We now have written fairly a couple of posts about litigation over inferior vena cava filters made by numerous corporations. Most of these posts centered on choices in circumstances pending in or remanded after a stint in one in every of two MDLs. Broadly talking, these choices concerned filters supposed to stay in place completely and alleged accidents from failure to stop embolic occasions, removing of the gadget, or a fracture of the gadget as soon as in place. Gomez v. ALN Int’l, Inc., No. H-19-3852, 222 WL 6468725 (S.D. Tex. Oct. 10, 2022), is just not a type of. It includes an IVC filter designed to be detachable, not in an MDL, and with out an obvious compensable damage. After three years on the docket, two rulings on motions to dismiss, and discovery, the courtroom thought of a movement for abstract judgment on the remaining claims. We expect the choice is fascinating for the way it dealt with some recurring points and for the absence of debate of a minimum of one different subject.
The medical info could be summarized thusly—in the best way that somebody who makes use of “thusly” may: 1) plaintiff had numerous medical circumstances putting him at a excessive threat of pulmonary embolism however couldn’t take anticoagulants, so Dr. Ok implanted him with defendant’s detachable IVC filter; 2) this implant was a part of a scientific examine run by Dr. C; 3) a part of the filter was penetrating the wall of his vena cava (the VC in IVC), however was nonetheless working and his physicians determined to depart it in place; 4) plaintiff was hospitalized for painful kidney stones, it was decided that he not wanted safety towards pulmonary embolism, and the filter was eliminated with out incident by Dr. A; and 5) plaintiff’s belly ache (which gave the impression to be his solely claimed symptom) continued after removing. Id. at **1-2 & 4-5. (Sure, ache from kidney stones that was extreme sufficient to require hospitalization would appear to be a fairly apparent supply of his belly ache.) Plaintiff’s remaining claims superior failure to warn and design defect theories in numerous guises.
First up was the difficulty of causation for any alleged accidents. Texas has a lingering popularity as being a plaintiff-friendly jurisdiction. Whereas which may be true in relation to trial judges and juries in sure elements of the state, the Texas Merchandise Legal responsibility Act and far of the appellate case legislation relevant to product legal responsibility are fairly tight. As an illustration, a plaintiff has to show each “substantial issue” and “however for” causation and that has to come back from professional testimony for a prescription medical gadget. Id. at **3-4. For some motive, although, plaintiff tried to depend on the deposition testimony of two of the treating physicians, Drs. C and A, and no retained consultants. (It seems like Dr. A was designated as a non-retained professional for plaintiff, although it’s onerous to inform if she went past her function as a treater.) It additionally seems that plaintiff didn’t depose the implanter, Dr. Ok, however we point out that now largely for foreshadowing. Neither deposed physician supplied testimony that got here near an professional opinion supporting causation. This may occasionally sound like a low bar, however we recognize the courtroom not descending to “this can be a jury query” when there clearly was nothing within the report to hold plaintiff’s burden. “The related query is whether or not an inexpensive juror might conclude there’s a preponderance of proof that the ALN filter triggered the accidents for which Gomez seeks restoration.” Id. at *5. One physician testifying that he thought the penetration of the vena cava was unrelated to the hospitalization and the opposite testifying that she couldn’t rule out some relationship, nonetheless unlikely, between the filter and the belly ache didn’t reduce it. Id. at *4.
Plaintiff additionally had no proof that the removing itself triggered hurt, so he tried to argue that the removing prevented attainable future issues the filter might need triggered. The courtroom noticed by way of this, as the opportunity of future issues that had been averted was not the identical factor as proof of an damage that had occurred. Id. at *5. Nor was the removing itself an damage attributable to some drawback with the detachable filter. Its presence was not required for embolism prevention, which was the indication to take away the filter as per the unique plan. Id.
There is no such thing as a dispute of a fabric truth from which a jury might conclude by a preponderance of the proof that the situation of the filter, relatively than the absence of that situation, triggered the filter to be eliminated and thereby triggered damage within the type of a process that Gomez wouldn’t have in any other case endured.
Id. That meant abstract judgment on all claims.
Being who we’re, we do query why two different points weren’t raised. First, plaintiff had no retained consultants. Whereas the treaters had been most likely certified to provide causation opinions, it appeared clear from their depositions that they supplied no opinions framed when it comes to cheap medical chance, as required by Texas legislation. If professional testimony was required, because the courtroom acknowledged and plaintiff conceded, then how might plaintiff ever carry his burden? Second, whereas interrelated, we expect the ideas of a “compensable damage” and causation are separate. As an illustration, an publicity may trigger a threat of future damage, however state legislation might maintain that such a threat with out current damage is just not compensable. Or a subclinical damage like pleural thickening might not be compensable, partially due to the inconsistency with the ideas of accrual of claims for statute of limitations functions. Is a medical process not required by particular signs—no matter what triggered them—itself a compensable damage? We expect not. A surgical procedure could also be a part of the damages allegedly associated to an damage allegedly attributable to the drug/gadget/publicity, however is just not an damage in and of itself. Gomez didn’t delve into this both.
It did go forward and discover different causes for abstract judgment, although. On failure to warn, as a result of Texas follows the discovered middleman doctrine and no testimony from the implanting/prescribing doctor was within the report, it was clear that plaintiff might by no means fulfill the proximate trigger requirement. Id. at *8. Nonetheless, the courtroom regarded on the proof on (in)adequacy of warnings. Not surprisingly, with no consultants, it was clear that the plaintiff couldn’t carry his burden. The courtroom rejected the argument that the absence of comparative fee knowledge—considerably paradoxically, plaintiff contended that detachable filters had been riskier than everlasting filters—was sufficient to create a real subject. As a result of the IFU described the chance of plaintiff’s alleged damage and plaintiff had no professional testimony, the label was held to be satisfactory as a matter of legislation. Id. at *7. In so holding, the courtroom rejected some circumstances from the pelvic mesh MDLs that “qualifying language” might create real points on adequacy (when supported by professional opinion). The courtroom additionally rejected the argument that the IFU ought to have referenced an FDA assertion on eradicating a filter as soon as the chance of embolism handed, which is what the treating docs did anyway. Going a step additional, plaintiff couldn’t cobble collectively proof on proximate trigger for failure to warn by referring to the testimony of the (non-prescribing) treating physicians, neither of whom indicated they might have modified any habits. We might have appreciated a cleaner assertion that proximate trigger proof should come from the prescriber, not a later treater (to whom the gadget producer owed no responsibility to warn). Nonetheless, we had been happy with the rejection of the facile argument that plaintiff—or, relatively, the one who held medical choice making authority on the time—might present proof of proximate trigger primarily based on self-serving statements. “However it isn’t sufficient for the affected person to argue that he would have refused remedy primarily based on the proof within the lawsuit.” Id. at *8.
The final a part of the choice doubled down on the failure of proof as to design defect. Texas requires that the plaintiff show {that a} safer different design existed on the time of sale. Plaintiff couldn’t carry that burden with the testimony of his treating physicians, notably that one in every of them usually most popular to implant a tool with decrease dangers in comparison with one with increased dangers. That has nothing to do with different design and plaintiff failed to hold his burden on this subject as nicely. Once more, with out an professional within the related subject opining on different design in any respect, plaintiff’s declare was clearly doomed. Simply as we would want {that a} case with out obvious damage and the place plaintiff didn’t trouble to retain any consultants didn’t linger for 3 years, by way of two motions to dismiss, discovery, and a movement for abstract judgment, we are able to quibble with a couple of areas the place we expect the Gomez courtroom didn’t go far sufficient. We can not quibble with the analyses it did or the consequence it reached.
