By Paul Knoepfler and Lakshmi Bharadwaj
What can clouds tell us about stem cell legal court case strategy?
It turns out, quite a lot.
In about a week a Federal Appeals Court Case will begin to review the ruling in the USA v Regenerative Sciences that favored the FDA.
This is arguably one of the most important stem cell-related court cases in years and could have as far reaching implications as the Sherley v Sebelius Case, but of course in a different way.
The USA v Regenerative Sciences case has many components, but is focused primarily on one key question:
are stem cell-amplified stem cell products intended for autologous use a biological drug?
The latest ruling in the case went in favor of USA and the FDA, essentially answering that question “yes”.
Will that decision be upheld on appeal or overturned?
The stakes are huge for the field.
The Appellant in this case, Regenerative Sciences, has a cultured stem cell product called Regenexx that the FDA has defined as a biological drug.
In its court filing, Regenerative Sciences asks:
Is the Cultured Regenexx Procedure the manufacturing of a drug as defined by Federal law or the practice of medicine as defined by State law?
At the top of this post is a word cloud of the Appellant’s Brief. Below is a word cloud of the Appellee’s Brief.
They are very different and in fascinating and telling ways.
To me, the Regenerative Sciences Cloud suggests their areas of focus in the case (with major cloud words in bold here): the FDA, State level regulation of stem cells, and the practice of medicine rather than a biological drug. The words District Court are also very prominent. This is the court whose ruling went against them so it is not surprising they would be heavily mentioned.
The USA/FDA Cloud is quite different, more narrowly focused far more prominently on fewer main words: drug product and defendant. Some smaller, but still major words here include U.S.C., USCA, FDCA, Culture, Manufacture and Manipulate. Other smaller but still prominent words include cell and regulate. It seems the USA is emphasizing their assertion that this is a manufactured, manipulated cellular drug product because it spends time in culture, and asserting that their authority to regulate stem cells arises from specific Act’s and such.
These word clouds are not who is right or wrong in the case or who will win or lose, but rather to me they simply and elegantly tell us some things about respective strategies in the case.
What I found missing (or only present as very tiny) in both clouds that was particularly notable was safety and I would have liked to have seen the word patient be larger in both.
Paul wrote this piece and Lakshmi did the word cloud text mining analysis.