Manufacturer's Representatives

Sometimes it takes us a while to catch on to things. This is more than a little embarrassing for a Jersey guy to admit, but while many of our high school classmates were devout Springsteen fans after his first two albums, Greetings from Asbury Park and The Wild, The Innocent, and The E Street Shuffle, we would not commit until after the release of Born to Run, by which time Bruuuuuuuce had become a national phenomenon. For years we saw shaved kale salad on menus and passed it by, thinking that we probably did not like kale and definitely did not like shaving, so why bother? Now it is our go-to appetizer for when we want to feel vaguely virtuous. We were late adopters of on-line banking, Apple Pay, and Twitter. Our garage will surely be the last in the neighborhood with a hybrid powered car, a self-driving car, or a flying car. On the way back from visiting the Drug And Device Law Son in Moscow, the British Airways entertainment offerings included season 2 of Catastrophe, an Anglo-American miracle of fun and filthy television comedy. Now we are queuing up season one on Amazon Prime. We are complete-ists, even backwards, if nothing else. Better late than never, right?

Today we are taking a look at an old case (two and a half-years old, but turning up in our topic searches just now). The case is called Meredith v. Nuvasive, Inc., 2013 U.S. 190130 (W.D. Texas Dec. 9, 2013). The plaintiff in Meredith alleged injuries from malfunction of a neuromonitoring device during spinal surgery. Her claims were for manufacturing defect, breach of implied warranties, negligence, gross negligence, and res ipsa loquitur. There is nothing especially unusual in any of that. But here is the man-bites-dog aspect of the case: the product liability plaintiff moved for summary judgment against two relatively unusual defenses, the manufacturer defendant as a “health care provider” under the Texas malpractice statute, and lack of any sale of a medical device precluding warranty claims.

For those of you in need of an executive summary, know this: The plaintiff in Meredith went one for two. (1) The court held that a device manufacturer was not a health care provider under the relevant medical malpractice statute. (2) Because the device was simply used in the hospital, and not sold to the plaintiff or anyone else, the defendant had a real shot at picking off the warranty claims.


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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.


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We’ve read a fascinating new case out of Texas, Verticor, Ltd. v. Wood, ___ S.W.3d ___, 2015 WL 7166024, No. 03-14-00277-CV, slip op. (Tex. App. Nov. 13, 2015), posing the question whether a medical device company can be a “health care provider” within the meaning of that state’s pretty restrictive laws regarding medical malpractice.  While rejecting the manufacturer’s appeal on the record before it, the court in Verticor didn’t flatly say “no.”  Instead, it held:

As the issue is framed here, [[manufacturer’s] license authorizes it “to provide” (at least in the sense of manufacturing and selling) the [device] − and nothing more.  Consequently, [manufacturer] can be “licensed . . . by the State of Texas to provide health care” only if the [device] is, in itself, “health care” as the [statute] defines that term. . . .  Under it, “health care” is distinguished by either of two nouns − “act” or “treatment” − that is “performed or furnished,” or should have been, “for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement.”  The first alternative, an “act,” denotes some sort of deed or activity.  As an inanimate object, [the device], in itself, could not be an “act,” although it might be utilized in acts that qualify as “health care,” such as surgery.  Similarly, the other alternative, “treatment” also denotes some form of activity that is performed or furnished for or to a patient. Consequently, the [device] would not, in itself, be a “treatment,” although it might be utilized in a “treatment.”

Verticor, slip op. at 10 (footnotes omitted).  All this manufacturer submitted was that it was licensed to manufacture medical
devices.  That wasn’t enough.  Texas medical malpractice tort reform was separate from that state’s product liability tort reform.  Id. at 11-12.  Further, the “common usage” (how such statutes are construed) of the term “health care” denoted something different from manufacturing:

In common usage, one associates “health care” with medical intervention, assistance, or other acts − e.g., one’s family doctor performing an annual physical or a nurse administering a flu shot − as opposed to the mere making or selling of a product used in providing such services.  Focusing as it does on acts and treatment provided to patients, the [statute’s] definition of “health care” does not clearly depart from this basic notion.

Id. at 13.


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We confess that among the many benefits of being a DDL blogger, one of our favorites is our ability to have a little fun.  Let’s face it, legal writing can sometimes be a bit boring.  Try as we might, it tends toward being dry.  Even when railing against grave injustices, we need to be organized and strategic; we need to include often mundane facts and details; we need to discuss dense, arcane legal precedent.  But here, we can compare a legal decision to the most recent episode of the Walking Dead.  We can interweave sports loyalties with discussions of local court trends.  And we’ve never had to hide our bias – if we don’t like something, we tell you.

