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The Trial: FDA v Samuel Girod Day 2
If you don’t know the story, start here. Ignore all links to kyfreepress, those posts have been moved here.
General Comments for Tuesday, February 28th, 2017:
All of the federal witnesses are either federal employees (FDA or US Marshal) or they're subpoenaed witnesses who clearly do not want to be there and they're obviously sympathetic to Sam. In a few cases, the strain of being compelled to testify against Sam was almost more than they could take. A few of these witnesses were mad as wet hens and were outwardly antagonistic to the FDA and the federal prosecutor.
For Sam's customers, the prosecutor's questioning compelled the witness to testify that Sam didn't inform them that he was under a court order prohibiting the sale of his products, and further compelled them to admit that they wouldn't have purchased the product if they had known of the court order. The witnesses were very uncomfortable with this line of questioning. They were clearly in a moral dilemma, caught between doing what they considered to be the right thing, defying the federal court order, and doing the legal thing by obeying the court order.
In every case they did the legal thing, usually with the urging of Special Agent Steven Lamp who was on their premises to compel them to "voluntarily" surrender the products and literature and relevant accounting records.
These witnesses were clearly happy with their business arrangement with Sam and they were all of the opinion that their problems resulted not from Sam or any action he took, but rather from the FDA's actions.
It can't be stressed too much how difficult this testimony was for most of the subpoenaed witnesses. There were long pauses as they wrestled with their conscience to craft the least harmful response. After a pause, some blurted out their answers, clearly wanting to say the opposite or to lash out at the prosecutor for deliberately manipulating them into this legal trap. For each of the FDA's subpoenaed witnesses, Sam's customers, Sam's cross examination consisted of asking them if they had ever received any complaints about his products from their customers and they all answered no.
The FDA called twelve witnesses today:
1) Dr. Jane Liedtka - FDA dermatologist. She stated that the FDA approves all advertising for medications, and the FDA makes them list all of the side effects, and the drug manufacturers are good about not making medical claims without approved studies demonstrating efficacy. She also stated that the FDA would never approve a drug named TuMorGone because that would be considered to be misleading.
Per the FDA compliance division, she started an investigation of black salve and TuMorGone in particular back in 2009. She claimed that there is one case in the literature of someone using a black salve (not TuMorGone) on basal cell carcinoma and dying from that very non-aggressive form of cancer 20 years later. Typically, basal cell carcinoma is so slow growing that something else kills the patient. She stated that bloodroot salves indiscriminately kill tissue so they can kill healthy tissue as well as cancerous tissue, omitting that the standard surgical treatment requires a significant margin of healthy tissue be removed to ensure that all the cancer is removed.
She also claimed to find a case in the literature where someone used black salve and eventually had no nose as a result. She stated that dermatologists use FDA approved topical drugs to treat basal cell and squamous cell carcinomas with an 80% rate of re-occurrence (higher than the more common surgical removal) but topical agents are never used on melanoma.
Her main take home point is that it's essential to have a dermatologist diagnose anything that might be a tumor to know what it is before treating it, and using a topical agent like TuMorGone could kill the melanoma on the surface and leave the cancer aggressively growing underneath with fatal results. She also discussed FDA liquid chromatography mass spectrometer analysis that confirmed the ingredients in all three of Sam's products, including the active bloodroot ingredient in TuMorGone.
Sam asked her to read the conclusion statement for all three FDA product tests. "There were no drugs or poisons identified with this test." The federal prosecutor then had the dermatologist clarify that there were no drugs or poisons found in addition to the active component in bloodroot which would be considered to be a drug. Sam then made a statement that God made the bloodroot plant complete, and when used whole there would be something good to counteract anything bad, but that wasn't a question for the witness and was struck from the record.
2) Mary Miller - Owner of Miller's Country Store in Greenville Indiana. They have mostly Amish customers, but some English. Mary was way out of her element. She seemed under great duress and on the verge of passing out from the strain of being forced to leave her Amish community and testify against Sam. Sam delivered the chickweed salve in person and Mary paid with a check for $765.
Later, Mary and Sam discussed the subpoena that Mary had received from the FDA and Sam told her that he thought that turning over her customer records was a violation of medical privacy laws (HIPAA), and told her (incorrectly) that he thought the FDA issues would all dissipate. He also advised her in the follow-up letter that he sent to several customers that stated that they could all do whatever they wished.
From what we were allowed to hear of the letter, it didn't sound coercive. It seems that Sam wanted to keep his business, but he was concerned for how the FDA's efforts were adversely impacting his customers. The discussion with Mary and the letter are the basis of the charge of impeding a federal investigation or possibly witness tampering.
