Thursday, December 31, 2009

Them's The Breaks

A recent case, Koger v. Synthes North America, Inc., 2009 WL 5110780 (D. Conn. 2009), underscores what should be a simple fact of life in product liability litigation involving orthopedic implants in particular, and implanted medical devices in general – plaintiffs shouldn’t expect to get anywhere with nothing more than a broken device.

That’s because the environment inside the human body is really hostile. For an orthopedic implant, the repetitive stress of everyday movement will inevitably cause anything metal to give way to metal fatigue over time – particularly if the implant is weight bearing, and especially if there’s a medical complication such as non-union of a fracture. For any electronic implant, being inside the body is like constantly being submerged in salt water. If you’ve ever dunked a camera or a non-water-resistant watch in the ocean, then you know how well that’s likely to turn out. Trying to maintain device integrity against not only salt water, but the combined assault of bodily immunity and other defenses against foreign objects is a constant, uphill battle against the best that billions of years of evolution have been able to come up with.

To put this all in legal terms, we think that the various stresses of bodily environment should always be – as a matter of law – a “reasonable secondary cause” of device failure in any implant case that would preclude using any form of res ipsa loquitur or "malfunction" theory.

That’s pretty much what Koger did. The case involved orthopedic bone screws used for internal fixation of a fracture that the plaintiff received in a motor vehicle accident. Almost two years after the screws were inserted, an x-ray showed that they had broken. Other medical tests indicated a “non-union” – that is, that the fracture had failed to heal. 2009 WL 5110780, at *1. That’s not good. People can disagree over whether non-union is beneficial in the workplace, but there’s no disagreement that non-union’s a bad thing for a bone fracture.

Plaintiff sued the manufacturer of the broken screws. For whatever reason – not wanting to invest money in a lousy case, inability to find an expert willing to offer a defect opinion in a two-year non-union case, sheer lassitude – the plaintiff in Koger tried to get by summary judgment without any expert at all. The plaintiff’s argument was simple: the device broke, therefore a jury could find it defective. That’s res ipsa loquitur.

And it's a bunch of hooey.

The court, quite correctly, concluded that the plaintiff’s theory was simply wrong. Res ipsa loquitur isn’t available in a “complex” situation, such as the performance of an implanted medical device. Koger, 2009 WL 5110780, at *3. The effects of the non-union was a possible alternative cause that could not be eliminated:

[P]aintiff’s case requires complex medical and technical expert testimony to determine whether the breakage occurred as a result of a defect or a nonunion. According to the record, it appears more probable than not that a nonunion occurred. Thus, absent expert testimony, plaintiff cannot adduce sufficient proof of her claim to survive summary judgment.
Id. That’s it, short and sweet.

And not only short and sweet, but in accordance with the great weight of well-reasoned precedent. For instance The Wyoming Supreme Court reached essentially the same decision in Rohde v. Smiths Medical, 165 P.3d 433, 438 (Wyo. 2007) (our prior post here), where the plaintiff claimed a defect could be “inferred because a medical device fractured while implanted in his body.” The court held that it was plaintiff’s burden to eliminate all reasonable secondary causes for a device failure, and that if the case was so bad that the plaintiff couldn’t find an expert – too bad. Allowing mere device failure to create a jury submissible case would “unduly expand” product liability:

[Plaintiff] suggests that products liability plaintiffs should not be required to present evidence that secondary causes did not cause the product’s malfunction because, in any given case, there are innumerable possible causes and it is unduly burdensome for plaintiffs to disprove all of them. He claims it should be enough to establish that the device malfunctioned. . . . [Plaintiff] overstates the burden imposed on plaintiffs by the inference of defect rule. In this case, [defendant] presented evidence of a reasonable secondary cause. . .[thus plaintiff ] was not required to disprove numerous or vague secondary causes. . . .

