Dr. P. Marazzi/Science Source

Vaccines on trial: U.S. court separates fact from fiction

Leah Durant was cleaning the unfinished basement of her home in Falls Church, Virginia, one day in October 2010 when she scraped her hand on a rusty nail. Not long after, the then-37-year-old lawyer was seated in her doctor's office, preparing to receive a tetanus vaccine—a preventive measure that since 1947 has reduced U.S. fatalities caused by the soil-borne bacterium Clostridium tetani 500-fold.

Her physician stood to her left and leaned over her shoulder with the needle.

The pain was immediate, and so excruciating that Durant screamed.

"I knew right then and there that something had gone terribly wrong," she recalls.

Six years later, driven by that painful jab, Durant has become a vaccine injury lawyer with a bustling practice in Washington, D.C., half a mile from a red brick building that houses what is popularly known as the vaccine court. Thirty years ago, federal law established that court—part of the U.S. Court of Federal Claims—to remove vaccine injury cases from the civil courts, where a wave of lawsuits had spooked vaccinemakers and was threatening to cause vaccine shortages.

That law, the National Childhood Vaccine Injury Act of 1986, limited the legal liability of vaccinemakers and created the National Vaccine Injury Compensation Program (VICP) in the Department of Health and Human Services. The VICP is a no-fault route for people injured by vaccines to win damages from a government trust fund financed by an excise tax on vaccines. (Despite the law's title, adults, too, can win compensation for vaccine injuries.)

Vaccine injury attorney Leah Durant, whose shoulder was damaged by an improperly administered tetanus vaccine.

© PAUL FETTERS

Since its first case in 1988, the vaccine court has adjudicated more than 16,000 petitions and dismissed two-thirds of them. To the successful petitioners, and their lawyers, it has awarded about $3.6 billion. The system has attracted scores of attorneys, who are paid hourly legal fees of up to $430 regardless of whether a claim succeeds. The court's website lists 195 lawyers nationwide who are willing to take vaccine cases, although petitioners can hire others. Many are clearly in search of their piece of the $3.7 billion sitting in the trust fund today. A sampling of the bold proclamations on vaccine lawyers' websites include these: "WE HAVE RECOVERED MILLIONS FOR OUR CLIENTS"; "Pursue Compensation"; and "NO COST to you."

Durant's website makes the same point, although in smaller fonts and classier prose. Yet she might be unique in that her own experience drove her into vaccine law. Once an immigration lawyer at the U.S. Department of Justice and later the outspoken director of a nonprofit advocating for stricter enforcement of immigration law, she changed her career course and ultimately became a full-time vaccine injury lawyer after that tetanus shot gone wrong.

Durant's injury, her legal practice, and the petitions filed at the vaccine court offer a window into the real risks of vaccination. Those risks can be as severe as extremely rare, dramatic deaths from anaphylaxis—an overwhelming allergic reaction—or as quotidian as shoulder injuries like Durant's. And although petitions to the court do include the kind of bogus injuries that frighten parents, the most common, and prominent, of those has not been warmly received: Not once has the court compensated a petitioner claiming that a vaccine caused autism.

Durant, who says she makes her living by winning compensation for genuine vaccine injuries, emphasizes the point. "Vaccines keep us healthy. They eradicate disease. If I had children, I would get them vaccinated."

The vaccine court's data show that bona fide vaccine injuries are rare. For every million vaccine doses eligible for compensation that were distributed in the decade beginning in 2006, the court compensated one injury victim. Depending on the gravity of the disease in question, receiving a vaccine is orders of magnitude less dangerous than staying unvaccinated. The tetanus vaccine that Durant received causes a life-threatening allergic reaction in at most 0.0006% of people who get the shot. The U.S. case fatality rate from tetanus, by contrast, is 13.2%.

"One injury from vaccines is one too many, but it is also important to keep perspective," says Sarah Atanasoff, a physician at the VICP in Rockville, Maryland. "The benefits of vaccination to the individual, the local community, and the nation as a whole far outweigh the risks."

