Compliance Expert’s Testimony on the Marketability of the Olivetol Excluded
Posted on October 21, 2025 by Expert Witness Profiler
Noramco and Dishman entered into a contract (“the Supply Agreement”) under which Dishman agreed to provide Noramco with a large amount of olivetol, an ingredient used in the manufacture of pharmaceutical products.
The Supply Agreement required Dishman to supply Noramco with olivetol manufactured at Dishman’s facilities in India. The Agreement represented that those facilities were “c-GMP compliant,” i.e., compliant with the current Good Manufacturing Practice standards set by the U.S. Food and Drug Administration.
In February 2020, the European Directorate for the Quality of Medicines & HealthCare (“EQDM”) inspected Dishman’s facility in India where the olivetol was manufactured. The EQDM subsequently informed Dishman on March 19, 2020, that the facility had failed the inspection and was not compliant with cGMP.
The batches of olivetol at issue in this case were manufactured by Dishman after the failed inspection. The were shipped by Dishman on March 26, 2020, and received by Noramco on April 2, 2020. After an exchange of emails between the parties regarding the effect of the failed inspection, Noramco rejected the olivetol and sought a refund of the amount Noramco had paid for the product. When Dishman refused to accept the return of the olivetol and to return the funds Noramco had paid for the olivetol, Noramco brought this action seeking damages for breach of contract.
The Plaintiff, Noramco LLC (“Noramco”), has filed a motion to exclude the opinion testimony of Dr. Rino C. Coladangelo, an expert witness for the Defendant, Dishman USA, Inc. (“Dishman”).
Compliance Expert Witness
Dr. Rino Casmira Coladangelo MB BS MRCP is a medical doctor with experience in the field of pharmaceutical compliance.
He led the global consultancy company Rephine which provided a world class compliance and regulatory service to pharmaceutical companies. His expertise includes regulatory and quality aspects of pharmaceutical manufacture and covers all major global markets.
Discussion by the Court
To begin with, Noramco challenged Coladangelo’s qualifications as an expert and argued that his reports “lack reliable methodology, are based on unsupported speculation, offer legal conclusions, opine on Plaintiff’s state of mind, and do not establish the expert’s qualifications in the relevant subject matter.”
The Limits of Coladangelo’s Qualifications
From April 2009 until October 2021, Coladangelo served as Chief Executive Officer of Rephine Ltd., a global pharmaceutical consultancy specializing in quality compliance in manufacturing, and regulatory affairs.In that capacity, Coladangelo “led the training and development of the staff and consultants, as well as accreditation of specialty staff.”
Based on Coladangelo’s experience at Raphine Ltd., the Court found that Coladangelo was qualified to testify as an expert on matters of quality compliance and regulatory affairs in the pharmaceutical industry. However, Coladangelo’s expertise in the field of pharmaceutical quality compliance and regulatory affairs did not qualify him to testify on legal issues or the state of mind of representatives of the opposing party, which are the subjects of much of his expert report.
In his report, Coladangelo stated that “[t]he supply agreement makes clear that any rejection of material must be made within 30 working days of receipt” and that the actions taken by Noramco “contravene the terms of the agreement.” According to the Court, Coladangelo lacked the qualifications to provide an opinion interpreting the contract in this case, and even if he were qualified to give such an opinion, it would be improper for him to express a legal opinion as to whether Noramco failed to comply with the terms of the Supply Agreement, which is an ultimate issue in this case.
To the extent Coladangelo purports to offer legal opinions or speculate as to the Noramco representatives’ state of mind, his testimony will be excluded.
The Reliability of Coladangelo’s Testimony
First, Coladangelo’s report contains a list of 24 manufacturers of medicinal THC and asserted that “[s]ome of these might have been interested in acquiring the Olivetol batches.” However, aside from the list of THC manufacturers, the report contained no other facts, data, or methodology supporting Coladangelo’s conclusion that all or some number of the listed manufacturers might have been willing to purchase the non-compliant olivetol.
Second, Coladangelo’s report points to Noramco’s failure to promptly reject the olivetol and its act of sampling the product as causing a reduction in the shelf life and marketability of the olivetol. According to Coladangelo, “[n]on-conformity with the proper protocol would make the material unusable by others.” However, the Court concluded Coladangelo’s naked assertion that non-conformity would make the olivetol unusable by others lacked sufficient support in facts, data, or methodology.
Third, Coladangelo asserted in his report that the non-cGMP compliant olivetol “could still be used if a Risk Assessment Analysis (RAA) is undertaken.” In support of that assertion, Coladangelo cited certain guidelines from the EQDM and noted that certain other pharmaceutical products have been accepted by Belgian, German, and Brazilian manufacturers following an RAA.
Without some reasoning or methodology to connect the use of an RAA to the olivetol at issue beyond an “implication” or speculation, the Court held that Coladangelo’s conclusion regarding olivetol’s potential use after an RAA lacked the scientific support that Daubert demands.
The Fit of Coladangelo’s Testimony
Coladangelo’s expert testimony must help the trier of fact decide (1) the timeliness of Noramco’s rejection and (2) the mitigation of Dishman’s damages.
On the issue of timely rejection, the Court held that Coladangelo’s opinions, as expressed in his report, are of limited value to the trier of fact. Specifically, the timely rejection issue is primarily a question of contract interpretation as applied to the series of events and correspondence that unfolded between Noramco and Dishman. Moreover, the testimony that Coladangelo is qualified to give on pharmaceutical compliance and regulatory affairs did little to help resolve whether Noramco timely rejected the olivetol at issue.
On the issue of mitigation of damages, however, the opinions offered by Coladangelo may offer some assistance to the finder of fact in determining whether Noramco’s actions constituted reasonable steps to mitigate Dishman’s damages under the circumstances. In other words, Coladangelo may be able to help the finder of fact understand industry customs and practices for regulatory compliance testing and for opening and resealing tested materials.
Held
The Court granted in part and denied in part Noramco’s motion to exclude opinions and testimony of Dr. Rino Casmira Coladangelo.
Key Takeaway:
While there are portions of Coladangelo’s report (and, thus, his proposed testimony) that are legitimately within his expertise, much of his report reads like the first closing argument for the Defendant. It appears to be an example of the increasingly common practice of allowing the presentations of expert witnesses to bleed over from expert testimony on discrete factual issues into legal argument on the merits of their proponent’s case. That is decidedly not the role of expert witnesses.
Case Details:
| Case Caption: | Noramco LLC V. Dishman USA, Inc. |
| Docket Number: | 1:21cv1696 |
| Court Name: | United States District Court, Delaware |
| Order Date: | October 16, 2025 |
