Saving Vaccines: A Look at How Current Liability Laws Are Keeping Much-Needed Vaccines Off the Market

On April 12, 1955, Thomas Francis stood on a podium at the University of Michigan and announced that Jonas Salk's polio vaccine was safe and effective. At last, Americans would be freed from the bonds of polio, a disease that routinely crippled as many as 50,000 children every year. However, triumph quickly turned to tragedy.

On April 28, 1955, 2 weeks after millions of doses of Salk's formaldehyde-inactivated polio vaccine had been sold to the public, several children developed paralysis. All of the paralyzed children lived in the West and Southwest; all first developed paralysis in the arm that was injected and, although five companies made polio vaccine in 1955, all had received vaccine made by one company ' Cutter Laboratories of Berkeley, CA.

The federal agency responsible for licensing vaccines in 1955, the Laboratory of Biologics Control, asked Cutter to recall all of its vaccine. Unfortunately, it was too late; 120,000 children had already been injected with a vaccine that inadvertently contained live, dangerous polio virus. As a consequence, 40,000 children developed mild polio; 200 were permanently paralyzed, and 10 were killed. It was one of the worst pharmaceutical disasters in U.S. history.

Two years later Melvin Belli, on behalf of his client, Anne Gottsdanker, took Cutter to court. Belli claimed that Cutter was negligent and that it had breached an implied warranty that its vaccine ' listed as inactivated on the label ' did not contain live polio virus (Gottsdanker v. Cutter Laboratories, 6 Cal. Rptr. 320 (Cal. Ct. App. 1960)). The defense team, headed by Wallace Sedgwick, showed the jury two pieces of information that surprised them. First, Cutter was not the only company having trouble inactivating polio virus. All five companies that made Salk's polio vaccine had difficulties inactivating the virus; apparently, scaling-up Salk's polio virus-inactivation protocol had proven to be far more difficult than predicted. Second, Wyeth Laboratories also made a polio vaccine that caused paralysis and death in several children in the Northeast.

After 2 weeks of deliberation, realizing that polio vaccine manufacture was a process still in its infancy, the jury found that Cutter was not negligent. However, under the strong hand of Judge Thomas Ledwich, the jury found that Cutter was guilty of breaching an implied warranty.

Although liability without negligence had been established for foods and beverages, the Gottsdanker verdict was among the first to extend liability without fault to pharmaceutical companies. An article in the Yale Law Journal, titled “The Cutter Vaccine Incident,” stated “[The courts should] establish clearly that manufacturers of products for human consumption are liable for personal injuries caused by their products, not because they are at 'fault' for the injuries, nor because they would have prevented them, but because they can best distribute this unavoidable cost to all persons who benefit from the enterprise.” (Yale Law Journal 65 [1955]: 262-273) The authors of the law review article were saying that it did not matter who was wrong, why they were wrong, or whether the wrong was predictable. The only thing that mattered was who was in the best position to pay when products caused harm.

For 20 years, vaccines were unaffected by the Gottsdanker verdict. In the mid-1970s, however, one vaccine changed everything.

In 1974, a British researcher published a paper claiming that the pertussis (whooping cough) vaccine caused permanent brain damage. At the time the article was published, 80% of children in the United Kingdom received pertussis vaccine; also, mental retardation and epilepsy occurred in children even before the vaccine was available. So the only way to determine whether the British researcher was right was to examine the incidence of mental retardation and epilepsy in children who received the vaccine and compare it with those who did not. Unfortunately, the media in England ' failing to appreciate the difference between proposing a theory about a vaccine and proving that a vaccine was harmful ' seized upon the publication as fact. Urgent reports in the British media warned of permanent brain damage caused by the pertussis vaccine and most parents in England stopped giving the vaccine to their children. Immunization rates dropped from 80% to 30% and, within 2 years, more than 100,000 children in England were hospitalized and 40 killed by pertussis.

Stories that pertussis vaccine harmed children soon appeared in the United States and personal injury lawyers attacked vaccine makers. American lawyers claimed that the pertussis vaccine caused epilepsy, mental retardation, learning disorders, unexplained coma, Reye's syndrome (the sudden onset of coma later found to be associated with aspirin), and Sudden Infant Death Syndrome (sudden unexplained death in the first year of life later found to be associated with sleep position). By 1987, 800 lawsuits totaling more than $21 million were filed and new claims were filed every week. To meet the demand for increased liability insurance and to pay for legal fees and settlements, the cost of the pertussis vaccine increased from 17 cents per dose to $11 per dose.

