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A Case of Bad Blood - Lawyers Weekly

Submitted by bierlaw on Mon, 01/01/2007 - 1:00am

"Will you take our case?"

Attorney Bruce A. Bierhans looked across his desk at Bill Modestino and his wife, Brenda. Their son's short life had been filled with illness - first, severe hemophilia, and then the devastating AIDS virus that killed him in 1993.

But Bierhans had to be honest."You're never going to get an expert witness to testify against the doctors. I can't help you," he apologized.

The Modestinos had come to Bierhans' office in search of an attorney to help them sue the doctors who had treated their son Bill Jr. for his hemophilia in the 1980s.

They claimed that these doctors knew about the AIDS virus and its potential to be transmitted through the blood products used by hemophiliacs like their son. But instead of warning the Modestinos about the danger, the doctors continued to prescribe infusions of clotting factor for Bill Jr. "These doctors were the safety net. They failed. I want to tell the story," Bill Modestino told Bierhans.

When the couple left his office that afternoon, Bierhans assumed that he would never see them again. He hoped that they would be able to receive some compensation from the blood-products companies that were being sued for products liability in AIDS-tainted blood class actions. Bierhans never expected to be the one who would help them tell their story.

But one year later, Bill Modestino walked back into Bierhans' office. He had found a doctor to testify against the hematologists who had treated his son.

Dr. Ben Dawson, a hematologist at Johns Hopkins Medical Center in Maryland, had been persuaded by the persistent client to testify in the case.

"His affidavits got us over the first medical malpractice hurdle in this case," recalls Bierhans, who agreed to represent the Modestinos after their second visit to his office.

It was a pivotal decision for the lawyer, and the inception of what is believed to be the first medical-malpractice case involving blood tainted with AIDS to go to trial.

The case held remarkable challenges for Bierhans and Stephen J. Delamere, in tracking down expert witnesses, reconstructing the history of a blood supply (and, in some ways, the AIDS virus itself) and overcoming tenuous notions of causation.

And while the Modestinos would not win a money verdict in the case, a jury would make a critical finding of negligence on the part of doctors - a ruling that could pave the way for future trial wins.

 

Severe Hemophilia

William M. Modestino Jr. was born on Jan. 13, 1961 in Scituate, the fourth child and only son in a close-knit family. Shortly after he was born, doctors told his parents Brenda and Bill Sr. that their new baby was a hemophiliac.

Bill Jr. had been born with the genetic code for Hemophilia B, meaning that he lacked the protein known as Factor IX, which would enable his blood to clot.

Bruises, bumps and stress that would hardly slow a normal child could be life threatening for Bill Jr., and his parents quickly learned that his life could depend on a blood coagulation product known as factor concentrate. In the 1960s and early '70s, the Modestinos would take their son to the hospital for infusions. But eventually they learned to use factor concentrate at home, where his mother or sister - who is a nurse - would infuse him.

Factor concentrate contains the clotting factor that stops bleeding in people without hemophilia. Each vial of factor concentrate contains the coagulating factor from the blood of approximately 20,000 donors.

In 1974, at the age of 13, Bill Jr.'s parents took him to see Dr. Peter H. Levine at New England Medical Center in Boston. A renowned hematologist, Dr. Levine and his team began treating Bill Jr. The Modestinos eventually followed their doctor to Memorial Hospital in Worcester, where he established the New England Comprehensive Hemophilia Treatment Center.

Bill Jr. was treated for his hemophilia at the Worcester clinic until his death in 1993. Soon after Dr. Levine started the clinic, Bill Jr. began seeing Dr. Doreen B. Brettler. The Modestinos were concerned about Bill Jr. seeing anyone other than Dr. Levine, but he assured them that although he had less patient contact, he was still running the clinic, and the doctors there were as qualified as he was.

In the late 1970s, the Modestinos began a home infusion program for Bill Jr., which enabled them to treat his "bleeds" without a trip to the hospital. Bill's doctors encouraged his parents to treat him "early and aggressively" by infusing him with factor concentrate when he had a bleed, or in anticipation of a stressful event like a math exam.

In September of 1982, Bill Jr.'s doctors prescribed a new and more effective factor concentrate, Autoplex, to treat his bleeds. A vial of Autoplex contained the coagulating factor from the blood of approximately 100,000 donors.