3) Marc Wooten - Employee of Miller's Country Store. Not Amish. During a visit to the store, Sam asked Marc if he was an FDA agent, to which Marc snickered and said no. The prosecutor asked Marc what he thought when he opened the subpoena that was mailed to the store and Marc responded, "Uh oh", which got a chuckle from most people in the court. Sam did not cross examine Marc.
4) Kevin Miller - Amish, but not related to Mary Miller. Works at Family Health Foods, a brick & mortar and mail order store in Arthur Illinois, catering to the local Amish community as well as several neighboring states. They had sold Sam's products including TuMorGone. The prosecutor introduced an invoice and check for $126 to establish interstate commerce, to fulfill a requirement for FDA jurisdiction.
5) Jeffrey Eurkholder - Co-owner of Cloverdale Warehouse, a food distributor in Curtis Wisconsin. They've been distributing Sam's products in 15 regional states since 2009. The prosecutor wanted to establish interstate sales again, based on Sam loading his products onto their truck in Kentucky to be driven to their out-of-state warehouses, then mailing Sam the check to pay for the products, as well as them wholesaling Sam's products regionally.
The prosecutor also sought to prove that Sam increased sales of his products in defiance of a court order in Missouri instructing Sam to stop selling his products. The prosecutor also established that Sam didn't recall the product when the FDA told him to do so, and there was no lot number or expiration date on Sam's products.
Jeffrey's responses came increasingly more slowly and with uncomfortably long pauses. At the end of his testimony, he blurted out something about not wanting to be here and not wanting anything to do with the federal government. There was an impression that the prosecutor may have had another question or three that she wanted to ask but cut her examination of this witness short rather than risk her witness cracking and launching into an anti-FDA tirade and volunteering his uncensored opinion of how he had been treated by the federal government throughout this ordeal.
Sam didn't encourage any more exposition on that subject when he cross examined. Just his usual question about any customer complaints and the same response that there were no customer complaints.
6) Mary J. Miller - No relation to any of the other Millers in this case. Manages Miller's Dry Goods, an Amish store in Arcola Illinois. Sam visited the store in 2013 and Mary purchased $703 worth of all three products. The invoice and check were entered as evidence. Same as always. Sam didn't advise Mary of the court order prohibiting the sale of the products, Mary would not have purchased had she known, Special Agent Lamp confiscated the unsold products, and Mary had never heard any customer complaints about any of Sam's products.
7) Darrell Mandrell - Owner/operator of the print shop in Mt. Sterling Kentucky that printed Sam's product labels, tri-fold product info pamphlet and his bound product brochures. There were several print orders spanning years. The prosecutor tried to imply that Sam increased production after the court ordered halt on his production, but I think it's more likely that Sam was ordering replacement labels that removed problematic wording after the FDA warnings, and to include a notice on the TuMorGone label that it's only available through a private buying club to try to comply with the federal government's prohibition on sales to the public and interstate commerce jurisdiction.
Sam's only cross examination was a statement that the labels advised, "For informational purposes only" and "Not responsible for any adverse effects resulting from use." This wasn't a question for the witness so the judge ordered Sam's statement stricken from the record and instructed the jury to ignore the statement.
8) Charles Miligan - A very entertaining witness! Preston Kentucky, Bath County. Retired from the US Army in 1998 after 22 years of service. He was Sam's driver for approximately 12 years, until approximately two years ago. Sam would call when he needed a ride and Sam paid all expenses, including gas, food, lodging, and repairs on Charles' van. They'd make on average two trips per month to Oklahoma, Pennsylvania, Georgia, Michigan, etc. They were introduced by a deputy sheriff in Indiana, when they both lived there.
Darrell moved to Kentucky approximately eight months after Sam, because, "I like Kentucky, I needed a change of pace, and I like the Amish." Charles was a very personable witness and he was very hostile to the FDA and the federal prosecutor. He'd anticipate the end of the prosecutor's questions and would cut her off with his very curt answers. He testified that, "the FDA asked Sam to take off the skin cancer stuff and he did" (referring to the product label).
His comments managed to be sarcastic but in a way that generated sympathy for Sam and made the prosecutor look like a petty bureaucrat deserving of his dismissive barbs. The appreciation was not confined to the court gallery. The jury was laughing at Charles' answers and his dismissively hostile attitude toward prosecutor Smith.