By the late 1980s and early 1990s, many investigators had examined the question raised by the British researcher; they evaluated hundreds of thousands of children who did or did not receive pertussis vaccine in several different countries. The results were clear, consistent, and reproducible ' the incidence of epilepsy and mental retardation in children who had received pertussis vaccine was the same as in those who did not. The British researcher's hypothesis was wrong; but the damage was done. The number of companies making pertussis vaccine for children in the United States decreased from four (Wyeth, Connaught, Sclavo, and Lederle) to one (Lederle).

In the mid-1980s, Lederle was punished for its persistence. In 1979, 3-month-old Kevin Toner received a pertussis vaccine made by Lederle (Toner v. Lederle Laboratories, 779 F.2d 1429 (9th Cir. 1986); Toner v. Lederle Laboratories, Idaho 732 P.2d 297). Soon after receipt of the vaccine ' because of inflammation of one segment of his spinal cord ' Kevin was completely and permanently paralyzed below the waist. Kevin's parents sued Lederle Laboratories claiming that the pertussis vaccine paralyzed their son. Lederle had several facts on its side: The incidence of children with spinal cord swelling did not increase after the pertussis vaccine was first introduced in the United States in the early 1940s; children immunized with pertussis vaccine did not have a higher incidence of spinal cord swelling than unimmunized children; and natural infection with pertussis bacteria did not damage the spinal cord. In the courtroom, however, science did not matter. The jury ruled against Lederle and awarded Kevin Toner $1.13 million. At the time of the award, gross sales from the pertussis vaccine in the United States were about $2 million and gross sales from all vaccines were about $7 million.

The case of Toner v. Lederle Laboratories showed exactly what can happen when unanticipated events occur. The framers of the revolution in liability law reasoned that pharmaceutical companies should pay for harm caused by their products because, by increasing the price of the product, they were in the best position to defray the cost of increased insurance. However, the framers could not predict how massive those awards would become, and they did not predict that awards would be made even when products were not harmful. The award in the Toner case was the equivalent of one-half of the pertussis vaccine market in the mid-1980s. Pharmaceutical companies looked at this situation and decided to leave the vaccine business. The revolution in liability law ' designed to coerce companies to make safer products by threatening financial punishment ' was causing companies to abandon safe products vital to the nation's health.

Threatened by a return to the pre-vaccine era ' when hundreds of thousands of children were routinely hospitalized, permanently harmed, or killed by vaccine-preventable diseases ' the government stepped forward. In 1986, Congress passed the National Childhood Vaccine Injury Act. The heart of the Act was the Vaccine Injury Compensation Program, a program designed to protect companies from lawsuits not supported by scientific evidence; the program was funded by a federal excise tax on every dose of vaccine. In many ways, the vaccine compensation program was a model system to prevent abuses by personal injury lawyers. Scientists, epidemiologists, virologists, microbiologists, clinicians, and statisticians reviewed scientific studies and recommended to the courts which problems were actually caused by vaccines and which coincidentally followed vaccines. If a child suffered a reaction caused by a vaccine, the program was designed to compensate the family for medical expenses and damages quickly, generously, and fairly.

Unfortunately, the national injury compensation program did not prevent pharmaceutical companies from abandoning vaccines. In 1957, when Cutter Laboratories made a vaccine that was not safe, 26 companies made five vaccines. In 1980, when the first lawsuits against the makers of pertussis vaccine were filed, 17 companies made eight vaccines. In 2004, four big companies (GlaxoSmithKline, Sanofi-Aventis, Merck, and Wyeth) made 12 vaccines. Although some of this de-crease can be accounted for by merger, most represent drop-outs. For example, Eli Lilly and Parke Davis ' the two large companies that made Jonas Salk's polio vaccine ' eventually abandoned vaccines.

Now 20 years old, the federal compensation program is showing its age.