 

Deadly Blood Supply

Unfortunately for Bill Jr., more potent factor concentrate was not the only change to blood products in the United States in the early 1980s. Patients were showing up in hospitals across the country with a terrifying and unknown disorder that shut down their immune systems and made them vulnerable to a host of horrible illnesses.

We now know that these patients, at that time most often homosexual men or IV drug users, were suffering from AIDS. And in the early 1980s, Bill Jr.'s family and lawyer contest, his doctors knew it too.

According to Bierhans, blood products are big business. Families of hemophiliacs spend up to $100,000 a year on factor concentrate. And donors are literally the lifeline of the blood products industry.

Frighteningly, the donors who were targeted well into the 1980s were often homosexual men, IV drug users and prisoners. They were the population most likely to be infected with Hepatitis, and the blood companies wanted their blood because it contained antibodies needed to make hepatitis vaccine.

Advertisements ran in gay men's magazines soliciting blood donors who had had hepatitis. What the ads didn't say was that blood left over after the hepatitis vaccine was created would be added to the blood supply to make factor concentrate.

Remarkably, the vast ocean of blood use to treat hemophiliacs was carelessly being poisoned with hepatitis - or worse.

"Hepatitis was always in the factor," says Bierhans. "Doctors knew for years that factor concentrate carried hepatitis. So if you're treating hemophiliacs and you now know about AIDS, you'd have to say, why couldn't factor concentrate also carry AIDS?" Bierhans argued that Bill Jr.'s doctors should have made the connection, and that they had enough information to make it as early as July 1982.

"A lot of meetings were held nationally with the Center for Disease Control and the National Hemophiliac Foundation, and physicians like Drs. Levine and Brettler attended and read about these meetings," says Bierhans.

The doctors at the Worcester clinic "had more access to knowledge about the AIDS threat to hemophiliacs than other doctors all over the country," Bierhans notes, pointing to CDC meeting minutes with Dr. Levine's name on them.

 

Safety Net Fails

But, says Bierhans, Bill Jr.'s doctors did not warn him or his family about the threat of AIDS. They did not suggest that he attempt alternatives, such as rest and immobilization, to infusing himself with factor concentrate.

"He could have stayed home. He might not have worked full time. If he had a minor bleed, he might have chosen not to use factor, but to stay home and immobilize the joint to stop the internal bleed rather than injecting himself with something that we now know killed him," says Bierhans, pointing out that the doctors' silence did not give Bill Jr. these choices.

Instead, in 1983, Bill Jr.'s doctor prescribed 20 vials of clotting factor from a lot known as NC9117. His mother infused him with the factor, and as parents of all hemophiliac children do, she logged the date, lot number and number of units in an infusion log book.

This simple entry would prove crucial in a courtroom nearly 20 years later.

 

"Choice Between Life And Death"

When Bierhans took the Modestinos' case, he focused on an informed consent theory.

"How could infusion with infected factor concentrate have potentially been averted? That is the question I wanted answered in the case," says Bierhans.

The theme of the lawyer's opening statement was that "he had a right to make a choice between life and death. It was his right, not his physician's, to make a choice about whether to use factor concentrate or not," Bierhans recounts.

Bierhans used documents gathered from earlier blood products litigation to support this theory of negligence and medical malpractice by Bill Jr.'s physicians.

"A lot of the information wasn't produced to us by the doctors in discovery, but was available to us through the document depository in the earlier class action," notes Bierhans, referring to the class action brought by hemophiliacs and their families against the blood products manufacturers.

That case settled for more than $1 billion after "60 Minutes" aired a searing expose entitled "Bad Blood," covering what the blood products companies knew about AIDS-tainted blood, and when they knew it.

The Modestino family opted out of that settlement, which would have paid them approximately $100,000. They later settled with the blood products companies for more than three times that amount, and funded their medical-malpractice case with that money.

One of the documents from the blood products litigation ended up being marked as Exhibit 15 in the Modestino case.

It was an excerpt from the MMWR - Morbidity and Mortality Weekly Report - dated July 16, 1982, and was frighteningly prescient.

The document stated that the "CDC recently received reports of three cases of Pneumocystis carinii pneumonia among patients with hemophilia A and without other underlying diseases. Two have died ... all three were heterosexual males: none had a history of intravenous drug abuse. ... The clinical and immunologic features these patients share are strikingly similar to those recently observed among certain individuals from the following groups: homosexual males, heterosexuals who abuse IV drugs, and Haitians who recently entered the United States. Although the cause of the severe immune dysfunction is unknown, the occurrence among the three hemophiliac cases suggests the possible transmission of an agent through blood products."

