The Defendant, Laura Perryman, the founder and former CEO of Stimwave Technologies Incorporated and Stimwave LLC (together, “Stimwave”), was responsible for overseeing the design of the StimQ Peripheral Nerve Stimulation (“PNS”) System, a medical device (the “Device”) aimed at treating chronic pain by using electrical currents to target peripheral nerves, that is, the nerves outside the spinal cord. The device comprised four key components during the time at issue: the Lead, the Battery, the Pink Stylet, and the White Stylet. The Lead served as an implantable electrode array to stimulate the targeted nerve, while the externally worn Battery supplied power to the Lead. The Pink Stylet, containing copper, was implanted into the body to act as an “antenna,” lengthening the transmission range of the Battery.
Stimwave labeled both the Pink Stylet and the White Stylet as “receivers” in its product materials for the Device. Perryman advised medical providers that they could bill insurers for implanting the White Stylet as a receiver using Current Procedural Terminology (CPT) code 64590. However, it was established that the White Stylet lacked copper and therefore could not function as a receiver.
On December 19, 2023, the Government filed a superseding indictment against the Defendant, charging her with one count of conspiracy to commit health care fraud and wire fraud, one count of health care fraud, and one count of securities fraud. Both the Government and the Defendant filed their respective motions in limine on January 12, 2024. The Government’s motions included a motion to exclude the testimony of Dr. David A. Spinner. His expert report was attached to the Government’s motion. The parties filed their opposition to these motions on January 19.
During the final pretrial conference on February 2, the Court excluded Spinner’s testimony under Fed. R. Evid. 401, 403, and 702. One of Spinner’s opinions focused on the White Stylet’s functionality, suggesting it served a medical purpose by preventing fluid ingress into the Lead and possibly averting collapse of the Lead’s lumen. However, the Court deemed Spinner’s opinion on the functionality of the White Stylet inadmissible, noting a lack of description on how he formed his opinion or his experience with the White Stylet or his basis for opining that it served a medical purpose. The expert’s opinion was merely his assertion without providing any evidence of testing or experimentation with the White Stylet, nor did he reference any widely accepted views within the medical community. The Court also ruled Spinner’s speculation on the White Stylet’s ability to prevent collapse of the lumen as inadmissible.
Spinner also opined that reimbursement claims for implanting the Device could have been appropriately submitted to medical insurers using CPT code 64590, regardless of whether the White Stylet, the Pink Stylet, or no stylet was used with the StimQ PNS System. The Court emphasized the importance of the jury’s familiarity with the CPT codes, as they facilitated payment to medical providers. However, Spinner’s expertise on CPT codes was questioned, as he did not demonstrate specialized knowledge as to the interpretation or application of CPT codes. His opinion on CPT codes lacked explanation and failed to cite any sources or authorities on which his opinion was based. Furthermore, the Court deemed his opinion on CPT codes irrelevant, as it did not address the fact that Stimwave had marketed the White Stylet as a receiver.
Following the Court’s ruling, the Defendant sought leave to supplement Spinner’s expert report. The Court approved the request, instructing the Defendant to submit the supplemental report to the Government by February 6. Additionally, the Court asked the Defendant to identify any section in the Stimwave materials that detailed the functionality of the White Stylet as Spinner did. On February 9, the Government renewed its motion to exclude Spinner’s testimony, which the Defendant opposed on February 12.
Pain Management Expert Witness
David A. Spinner is the Director of Pain Management at White Plains Hospital. He is double board-certified and specializes in interventional spinal care and musculoskeletal care, along with a sub-specialty in peripheral nerve stimulation (PNS) for chronic pain. Previously, Spinner served as the Medical Director at Westchester Pain Management. He obtained his Doctor of Osteopathic Medicine degree from the New York College of Osteopathic Medicine and completed his post-graduate training with an internship at Maimonides Medical Centre followed by a residency at Mount Sinai School of Medicine as well as a fellowship at Harvard Medical School’s Beth Israel Deaconess Medical Centre. Spinner is also recognized as the lead author and editor of “The Atlas of Ultrasound-Guided Musculoskeletal Injections,” one of the earliest textbooks on the subject of musculoskeletal injections. With extensive experience, Spinner has performed numerous PNS procedures and regularly trains other physicians in this field.
Discussions by the Court
The Government renewed its motion to exclude the opinions offered by Spinner in the February 6 report, as unreliable, unsupported, irrelevant, and unduly prejudicial. Spinner was given the chance to supplement his earlier report to demonstrate the reliability of the opinions he expressed in his initial report as per the requirements of Rule 702 and Daubert. The Court noted his failure to do so as well as addition of new opinions regarding CPT code and the functionality of the White Stylet as well as an entirely new opinion regarding patient harm, all deemed untimely and thus stricken. Furthermore, the Court observed that the Defendant could not establish the admissibility of any opinions in the February 6 report under Rule 702.