Petitions filed with the court suggest that among those real risks, shoulder injuries have become by far the most common. Rarer injuries include Guillain-Barré syndrome (GBS), a neurological malady associated with some influenza vaccines; anaphylaxis, a life-threatening allergic reaction that almost any vaccine can cause and occurs 1.3 times per million vaccinations; intussusception, an intestinal blockage that occurs in between one and five of every 100,000 infants vaccinated against rotavirus; and brachial neuritis (also called Parsonage-Turner syndrome), a painful inflammation of the nerves supplying the hand and arm, which afflicts up to 10 of every million tetanus vaccinees.

Vaccination also can provoke (as well as prevent) febrile seizures, which occur in up to 5% of toddlers who become feverish for any reason. Those seizures are most common after measles, mumps, and rubella (MMR) or the combined MMR and chickenpox vaccine, occurring in up to 300 of each million children vaccinated. Typically lasting 1 to 2 minutes, the seizures can be frightening to witness. But they are transient and almost always without lasting effects.

A cadre of medical experts at the VICP initially assesses injury claims, calling in lawyers from the Department of Justice to defend the government if they think the facts don't support a vaccine injury claim. Eight senior attorneys—called special masters and appointed by judges on the U.S. Court of Federal Claims—rule on the claims. The court is rarely asked to determine whether an injury has occurred—that is virtually always abundantly clear—but whether a vaccine caused that injury. Where the evidence shows that a vaccine did serious or fatal damage, as with a 4-year-old girl who died of anaphylaxis the day after receiving several childhood vaccines, the court awards substantial damages. Her parents received the maximum death benefit under the law: $250,000.

But the court also draws lines when petitioners and their lawyers present weak, implausible cases—like that of a 4-month-old boy who was vaccinated and that night died, facedown, while sleeping under the same heavy covers as his mother. An autopsy found clear evidence that the baby had suffocated—and no evidence of vaccine-induced injury. The case was dismissed.

And in 2010, the court declined to award compensation in an omnibus proceeding that grouped more than 5000 autism claims. Such petitions continue to fail. One typical, recent opinion reads: "The factual record simply does not support Petitioners' contention that the MMR vaccine had any connection to R.A.'s ASD [autism spectrum disorder] diagnosis."

The stabbing pain in Durant's left shoulder worsened in the days after her tetanus shot. "I felt like my arm was falling off," she recalls. She couldn't carry her purse or hold a cup of coffee. She couldn't lift that arm above her head or place it on the steering wheel of her car. She contacted her doctor and relayed her fears that, whatever was going on, the vaccine had caused it. "That's not possible," she recalls him saying. "Needles aren't long enough to do that kind of damage."

Shooting for success

Shoulder injuries are by far the commonest claims at the vaccine court. They result when a needle penetrates the shoulder joint, causing inflammation of tendons and fluid-filled bursas.

Acromion Clavicle Supraspinatus Subacromial bursa Subdeltoid bursa Scapula Deltoid Humerus Radial nerve Axillary nerve To C6 spinal nerve Aim for middle of triangle.Avoiding upper third ensures delicate struc-tures are not touched. Patient and vaccinator both seated.Lowers risk of aiming from above. Lift arm slightly out to side.Bursa will slide underneath the acro-mion for protection. Insert at 90 o angle with dartlike motion. Higher likelihood of reaching muscle depth. Use appropriate needle length.Different builds have various thicknesses of subcutaneous fat. Do no harm 0.625” 1” 1.5”
GRAPHIC: V. ALTOUNIAN/SCIENCE

In fact, needles can do precisely that kind of damage if a vaccine is improperly administered too high on the upper arm, and the needle pierces the deltoid muscle and continues into the shoulder joint. There, physical damage from the needle and, more important, an immune reaction to the injected vaccine can provoke an inflammation that damages tendons, ligaments, and the fluid-filled sacs called bursas that reduce friction in the joint. Late in 2010, scientists in the government's VICP published a description of such injuries and gave them a name: shoulder injury related to vaccine administration.