Bierhans argued that information like this was widely available to hematologists in 1982 and 1983, and that Bill Jr.'s doctors camped on the blood products companies' party line that a hemophiliac's chances of getting AIDS from factor concentrate were a million to one. Unfortunately, they were wrong.

By the time "60 Minutes" aired "Bad Blood," 10,000 hemophiliacs had been infected by AIDS-tainted blood products.

On the program, interviewer Ed Bradley sat with Dr. Don Francis, a world renowned epidemiologist who was heavily featured in Randy Shilt's 1987 bestseller "And The Band Played On: Politics, People and the AIDS Epidemic" as one of the first doctors to sound the alarm about AIDS.

Bradley turned to Francis, and asked him point blank if he thought the blood products companies had murdered 10,000 people. The camera closed in on Francis, who said that yes, they had.

Francis likened infusing with just one lot of factor complex to having sex with 20,000 people - many of whom were donors targeted for their contribution to hepatitis vaccines, meaning that they were often gay men from big cities and IV drug users.

Bierhans knew he needed Francis to testify as an expert in the Modestino case.

A hero to the hemophiliac community, Francis had taken on the blood companies during the '80s, had testified in hundreds of lawsuits, and had been portrayed by Matthew Modine in HBO's version of "And The Band Played On."

But Francis was through testifying in lawsuits. In fact, as Bierhans prepared the Modestino case, "Don was in Thailand with his company VaxGen, doing Phase III clinical trials on what will probably be the world's first HIV vaccine," recalls the lawyer.

Bierhans explains that Francis had stopped testifying in blood-products lawsuits because it had become almost a full-time job for the former CDC epidemiologist.

Fortunately for the Modestinos, Bierhans had a connection to Francis.

"I met Marcus Conant, who was the dermatologist in 'And The Band Played On,' in New York in 1998. He had testified in the products cases, and he agreed to testify as our AIDS expert in the Modestino case," recalls Bierhans, adding that Conant has treated more than 5,000 AIDS patients since he first noticed the new outbreak of Kaposi's sarcoma, a rare cancer, among his gay patients in San Francisco in 1981.

In further meetings in California, Conant told Bierhans, "I think I can get Don." The two doctors were friends, brought together by their work with HIV, and Conant thought Francis would be willing to testify in the first medical-malpractice case involving AIDS-tainted blood.

He was right.

"I flew to San Francisco and had dinner with Don Francis and Marc Conant. I flew back that night with an agreement from Francis to testify in our case, and he did," remembers Bierhans.

 

Learn As You Go

From what began as an initial client meeting in which Bierhans told the Modestinos that they would never find an expert, the case "took on a life of its own."

"It was like a huge snowball rolling down a hill," says Bierhans, who now had Conant as an AIDS expert, Francis as an epidemiologist, and the head of a hematology clinic at Children's Hospital in Orange County, Calif., Dr. Geni Bennetts, as a hematology expert. Bennetts had taken almost all of her patients off of factor concentrate as soon as she learned of the possible AIDS risk, and had lost only one patient to the disease.

But Bill Modestino Sr. felt that there was another chapter of the story that needed to be told.

"Bill's father's chief complaint was always that the doctors had not treated his son properly once they knew that he was a potential victim of AIDS," says Bierhans.

"I was always more focused on informed consent, but as the case developed, the AIDS treatment aspect of the case became equally important," Bierhans admits.

Bierhans and Delamere found a lab report showing that Bill Jr. had given blood in 1984, which was not tested for HIV until 1987. A blood test for HIV was available in 1985.

Delamere also found a crucial document cataloging Bill Jr.'s CD4, or "helper cell," counts. This report showed that "his CD4 count was 228 in 1986, and in 1989, it had dropped to literally nothing, meaning that he had no helper cells left, no immune system," explains Bierhans.

Even more disturbing was the fact that Bill Jr.'s blood was not tested for two years. No samples were taken in 1987, or 1988.

"His AIDS was neglected for two years, and possibly during the most important years for him, because AZT became available in 1987," notes Bierhans. "He was not even told that he had AIDS until 1988."

Had Bill Jr.'s AIDS been treated aggressively, there is a possibility that he would have lived to receive the "cocktail," a combination of drugs that allows many people with HIV to live healthy lives long past the initial incubation period of 10 years.

