We have written quite a few posts about litigation over inferior vena cava filters made by various companies.  Most of those posts focused on decisions in cases pending in or remanded after a stint in one of two MDLs.  Broadly speaking, those decisions involved filters intended to remain in place permanently and alleged injuries from failure to prevent embolic events, removal of the device, or a fracture of the device once in place.  Gomez v. ALN Int’l, Inc., No. H-19-3852, 222 WL 6468725 (S.D. Tex. Oct. 10, 2022), is not one of those.  It involves an IVC filter designed to be removable, not in an MDL, and without an apparent compensable injury.  After three years on the docket, two rulings on motions to dismiss, and discovery, the court considered a motion for summary judgment on the remaining claims.  We think the decision is interesting for how it handled some recurring issues and for the absence of discussion of at least one other issue.

The medical facts can be summarized thusly—in the way that someone who uses “thusly” might:  1) plaintiff had a number of medical conditions placing him at a high risk of pulmonary embolism but could not take anticoagulants, so Dr. K implanted him with defendant’s removable IVC filter; 2) this implant was part of a clinical study run by Dr. C; 3) part of the filter was penetrating the wall of his vena cava (the VC in IVC), but was still working and his physicians decided to leave it in place; 4) plaintiff was hospitalized for painful kidney stones, it was determined that he no longer needed protection against pulmonary embolism, and the filter was removed without incident by Dr. A; and 5) plaintiff’s abdominal pain (which appeared to be his only claimed symptom) continued after removal.  Id. at **1-2 & 4-5.  (Yes, pain from kidney stones that was severe enough to require hospitalization would seem to be a pretty obvious source of his abdominal pain.)  Plaintiff’s remaining claims advanced failure to warn and design defect theories in various guises.

First up was the issue of causation for any alleged injuries.  Texas has a lingering reputation as being a plaintiff-friendly jurisdiction.  While that may be true when it comes to trial judges and juries in certain parts of the state, the Texas Products Liability Act and much of the appellate case law applicable to product liability are pretty tight.  For instance, a plaintiff has to prove both “substantial factor” and “but for” causation and that has to come from expert testimony for a prescription medical device.  Id. at **3-4.  For some reason, though, plaintiff attempted to rely on the deposition testimony of two of the treating physicians, Drs. C and A, and no retained experts.  (It looks like Dr. A was designated as a non-retained expert for plaintiff, though it is hard to tell if she went beyond her role as a treater.)  It also appears that plaintiff did not depose the implanter, Dr. K, but we mention that now mostly for foreshadowing.  Neither deposed doctor offered testimony that came close to an expert opinion supporting causation.  This may sound like a low bar, but we appreciate the court not descending to “this is a jury question” when there clearly was nothing in the record to carry plaintiff’s burden.  “The relevant question is whether a reasonable juror could conclude there is a preponderance of evidence that the ALN filter caused the injuries for which Gomez seeks recovery.”  Id. at *5.  One doctor testifying that he thought the penetration of the vena cava was unrelated to the hospitalization and the other testifying that she could not rule out some relationship, however unlikely, between the filter and the abdominal pain did not cut it.  Id. at *4.

Plaintiff also had no evidence that the removal itself caused harm, so he tried to argue that the removal prevented possible future complications the filter might have caused.  The court saw through this, as the possibility of future complications that were avoided was not the same thing as proof of an injury that had happened.  Id. at *5.  Nor was the removal itself an injury caused by some problem with the removable filter.  Its presence was no longer required for embolism prevention, which was the indication to remove the filter as per the original plan.  Id. 

There is no dispute of a material fact from which a jury could conclude by a preponderance of the evidence that the condition of the filter, rather than the absence of that condition, caused the filter to be removed and thereby caused injury in the form of a procedure that Gomez would not have otherwise endured.

Id.  That meant summary judgment on all claims.

Being who we are, we do question why two other issues were not raised.  First, plaintiff had no retained experts.  While the treaters were probably qualified to give causation opinions, it seemed clear from their depositions that they offered no opinions framed in terms of reasonable medical probability, as required by Texas law.  If expert testimony was required, as the court acknowledged and plaintiff conceded, then how could plaintiff ever carry his burden?  Second, while interrelated, we think the concepts of a “compensable injury” and causation are separate.  For instance, an exposure might cause a risk of future injury, but state law may hold that such a risk without present injury is not compensable.  Or a subclinical injury like pleural thickening may not be compensable, in part because of the inconsistency with the principles of accrual of claims for statute of limitations purposes.  Is a medical procedure not required by specific symptoms—regardless of what caused them—itself a compensable injury?  We think not.  A surgery may be part of the damages allegedly related to an injury allegedly caused by the drug/device/exposure, but is not an injury in and of itself.  Gomez did not delve into this either.

It did go ahead and find other reasons for summary judgment, though.  On failure to warn, because Texas follows the learned intermediary doctrine and no testimony from the implanting/prescribing physician was in the record, it was clear that plaintiff could never satisfy the proximate cause requirement.  Id. at *8.  Nonetheless, the court looked at the evidence on (in)adequacy of warnings.  Not surprisingly, with no experts, it was clear that the plaintiff could not carry his burden.  The court rejected the argument that the absence of comparative rate data—somewhat ironically, plaintiff contended that removable filters were riskier than permanent filters—was enough to create a genuine issue.  Because the IFU described the risk of plaintiff’s alleged injury and plaintiff had no expert testimony, the label was held to be adequate as a matter of law.  Id. at *7.  In so holding, the court rejected some cases from the pelvic mesh MDLs that “qualifying language” could create genuine issues on adequacy (when supported by expert opinion).  The court also rejected the argument that the IFU should have referenced an FDA statement on removing a filter once the risk of embolism passed, which is what the treating doctors did anyway.  Going a step further, plaintiff could not cobble together evidence on proximate cause for failure to warn by referring to the testimony of the (non-prescribing) treating physicians, neither of whom indicated they would have changed any behavior.  We would have liked a cleaner statement that proximate cause evidence must come from the prescriber, not a later treater (to whom the device manufacturer owed no duty to warn).  However, we were pleased with the rejection of the facile argument that plaintiff—or, rather, the one who held medical decision making authority at the time—could provide proof of proximate cause based on self-serving statements.  “But it is not enough for the patient to argue that he would have refused treatment based on the evidence in the lawsuit.”  Id. at *8.

The last part of the decision doubled down on the failure of proof as to design defect.  Texas requires that the plaintiff prove that a safer alternative design existed at the time of sale.  Plaintiff could not carry that burden with the testimony of his treating physicians, particularly that one of them generally preferred to implant a device with lower risks compared to one with higher risks.  That has nothing to do with alternative design and plaintiff failed to carry his burden on this issue as well.  Again, without an expert in the relevant field opining on alternative design at all, plaintiff’s claim was clearly doomed.  Just as we might wish that a case without apparent injury and where plaintiff did not bother to retain any experts did not linger for three years, through two motions to dismiss, discovery, and a motion for summary judgment, we can quibble with a few areas where we think the Gomez court did not go far enough.  We cannot quibble with the analyses it did or the result it reached.