The biggest weakness is that plaintiffs can opt out of the program. Probably the best example is the case against thimerosal. In the spring of 2001, thimerosal (an ethylmercury-containing preservative) was removed from most vaccines. The removal of thimerosal was precipitated by the contention that the level of mercury in vaccines exceeded that recommended by the Environmental Protection Agency. (High levels of mercury can damage the nervous system.) Although mercury levels in vaccines did not exceed guidelines recommended by the Food and Drug Administration, the World Health Organization, or the Agency for Toxic Substances Disease Registry, thimerosal was removed as a precautionary measure. Not surprisingly, some parents felt that thimerosal was removed from vaccines because it caused neurological damage. So they sued vaccine makers. Since lawsuits against thimerosal were filed, four large studies performed in Denmark, the United States, and the United Kingdom showed that children who received vaccines containing thimerosal were not more likely to have neurological problems ' such as speech and language delays, tics, learning disabilities, or autism ' than those who did not receive these vaccines. In 2004, a group of scientists from the Institute of Medicine ' an independent research organization within the National Academy of Sciences ' reviewed studies that examined the relationship between thimerosal and neurological damage; all studies found the same thing: Thimerosal, at the level contained in vaccines, did not cause harm.

Although the science was against them, lawyers pressed forward. About 300 separate lawsuits against vaccine makers are now pending in U.S. courts, and vaccine makers, who have already spent more than $200 million in their defense, are bracing against awards that could threaten their capacity to remain in the vaccine business.

Another problem with the federal vaccine compensation program is that it does not cover vaccines that are not routinely recommended for children. This lack of coverage in part contributed to the elimination of the Lyme vaccine, designed to prevent a disease that affects 23,000 people in the United States every year. Within months of the release of the vaccine in 1998, some people complained of chronic arthritis and sued the vaccine maker, GlaxoSmithKline.

Given the biology of Lyme disease and Lyme vaccine, it did not make sense that the vaccine would cause chronic arthritis. During natural infection, Lyme bacteria enter the joints, multiply, and cause intense inflammation. The Lyme vaccine, consisting of only one bacterial protein, does not enter the joints, does not reproduce itself, and does not cause joint inflammation. Two large studies confirmed the biological implausibility that the Lyme vaccine caused chronic arthritis. Lyme vaccine or no vaccine was given to 20,000 people who were observed for 2 years. The incidence of chronic arthritis ' a fairly common disease in older adults ' was the same in both groups. Nevertheless, lawyers filed many lawsuits on behalf of people claiming that the Lyme vaccine caused them to suffer chronic arthritis, as well as muscle pain, headaches, forgetfulness, memory loss, paralysis, and fatigue. GlaxoSmithKline spent millions of dollars defending its product. The media covered the story that Lyme vaccine might cause chronic arthritis and sales decreased. In 2002, the vaccine was taken off the market. Now, people who live in areas where Lyme disease is prevalent can only hope that they are not among those who are permanently and severely harmed by the bacteria. Because of fears of litigation, it is unlikely that a second Lyme vaccine will ever be made.

A further problem with the federal vaccine compensation program is that it does not include the unborn child when the mother is immunized. For example, newborns are occasionally infected by a bacterium called group B streptococcus (“GBS”). GBS infects the bloodstream, the brain, and the spinal cord; every year in the United States about 2000 babies are infected with GBS and 100 die. GBS kills more children in the first month of life than any other bacterial infection. Unfortunately, most vaccines in the United States and the world are not given until 1 or 2 months of age ' too late to prevent GBS.

In 1988, Carol Baker, a pediatrician and researcher at Baylor University in Houston, TX, found a way to eliminate GBS infections in babies by immunizing pregnant women with a GBS vaccine. Although several pharmaceutical companies were interested in Dr. Baker's findings, none stepped forward to develop her vaccine; they did not step forward because they did not dare to immunize pregnant women.

Pharmaceutical companies know that about 2% of all children born in the United States have birth defects and that, by chance alone, if 100 mothers were immunized with a GBS vaccine, two would bear children with birth defects. Even if study after study showed that the incidence of birth defects was the same in women who got the vaccine as in women who did not get it, manufacturers could not trust that the value of these studies would be appreciated by judges and juries. So a technology that would clearly save lives sits on the shelf. “We could make a group B strep vaccine tomorrow,” said one senior pharmaceutical company scientist. “But it would have to be given to pregnant women and we couldn't handle the liability.”

In the end we have to ask ourselves this question: “Who represents the interests of the thousands of children hospitalized, permanently harmed, and killed by viruses and bacteria for which new vaccines ' because of fear of liability ' may never be developed?”

