Friday, October 31, 2008

A Halloween Special: Bodysnatchers! And Jujyfruits!

We published a quick post last week about In re Human Tissue Prods. Liab. Litig., No. 06-135, MDL No. 1763 (D.N.J. Oct. 22, 2008) (link here).

Now that we've had a chance to read the opinion, we thought we'd do a slightly longer post, and today seemed like the day: The case of the bodysnatchers on Halloween!

These are the ghoulish facts: Biomedical Tissue Services and its principal illegally harvested tissue from human corpses without obtaining the necessary consents or screening the donors for certain infectious diseases. That ain't just scary -- it's against the law!

"Several individuals in the BTS operation were indicted . . . and certain of those individuals have since pled guilty to crimes related to the unauthorized recovery of tissue and falsification of donor records." Slip op. at 7. That doesn't sound scary to us; it sounds more like justice being done.

The many plaintiffs included both folks who received implants made out of the stolen tissue and relatives of the decedents, who were distressed to learn that tissue had been harvested without their consent. Defendants included, among others, the folks who did the crime (and are now doing the time), the funeral homes that gave BTS access to the corpses, and the companies that processed the purloined tissue into medical products.

Maybe it's just because we defend device companies for a living, but naming that last category of defendants sounds pretty scary to us. The companies were not alleged to have actually known about the illegal bodysnatching operation; they were supposedly negligent in failing to detect the criminal scam. (We don't know anything about the real facts in this case, but that allegation smells to us like a pumpkin past its prime.)

The FDA recommended that recipients of the harvested tissue be tested for certain infectious diseases; Medtronic Sofamor Danek (a device company) offered free blood tests to patients who received its implants. Medtronic and the other device companies also routinely disinfected and sterilized their products before distributing them.

In the motion that Judge Martini granted last week, Medtronic and the other device companies
asserted that, even if BTS did not properly screen the tissue donors, no virus could survive the sterilization process and storage at room temperature for a prolonged period of time. Id. at 9.
The judge set aside the sterilization process and addressed only whether tissue stored at room temperature for thirty days could theoretically transmit the relevant viruses or diseases -- hepatitis B, hepatitis C, HIV, syphilis, cancer, and prions.

The parties agreed that there is no study -- epidemiological, cohort, or case-controlled -- that addresses whether unprocessed human bone tissue stored at room temperature for thirty days or more is capable of transmitting infectious diseases to a human recipient. Id. at 27. The court then meticulously reviewed the few marginally relevant epidemiological studies, animal studies, and lab studies that existed. The court ultimately granted the companies' motion to exclude all expert testimony that "unprocessed bone tissue kept at room temperature for thirty days or longer can transmit" the relevant viruses or diseases. Id. at 26. (The court reached a few other scientific issues, too, which we're not discussing here, so we can get home in time to hand out candy.)

Suzanne Parisian's testimony was stricken because she did not "adequately explain how her conclusions could be extrapolated from the results or conclusions from any of the studies." Id. at 44. "Her extrapolations from these studies were not tested, were not subject to peer review, and had no known rate of error." Id. at 46. Snickers bar!

John Kowalski's opinion "suffers from the same issues as Dr. Parisian's opinion in that Dr. Kowalski failed to articulate the scientific and medical rationale for extrapolating the results of the available studies to the set of facts in this litigation." Id. at 57. Milky Way!

Andrew Klein tried "to more fully bridge the gap between the existing literature and his conclusion regarding transmission," id. at 67, but the court didn't find his extrapolations "reliable" and they didn't "fit the facts of this case." Id. Judge Martini trots through several studies and discusses Klein's opinions in some detail, but much of that is very fact-specific. Although that analysis wouldn't be of general interest, keep this case in mind if you're ever facing Dr. Klein as an adverse expert in some future case. Three Musketeers!

Dr. Cosme Manzarbeitia suffers the same fate. His "proposed testimony on transmission has no basis in any specific medical literature and is merely based upon his belief." Id. at 77. His testimony was thus excluded. Baby Ruth!

For lack of evidence of general causation, the court thus granted summary judgment on, among other things, all claims relating to the "transmission of HIV, HBV, HCV, cancer, and syphilis through unprocessed human bone tissue that has been stored at room temperature for thirty days or more." Id. at 104. Same result for prion disease, though on slightly different reasoning. Id. Reese's Pieces!

"Multidistrict litigation courts are often confronted with evaluating limited or evolving scientific and medical theories and evidence. . . . . The Rules of Evidence, however, cannot be disregarded even if at a future date, medical and scientific literature proves the contrary. As Judge Richard Posner put it, 'the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.'" Id. at 103 (citation omitted). 100 Grand bar!

That's quite a treat for the device companies -- an opinion that Krackles. The decision is Good, 'n Plenty of it, although, at 105 pages in length, it could be criticized as being a bit Chunky. For the most part, Almond Joy after reading it. And for defendants facing these experts in the future, the decision could be a true Lifesaver.

Have a Happy Halloween!

2 comments:

Anonymous said...

This was a very fun and legally interesting Halloween post. Thanks!

Anonymous said...

I am a recepient of the illegally harvested tissue. I find your witty piece quite offensive. If you personnaly knew a recepient or if yoi were one you would understand and have sympathy. I live constantly with the thought of the possibility of 'what if' as well as the knowledge that I have someones body parts in me who did not willingly donate them. The only thing fitting about your article is grisley Halloween