Just a few years after HIV entered the world blood supply over half of the hemophiliacs in the U.S. were infected with HIV, not to mention other dangerous viruses like hepatitis B and hepatitis C. The story of how and why this happened is recounted in “Blood on Their Hands: How Greedy Companies, Inept Bureaucracy, and Bad Science Killed Thousands of Hemophiliacs” (Rutgers University Press), a first-hand account of the legal battles fought on behalf of the hemophiliacs who were sickened by tainted clotting products.
It’s a riveting story, expertly told by Eric Weinberg—a New Jersey attorney who worked tirelessly for years on end on behalf of victims—and co-author Donna Shaw, a professor of journalism and the chair of the Journalism and Professional Writing program at The College of New Jersey. It’s also a hair-raising story, because what unfolded was anything but unforeseeable.
As Eric Weinberg notes in the following Failure interview, clotting medicines like Factor VIII and Factor IX transformed the lives of hemophiliacs beginning in the last 1960s and ’70s, allowing them to live relatively normal lives. (Hemophilia is a bleeding disorder in which the blood doesn’t clot normally. As a result, people with hemophilia bleed for a longer time than others after injury, and may also bleed internally, especially in the knees, ankles and elbows.) The advent of freeze-dried blood-clotting concentrates—made from human plasma and sold in glass vials along with sterile saline and syringes—allowed patients to self-administer the medicines, whenever and wherever they needed treatment.
Yet the process of manufacturing medicines like Factor VIII involved collecting plasma at commercial plasma centers, which were often located in prisons, low-income communities and skid row neighborhoods. As such, they attracted donors who were more likely than most to be infected with dangerous viruses. Worse yet, once collected, big shipments of the frozen plasma would be taken to a processing facility, where thousands of units at a time would be dumped into enormous vats. This saved on manufacturing costs but meant that patients who took “the factor” were exposed to a high risk of contracting hepatitis and HIV.
As we now know, Big Pharma, government regulators and many doctors were aware of the potential dangers, especially after patients began falling ill. Manufacturers could have rendered the medicines germ-free, yet “until a foreign competitor began heat-treating its hemophilia medicines to kill viruses, none of the major fractionators that purchased plasma from prisoners or other high-risk sellers followed suit,” note Weinberg and Shaw in the book.
In the course of the interview below, Weinberg discusses the process that was used to collect and process the plasma, the legal challenges faced in trying to get justice for the victims, how the litigation was resolved, and whether he views the outcome of the cases as a success or failure.
The book opens with a vignette from Louisiana State Penitentiary at Angola. Tell me about where companies were getting their supplies of plasma in the 1970s and ’80s.
The manufacturers—which included Baxter, Bayer and Rhone-Poulenc—would collect plasma from paid donors. People would come in, they would be hooked up to the collection machines, the whole blood was taken from them, then the plasma would be fractionated out and the red blood cells returned to the body. Since this was the method of collection, it would permit donors—who were paid five, ten or fifteen bucks—to return more than once a week. So vast amounts of the human plasma were collected from paid donors in prisons and urban areas, and these were the sources of most of the human plasma used to produce the products.
There was some controversy about the source of the plasma, and buying the plasma was not a great idea. That was the position taken by some pretty responsible people in the medical and scientific community, because when you are purchasing plasma from folks—they used the word donors but they were paid—those people need money. They are usually not working and have other issues, and in the prisons there were high incidences of hepatitis. In the private community—same thing—you had people who had already been infected with transmissible blood borne viruses. So using paid donors was controversial because there were concerns about the rates of infected or tainted plasma. Going back to the seventies the concern was not HIV, which was not known yet, it was hepatitis B and a newly discovered strain of hepatitis initially called Non-A, Non-B, which later became known as hepatitis C.
Part of what we argued as a duty of care on the companies was to find ways to sterilize the plasma collected from paid donors. To be clear, when companies like Baxter and Bayer would collect this plasma they would either have their own centers or have contracts with companies that ran these plasma centers. The plasma would be collected from donors and it would be frozen and shipped to the manufacturers’ plants, which were located mainly in the U.S. When shipments arrived they would be fractionated and the clotting factor—Factor VIII or Factor IX—would be dumped into vats—big, gleaming metal vats.
So when the plasma products were produced and packaged and put into vials that could be mixed with saline and drawn into needles and infused in the body, the plasma came from thousands or tens of thousands of paid plasma donors. The relevance of that to the litigation was, when you’re exposing someone who is a hemophiliac to the plasma of literally thousands of paid donors, you’re increasing the risk that there will be infectious viruses in the product because the more donors the more risk.
Of course, the endgame that brought us into the litigation was that the rate of infection in the hemophilia community was very high. As a result of the way the product was manufactured, most of the community that was using these products on a regular basis got infected with viruses, including HIV.
The process of pooling the plasma sounds egregious. Did the companies have an understanding of what they were exposing people to?
That was an issue in the case. They did have an understanding; the feeling expressed by the companies was that the benefit of the product outweighed the risk. That is, the benefit of the clotting factor product—the way it affected and impacted people’s lives was substantial. It enabled them to travel and move around and not have to go to the doctor’s office or the hospital. They could infuse themselves or could be infused by family members.
But it also increased the risk of infection and ultimately our contention was that the risk, which was known to the companies, outweighed the benefits, particularly since the sterilization of fractions of plasma had been developed back in the 1940s and ’50s when plasma products were used on soldiers and there were outbreaks of jaundice. [That is], scientists were hired by the companies to develop methods of sterilization, methods that were very successful. Our position was that that could have been done for these clotting factor products as well.