We recognize it may have been difficult for [plaintiff] to meet the challenge of showing a specific defect. . . . Nevertheless, if the [device] was defectively designed making it prone to fracture then, presumably, he could have located an expert to analyze the design and provide his opinion. . . . [Plaintiff’s] failure to meet his burden to establish a specific defect or an inference of defect. . .does not justify expanding the inference of defect rule to allow a plaintiff to proceed to trial simply because the product failed. Such a holding would unduly expand product liability jurisprudence without justification.
165 P.3d at 440. An appellate court in Tennessee reached the same conclusion over a decade earlier. Fulton v. Pfizer Hospital Products Group, Inc., 872 S.W.2d 908, 911-12 (Tenn. App. 1993) (“the product in dispute is a technically complex medical device”; although it broke, “res ipsa loquitur is not a substitute for proof of defect”); see King v. Danek Medical, Inc., 37 S.W.3d 429, 435 (Tenn. App. 2000) ("the failure or malfunction of the device, without more, will not make the defendant liable"). See Guillory v. Employers Mutual Liability Insurance Co., 411 So.2d 504, 506 (La. App. 1982) (res ipsa loquitur inapplicable, given other possible causes for broken device, including misuse and use of wrong sized product).

Similarly, in Stilwell v. Smith & Nephew, Inc., 482 F.3d 1187, 1193 (9th Cir. 2007), the plaintiff “ask[ed the court] to blindly accept the [product’s] failure before her fracture healed as prima facie evidence that they were defective.” The court (as might be expected from its use of the adverb “blindly”) refused. Even with an expert, the plaintiff had nothing to establish any definite “duration of [the device’s] use” as a weight-bearing implant. Id. at 1194.

[Plaintiff] failed to explain the defect that formed the basis for her claim. She seemed to suggest that, at a minimum, the second [implant] should have performed for longer than it did, but she did not rely on any record evidence to support that contention. She has repeatedly reminded us that her treating physicians testified that [implant] failure is rare, yet rarity does not indicate infallibility. [Plaintiff’s] vague arguments regarding the expected life of the [implant] thus do not refute [defendant’s] evidence that the [implant] performed as intended in this case.
Id. at 1195-96 (also citing patient smoking as a secondary cause). See White v. Howmedica, Inc., 490 F.3d 1014, 1016 (8th Cir. 2007) (fragmentation of device after six years of implantation “not something that is so generally recognizable as to qualify under the so-called common knowledge exception”) (applying Nebraska law); Rolon-Alvarado v. Municipality of San Juan, 1 F.3d 74, 79-80 (1st Cir. 1993) (res ipsa loquitur not applicable broken medical device situation) (applying Puerto Rico law).

One of our favorite cases – Riegel itself – also rejected a claim that the fact that the now-famous catheter burst was sufficient circumstantial evidence of a defect – given that the physician both overinflated the device and put it to a contraindicated use:

We agree with the district court that [plaintiffs] did not come forward with competent evidence excluding [defendant’s] proffered causes as the origin of the [failure. It is undisputed that [the prescriber], in performing [surgery], inflated the balloon catheter. . .beyond the maximum rated burst pressure explicitly specified on the device label. . . . Although it may well be that inflating the balloon catheter up to ten atmospheres was the best decision under the circumstances, this does not indicate that the inflation was not the cause of the catheter’s rupture. It is similarly undisputed that [plaintiff] had heavily calcified arteries, and that the label for the [device] contraindicated its use in such an instance . . . . [T]his does not mean that in this particular instance, we can exclude the calcified nature of [plaintiff’s] artery as a cause for the catheter’s rupture.
Riegel v. Medtronic, Inc., 451 F.3d 104, 125-26 (2d Cir. 2006), aff’d on other grounds, 552 U.S. 312 (2008) (you know what).

Likewise, a break did not equate to a defect in Reed v. Biomet Orthopedics Inc., 318 Fed. Appx. 305, 307 (5th Cir. 2009) (applying Louisiana law), in the absence of any expert testimony “that would suggest a material deviation from [defendant’s] production standards or identical products.” The same argument – “the fact that the [implant] failed is significant evidence of a defect” – was rejected in Yanovich v. Zimmer Austin, Inc., 255 Fed. Appx. 957, 966 (6th Cir. 2007) (applying Ohio law). “Circumstantial evidence” (another way of saying res ipsa loquitur) was unavailing, because an implantable medical device isn’t the same as a tire. Given that the plaintiff couldn’t say that other devices would have failed under the same circumstances (plaintiff’s “biometrics” and implant technique), he “failed to eliminate other potential causes for the. . .breakage.” Id.

