Take My Hand(73)
One day, after I handed Lou a sack containing a peanut butter sandwich and a banana, I heard him mutter something under his breath.
“What’s wrong?”
“The American Civil Liberties Union just sent me documents revealing that hundreds of Black women in North Carolina and South Carolina were sterilized. But the defense is objecting to me introducing them, because they weren’t in pretrial discovery.”
“Can you ask the judge for an exception?”
“I can, but he might not allow it.”
“Eat your banana.” I peeled back the skin. He took a bite, resting his other hand on the railing. The mezzanine had emptied. Two students smoked cigarettes over an ashtray in the lobby down below.
“What’s happening here is unfolding every day, Lou. Surely the judge reads the newspaper.”
Lou paused his chewing. “He’s not supposed to read stories that might affect his judgment.”
“You have indigestion, don’t you?” I watched him closely.
“How do you know?”
“You just rubbed your belly.”
“Do you mind going to buy me some Tums?”
“Sure. How long do we have?”
“An hour. I’ll meet you back here.” He took off, swinging his briefcase at his side.
After the recess, Lou sat at the table, rolling the unopened Tums package between his fingers. The judge entered, and everyone stood.
“Please be seated.”
“Your Honor,” Lou said. “Counsel would like to approach the bench.”
The defense lawyers followed Lou to the judge’s podium. They conferred with the judge and returned to their places.
“Your Honor, you have in front of you Exhibit A. The Food and Drug Administration’s Code of Federal Regulations, updated April 1 of this year.”
“Thank you.”
“You also have Exhibit B, the FDA’s guide on the protection of human subjects. This guide references the Kefauver-Harris Amendment to the act in 1962, which increased the FDA’s regulatory authority over the clinical testing of new drugs.”
Either the judge’s face was naturally set in a permanent scowl or he did not like Lou. Whenever he peered at the young lawyer over his spectacles, it appeared to be a look of disdain. I could see why Lou was wary of him.
Lou continued, “As you will see, Article 130.37 stipulates that any use of investigational new drugs on humans must be based on the condition that investigators have obtained consent. In the eighth section of that article, it defines consent as”—he looked down to read—“?‘the person involved has legal capacity to give consent, is so situated as to be able to exercise free power of choice, and is provided with a fair explanation of pertinent information concerning the investigational drug.”
“I can read, Mr. Feldman.”
“Of course, Your Honor.”
The defense lawyer stood. “Your Honor, the use of Depo-Provera was hardly used for investigative purposes. It was authorized for use as a contraceptive.”
“It was not authorized by the Food and Drug Administration,” Lou countered.
“This was not an investigational study. The federal government would never do that, particularly in the case of minors.”
“Gentlemen, please be seated. You will have your opportunity to present your case. Mr. Feldman, are you alleging that the plaintiffs were injured by Depo-Provera?”
“Your Honor, this is a new drug. The long-term effects on human subjects are yet unknown. We do know that it has caused cancer in laboratory animals.”
“Mr. Feldman, the threshold question is whether the plaintiff alleges that the drug has caused an injury in fact.”
“No, Your Honor, we cannot yet make that claim.”
“Thank you, Mr. Feldman.”
I thought of the time I’d injected the needle into India’s arm. The girl could not speak. She could not protest. She had merely trusted. I had given her the shot only once, but the memory of that moment haunted me. I had not known about the drug, but it had been my duty to know. I was the medical professional, the one with the knowledge that was out of reach for a family like the Williamses. I might as well have landed from outer space and told them I was going to feed them a miracle food that would save their lives. And they’d partaken. Because even though I was a Martian, I looked like them. Sitting in that courtroom, I understood for the thousandth time the enormity of my mistake. The utter failure of it. I should have questioned Mrs. Seager about this new drug I knew virtually nothing about before I shot it into the arm of an eleven-year-old girl. Ignorance was not an excuse. I should have known. I had been trained to know and to ask.
“Your Honor, I submit Exhibit C, the Food and Drug Administration’s policies on oral contraceptives. The plaintiffs were never given written material outlining the side effects of the drug.”
The defense lawyer stood again. “Your Honor, the plaintiffs signed consent forms containing the obligatory warnings and notices.”
“Your Honor, three directors at clinics across Alabama have signed affidavits claiming that it was not standard procedure to give written notices to the patients to review. The prosecution contends that this administration of experimental drugs is particularly egregious when the recipients are poor.”
I sat up straighter. The nurses had helped with those affidavits. That was our contribution to the case so far. But we would need more. Three were hardly enough. We had worked in the Montgomery clinic, and we knew firsthand that the warnings about Depo-Provera were given orally, if they were given at all.