The reason it wasn’t done, I believe, is that Factor VIII and Factor IX are heat sensitive enzymes and if the enzymes are not stabilized they can be destroyed by heat very easily. But our contention was that those processes were available and discoverable and developable and they could be scaled up—and should have, given the risk.
Our argument was that infectious diseases in products made from human plasma hold the risk of transmitting new, previously undiscovered viruses. The story of hepatitis C was a baseline story for us because that was an example of a virus not previously recognized that was recognized by the mid-1970s or so to be in the plasma. That confirmed the risk that new viruses can appear, therefore sterilization is essential for the protection of the patients.
Hemophiliacs didn’t understand the dangers they were being exposed to, right?
Well, every person with hemophilia has a different understanding; everybody comes to the table with their own mindset. I don’t think it’s fair to say they didn’t have an understanding. Having worked closely with folks in the community, I believe they accepted the position of the companies that the benefits of the product outweighed the risks. But our argument was that that was an incorrect assumption and the proof of that is what happened, because HIV infection was devastating.
Tell me about some of the challenges faced in getting justice for the victims.
When I got into the cases back in the early nineties a number had been tried to verdict. All but one had been defense verdicts and the one plaintiff’s verdict had been reversed. So it was difficult to prove risk, it was difficult to prove knowledge; it was difficult to prove the availability of methods to inactivate or sterilize—to basically remove the viral contaminants. And the arguments about benefit and risk were compelling. Those were defenses that were raised very effectively by companies and the lawyers who represented them. These were very difficult cases to win. Our job was not easy.
And the statute of limitations was an issue as well?
The statute of limitations was a defense because most people with hemophilia were infected beginning in 1978, ’79, ’80, ’81, ’82. The infections with HIV continued into ’83, ’84, ’85. But a lot of time passed between when the infections occurred and when people came forward with their claims.
The statute of limitations varies state by state but is basically calculated from when someone is aware they have been injured due to the potential negligence or improper conduct of another, and it’s a year up to sometimes three or four years. But those periods of time had passed.
In our cases, which were in New Jersey and New York, we recognized this was a major problem. So we were motivated to develop a strategy to get the laws changed—to extend the statutes of limitations for these people, who were innocent people. They didn’t delay filing lawsuits because they didn’t care or because they thought the law didn’t apply to them. They didn’t file cases because having HIV was humiliating and it was a difficult decision to make.
Ultimately, one of the things that we did that I was very pleased about was to develop community-based efforts to persuade legislators in New Jersey and New York to extend the time within which people with hemophilia could bring their claims. And we were successful. Christy Whitman in New Jersey and George Pataki in New York signed these bills into law. I don’t think there were any other states in which the statutes of limitations were extended by statute. So it was a problem.
But we were able to survive statute of limitations challenges in many cases because of changes in the law, or based on arguments that statutes of limitation for children under the age of 18 typically don’t begin to run until they reach the age of majority.
Then there were some cases that survived because the arguments were made that “I didn’t know that there was a failure on the part of the companies,” so the statute couldn’t have begun to run when I was infected. And those arguments were successful. But it was a tough issue for the plaintiffs, for sure.
How was the litigation resolved?
We started in 1991; the litigation started a few years before that. We got a lot of people coming in the door in the community and we filed individual cases. Then in 1993 a number of lawyers filed for Multidistrict Litigation and class action litigation. Multidistrict Litigation is a statutory setup that’s the consolidated litigation of a large number of claims with similar background. If the panel of senior federal judges deems the matter appropriate for Multidistrict Litigation (MDL) handling, the motions are granted and the matter is assigned to a single federal judge. In our case it was Judge John F. Grady in Chicago, in the northern district of Illinois.
All of the cases that had been filed in federal court were then transferred to that court for management. And that judge would then appoint steering committees—on both sides—of lawyers who had experience and knowledge. I was appointed to that committee by Judge Grady. We also had individual cases in New Jersey and New York that were in state court so they were not transferred to the MDL.
Basically what happened was that the companies made offers of settlement in 1996 that resolved most of the claims. The damage was $100,000 per victim, which some of us thought was a low number, but again, the risks of litigation were substantial. So it was accepted by most. Then a number of folks who had filed their individual cases rejected the offer and had their cases proceed individually. Ultimately those cases were also resolved and the settlements were, in our cases, higher than $100,000. The settlements were confidential but we were pleased with those results. It all came to an end in the early 2000s.
What should we learn from this?
The lesson is that when products are made in the health industry, whether they are biologic products, blood products, pharmaceutical drugs or other kinds of products, there’s always going to be a balance of benefit-risk assessment. Always. It’s part of the basic format of drugs being approved in the United States. So make sure you understand the risk and benefit. And where there is a risk—and the risk can be eliminated or substantially reduced—the duty of care requires that that be done.
With some time to reflect, do you view the legal resolutions as a success or failure?
I think that getting recovery for everyone was a success. I think that most of the people in the community who received settlements were satisfied, even if the numbers were in some instances lower than we thought or hoped to recover for the group. It took a lot of time and the sadness of this was that a lot of victims died from the diseases that they got from the products.
Was it a success or failure? That’s a very good question and I think the answer is it was both. I think the products are better; the companies have done better and I think they learned. I got to meet folks on the company side and a lot of the lawyers representing them. They weren’t bad people but lessons did need to be learned.