Apparently the prosecutor wanted to establish the extent of Sam's interstate commerce, but I think Charles did much more to harm the FDA's case than to help it. Sam cross examined Charles, asking if he had ever used the chickweed salve. Charles described a very bad burn when five gallons of gasoline exploded in his hand. He stated that he used the chickweed salve, and amazed the doctors and nurses in Louisville when he was able to be released from the burn ward in only eleven days.
9) Bridget Sargent - General Manager of Herbs & More in Madison Indiana. Typical subpoenaed retail store witness. Sam didn't inform her of the court order prohibiting the sale of his products, nor the recall, and she wouldn't have purchased the chickweed salve had she known. No customer complaints.
10) Mathew Suddkemp - FDA Consumer Safety Officer. Accompanied CSO Paulin in the visits to Sam's farm. This was pretty much a rehash of Paulin's testimony from yesterday (aggressive Amish intimidation, threatening behavior, anti-FDA and anti-federal government statements), even though Mr. Fox's cross examination yesterday thoroughly discredited Paulin's version of the encounters at the Girod farm.
The notion of aggressive, threatening and cursing Amish is laughable to anyone who knows the first thing about the Amish. Maybe the prosecution wanted to enter that nonsensical testimony again, given that Mr. Fox was no longer providing any cross examination as Sam's public defender.
There was a closed meeting to discuss Sam's "hybrid representation" and it looks like it was decided by some means that Sam would not be using Mr. Fox for any cross examinations.
CSO Suddkemp added to Paulin's testimony by stating flat out what Paulin had implied, that the Bath County Deputy had deliberately led them through an extended tour of Amish country to tip off the Girod family, and possibly Sam himself, of the FDA's unannounced inspection. After leaving when Sam refused their follow-up inspection, the deputy told the FDA agents not to return to Bath County without checking with the sheriff first.
11) Steven Lamp - FDA Special Agent. Unlike the other FDA agents in this case, Special Agent Lamp is a federal law enforcement officer. He investigates criminal cases. He started his investigation of Sam Girod in December of 2013. He traveled extensively in Missouri, Indiana, Illinois, Ohio, Kentucky and Wisconsin. He had the court issue 75 subpoenas in this case, including Sam's bank in Owingsville Kentucky, shipping companies, retailers and wholesalers.
Evidence was introduced from loan documents at Sam's bank where Sam had provided revenues for his business totaled by the month, typically in the $12,000 to $20,000 range. Special Agent Lamp conflated revenue with profit in his testimony, perhaps in an intentional attempt to portray Sam to the jury as something other than a poor Amish farmer. There was enough evidence presented throughout the trial of Sam's business expenses to indicate that his markup on his products was fairly slim.
But that's not what Special Agent Lamp testified. He created projections that estimated that Sam Girod was making $111,000 to $188,000 per year. Again, these were not only based on gross receipts as opposed to net profit, but these estimates were also fabricated out of whole cloth using the assumption that Sam's sales were reflected in the number of labels he ordered, not considering that Sam was forced to repeatedly alter his labeling in his attempts to comply with the vague but threatening FDA labeling recommendations.
The estimate also doesn't consider that most of the final orders of labels have not been used because the FDA shut down Sam's business.
Finally, Special Agent Lamp's estimates of Sam's earnings confused the wholesale value of the products Sam was selling with the retail value. Sam almost always sold at the much lower wholesale price which is typically half of the retail value, and offered additional discounts for larger bulk purchases. Was this a deliberate deception, with intent to mislead the jury?
Hopefully, someone in the jury will be an accountant or will have some small business experience and will see this deception for what it is.
There is no doubt that Special Agent Lamp was very busy in his investigation of Sam Girod. There is no telling how much money the FDA has spent on the case of the Amish farmer and the salve he sold to satisfied customers in the Amish community.
Special Agent Lamp visited a great many of Sam's customers in their wholesale and retail businesses, and based on the demeanor of the ones who were subpoenaed to appear in court, they were not happy at the intrusion into their businesses and the time and grief that this investigation has cost them.
These business owners and managers were convinced by Special Agent Lamp to "voluntarily" surrender their inventory of Satterfield Naturals products, in many cases at significant financial loss.
In March of 2016, Sam filed a motion with the 6th Appellate Court, essentially requesting that the court assume that he would be found guilty in the US District Court for the Eastern District of Kentucky (judge Reeves' court), and that they forgo the waste of the court's time and proceed directly to the appeal. That's not how the legal system works, but it apparently made sense to Sam and that was how he was proceeding.