On April 12, 1955, Thomas Francis stood on a podium at the University of Michigan and announced that Jonas Salk's polio vaccine was safe and effective. At last, Americans would be freed from the bonds of polio, a disease that routinely crippled as many as 50,000 children every year. However, triumph quickly turned to tragedy.

On April 28, 1955, 2 weeks after millions of doses of Salk's formaldehyde-inactivated polio vaccine had been sold to the public, several children developed paralysis. All of the paralyzed children lived in the West and Southwest; all first developed paralysis in the arm that was injected and, although five companies made polio vaccine in 1955, all had received vaccine made by one company ' Cutter Laboratories of Berkeley, CA.

The federal agency responsible for licensing vaccines in 1955, the Laboratory of Biologics Control, asked Cutter to recall all of its vaccine. Unfortunately, it was too late; 120,000 children had already been injected with a vaccine that inadvertently contained live, dangerous polio virus. As a consequence, 40,000 children developed mild polio; 200 were permanently paralyzed, and 10 were killed. It was one of the worst pharmaceutical disasters in U.S. history.

Two years later Melvin Belli, on behalf of his client, Anne Gottsdanker, took Cutter to court. Belli claimed that Cutter was negligent and that it had breached an implied warranty that its vaccine ' listed as inactivated on the label ' did not contain live polio virus ( Gottsdanker v. Cutter Laboratories , 6 Cal. Rptr. 320 (Cal. Ct. App. 1960)). The defense team, headed by Wallace Sedgwick, showed the jury two pieces of information that surprised them. First, Cutter was not the only company having trouble inactivating polio virus. All five companies that made Salk's polio vaccine had difficulties inactivating the virus; apparently, scaling-up Salk's polio virus-inactivation protocol had proven to be far more difficult than predicted. Second, Wyeth Laboratories also made a polio vaccine that caused paralysis and death in several children in the Northeast.

After 2 weeks of deliberation, realizing that polio vaccine manufacture was a process still in its infancy, the jury found that Cutter was not negligent. However, under the strong hand of Judge Thomas Ledwich, the jury found that Cutter was guilty of breaching an implied warranty.

Although liability without negligence had been established for foods and beverages, the Gottsdanker verdict was among the first to extend liability without fault to pharmaceutical companies. An article in the Yale Law Journal, titled “The Cutter Vaccine Incident,” stated “[The courts should] establish clearly that manufacturers of products for human consumption are liable for personal injuries caused by their products, not because they are at 'fault' for the injuries, nor because they would have prevented them, but because they can best distribute this unavoidable cost to all persons who benefit from the enterprise.” (Yale Law Journal 65 [1955]: 262-273) The authors of the law review article were saying that it did not matter who was wrong, why they were wrong, or whether the wrong was predictable. The only thing that mattered was who was in the best position to pay when products caused harm.

For 20 years, vaccines were unaffected by the Gottsdanker verdict. In the mid-1970s, however, one vaccine changed everything.

In 1974, a British researcher published a paper claiming that the pertussis (whooping cough) vaccine caused permanent brain damage. At the time the article was published, 80% of children in the United Kingdom received pertussis vaccine; also, mental retardation and epilepsy occurred in children even before the vaccine was available. So the only way to determine whether the British researcher was right was to examine the incidence of mental retardation and epilepsy in children who received the vaccine and compare it with those who did not. Unfortunately, the media in England ' failing to appreciate the difference between proposing a theory about a vaccine and proving that a vaccine was harmful ' seized upon the publication as fact. Urgent reports in the British media warned of permanent brain damage caused by the pertussis vaccine and most parents in England stopped giving the vaccine to their children. Immunization rates dropped from 80% to 30% and, within 2 years, more than 100,000 children in England were hospitalized and 40 killed by pertussis.

Stories that pertussis vaccine harmed children soon appeared in the United States and personal injury lawyers attacked vaccine makers. American lawyers claimed that the pertussis vaccine caused epilepsy, mental retardation, learning disorders, unexplained coma, Reye's syndrome (the sudden onset of coma later found to be associated with aspirin), and Sudden Infant Death Syndrome (sudden unexplained death in the first year of life later found to be associated with sleep position). By 1987, 800 lawsuits totaling more than $21 million were filed and new claims were filed every week. To meet the demand for increased liability insurance and to pay for legal fees and settlements, the cost of the pertussis vaccine increased from 17 cents per dose to $11 per dose.

