I didn’t even knock on Justin’s door, I busted in like Kreamer on a Seinfeld episode. Justin had a client sitting in front of his desk.
“Sir–” Justin began as a young lance corporal turned around to see who had just come in.
“Oh, shit. Sorry. When you’re done, could you come by my office?” I asked.
“Yes, sir, we’re almost done.” Justin continued to call me “sir” for appearances, but we had already tried a case or two as co-counsel, he was due to pin on Captain soon, and we spent a lot of time off-duty, playing rugby and roller hockey, along with the fact that as a single guy there wasn’t a whole lot for him to do off-base in Okinawa. My kids loved him, while he and my wife had an ongoing North-South argument that made the Civil War appear just that. I went back to my office to wait.
“What’s goin’ on?” he asked curiously, when he came by a few minutes later. He could see the smile on my face.
“Dude, I got this in the mail.” I held up a stack of documents, about four hundred pages total, bound together.
“Is that the stuff from Bates’s attorney, what was his name?” Justin asked.
“Yes, Bruce Smith and a guy named Lou Michels, who’s a partner in McGuire, Battle, and Woods, by the way.” McGuire, Battle and Woods was a fairly well-known law firm outside of Washington, D.C. in Virginia, not far from where Justin went to high school. He raised his eyebrows.
“Well, what’s in there?” he asked.
“Listen to this carefully – there is a federal statute, ten u.s. code section one-one-zero-seven, that says the DoD cannot give a service member an investigational new drug or a drug unapproved for its applied use without the service member’s informed consent.”
“Okay . . .” Justin waited for the punch line.
“Here, my good man,” I brandished a thick sheaf of papers, “I hold in my hand, the investigational new drug application from the company that makes the anthrax vaccine.” Justin’s eyes opened wide. “And,” I went on, “here is the cover page for the IND application, in which the DoD asks to join the application and even asks the FDA to hurry up and approve it so they can start testing!”
“No way! Come on.” I handed him the application, which contained the entire clinical protocol.
“And, better yet, the application specifically asks for a change to get the anthrax vaccine licensed for an aerosolized exposure.” Justin looked at me quizzically. “You know how all of those AFARTS radio commercials have been saying that the vaccine has been licensed for thirty years; that it’s been licensed against anthrax?”
“Oh, you mean the ‘education program’ – the DoD brainwashing campaign? Yes, I’ve been taking copious notes since there’s only one English speaking radio station on the island and the Armed forces owns it.” Justin’s voiced dripped with sarcasm. I laughed. I was sick of hearing about the mandatory anthrax education video, too.
“Well,” I ploughed on, “you can get anthrax three ways: you can get it through your skin, you can get it intestinally by eating some infected food, or you can inhale the spores – and that’s how it would be delivered in combat, in an aerosolized form –”
“— from an artillery round,” Justin jumped in.
“. . . or a sprayer from a crop duster, or bomb of some kind.” I finished. “The company that manufactures it and the DoD specifically asked the FDA for a modification of the existing license in order to get it approved for that use.”
“What does that mean, though? Was it approved or just ignored?” Justin was still suspicious.
“Neither, it was acted upon, and here’s the ace in the hole, the President of the company testified before Congress like six months ago that ‘we still continue to hold an IND for the anthrax vaccine.’ Dude, it’s an IND, hence you can’t give it without informed consent, hence the program currently violates federal law. Quod Erat Demonstratum, Homes.”
Justin looked at me.
“I follow everything except the Latin.”
“Oh, sorry, dude. Q.E.D. It’s what you put at the bottom of a geometry proof when you solve it. It means like ‘what was to be shown, was’ or something like that. You didn’t have to do that in high school?” Justin looked at me and shook his head.
“Proofs, yes. Trivial Latin phrases, no. We had to learn to speak English first,” he deadpanned.
“Backwards Virginia school systems.”
“Yeah, right.” He sat down.
“I can’t believe this,” he went on, thumbing through some papers. “I mean, how the hell did somebody not find this before? Don’t get me wrong, Dale. I think you’re a good attorney, and I know I’m great, but these aren’t the first anthrax refusal cases. How come it hasn’t come up before?” I had asked myself this same question and done some research.
“I think a couple of reasons. First, the law only changed in late 1998 and some of the first cases were at 29 Palms. Second, would you have ever thought to look for a federal statute regarding investigational drugs in order to show the order wasn’t lawful?”
“Hmmmm. Yeah, good point. But how come no one in the SecDef’s office picked up on this? He must have a host of lawyers working for him.”