Harrison v. Howmedica Osteonics Corp., 2008 WL 906585 (D. Ariz. March 27, 2008), produced a similar result even though that plaintiff had an expert. The expert didn’t give any real opinions – he didn’t opine exactly how much longer a “nondefective” device should have remained intact, only that it would have been longer than what happened in this case. Id. at 11. The device was defective because of “the fact that it broke.” Id. at *12. Essentially this wasn’t any opinion at all, just res ipsa parroted by an expert, and it was thrown out on Daubert grounds. Id. at *15-18. The court then granted summary judgment, observing that there was no evidence either of how long the device was intended to last, or how long bony union would have taken. Because “[i]nferences cannot be drawn out of thin air,” summary judgment was appropriate.  Id. at *26.

And we've got lots more (that's why anybody who's still reading this is still reading it).

A raft of other district court opinions agree that a medical device is not defective just because it broke or otherwise malfunctioned. Hare v. Hoveround Corp., 2009 WL 3086404, at *7 (N.D.N.Y. Sept. 23, 2009) (“the fact that a product does not operate properly does not by itself mean that the product was defectively designed”) (wheelchair); Harrington v. Biomet, Inc., 2008 WL 2329132, at *5 (W.D. Okla. June 3, 2008) (“circumstantial evidence [eleven dislocations] does not support an inference that a defect in the. . .[device] was probable”); Mead v. Synthes Spine Co., 2007 WL 1530114, at *4 (E.D. Mo. May 22, 2007) (“plaintiff has not presented sufficient circumstantial evidence”; “it is well-known that the devices will fail if fusion does not occur”); Hall v. Johnson & Johnson, 2006 WL 1096940, at *3-4 (D.N.J. April 25, 2006) (“premature failure" of device did not excuse need for expert testimony on defect; “[w]ithout expert testimony, the average lay juror has no grounds to know if an implant should last two, five, or twenty years”); Evans v. Mentor Corp., 2005 WL 1667661, at *2-3 (E.D. Va. June 28, 2005) (“circumstantial evidence that a product defect may have caused the [failure] is speculative at best and cannot establish that plaintiff's injuries were probably caused by a product defect”); Enlow v. St. Jude Medical, Inc., 327 F. Supp.2d 738, 743 (W.D. Ky. 2003) (“res ipsa loquitur analysis is ill-suited to this and most product cases involving the use of medical devices”); Webster v. Pacesetter, Inc., 259 F. Supp.2d 27, 32 (D.D.C. 2003) (“one cannot presuppose the existence of a defect solely on the basis that unintended or undesirable results have occurred”); Muller v. Synthes Corp., 2002 WL 460827, at *8 (N.D. Ill. March 26, 2002) (“[t]he mere fact plaintiff’s [devices] both cracked does not lead to an obvious conclusion of defective design”); Prohaska v. Sofamor, S.N.C., 138 F.Supp.2d 422, 443 (W.D.N.Y. 2001) (broken device case; “a design defect claim cannot be established simply on the basis of a product's inherent risks”); Minisan v. Danek Medical, Inc., 79 F. Supp.2d 970, 977 (N.D. Ind. 1999) (“[i]t is a known fact in the medical community that [a device] may break due to a number of factors unrelated to any defect”; “if this Court assumes as fact that the fracture of the [device] did directly cause continuing pain and discomfort that necessitated further surgery, this does not mean that ipso facto the device was defective”); Samarah v. Danek Medical, Inc., 70 F. Supp.2d 1196, 1203 (D. Kan. 1999) (“plaintiff essentially requests the court to infer the existence of a defect in defendants’ product solely from the fact that plaintiff sustained an injury. . . [S]uch proof is inadequate to establish a viable products liability claim”); Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 827 (N.D. Ind. 1999) (that three surgical screws broke “does not mean that ipso facto the device was defective”); Sita v. Danek Medical, Inc., 43 F. Supp.2d 245, 257 (E.D.N.Y. 1999) (“the fact that a medical device broke is not proof of a defect”); Savage v. Danek Medical, Inc., 31 F. Supp.2d 980, 983 (M.D. Fla. 1999) (the “conclusion reached by Plaintiffs, however – that because the [device] is loose. . .[it] is a fortiori defective – is a faulty one”); Ontiveors v. Danek Medical Group, Inc., 1999 WL 1129651, at *4 (D. Utah Aug. 3, 1999) (“fact that [the device] broke, in the absence of other evidence, is not sufficient to establish a defect”); Carter v. Danek Medical, Inc., 1999 WL 33537317, at *8 (W.D. Tenn. June 3, 1999); (“a device failure or malfunction will not, without more, render a manufacturer liable”) (there are over a dozen more identical cases for this point in Tennessee); Clark v. Danek Medical, Inc., 1999 WL 613316, at *3 (W.D. Ky. March 29, 1999) (“[s]imply because non-union occurs in this case does not tend to suggest that the device is defective”); Mozes v. Medtronic, Inc., 14 F. Supp.2d 1124, 1129 (D. Minn. 1998) (“res ipsa loquitur is clearly inapplicable” where one or more causes for which defendant is not responsible” is responsible for device failure); Minda v. Biomet, Inc., 1998 WL 817690, at *3-4 (E.D.N.Y. Feb. 5, 1998) (rejecting argument that “the device had to be defective because it failed”; res ipsa loquitur inapplicable where device could have failed due to plaintiff’s weight); Moeller v. Danek Medical, Inc., 1997 WL 1039333, at *3-4 (W.D. Pa. Dec. 1, 1997) (“plaintiff has not eliminated the realistic possibility that the [device] broke while he attempted to lift the bench in contravention of his doctor’s instructions”); Cather v. Catheter Technology Corp., 753 F. Supp. 634, 638-39 (S.D. Miss. 1991) (“mere conclusory allegation that, because the catheter broke, there must have been some defect in its design or in the materials with which it was produced” insufficient to avoid summary judgment).