"The AIDS treatment aspect of the case really developed while the case was being tried. We had the evidence, but its significance took on meaning as the case was being tried," Bierhans explains, adding that medical science was constantly changing even while the Modestino case was progressing between 1995 and 2001.

 

Putting The Puzzle Together

Everything was coming together for Bierhans and Delamere. They now had a log proving that Bill Jr. had infused with NC9117 in 1983. They also had a February 1984 letter from the National Hemophilia Foundation, sent to doctors across the country, which stated that NC9117 had been recalled by its maker, Cutter Laboratories, because a donor whose plasma had been used in that lot had developed AIDS.

"We were actually able to match up [one of Bill's] infusions with a lot that was recalled because there was an AIDS victim in the donor pool," Bierhans says. "Bill Jr. was never informed of this recall. His family didn't even know about NC9117 until we made the discovery in this case.

"He died in July of 1993, and infused with NC9117 in July, 1983, exactly 10 years, which was the accepted CDC incubation period for AIDS."

Bierhans knew that it was going to be difficult to prove with medical certainty that NC9117 had been the factor concentrate that killed Bill Jr. A severe hemophiliac who needed large doses of factor concentrate to stop his bleeds, Bill Jr. had infused with many lots in the early 1980s, and any one of them could have contained the HIV bullet that eventually caused his death.

But Bierhans and Delamere now had strong support for the argument that the Modestinos' doctors knew about the AIDS risk in the early 1980s, that they were negligent in failing to warn Bill Jr. of the risk, and that they were negligent in failing to aggressively test him for AIDS or treat him for it.

"Dr. Brettler didn't start Bill Jr. on AZT until 1989. It was licensed in 1987. She tried to use the excuse [at trial] that AZT wasn't used in hemophiliacs then, but she wasn't able to produce any evidence that AZT was used in hemophiliacs any later than it was used in other AIDS patients," says Delamere, noting that he thinks Brettler's weak testimony on this subject led the jury to find her negligent in tracking and treating Bill Jr.'s AIDS.

After listening to Bierhans' stable of world-renowned experts, the Worcester Superior Court jury also found Dr. Brettler negligent in failing to inform the Modestinos about the potential that their son could contract AIDS if he continued to infuse with factor concentrate.

The Modestinos were thrilled. Six years of emotionally and physically exhausting preparation had resulted in a trial that allowed them to tell the story of "the safety net that failed."

"Very often people make the tired remark that the case wasn't about money. This really wasn't about money for the Modestinos. They accomplished exactly what they set out to accomplish," Bierhans smiles, noting that the Modestinos have two grandchildren who are hemophiliacs.

He admits that the six years leading up to trial were difficult and draining for both him and Delamere, as well as the Modestino family.

"There were times when they were close to giving up. But they felt that they owed it to their son to follow this case all the way through," says Bierhans, admitting that the case was also a strain on his small practice.

"We have attempted to run a law practice at the same time we've been doing this, but I'd be lying if I didn't tell you that this took up a substantial portion of the last six years," admits Bierhans.

Although the jury found Dr. Brettler negligent, it could not make the causal connection between her negligence and Bill Jr.'s death.

So the amount of the verdict totaled $0.

But Bierhans dismisses the notion that the case was a "loss."

"The importance is that we got the verdicts on negligence, which is something that had never been decided before," says Bierhans, noting that he was aware all along that proving that Bill Jr. died as a result of the factor concentrate that Dr. Brettler prescribed, or that he would have lived to receive the AIDS cocktail if she had started him on AZT sooner, was close to impossible.

"But even if they couldn't have saved the lives of severe hemophiliac adults like Bill, they could have saved the lives of children," Bierhans adds, noting that he has a similar case close to trial that involves a hemophiliac AIDS patient who was 4 years old at the time that the CDC recommended that children under 4 stop using factor concentrate until it could be treated to kill the AIDS virus (a process that is used now).

Bierhans and Delamere hope that the negligence finding in the Modestino case will open the door for the families of other hemophiliac AIDS patients, and that their hard work and the Modestinos' perseverance will have paid off.

"It was unbelievable when the jury came back and the verdict was read, because I never really thought we'd get there, but we did. Because of the relationship I developed with this incredible family, I'd do it all over again," concludes Bierhans.

In a few months, when Bierhans tackles his second hemophiliac/AIDS case, he will do just that.

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