Posted By Bexis to Drug and Device Law at 1/11/2016 08:00:00 AM --
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