There are also some cases where preemption is available as a defense, and plaintiffs have tried to stretch an already invalid inference even further – arguing that because a device failed, it must have been manufactured, or designed, or somethinged in violation of the FDCA. This unwieldy pile of inferences upon inferences has uniformly been rejected. Funk v. Stryker Corp., ___ F. Supp.2d ___, 2009 WL 4281389, at *8-9 (S.D. Tex. Dec. 1, 2009) (“one may not infer a defect in the product simply because a patient encountered negative side effects in using it”) (our prior post here); Williams v. Cyberonics, Inc., ___ F. Supp.2d ___, 2009 WL 2914414, at *5 (E.D. Pa. Sept. 10, 2009) (argument “that the medical device failed to function according to its design because it simply stopped working” was “absolutely no reason to believe that [the device] failed to meet all of the FDA’s requirements”); Clark v. Medtronic, Inc., 572 F. Supp.2d 1090, 1094 (D. Minn. 2008) (medical devices “can fail for a variety of reasons, including medical complications, body rejection phenomena, allergic reaction, and surgical techniques, all of which occur without someone acting in a negligent manner”); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 438 (E.D. Pa. 2004) (claim that “the [devices] should not malfunction as it did unless [they] were defective” rejected; plaintiff “cannot simply point to the malfunction itself to prove that the [devices] were not manufactured in accordance with the FDA/PMA specifications”); Enlow, 327 F. Supp.2d at 743 (finding an “unwarranted leap of faith from the malfunction of the valve. . .to the conclusion that [defendant] failed to adhere to FDA requirements”).

Finally, no discussion of broken device cases would be complete without mention of Adams v. Synthes Spine Co., 298 F.3d 1114 (9th Cir. 2002) (applying Washington law). In Adams the plaintiff creatively tried to repackage the device-was-defective-because-it-broke claim as a warning defect. Creative, yes; successful no. There was a risk of breakage, but most surgeons elected to leave the plate in because that risk was less than the inherent risks of explantation surgery. Thus a warning of the obvious – that the implant could break – was not defective just because doctors didn’t follow it:

That the surgeons usually did not remove the device does not show that they didn’t understand the warning, just that they generally didn't agree with the recommendation. [Plaintiff’s surgeon] explained why-the risk of the surgery to remove the plate exceeded the risk of leaving it in, because in most cases it wouldn't break. A second surgery could safely be left for the rare cases when it broke. Even the rarest events happen sometimes, to someone. It is extremely unfortunate that [plaintiff] was that someone . . . . That doesn't show anything inadequate about the warning, just that breakage was rare. Whenever a rare event occurs, the occurrence is surprising. People often choose to bear the risk of a rare event in order to avoid a certain and unattractive alternative, which in this case would be a second surgery, unnecessary in most cases.
Id. at 1118. That a risk of breakage happens in a particular case, in and of itself, doesn’t make a warning defective any more than the break itself is sufficient evidence of a design or manufacturing defect.

It may be a tough break for plaintiffs (particularly those with cases that are so lousy that they won't spring for/can't get an expert) – but the law has to require more than device failure to make out a prima facie case. Otherwise, as the court recognized on Rohde, we’ve turned product liability into a form of absolute insurance against all risks.

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