Spinner’s February 6 report asserted that CPT codes were “drafted in a manner that contemplated application to the medical procedure employed.” Spinner acknowledged their susceptibility to varying interpretation. Drawing from his familiarity with the Device itself and the implantation procedures for neurostimulator devices to treat chronic pain, he opined that the procedure for permanently implanting the StimQ PNS System “came within the plain language interpretation” of CPT code 64590, regardless of the use of the White Stylet, the Pink Stylet, or no stylet, as the procedure always involved the insertion of a receiver. Spinner also shed some light on the process of drafting CPT codes and discussed the revision of CPT code 64590 in January 2024, suggesting that the revised CPT code 64590 and a new code that was created were “issued to cover new and innovative PNS devices such as the StimQ PNS System.”
The Court noted that Spinner did not provide any basis for his expertise in the drafting or revision of CPT codes. As a physician specializing in pain management, he is personally responsible for claims submitted to insurers when he has implemented PNS devices. He highlighted a book for which he is the lead author that addressed the use of ultrasound techniques, which he explained were used to properly place neurostimulators implanted to treat peripheral nerve pain. He trained other physicians in PNS procedures. During that training, he was frequently asked to give advice on CPT codes and would typically advise that the prior version of CPT Code 64590 was applicable prior to the release of new CPT codes in 2024.
Spinner did not demonstrate experience with implanting the White Stylet, which was necessary for him to be able to opine on the use of CPT codes for that procedure. He did not say that he ever implanted the White Stylet as a component of the StimQ PNS System. While he mentioned that he led trainings on implanting the Device, it was unclear whether the White Stylet was a component of the Device at that point in time and whether his advice on CPT Codes addressed what code should be used in connection with a procedure that included implanting the White Stylet. Spinner did not address the central allegations of the indictment, namely, that Perryman and her company informed medical providers that the White Stylet was a receiver and that they could use CPT code 64590 to bill insurers for implanting it as a receiver.
In summary, the revised report did not address the deficiencies pointed out by the Court during the February 2 conference. Consequently, Spinner’s testimony on CPT codes was excluded under Rule 702 due to being beyond his areas of expertise, unreliable, and irrelevant. Pursuant to Rule 403, it was also excluded due to the risk of unfair prejudice and the likelihood of confusing the jury and diverting their attention from the pertinent issues. These concerns were deemed to outweigh any minimal probative value the testimony may have had.
In her opposition to the Government’s motion to preclude Spinner from testifying, the Defendant did not suggest that Spinner had any expertise in CPT codes beyond his experience as a practitioner. She argued that Spinner’s experience as a provider qualified him to serve as an expert because it is the provider’s responsibility to determine the applicable CPT code for their medical procedures. However, Spinner’s experience as a provider did not qualify him to opine on the drafting or revision of CPT codes, as he was not involved in those processes. Therefore, any discussion of those topics in his February 6 report was beyond his area of expertise and deemed inadmissible.
The Court observed that, while the Defendant demonstrated that Spinner was an experienced practitioner in the use of PNS devices, it was worth noting that his expert report did not address his experience with the White Stylet. He did not explain whether he had personally ever implanted the White Stylet or trained others to do so, or decided in either context which CPT code should be used to bill for a procedure involving the White Stylet being implanted. His experience in selecting CPT codes when implanting PNS devices did not automatically qualify him as an expert in CPT codes. Similarly, answering questions about CPT codes during training sessions about implanting a PNS device did not make him an expert on the codes. These deficiencies were relevant to determining whether he was qualified to serve as an expert on CPT codes in general and specifically as an expert on CPT codes relevant to the issues in this case.
Spinner asserted that the White Stylet served several medical functions but stopped short of discussing its potential role as a receiver. Instead, he stated it “filled the inner lumen, thereby helping to prevent fluid ingress into the stimulator receiver and electrode array, which could result in a loss of function and heightened risk of infection or other collateral complications.” He added that it “would also assist in preventing the collapse of the lumen and in stabilizing and providing additional rigidity to stimulator receiver.”
Spinner’s opinion regarding the functionality of the White Stylet was excluded under Rules 702 and 403. The Court noted that Spinner had provided no basis to establish that this testimony constituted a reliable expert opinion as required by Rule 702 and Daubert. Any probative value, which was minimal, was substantially outweighed by the risks of confusion, misleading the jury, and unnecessarily prolonging the trial.
Spinner did not explain the basis for his opinions regarding functionality. He did not refer to any testing that supported his views on the necessity to use the White Stylet, which was marketed as a receiver, to perform separate functions. Nor did he reference any company-issued literature describing these functions as essential for the success of its electrode array or as reasons for implanting the White Stylet. Despite the Court’s request during the February 2 conference for the Defendant to identify any relevant company-issued literature regarding functionality, no such documentation was provided. Additionally, Spinner did not describe his own experience with the White Stylet, such as explaining why he deemed it necessary to implant it despite knowing it was not a receiver. Overall, there was no support or explanation provided to establish that these opinions on functionality were based on a reliable foundation or were anything other than Spinner’s assertions.