Judge Reeves responded that Sam must appear in his court on July 27th, 2016. There were some back and forth motions with Sam trying to take his case out of judge Reeves' court and judge Reeves denying the motions. Sam was dealing with the 6th Appeals Court by this time and apparently marked a letter requiring his appearance before judge Reeves "RETURN TO SENDER", and it was returned unopened. Sam did not cross examine Special Agent Lamp.
12) Gary Heiden - Deputy US Marshal for the past 14 years. He had served Sam's initial subpoena and could recognize Sam, so he was tasked to locate Sam when he didn't appear on July 27th, 2016. When Marshal Heiden visited Sam's farm to apprehend him, he spoke to Sam's son Noah, who had the wherewithal to ask for a warrant. The requested warrant was produced, and Mr. Heiden expressed a concern that this may have been a stalling tactic to allow Sam Girod to escape.
The women and children were removed from the home and were detained in the back yard in the August heat [AT GUNPOINT] while the house was thoroughly searched. The outbuildings were also searched but Sam wasn't found. They made a note of an old rifle that was found in the house, although it may not have been functional.
Sam had filed a motion with the 6th District Court of Appeals, and Bath County Sheriff Tuffy Snedegar sent a letter on September 12, 2016 informing the US Marshal Service that Sam was under his protective custody. Sam was apprehended by Marshal Heiden on January 12th, 2017.
Sam's 2015 bond release had numerous standard stipulations, one of which was the requirement to supply a DNA sample, which was interesting. Apparently, to be released on bond, people are required to register their DNA with the government. Marshal Heiden explained that apprehending an Amish fugitive was particularly challenging because there is no cell phone to tap or trace, no utility bills, and no driver's license. There aren't even any pictures. He was advised not to take any pictures of Sam out of respect for his Amish beliefs, but he did secure an image of Sam from a video camera at the 6th Court of Appeals, where Sam had apparently filed a motion to have his trial moved from judge Reeves' court.
It's apparent that the FDA has been expending a great deal of resources in their pursuit of Sam for almost nine years, and has spent millions of dollars on this case in an effort to stop an Amish farmer from selling homemade salve made from all natural ingredients to willing and satisfied customers.
Despite their extensive investigations, the FDA's only witnesses were federal employees and subpoenaed hostile witnesses who are all sympathetic to Sam's position. They have been unable to produce a single witness who was harmed by any of the products that Sam sold.
They claim jurisdiction based on two principles. First, Sam is manufacturing a drug, not based on the ingredients (verified through FDA testing), but rather because there were medical claims made on the labeling. Despite the all natural ingredients, Sam's products are drugs according to the FDA because they were sold along with claims that they promote healing. Secondly, the FDA claims jurisdiction based on the Interstate Commerce Clause in the US Constitution, because Sam's business, including purchasing raw materials and selling finished products, crosses state lines.
Hopefully, the jury will be offended by the FDA's federal overreach, will perceive this case as an Amish witch hunt that is probably an attempt to set legal precedent in a case where the Amish can be counted on not to resist, not to understand the foreign ways of the federal government and its complex court system, and for the Amish aversion to lawyers.
The Amish are easy targets. Their communities are relatively small and isolated, and they won't mount a rigorous legal defense. Once it reaches the jury, this case may boil down to a matter of religious beliefs. Can the federal government compel the Amish to rely on modern mainstream medical treatments when they have an aversion to such treatments and have chosen to rely instead on their faith and the use of natural folk remedies?
The federal government has made numerous attempts to limit healthcare choice for all Americans lately, and this case is a relatively small but important example. Will the jury sentence Sam to life imprisonment for living outside of mainstream American culture while harming nobody, in accordance with his religious beliefs?
Sam will be delivering his closing argument at 9:00 AM on Wednesday, March 1st. He estimated that this will take no more than an hour. The format is rumored to take the form of Sam acting as a witness and being asked a series of questions that he has prepared in advance for his public defender Mr. Fox to read. Even though this is Sam's closing argument, a time when a defendant can say almost anything directly to the jury, judge Reeves has stated a couple of times that the witness testimony format will open Sam to objections and cross examination by the prosecutor.
If that's the case, Sam may essentially be calling himself as a witness, with the positive and negative aspects of that, while forgoing his opportunity to present a true and uninterrupted closing statement to the jury.
This legal system is very much stacked against Sam. It's widely believed, at least among the English court watchers, that Sam would have been much better served by availing himself of the services of public defender Fox. At least we should finally hear some defense by Sam, who has offered almost no defense so far. After whatever closing argument Sam decides to make, prosecutor Smith will make her closing argument. She tends to be verbose, so this may take two or three hours. After that, the jury will deliberate and render a verdict.
The trial will probably conclude on Wednesday March 1st.