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9th Circuit Reverses, Remands Shoulder Pain Pump Defense Verdict

SAN FRANCISCO — (Mealey’s) A panel of the Ninth Circuit U.S. Court of Appeals on Jan. 23 reversed a defense verdict and judgment in a shoulder pain pump case and remanded after finding that the plaintiffs’ negligence per se claims were not preempted by federal law, as the trial court held (Christina McClellan v. I-Flow Corporation, et al., Nos. 11-35109 and 11-35134, 9th Cir.; 2015 U.S. App. LEXIS 1062). 

(Opinion available.  Document #28-150205-001Z.

Christina McClellan underwent shoulder surgery after which local anesthetic was continuously delivered through a catheter into the surgical site using a PainBuster continuous infusion pump (shoulder pain pump) made by I-Flow Corp. and distributed by DJO LLC and DJO Inc.  McClellan alleges that her prolonged exposure to local anesthetic caused chondrolysis, or the loss of articular cartilage in her shoulder, causing the bones to fuse and making her shoulder nearly immobile. 

McClellan sued I-Flow and the DJO defendants in the U.S. District Court for the District of Oregon.  Her case went to trial along with two others in 2010.  A jury returned three separate defense verdicts. 

The jury found that the plaintiffs did not prove by a preponderance of evidence that the pump was defective due to inadequate warnings and did not prove that the defendants negligently failed to warn the plaintiffs of the alleged defect. 

Only McClellan appealed.  She argued that the District Court erred: 

  • By refusing to give jury instructions regarding negligence per se and federal standards because the court said they were preempted by the federal Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act.
  • By barring expert testimony as to safety standards.
  • By barring expert testimony associating the pain pump and chondrolysis.
  • By excluding documentary evidence as hearsay. 

Buckman Inapplicable 

The Ninth Circuit panel said the District Court erred in concluding that McClellan’s negligence claim is preempted by the U.S. Supreme Court’s ruling in Buckman Co. v. Plaintiffs’ Legal Comm.(531 U.S. 341 [2001]

[enhanced opinion available to subscribers]).  “Unlike the plaintiff in Buckman, McClellan has not alleged failure-to-warn theories that are clearly concerned with the labeling and regulation of medical devices,” the panel held. 

With no Buckman preemption, the panel said the federal courts’ presumption against preemption applied to McClellan’s case. 

The panel also noted that Buckman concerned a medical device that was approved by the Food and Drug Administration through the premarket approval process. 

“Further, Buckman recognized that Lohr [Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996)] [enhanced opinion available to subscribers] while dealing explicitly with only express preemption, left the door open to state-law claims ‘parallel’ to federal requirements,” the panel said. 

MDA Not Controlling 

“In this case, we perceive nothing about McClellan’s requested instructions that conflicts with the congressional intent behind the MDA,” the panel said.  “McClellan’s claims were not fraud-on-the-FDA claims.” 

“The failure-to-warn claims McClellan alleged did not arise solely by virtue of the MDA,” the panel continued.  “Further, there is no suggestion that Congress intended to displace traditional tort law by making all policing of medical labels and warnings the exclusive province of the FDA.”

 “More generally, McClellan’s requested instructions would not usurp the exclusive federal enforcement power over the MDA,” the panel said.  “The allegations at issue occur outside the context of the regulatory process, unlike in Buckman.  Where the plaintiff in Buckman alleged that the defendant made fraudulent representations during the market approval process, to the FDA, 531 U.S. at 346–47, McClellan’s requested instructions here have little to do with direct regulatory interaction with the FDA.” 

No Obstacle

 “The appellees would have us conclude that any use of federal law to establish a standard of care is an attempt to enforce the underlying federal provisions, but we do not accept that proposition,” the panel continued.  “Appellees’ arguments fail to convince us that allowing a jury to look to the MDA to establish certain standards of care will create an obstacle to accomplishing the goals Congress envisioned in passing the MDA,” the panel wrote.  “I-Flow’s and DJO’s attempts to characterize McClellan’s claims as torts in form only are poorly explained and unpersuasive. 

“Having concluded that no preemption applies, we disagree with I-Flow and DJO that refusal to give the requested instructions was harmless error,” the panel said.  “The instruction actually given by the district court — allowing the jury to consider federal law discussed during trial — is not equivalent to instructions specifically including reference to federal law.” 

“Moreover, the instruction given was far weaker than the requested negligence per se instruction,” the panel said.  “We cannot say the error was more probably than not harmless.” 

I-Flow and the DJO defendants argued that the error was harmless because the jury implicitly made two findings that would make the instructions irrelevant.  “Those arguments lack merit as they speculate regarding how the jury reached its verdict,” the panel said.

 Vacated, Remanded

“In sum, we vacate the judgment and remand for a new trial due to the instructional error,” the panel held.  “We leave it to the district court to determine in the first instance whether the requested instructions are otherwise appropriate under Oregon law.” 

The panel said that because the preemption error warrants a new trial, it did not need to address McClellan’s other evidential arguments. 

I-Flow argued that the Ninth Circuit lacked jurisdiction because there is no final, appealable judgment and because the trial court did not expressly find that there is no just reason for delay.  It argued that because the District Court severed claims against the DJO defendants, McClellan’s claims are unresolved and the judgment is not appealable. 

The panel agreed with McClellan that the judgment identifies I-Flow and the DJO defendants as the prevailing parties.  

Even if that did not settle the issue, “given the alleged derivative liability of DJO, Inc., there can be no serious argument that judgment in favor of DJO, LLC and dismissal of the action could preserve DJO, Inc.’s alleged liability.” 

Costs Denial Moot 

I-Flo cross-appealed the District Court’s denial of its costs.  The trial court said awarding costs would have a chilling effect on other shoulder pain pump cases that were pending at the time.  The Ninth Circuit panel said its decision on a new trial makes the costs issue moot. 

Circuit Judge Alfred T. Goodwin wrote the opinion.  The other panel members were Circuit Judges Harry Pregerson and Morgan Christen. 

McClellan is represented by R. Daniel Lindahl of the Lindahl Law Firm, Leslie W. O’Leary of William O’Leary and Jeffrey B. Wihtol of the Law Offices of Jeffrey B. Wihtol, all in Portland, Ore. 

I-Flow is represented by Andrew G. Klevorn, James W. Joseph and Elmer Stahl of Klevorn & Solberg in Chicago and Erin J. Neiman and George S. Pitcher of Kastner & Gibbs in Portland.  The DJO defendants are represented by Richard H. Nakamura Jr. of Morris, Polich & Purdy in Los Angeles, Patrick Lysaught of Baker, Sterchi, Cowden & Rice in Kansas City, Mo., and Roger G. Perkins of Morris Polich in San Diego. 

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