“Same answer, man. The anthrax program was launched in late 1997 and early 1998, but the law didn’t change until late 1998. So, in the Secretary of Defense’s defense, that law wasn’t out yet. However, the law actually reached back and so it doesn’t grandfather anything. In other words, if the SecDef wants to give troops an IND or a drug unapproved for its applied use, then he has to get a waiver from no one less than the President himself.” I sat back in my chair. I couldn’t have been prouder, although in truth I had done very little of the grunt work. My client, David Ponder, had actually hounded me to contact Mr. Bruce Smith, who had in turn put me in touch with Mr. Lou Michels, a LtCol in the Air Force Reserves and partner at McGuire, Battle and Woods, who sent me a very nice packet of information. By miraculous coincidence, David Ponder was from the same part of Kentucky as Major Sonnie Bates and had followed Major Bates’ case in the press pretty closely, as had his wife Jennifer. Eventually, David’s wife got in touch with Major Bates’ wife, Roxanne, who then connected David with some information and now here I was.
“There’s one other possibility, ya know,” Justin murmured. I sat forward. He looked up. “They knew about the law and just fucking ignored it.” I hadn’t thought of that and refused to consider it; it sounded ominous the way he said it. He went back to reading.
“This is unbelievable,” he said it out loud, but he was talking to himself as he read. I was thinking the same thing. The anthrax program, on its face, violated a federal statute.
Normally, in an orders violation case, the government enjoys a strong presumption that an order is lawful. Usually, all the government has to do is ask the judge to find as a matter of law that an order was lawful and then, once the judge rules in the government’s favor, the prosecutor only has to show that the order was transmitted to the accused and the accused refused to obey it. The defense has a pretty high burden to overcome the presumption of lawfulness… but there I sat with the smoking gun.
The DoD’s own signature on an IND application to amend the existing anthrax license in order to get an indication against aerosolized anthrax, the exact use to which the government was putting the vaccine. I sat there smiling, luxuriating in the feeling. I could tell Justin was, too.
“You know what?” he began, smiling.
“What?” I was smiling back, almost laughing.
“I cannot wait to tell this to Jay tonight at the O club.” I bust out laughing. Jay Town was another of our classmates from Naval Justice School. He and Justin were close friends, had attended The Basic School together, a six month infantry school for all Marine officers, and lived near each other in the Bachelor’s Officers Quarters (BOQ). Unfortunately, however, depending upon one’s view, Jay was assigned as the Deputy Staff Judge Advocate for 1st Marine Aircraft Wing. He was the assistant to the General’s lawyer. In our parlance as defense attorneys, he was a government “hack” and we taunted him endlessly about it. With a few beers in us all, the Officer’s Club on Kadena Air Force Base should supply some laughs that night. He was constantly needling us about our job defending “criminals.”
“Do you think he’ll feel obligated as a government weenie to tell someone about this?” I asked, considering whether we should share it. Our anthrax cases had nothing to do with 1st MAW, so Jay was a spectator on this case. Jay was also a good friend, but then again….
“No, he won’t care.” I nodded agreement. “But that won’t stop me from harassing him as the government representative,” Justin said, laughing.
“In short, sir, that means that if the defense can show that the anthrax vaccine is an investigational new drug, then the order violates the express terms of . . . 10 U.S.C. §1107. The statute creates rights, namely the right to informed consent before any service member accepts an investigational new drug.”
June 27, 2000.
It was almost three months after our first session of court in April. We had a discovery hearing on 9 June that accomplished nothing, just jousting. I could probably get my hands on anything I needed. Bruce Smith, Lou Michels, and some of their cohorts, were quick to answer any email and seemed to have an incredible list of contacts. If, for example, I had a question about FDA licensing procedures, ten minutes later an affidavit from a former high-ranking FDA official, now retired, appeared on my fax machine.
“So,” I continued, “it’s the defense’s contention that under Supreme Court case law, under FDA regulations, and under any of the other applicable standards that have been set forth as to what is an investigational new drug, the defense will put on evidence to show that the anthrax vaccine is an investigational new drug.” Okinawa in late June was tropical, so it was hot in the courtroom. I looked over to see Petty Officer Ponder with a sheen of sweat on his forehead, but it might just as well be from nerves. I could feel my white tee-shirt sticking to me under my “Charlie”, service “C”, uniform. The air conditioner was on, which made a noise like a 707 engine being turned up. I had to speak loudly.
“Therefore, if it is an investigational new drug and service members are being forced to take it against their will, that violates statutory rights that have been conferred by the Executive Order and the statute, 10 U.S.C. §1107.” I felt like I was starting to hit my stride. “And I would note, sir, that in the Manual for Courts-Martial . . . on page IV-20, at the top of the page, the first full paragraph – it says, ‘Relationship to Statutory or Constitutional Rights. The order must not conflict with the statutory or Constitutional rights of the person receiving the order.’” I had set it out as clearly as I could and the judge appeared genuinely interested, or he was doing a good job of faking it.