We imagine judges sometimes get bored too.  And that leads to opinions such as Justice Scalia’s glib dissent in PGA Tour, Inc. v. Martin, 532 U.S. 661 (2001) – funny even for those who don’t like golf.  Another classic is Noble v. Bradford Marine, Inc., 789 F. Supp. 395 (S.D. Fla. 1992) in which the judge peppered his decision with lines from the movie “Wayne’s World” — holding that defendant’s “most bogus” attempt at removal is “not worthy” and finding that the defendant must “party on” in state court. Sections of the opinion are labeled “Hurling Chunks” and “A Schwing and a Miss.”  And there is any number of examples of decisions written in verse.

So, when we were reading the case for today’s post – granting a plaintiff’s motion to remand and rejecting defendants’ fraudulent joinder argument – we knew we wouldn’t be celebrating the result.  But we can tip our caps to the prose.  Not often do you find this smattering of words and phrases in a single decision:  “checkered history,” “potential hitch,” “time bomb,” “hangover,” and “tyranny of labels.” It’s not a poem and it doesn’t read like a mystery novel, but it made the read a little more enjoyable.  And that’s about the only thing that made it enjoyable.


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Those of  us whose childhood had low tech play options and at least a touch of OCD recall  playing with dominoes.  Not whatever the game is where the number of dots on a tile matters, which we understand exists from witnessing it in screen classics like “Boyz n the Hood.”  No, we mean the activity where you line up a series of dominoes in a sequence where tipping over the first one will cause a chain reaction where many or all fall over.  If you were really motivated or bored, then the arrangement of dominoes might have included the construction of elaborate stairs, towers, or catapults or tiles falling off of tables to start new chains.  There is probably some app for this now.

The decision in Grabowski v. Smith & Nephew, Inc., No. 14-433, 2014 La. App. LEXIS 2367 (La. Ct. App. Oct. 1, 2014), reminds us of dominoes.  (We do try to have our non-legal introductions have something to do with our purported point.)  The case was really a detour from what looked like a medical malpractice action against a surgeon who performed a knee replacement with an insert that was too small for the tray he used.  The details of the two part implant system are not terribly important here, but the sizing of the insert and tray should match up.  The surgeon blamed the sizing error on the sales rep present at the implant after learning about it from another rep at a revision surgery three months later.  Skipping over some procedural parts and a whole section of the decision about a motion to recuse the judge—arrangements of dominoes sometimes have dead ends on purpose—plaintiff sued the original rep, the distributor with whom he had a contract at the time of the implant surgery, and the manufacturer of the implant with whom he used to have a contract.  The defendants eventually moved for and were granted summary judgment.

The basic idea was the rep was not liable for negligence because the duty of providing medical care to the patient—including using the right size of any medical device—rested solely with the surgeon.  In addition, the distributor was not liable for acts or omissions of someone who was its independent contractor and the manufacturer was not liable for someone with whom it had no direct contractual relationship.  On appeal, all the tiles fell to bring the deep pockets back into the case.  (We cannot tell what happened in terms of litigation between the plaintiff and the surgeon.)


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Like pharmaceutical and medical device manufacturers, it is not surprising that compounding pharmacies facing personal injury/products liability litigation prefer the typically more defense-friendly federal arena over the often more challenging (to put it mildly) state court system.  But as today’s case demonstrates, that may not be the easiest path for compounders to follow.

The case

We don’t particularly like starting our week with an adverse decision; certainly not after a holiday weekend.  But, we seem to have stumbled upon a variety of negative decisions to report on this week, so we’ll just dive in and get it over with. Fittingly for the day after Labor Day (we think), we decided to start with a case that centers on employee liability – specifically whether plaintiff had sufficiently pleaded his claims against the non-diverse sales representative so as warrant remand to state court.  The court said yes.

The case is Hutchens v. Smith & Nephew, Inc., 2104 U.S. Dist. LEXIS 116839 (N.D. Tex. Aug. 22, 2014).  Plaintiff sued the manufacturer and one of its sales reps over an allegedly defective hip implant, including a claim for violations of the Texas Deceptive Trade Practices Act (“DTPA”).  Id. at *6.  Defendants removed the case to federal court alleging that the sales rep had been fraudulently joined.  On plaintiff’s motion to remand, the question before the court was whether the claims against the sales rep survived a Rule 12(b)(6) dismissal-type analysis. Although pending in federal court, the court opted to apply Texas’ more lenient “fair notice” pleading requirement finding that the “standard applicable at the time the initial lawsuit was filed in state court should govern.”  Id. at *10.  First strike – no TwIqbal.

Moving to the substantive analysis, the court only examined plaintiff’s DTPA claim – only one claim against the sales rep needed to survive to remand the entire case.  The DTPA claim allegations as to the sales rep were that he:

exercised substantial control over the provision of warnings and . . . provided inadequate warnings, instructions, or representations to Plaintiffs that were incorrect, violated the . . . [DTPA] and induced Plaintiffs to implant the identified devices, causing Plaintiffs’ harm.


