We have had occasion over the years to opine on cases involving allegations against sales representatives who are present in the operating room—a not uncommon practice when medical devices are being used.  While the practice is not uncommon, what is rare are instances where a sales representative participates in the surgery.  Rare, but not non-existent.  Where the line is drawn between presence and participation, and possibility liability or not, is extremely fact sensitive.  And as the court in Owens v. Boston SCI Corp. concluded, in the absence of facts, conclusory allegations of participation are not enough. 2022 U.S. DIST. Lexis 212427, *7 (E.D. Mo. Nov. 23, 2022).

 Plaintiff underwent surgery involving implantation of a pelvic mesh medical device.  Plaintiff alleged complications following surgery and filed a lawsuit against the manufacturer alleging design defects and against one of the manufacturer’s sales representatives for failure to warn both plaintiff’s surgeon and plaintiff.  The manufacturer removed the case to federal court alleging the sales representative, who was not diverse to plaintiff, was fraudulently joined.  Plaintiff moved to remand.Continue Reading Sales Representative’s Presence in Operating Room Not Enough to Beat Fraudulent Joinder

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.Continue Reading No Duty for Sales Representatives in the Operating Room

Plaintiffs love sales representatives.  They love to use them to try to keep cases in state court—naming them as non-diverse defendants.  They love to try to use them to get around preemption—claiming a direct duty from the rep to the plaintiff.  And they certainly love making sales representative statements and conduct a focal point of

Medical device sales representatives are often present in the operating room during surgical procedures, especially with procedures involving orthopedic devices.  With those kinds of devices (and others), the hospital typically contacts the sales representative in advance, and he or she is charged with delivering the device in the specified size and providing any specialized instrumentation

Court Finds Fraudulent Joinder by Relying on a Sales Rep’s Affidavit and Common Sense

Buckles v. Coombs, 2016 U.S. Dist. Ct. LEXIS 180784 (S.D. Fla. Jan. 4 2017), is a decision that illustrates how a defendant’s proper introduction of facts via an affidavit and a court’s introduction of common sense into its decision process can come together to result in the denial of a plaintiff’s motion to remand an action to state court.

In Buckles, the plaintiff alleged that she was injured due to an allegedly defective cutting device used in her knee replacement. In her state-court complaint, she sued not only the diverse manufacturer, Howmedica, but its non-diverse sales rep. The defendants, having seen that move before, claimed fraudulent joinder of the sales rep and removed the action to federal court based on diversity jurisdiction.

Plaintiff moved to remand the action back to state court. Plaintiff argued that the sales rep was, in fact, a proper defendant because he had been negligent in promoting, marketing, testing and warning about the device—and so on. She supported these arguments with nothing more than the allegations in her complaint, which were fairly broad and conclusory. That was her mistake.

The court made clear that the proper standard under which a court should determine whether a non-diverse defendant has been fraudulently joined is like that applied to summary judgment motions, not the standard for motions to dismiss: “A district court’s process for resolving a claim of fraudulent joinder is similar to that used for ruling on a motion for summary judgment.” Id. at * 5 (citing Crowe v. Coleman, 113 F.3d 1536, 1538 (11th Cir. 1997). And the defendants were relying on more than the general allegations in the complaint. They offered facts from the sales rep himself in an affidavit in which he specifically refuted the general allegations of the complaint:

As set forth in [the sales rep’s] affidavit, however: (1) he was present during [plaintiff’s] surgery “only to facilitate bringing the implants to the operating room and for no other purpose” (2) he did not call on [plaintiff’s] surgeon at any time prior to her surgery on August 21, 2012, or anytime thereafter (3) he did not “promote, advertise, represent, recommend or sell” the Cutting Guide used during [plaintiff’s] surgery; (4) he had no involvement in the preoperative imaging for [plaintiff’s] Cutting Guide and had no other involvement in the planning of her surgery; and (5) he has no medical training, but rather, relies on the materials and information provided to him by Howmedica in carrying out his job duties.

Id. at *8.Continue Reading Court Finds Fraudulent Joinder by Relying on a Sales Rep’s Affidavit and Common Sense

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.Continue Reading Sales Reps Denied Summary Judgment in Artificial Hip Case Despite Absence of Legal Duty to the Plaintiff

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.Continue Reading Not So Atypical Sales Rep Behavior

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.)Continue Reading Louisiana Liability For A Sales Representative’s Sizing Error