Photo of Bexis

Every now and then even Bexis comes across a decision involving legal propositions he’d never heard of before. Such was the human tissue case Kennedy-McInnis v. Biomedical Tissue Services, Ltd., No. 13-CV-6545, slip op. (W.D.N.Y. April 12, 2016). Kennedy-McInnis introduced us to the common-law “right of sepulcher” – and more importantly to the defenses, including broad “good faith “ immunity, that limit this little known “right.”

First, why should anybody interested in drug/device product liability care? The answer is that a lot of products, particularly implantable medical devices, are used in conjunction with so-called “allograft bone.” As everyone knows, many other types of tissue are transplanted as well. Other medical devices, and some drugs, are typically used in conjunction with – or to support transplants of – various types of human tissue that doctors and hospitals typically obtain from tissue banks. Human tissue used in this manner can be extremely medically beneficial – and anything so beneficial is potentially worth a great deal.

Anything that’s worth a great deal creates a market for itself, and in our market-based society, there is always temptation for somebody in the chain of distribution to cut corners. When that happens, we’ve seen product manufacturers end up getting sued. Thus, we have blogged several times about litigation involving human tissue incorporated into certain medical devices, and allegations that fly-by-night (and convicted) intermediaries hadn’t bothered testing the tissue in question for communicable diseases. Ultimately, the litigation fizzled because, as bad as the intermediaries’ conduct had been, plaintiffs couldn’t prove that it actually caused anybody to get sick.

Note – of course – that the plaintiffs didn’t sue (at least exclusively) those bad actors. There’s no money in that. Rather they sued the deep-pocketed manufacturers who facilitate public health by turning tissue into usable products. Our reaction to that is that device manufacturers shouldn’t be liable for the unknown criminal acts of third parties. That gets us back to Kennedy-McInnis, which is all about limits to such duties.

No product manufacturers were sued in Kennedy-McInnis – rather, the targets this time were the tissue banks. Slip op. at 2. Product manufacturers who, in turn, obtain material from tissue banks are even further removed, so everything decided in Kennedy-McInnis should a fortiori preclude liability for our more remotely situated clients. Plaintiffs, this time, were the relatives of deceased persons, whose tissue was allegedly (and probably) illegally harvested by unscrupulous funeral home personnel bribed by a tissue collection agency. Id.

The issue of interest in Kennedy-McInnis is whether tissue banks – and by extension everybody else further along the chain – be liable for allegedly criminal acts of their suppliers that the tissue banks had no idea were occurring.

Plaintiffs tried a variety of theories, but each time the court answered that question, “No.”

Plaintiffs first claimed that they could sue for alleged violation of federal record-keeping requirements pertaining to “body-parts donations.” Slip op. at 5. The court’s answer is the same answer that Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), famously gave about the FDCA – there’s no private right of action:

[N]either the regulations nor the Public Health Service Act, 42 U.S.C. §201, et seq., pursuant to which those regulations were promulgated, purport to give rise to a private right of action, much less a right of action to recover damages for “mishandling and desecration of a body.” This cause of action appears to be nothing but a duplicative restatement of the sixth cause of action, which sounds in negligence.

Kennedy-McInnis, slip op. at 5. Thus, in yet another context, a federal statute’s lack of a private right of action precluded its use as a basis for a state-law negligence per se claim.

Next, Kennedy-McInnis turned to the duty question inherent in regular negligence. Does a tissue bank (or anyone else obtaining tissue from such a bank) have a duty to verify the proper provenance of the tissue (“ensure the authenticity of the consent forms”) obtained in what appeared a regular manner? Here, the court had to deal with the “right of sepulcher.” First, what is it?

The common-law right of sepulcher affords the deceased’s next of kin an absolute right to the immediate possession of a decedent’s body for preservation and burial, and damages may be awarded against any person who unlawfully interferes with that right or improperly deals with the decedent’s body. Damages for interference with the right of sepulcher are awarded as compensation to the next of kin for the solely emotional injury experienced as a result of the interference with their ability to properly bury their decedent.

Slip op. at 7 (lots of citations and quotation marks omitted). So does this “right” allow damages for against actors beyond the person actually committing the interference? No. This peculiar “right” doesn’t apply at all to transplanted tissue. “[T]he deprivation of organ or tissue samples within a decedent’s body does not in itself constitute a violation of the right of sepulcher” – only the detention of the body. Id. at 8. Two down.

Plaintiffs tried to get around the duty problem by arguing that, contractually, the tissue bank agreed that it “would conduct annual audits of [the collector] of compliance .” Id. at 11. This contract, however, did not give any rights to persons, such as plaintiffs, who were not signatories:

To the extent that these provisions imposed any duties on [the tissue bank], I conclude that this does not aid plaintiffs. . . . in the case at bar. Plaintiffs were not parties to the contract between [the collector] and [the tissue bank], nor have they provided proof that they were intended beneficiaries of the agreement. . . . There is no evidence, however, that plaintiffs, who were not parties to the contract and who did not deal directly with [the tissue bank], were even aware of these contractual provisions, much less that they relied on them.

Slip op. at 11-12 (footnote omitted). So the contract claim also fails under third-party beneficiary principles.

Finally, the court turned to the Uniform Anatomical Gifts Act (“UAGA”), which “establishes duties of hospital administrators, organ procurement organizations, eye banks and tissue banks.” Id. at 13. Not only does the UAGA not create liability, but instead, it “contains a good-faith immunity provision.” Id. at 14. That provision is quite broad – and something all defendants should remember should they be faced with tissue-related litigation bottomed on a claim that human tissue was improperly obtained in violation of the procedures mandated by the UAGA:

[T]hat provision clearly bars all the claims asserted in this suit; the statute does not simply bar suits under the Act itself, but provides complete immunity “for damages in any civil action” within its scope.

Id. (quoting uniform act). That the relevant documentation was faked did not destroy immunity, as long as the fakes looked “appear[] valid on their face.” Id. at 17.. “Good faith” on the part of the tissue bank was all that was required:

[T]here is no evidence upon which a finder of fact could determine that [the tissue bank] should have suspected that [the collector] was faking the requisite consent forms for body parts or tissues, or that [the tissue bank] acted in less than good faith in accepting those body parts pursuant to its contract with [the collector].

I reach that conclusion based on an interpretation of the UAGA that has been widely accepted. . . . Good faith is defined in this context as an honest belief, the absence of malice, or the absence of a design to defraud or to seek an unconscionable advantage. . . .

* * * *

[W]here a defendant moving for summary judgment contends, and makes at least a minimal showing, that it acted in good faith within the meaning of [the UAGA], the burden falls to the plaintiffs to identify competent evidence sufficient for a reasonable jury to find to the contrary. . . . [The tissue bank] has presented evidence that it acted in good faith, and plaintiffs have not rebutted that showing with evidence from which a factfinder could conclude otherwise. The evidence shows that [the tissue bank] had been warned that [the collector] had a checkered past. . . . But that is a far cry from saying that [the tissue bank] had reason to think that the consent forms supplied to it by [the collector] were fraudulent.

Slip op. at 15-17 (citations and quotation marks omitted) (emphasis added).

So the result is one we like to see – summary judgment granted. As we hope this post makes clear, human tissue cases present legal issues that drug and device product litigators do not see every day. There are peculiar claims, like the “duty of sepulcher,” and equally peculiar defenses, such as the broad good faith immunity created by the UAGA. Manufacturers also get sued in these cases, so it behooves us, and our readers, at least to know the lay of the land.