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If anyone is still shocked that medical device manufacturers’ sales representatives are present during surgery – don’t be.  It’s a common practice.  If you don’t believe us, see our posts here and here.  Surgeons believe manufacturers’ representatives have an important role to play in making sure the surgical instruments and the surgical team are fully prepared.  That means that reps are in the OR to stay.

With that comes the very real possibility of sales representatives being sued by plaintiffs who believe something went wrong during surgery or the possibility of manufacturers being sued for the alleged acts/omissions of their representatives during surgery.  Our earlier posts cover both situations and today we’ve stumbled upon another example of the latter — McCartney v. U.S., No. 2:13-CV-1118 TS, slip op. (D. Utah Jul. 16, 2014). Plaintiff underwent multiple surgeries involving implantation of defendant’s spinal cord stimulator.  One or more of defendant’s representatives was present during plaintiff’s surgeries. McCartney, slip op. at 1-2.  During one of the procedures, one of these reps called the plaintiff’s wife to ask about the location of the plaintiff’s pain.  Plaintiff’s wife didn’t know which leg was afflicted.  Id. at 2.

Plaintiff brought two negligence claims against the manufacturer based on its representatives being present during his surgery.  The first claim is premised on an alleged general duty of care owed by manufacturers to ensure that their devices are properly implanted.  Id. at 4.  In support, plaintiff alleged that the manufacturer’s representatives “instructed” his surgeon as to how to implant the stimulator (an act) and failed to ensure that the device was properly implanted (an omission). Id. at 6.  The difference between an act and an omission was critical to the court’s decision on whether there was a duty.  “Acts of misfeasance typically carry a duty of care while nonfeasance generally implicates a duty only in cases of special legal relationships.”  Id.


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Not to over-generalize, but older people have been known to break their hips.  Based on anecdotal evidence, broken hips hurt more than stepping on a broken bottle or a sea urchin during a tropical vacation.  Based on more than anecdotal evidence, product liability plaintiff lawyers prefer state courts over federal courts.  This is because of various factors that, they think, make the state courts more likely to impose pain, and impose a lot of pain, on the defendants.  We have posted on many cases discussing the strategies used by product liability plaintiffs to stay out of federal court.   These cases often come up in the posture of a motion to remand by the plaintiff after the defendant has removed under 28 U.S.C. § 1446.  If the case can be transferred to an MDL court—potentially well-versed in the anti-removal strategies—before a ruling on the motion to remand, then the chance of the case staying put tends to go up.

In Millman v. Biomet Ortho., Inc., No. 3:13-CV-77 RLM-CAN (N.D. Ind. Dec. 10, 2013), and Akin v. Stryker Corp., Civ. No. 13-1811 (DWF/FLN) (D. Minn. Dec. 12, 2013), we have decisions on motions to remand from two different MDL courts on two different cases involving two different hip replacement implantable medical devices.  We also have two different results, although both are good.


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

As we pointed out earlier this week, we are typically more interested in defense victories on this blog.  But every once and a while, we find cases that go the other way that we believe merit a mention. Sometimes that is because the decision is too significant to ignore.

Sometimes it is because of the court that renders the decision. Sometimes – like yesterday and today – it is because we want to remind our readers of issues that while not common, are nonetheless real.  Unfortunate issues that crop up from time to time. Yesterday, that was about a loss on fraudulent joinder involving claims against a sales representative.  As we mentioned then, more often than not – defendants win that issue.

Today’s case continues the sales representative theme.  A couple of years ago, we posted a cumulative piece on cases dealing with sales representatives who are present in the operating room.  It isn’t something that we come across very often and from our review, the decisions are split (largely based on the particular facts) as to whether the actions of a sales representative create a cause of action against the device manufacturer.  The issue, boiled down to basics, is whether the sales rep got too involved in the actual treatment of the patient or use of equipment during surgery. It was on that basis that the plaintiff in Medtronic, Inc. v. Malander, 2013 Ind. App. LEXIS 499 (Ind. Ct. App. Oct. 11, 2013) brought a negligence claim against the manufacturer of her husband’s defibrillator.  The defibrillator, a Class III PMA medical device, was implanted in 1997 and upgraded in 2004.  In 2006, plaintiff’s husband began experiencing a problem with the device known as V-V intervals.  Id. at *3.

During another upgrade surgery, one of defendant’s “clinical specialists” was present to assist with testing the device.  The test revealed no problems.  During the procedure, plaintiff’s surgeon also called defendant’s “technical services department” requesting information on V-V intervals and lead failures.  Id. at *4.  Defendant’s technicians responded: “Don’t worry about that; it doesn’t mean anything . . . I don’t think that’s a problem . . .”  Id. The surgeon did not replace the device. Plaintiff’s husband died a month later, following more episodes of V-V intervals. Plaintiff’s claims against the defendant included design defect, failure to warn, failure to recall, and failure to recommend removal during the 2006 surgery.  Id. at *5.


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