I sat down and wrote some notes and we debated some discovery issues and eventually the government called the Group surgeon to put some evidence in the record about the threat of anthrax and the general nature of the anthrax program. During the doctor’s direct testimony, I made some notes, but I couldn’t have cared less about what he was going to say. While the judge was going to allow me to cross-examine the doctor, a Navy Commander, it would be for giggles mostly. He had very limited information on the program. Our case would rise and fall on 10 U.S.C. §1107, not on my cross-examination of a Navy doctor.
Back in my office, I put my air conditioner on full and tried to pull the sticky tee-shirt away from my body. David Ponder and Justin were in the room. I turned to newly pinned Captain Constantine.
“Well, how did it come off? Do you think the judge got it?” I was asking for reassurance more than critique. It was lonely in defense and it wasn’t often that someone came and watched a case to offer support.
“I was actually looking for pointers on how to present the arguments for Arroyo’s case. I thought it went pretty well.” Justin represented PFC Vittolino Arroyo, one of three Marines who had all refused the shot together. Justin and I represented LCpl Jason Stonewall together.
“Sir, I thought you did great.” David Ponder sounded genuinely impressed, with his southern drawl. He was as sincere a person as I had ever met. It was the first time a client had used such words; most clients I had acquitted were less effusive than David was being.
“I just hope he gets it,” I mumbled to myself as much as anyone else. On some visceral level, it was crucial for me to convince the judge. I had crossed over the line at some point from mere advocacy to personal entreaty. I believed in 10 U.S.C. §1107 as fervently as my young daughters believed in Santa Claus, probably more so.
I went to the window and opened it. There was a slight breeze stirring the hot, sticky, Okinawan air, a few scattered clouds in an otherwise blue sky. I heard a familiar slapping and thudding sound and looked to the right, over the trees toward Marine Corps Air Station Futenma, perhaps a mile straight line distance from where I was on Camp Foster. A Cobra helicopter was in a climbing left hand turn, the thirty-two inch thick blades beating the air as the pilot climbed to what must be the autorotation pattern altitude of one-thousand feet. Those blades were truly awesome in their power, the tips turning at just under the speed of sound, each blade weighing 385 pounds. I had once seen what they could do to another aircraft and the human body up close. In 1996, I had served on an aircraft mishap board for a mid-air collision between a Cobra and a CH-46 Sea Knight, or “Phrog”, as it was affectionately known. During that board I had learned that I was selected for the Funded Law Education Program. Sifting through the wreckage, and then having to return home at the end of the day, living a block from the wife and children of one of the dead pilots, had made my decision to either accept or turn down the program a lot easier.
“Beautiful day for flyin’,” I said to no one in particular.
“What’s that, sir?” Ponder asked. I turned around and brought my thoughts back to the present.
“Nothing. Hey, don’t worry too much about the judge denying our discovery. We’re just playing footsy at this point. I can get my hands on everything through “alternative means,” but I was hoping to have the government produce the documents to eliminate any concerns about their authenticity. Even the judge denying our expert, Doctor Nass, isn’t a killer. Remember that biology professor I told you about?”
“Yes, sir. Mr. Cohen, is that his name?”
“Yeah. He said he will testify if we can’t get our expert here and he may not have the specific knowledge that Dr. Nass does, but he’s got a PhD in microbiology and he thinks the program is shitty. So, that gets him there in my book.” Justin laughed.
“What are our chances, sir?” Nobody laughed at David’s question. I had thought about this a lot. I had four acquittals, three of them came in bench trials in front of the same judge now hearing the anthrax cases. Some of the prosecutors had needled me that Judge Stone was partial to me. In reality, the cases had not only been shitty for the government, but I believed, no – knew, they had come out the right way.
“I don’t know, BT3. I mean, there is a federal law that says pretty clearly that you can’t be ordered to take the shot without your informed consent. All we have to show is that the vaccine is investigational and we’ve got the friggin’ application. That would seem to sufficiently rebut the presumption of lawfulness, but the judge was saying some weird things in chambers in Stonewall’s case. I just hope he gives us our chance to put this on in front of a jury. We sure have a lot of evidence.” I nodded toward the box in the corner of my office that was filled with Government Accounting Office reports, briefs, binders, transcripts of other cases, an Inspector General’s report on the contractual relationship between the DoD and the manufacturer, and a number of Congressional committee transcripts and reports. And that didn’t include the stuff I had at home and on my computer, not yet printed.
“Looks like you’re earnin’ what I’m payin’ you, sir,” Ponder cracked. I laughed. Justin moaned. He was always talking about ‘getting out’ and finally getting paid like a ‘real lawyer’ for the work he did.
“Hopefully you’ll still be saying that if the judge loses his mind and things don’t go so well.” I was only half-joking.