[Drug and Device Law] Medical Device Decision Plays PA's Greatest Hits
When we read the opinion in Kline v. Zimmer Holdings, 2015 WL 4077495 (W.D. Pa. July 6, 2015), it felt like driving back from the mountains (or the Jersey Shore) after a holiday weekend, listening to classic rock radio playing last half-hour or so of some “countdown” of the top 500 (1000, whatever) songs of all time. Kline granted summary judgment to the defendant, ending a lot of bobbing and weaving by the plaintiff, who claimed injury from a hip implant that broke. It’s a two-part opinion, with the judge adopting and supplementing an earlier magistrate’s recommendation.
The design claims were dismissed because plaintiff ultimately couldn’t coax the necessary design defect opinions out of his experts – and non-experts. The most interesting witness was the plaintiff’s treater, who was also alleged to have “involvement with the design team of the device at issue.” Kline, 2015 WL 4077495, at *2. However, that “unique” status fell rather hard by the wayside because plaintiff played fast and loose with the rules, sandbagging the defendant by failing to file any expert report. Id. at *3. Yes, he was a treater, so that’s allowed – but only to the extent that the physician “give[s] opinion testimony based upon the physician's examination, diagnosis, and treatment of a patient.” Id. The opinions that the treater offered about his interactions with the defendant’s design team could not be considered:
[The witness] was not identified as an expert witness to testify about the design of the device at issue. While [he] may have been a consultant to [defendant] about the device at issue, there is no record that he is an expert in the design of or warning about the product or that his consulting services enabled him to give an opinion as a design or warnings expert. . . . There was no identification of his qualifications to be a design or warnings expert, he was not designated as such, and he did not submit an expert report about design defects or warnings.
Id. at *3. Oops. That’s what happens when a plaintiff tries to be too cute.
That wasn’t the only questionable expert. Another expert, this one designated as such, “only briefly discussed in her expert report and then retreated from at her deposition.” Id. at *4. Instead, when under oath, this expert stated “that this is mostly a warnings defect case” and denied having a design defect opinion. Id. See also Id. at *11 (magistrate’s opinion describing expert’s testimony at greater length). Plaintiff tried to rehabilitate the expert’s design-related testimony with a post-deposition affidavit. That failed because, in light of the sworn deposition testimony the affidavit was a “sham.”
It is appropriate to disregard [the expert’s] affidavit pursuant to the sham affidavit doctrine. A sham affidavit is a contradictory affidavit that indicates only that the affiant cannot maintain a consistent story or is willing to offer a statement solely for the purpose of defeating summary judgment.” If it is clear that an affidavit is offered solely for the purpose of defeating summary judgment, it is proper for the trial judge to conclude that no reasonable jury could accord that affidavit evidentiary weight and that summary judgment is appropriate.
Id. at *4 (citations and quotation marks omitted).
No other expert purported to give design-related opinions. Thus, summary judgment was proper against the design defect claim. Plaintiff lost one “expert” to the disclosure rules, and the second to poor deposition testimony that could not be rescued by a “sham” affidavit. Even so, plaintiff had a third expert, but that one “was not asked to review or comment on the design of the device.” Id. at *5. Called strike three. “Without the opinion of an expert, plaintiffs cannot prevail.” Id. Yer out!
And design defect isn’t even the most fun part. The warning claim? Plaintiff didn’t even bother objecting to summary judgment, so the magistrate's opinion was adopted.
The facts already discussed indicate where the warning defect claim was going. Since, the plaintiff’s prescribing surgeon was also a consultant for the defendant regarding the device, one can expect that this particular prescriber will have even more prior knowledge of this device’s risks than the average surgeon. Given these facts, it’s no surprise that plaintiff could not establish a warning claim under the learned intermediary rule. Here’s where the hits keep coming.
Plaintiff’s surgeon testified that he “has never read a package insert for any device he has implanted,” and “did not see, let alone read, the package insert that accompanied [plaintiff’s] device.” Id. at *13 (this discussion is from that part of the magistrate’s opinion adopted by the district court without objection by plaintiff). “It is standard practice for nurses in the operating room to open device packages without surgeons ever seeing the warnings.” Id. That didn’t matter because this surgeon “was also independently aware of the risks of total hip arthroplasty, including that an implant can break, from his practice and reading literature.” Id.
So what are the greatest hits?
First, plaintiff’s warning defect expert was unqualified. “[She] is not an orthopedic surgeon” and was thus “not qualified” to opine on how a warning defect could have caused injury. Id. at *15; accord id. at *26. That’s a hit because inadequate warning claims require expert testimony in Pennsylvania (something discussed more thoroughly here), and warnings directed to orthopods should be judged by orthopods. Free Bird.
Second, “plaintiffs must further establish proximate causation by showing that had defendant issue a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.” Id. at *24 (citations and quotation marks omitted). Gimme Shelter.
Third, “[p]ursuant to the learned intermediary doctrine, a manufacturer will be held liable only when it fails to adequately warn the intended user, which in the case of prescription drugs or medical devices, is the physician and not the patient.” Id. (citations omitted). Consistently with Pennsylvania law, but without specifically so stating, Kline thus applies the learned intermediary rule to medical devices. Stairway to Heaven.
Fourth, since the prescribing surgeon “testified that he did not read the package insert,” plaintiff loses. Id. at *25. Since it went unread, “even if the warning in this case were insufficient, it would not have made a difference.” Id. Baba O’Riley.
Fifth, plaintiffs can’t invent alternative channels for providing warnings – here the treater’s “work[] as a paid consultant for [defendant].” Id. “Plaintiffs point to no support for the contention that a defective warnings case can be based on information provided to a plaintiff's treating physician other than via the official warning on the package.” Id. Hey Jude.
Sixth, alleged inadequacy in discussion of patient selection criteria wasn’t a warning defect. There’s no duty to tell physicians how to exercise their “medical judgment.” “Pennsylvania law does not require such specificity in a warning, particularly where, as here, the question is one of patient selection for a particular medical device.” Id. at *26. Layla.
Seventh, plaintiffs can’t get around warning causation with a “heeding presumption.” Pennsylvania doesn’t recognize any such thing in prescription medical product cases:
Plaintiffs appear to be relying on a “heeding presumption” argument. . . . This argument fails, however, because the “heeding presumption” has been applied only to strict liability causes of action, which are no longer part of this case. Pennsylvania has never applied the heeding presumption to a negligence case.
By the end of the composite opinion, it was evident that both the magistrate and the district judge were frustrated with this plaintiff’s delaying tactics and oft-rejected arguments. Resolving that they Won’t Get Fooled Again, they entered summary judgment.
Note: song titles are those typically appearing in the final 10-15 of greatest hits lists, without bearing any particular relation to the legal propositions.
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Posted By Bexis to Drug and Device Law at 8/03/2015 01:34:00 PM --
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