The two documents cited by Spinner did not fill this gap. One was a document co-authored by the Defendant. While the Defendant would be given an opportunity at trial to explain her understanding of functionality, an expert could not serve as a substitute for that testimony under Fed. R. Evid. 704(b). In any event, Spinner did not quote any passage explaining that the stylet assisted the functionality of the Lead by sealing the lumen, preventing the lumen’s collapse, or stabilizing the Lead. His citation to a book regarding pacemakers was similarly vague.
Spinner’s testimony was not salvaged by his observation that he was unaware of any study suggesting that leaving an implantable device “open” in the body was “desirable or beneficial.” He added that there was no PNS device on the market that left the device “open.” However, Spinner did not explain how the White Stylet prevented fluid ingress into the lumen, describe any testing to confirm White Stylet’s success in that function, or compare its effectiveness in doing so with other solutions for that issue. Consequently, his testimony amounted to a bald, unsupported statement of opinion.
In her opposition to the Government’s motion, the Defendant argued that Spinner’s expert opinion was reliable because it was based on his professional experience. However, it was noted that Spinner did not describe any professional experience with the White Stylet, the functions it has served when he implanted the Device, or how he knew that the White Stylet prevented fluid from entering the Lead. He also did not mention ever implanting the Device during the years when it was sold with the White Stylet, nor did he state that he discussed the functionality of the White Stylet during the training sessions he conducted on PNS devices. Therefore, even if the use of the White Stylet in his own practice would have been sufficient to qualify Spinner as an expert on its functionality, his expert report did not describe such use. As a result, his testimony was not sufficiently reliable to meet the Rule 702 standard.
Finally, the Defendant asserted that Spinner’s testimony was supported by a learned treatise, specifically the publication co-authored by the Defendant in 2015. However, Spinner failed to explain why the article was trustworthy or authoritative. Although defense counsel provided citation to the article, it did not address the role of a stylet in preventing fluid from entering the lumen of the Lead, preventing the collapse of the lumen, or stabilizing the Lead. The only function of the antenna discussed was its function as a receiver. Therefore, the article co-authored by the Defendant did not provide a basis to establish that Spinner’s opinion about the functionality of the White Stylet was supported by a learned treatise or was otherwise sufficiently reliable to be presented to a jury.
Spinner added new opinions on the topic of patient harm that were not included in his initial report. He said that he was unaware “of any indication” that the use of the White Stylet “caused patient harm.” Additionally, he added that it was “highly unlikely” in his experience that its use would be the cause of any “actual patient harm.”
Those opinions were deemed untimely by the Court as they were not included in Spinner’s expert report due on January 5. Consequently, they were excluded solely on this basis. Additionally, the Defendant failed to demonstrate the admissibility of Spinner’s testimony regarding patient harm as evidence.
In any event, it appeared that the reason for proffering these opinions no longer existed. The Defendant had feared that the Government would offer evidence at trial suggesting that the use of the White Stylet had caused patient harm. For this reason, one of her motions in limine had requested that the Government be precluded from introducing such evidence. The Court had directed the parties to confer regarding the issue. In a letter dated February 13, the Government represented that it would not offer evidence of patient harm unless “the defense opened the door to the question of patient harm or benefit.”
The Defendant argued that she had a right to rebut the Government’s experts and that excluding Spinner’s testimony would deprive her of a fair trial. She pointed out that Spinner was a recognized expert in PNS procedures. However, these arguments did not address the legal barriers to admitting Spinner’s testimony. His proposed testimony was deemed inadmissible under well-established legal standards. The Rules of Evidence were crucial in safeguarding a party’s right to a fair trial, and the Defendant was allowed to present evidence and challenge the Government’s evidence within the boundaries set by those rules.
Held
The Court granted the Government’s renewed motion in limine of February 9 to exclude the expert testimony of David Spinner.
The Court has not arrived on an outcome for this case since the remaining issues involved in this case still await resolution.
Key Takeaways
The expert testimony provided by Spinner in the case against Laura Perryman, the founder of Stimwave Technologies, faced numerous challenges and ultimately was excluded by the Court. Spinner’s opinions on the functionality of the White Stylet, a key component of the StimQ Peripheral Nerve Stimulation System, lacked sufficient basis and evidence, rendering them unreliable and irrelevant under Rule 702 and Rule 403. Despite attempts to supplement his initial report, Spinner failed to address the deficiencies highlighted by the Court, leading to the exclusion of his testimony. His expertise on CPT codes was also questioned, as his report demonstrated no specialization in this area and failed to address critical allegations in the indictment. The Court’s decision underscores the importance of expert testimony meeting stringent legal standards to ensure fairness and reliability in judicial proceedings.
Case Details
| Case Caption: | United States v. Perryman |
| Docket Number: | 1:23cr117 |
| Court: | United States District Court, New York Southern |
| Citation: | 2024 U.S. Dist. LEXIS 26530 |
| Order Date: | February 15, 2024 |
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