By the late 1980s and early 1990s, many investigators had examined the question raised by the British researcher; they evaluated hundreds of thousands of children who did or did not receive pertussis vaccine in several different countries. The results were clear, consistent, and reproducible ' the incidence of epilepsy and mental retardation in children who had received pertussis vaccine was the same as in those who did not. The British researcher's hypothesis was wrong; but the damage was done. The number of companies making pertussis vaccine for children in the United States decreased from four (Wyeth, Connaught, Sclavo, and Lederle) to one (Lederle).

In the mid-1980s, Lederle was punished for its persistence. In 1979, 3-month-old Kevin Toner received a pertussis vaccine made by Lederle ( Toner v. Lederle Laboratories , 779 F.2d 1429 (9th Cir. 1986); Toner v. Lederle Laboratories , Idaho 732 P.2d 297). Soon after receipt of the vaccine ' because of inflammation of one segment of his spinal cord ' Kevin was completely and permanently paralyzed below the waist. Kevin's parents sued Lederle Laboratories claiming that the pertussis vaccine paralyzed their son. Lederle had several facts on its side: The incidence of children with spinal cord swelling did not increase after the pertussis vaccine was first introduced in the United States in the early 1940s; children immunized with pertussis vaccine did not have a higher incidence of spinal cord swelling than unimmunized children; and natural infection with pertussis bacteria did not damage the spinal cord. In the courtroom, however, science did not matter. The jury ruled against Lederle and awarded Kevin Toner $1.13 million. At the time of the award, gross sales from the pertussis vaccine in the United States were about $2 million and gross sales from all vaccines were about $7 million.

The case of Toner v. Lederle Laboratories showed exactly what can happen when unanticipated events occur. The framers of the revolution in liability law reasoned that pharmaceutical companies should pay for harm caused by their products because, by increasing the price of the product, they were in the best position to defray the cost of increased insurance. However, the framers could not predict how massive those awards would become, and they did not predict that awards would be made even when products were not harmful. The award in the Toner case was the equivalent of one-half of the pertussis vaccine market in the mid-1980s. Pharmaceutical companies looked at this situation and decided to leave the vaccine business. The revolution in liability law ' designed to coerce companies to make safer products by threatening financial punishment ' was causing companies to abandon safe products vital to the nation's health.

Threatened by a return to the pre-vaccine era ' when hundreds of thousands of children were routinely hospitalized, permanently harmed, or killed by vaccine-preventable diseases ' the government stepped forward. In 1986, Congress passed the National Childhood Vaccine Injury Act. The heart of the Act was the Vaccine Injury Compensation Program, a program designed to protect companies from lawsuits not supported by scientific evidence; the program was funded by a federal excise tax on every dose of vaccine. In many ways, the vaccine compensation program was a model system to prevent abuses by personal injury lawyers. Scientists, epidemiologists, virologists, microbiologists, clinicians, and statisticians reviewed scientific studies and recommended to the courts which problems were actually caused by vaccines and which coincidentally followed vaccines. If a child suffered a reaction caused by a vaccine, the program was designed to compensate the family for medical expenses and damages quickly, generously, and fairly.

Unfortunately, the national injury compensation program did not prevent pharmaceutical companies from abandoning vaccines. In 1957, when Cutter Laboratories made a vaccine that was not safe, 26 companies made five vaccines. In 1980, when the first lawsuits against the makers of pertussis vaccine were filed, 17 companies made eight vaccines. In 2004, four big companies (GlaxoSmithKline, Sanofi-Aventis, Merck, and Wyeth) made 12 vaccines. Although some of this de-crease can be accounted for by merger, most represent drop-outs. For example, Eli Lilly and Parke Davis ' the two large companies that made Jonas Salk's polio vaccine ' eventually abandoned vaccines.

Now 20 years old, the federal compensation program is showing its age.