The government physicians, led by Atanasoff, had identified 13 adults who between 2006 and 2010 petitioned the court for compensation for shoulder injuries and submitted voluminous medical records. None had previous shoulder problems, but each had developed sudden, acute pain and a limited range of motion in a shoulder after a vaccination. Four patients needed surgery, and half of those needed a second operation. Their MRI reports showed shoulder joints riddled with inflammation.

Half reported that the vaccine had been given "too high" in the shoulder. Most had received the vaccine in question—flu or tetanus, and in one case human papillomavirus—in the past, suggesting that the body's immune system was already primed to attack, in an immune response that led to serious, prolonged inflammation in the joint.

The clinical results are not surprising to G. Russell Huffman, an orthopedic surgeon who specializes in shoulders at the University of Pennsylvania Perelman School of Medicine. "If you create this inflammatory response in the shoulder joint, it's going to be manifested not with an hour of pain but with days, months, or possibly years of pain."

Shoulder injury petitions to the VICP have surged as annual flu vaccination has become routine—in 2010, the Centers for Disease Control and Prevention recommended it for everyone except the youngest babies. In 2012, the vaccine court published 15 decisions in which people alleged shoulder injuries. By 2016, 492 of its published decisions mentioned "shoulder injury." That trend may accelerate: Last month, the government added shoulder injuries to a list of injuries for which a victim does not have to prove causation. Now , petitioners need only document that they received a vaccine and within 48 hours developed acute, movement-limiting pain in that previously healthy shoulder.

Durant went through 6 months of physical therapy followed by 18 months of at-home exercises before she felt fully recovered, she says. By then, she had begun to study vaccine injuries and case law. Gradually, she began to take on clients and build a full-time practice. If not for her injury, "I certainly wouldn't be doing this today," she says.

Durant estimates that about 70% of her scores of clients past and present sustained shoulder injuries; the other 30% say they suffered from rare disorders such as brachial neuritis or GBS. Both diseases are thought to result from an autoimmune attack on the myelin that speeds conduction along the peripheral nerves. Both can therefore be triggered by a ramping up of the immune response—typically after an infection but also, on occasion, after a vaccine. Both can be seriously disabling. GBS can paralyze the legs, arms, and even the respiratory muscles. Brachial neuritis can leave arm and hand muscles weakened and wasted.

That was the case for Mark Davis, an implant dentist in Clearwater, Florida. At age 70, he had no plans to retire. But one fall afternoon in 2013, his right hand began cramping so badly that he had to remove the dental tool he was holding by prying open his fingers with his left hand. Over the ensuing weeks, part of his hand grew numb and he lost the ability to retract his thumb—a crucial movement for operating syringes. He awoke one night with excruciating pain extending from his right shoulder to his hand. Remembering his anatomy from dental school, he mused that his pain and the growing weakness in his arm and hand tracked with the brachial plexus, a network of nerves that supplies the limb . Soon, he was forced to sell his practice at a loss.

Weeks later, Davis happened to glance at a medical bill showing a routine tetanus injection he had received 2 weeks before his symptoms began. When he Googled "brachial plexus" and "tetanus vaccine," "my computer lights up like I've gone to the circus," he recalls.

Davis had developed what Joseph Feinberg, a rehabilitation medicine specialist at the Hospital for Special Surgery in New York City, diagnosed several months later as brachial neuritis. Not long after that, again using the internet, Davis found Durant. The vaccine court is still processing his petition: The government contends that irritated nerves in his cervical spine—a problem common in dentists who spend a lifetime leaning over patients—may be responsible.

Today, at 75, Davis's right bicep is withered. "My greatest loss is my inability to do what I really loved to do the most: work," he says. Still, he would get the tetanus shot again. "I am a very strong supporter of vaccination."

Durant is still considering whether to petition the court for compensation for her own injury. "I am keeping my options open."

On one thing she is not undecided: the importance of educating about vaccines. When parents contact her, asking how to get around a vaccination requirement for school entry, she doesn't offer help. Instead, she says, "I talk to them about my personal view about vaccinations and the fact that I feel vaccines are safe."