The biggest weakness is that plaintiffs can opt out of the program. Probably the best example is the case against thimerosal. In the spring of 2001, thimerosal (an ethylmercury-containing preservative) was removed from most vaccines. The removal of thimerosal was precipitated by the contention that the level of mercury in vaccines exceeded that recommended by the Environmental Protection Agency. (High levels of mercury can damage the nervous system.) Although mercury levels in vaccines did not exceed guidelines recommended by the Food and Drug Administration, the World Health Organization, or the Agency for Toxic Substances Disease Registry, thimerosal was removed as a precautionary measure. Not surprisingly, some parents felt that thimerosal was removed from vaccines because it caused neurological damage. So they sued vaccine makers. Since lawsuits against thimerosal were filed, four large studies performed in Denmark, the United States, and the United Kingdom showed that children who received vaccines containing thimerosal were not more likely to have neurological problems ' such as speech and language delays, tics, learning disabilities, or autism ' than those who did not receive these vaccines. In 2004, a group of scientists from the Institute of Medicine ' an independent research organization within the National Academy of Sciences ' reviewed studies that examined the relationship between thimerosal and neurological damage; all studies found the same thing: Thimerosal, at the level contained in vaccines, did not cause harm.

Although the science was against them, lawyers pressed forward. About 300 separate lawsuits against vaccine makers are now pending in U.S. courts, and vaccine makers, who have already spent more than $200 million in their defense, are bracing against awards that could threaten their capacity to remain in the vaccine business.

Another problem with the federal vaccine compensation program is that it does not cover vaccines that are not routinely recommended for children. This lack of coverage in part contributed to the elimination of the Lyme vaccine, designed to prevent a disease that affects 23,000 people in the United States every year. Within months of the release of the vaccine in 1998, some people complained of chronic arthritis and sued the vaccine maker, GlaxoSmithKline.

Given the biology of Lyme disease and Lyme vaccine, it did not make sense that the vaccine would cause chronic arthritis. During natural infection, Lyme bacteria enter the joints, multiply, and cause intense inflammation. The Lyme vaccine, consisting of only one bacterial protein, does not enter the joints, does not reproduce itself, and does not cause joint inflammation. Two large studies confirmed the biological implausibility that the Lyme vaccine caused chronic arthritis. Lyme vaccine or no vaccine was given to 20,000 people who were observed for 2 years. The incidence of chronic arthritis ' a fairly common disease in older adults ' was the same in both groups. Nevertheless, lawyers filed many lawsuits on behalf of people claiming that the Lyme vaccine caused them to suffer chronic arthritis, as well as muscle pain, headaches, forgetfulness, memory loss, paralysis, and fatigue. GlaxoSmithKline spent millions of dollars defending its product. The media covered the story that Lyme vaccine might cause chronic arthritis and sales decreased. In 2002, the vaccine was taken off the market. Now, people who live in areas where Lyme disease is prevalent can only hope that they are not among those who are permanently and severely harmed by the bacteria. Because of fears of litigation, it is unlikely that a second Lyme vaccine will ever be made.

A further problem with the federal vaccine compensation program is that it does not include the unborn child when the mother is immunized. For example, newborns are occasionally infected by a bacterium called group B streptococcus (“GBS”). GBS infects the bloodstream, the brain, and the spinal cord; every year in the United States about 2000 babies are infected with GBS and 100 die. GBS kills more children in the first month of life than any other bacterial infection. Unfortunately, most vaccines in the United States and the world are not given until 1 or 2 months of age ' too late to prevent GBS.

In 1988, Carol Baker, a pediatrician and researcher at Baylor University in Houston, TX, found a way to eliminate GBS infections in babies by immunizing pregnant women with a GBS vaccine. Although several pharmaceutical companies were interested in Dr. Baker's findings, none stepped forward to develop her vaccine; they did not step forward because they did not dare to immunize pregnant women.

Pharmaceutical companies know that about 2% of all children born in the United States have birth defects and that, by chance alone, if 100 mothers were immunized with a GBS vaccine, two would bear children with birth defects. Even if study after study showed that the incidence of birth defects was the same in women who got the vaccine as in women who did not get it, manufacturers could not trust that the value of these studies would be appreciated by judges and juries. So a technology that would clearly save lives sits on the shelf. “We could make a group B strep vaccine tomorrow,” said one senior pharmaceutical company scientist. “But it would have to be given to pregnant women and we couldn't handle the liability.”

In the end we have to ask ourselves this question: “Who represents the interests of the thousands of children hospitalized, permanently harmed, and killed by viruses and bacteria for which new vaccines ' because of fear of liability ' may never be developed?”