Polio Victim's 30-Year Crusade Garners $22.5 Million Award

In May 1979, Elizabeth Tenuto brought her 5-month-old daughter, Diana, to a Staten Island, NY, pediatrician for her second dosage of an oral polio vaccine. A month later, Ms. Tenuto's husband, Dominick, contracted polio, apparently by touching Diana's stool while changing her diaper. Now, three decades after becoming permanently paralyzed, Mr. Tenuto has won a $22.3 million verdict in New York state court against Lederle Laboratories, the giant pharmaceutical company he claims negligently manufactured the vaccine Orimune and failed to warn doctors adequately of its dangers.

The Case

The court action brought by Mr. Tenuto and his wife, Tenuto v. Lederle Laboratories, 001134/1981, finally went to trial in February before Supreme Court Justice Joseph Maltese. After Mr. Tenuto's lead trial counsel, Benedict Morelli, finished summations, Lederle offered $10 million to settle. Mr. Tenuto's lawyers, who had advanced approximately $500,000 in costs over the years, encouraged him to reject the offer. Morelli said in an interview that, after having stood within a few feet of the jurors for three weeks, he was confident of how they would rule. “You need the money,” Morelli said he told his client, “but before that, you need vindication.”

The jury deliberated for one day before awarding Mr. Tenuto $17.5 million for past and future pain and suffering, and $5 million for lost earnings and medical and rehabilitation expenses. The award is $7.5 million greater than the largest Staten Island verdict listed in the database of VerdictSearch, an Incisive Media affiliate of LJN's Product Liability Law & Strategy.

Martin Edelman, who has been on Mr. Tenuto's team from nearly the case's onset, said he was not joyous when the jury announced its findings, but rather “relieved” ' the case has been on his calendar his entire legal career. “This isn't a case,” Edelman said. “It's a crusade.”

Is It Really Over?

However, the case likely is not yet over. Lederle insisted at trial that it had done nothing wrong in its handling of the vaccine, which was approved by the U.S. Food and Drug Administration (FDA); both Morelli and Edelman said they expect the company to appeal.

Polio was officially eradicated from the Americas in 1994. However, litigation continues with regard to the risks posed by the oral vaccine developed by Dr. Albert Sabin, which was long the drug of choice in the campaign against the disease.

Filed in 1981, Tenuto v. Lederle Laboratories is the oldest ongoing non-guardianship case in New York City, according to the Office of Court Administration. Much of the case's first two decades were consumed by motions, discovery and appeals, including a half-dozen rulings in the Appellate Division, 2nd Department. In 1996, the 2nd Department affirmed the dismissal of the case against the Tenutos' now-deceased pediatrician, Leroy Schwartz. Tenuto v. Lederle Laboratories, 234 AD 2d 284. The Court of Appeals reinstated the case the following year. “We have concluded,” the unanimous panel held in the frequently cited Tenuto v. Lederle Laboratories, 90 N.Y.2d 606, “that a duty of reasonable care extended to plaintiffs despite the absence of a direct doctor/patient treatment relationship between them and Dr. Schwartz.”

The Attorneys

Mr. Tenuto's first attorney was Louis Mauriello, a Staten Island solo practitioner who, as he put it in a recent interview, “signed [Tenuto] up when he was in the iron lung.” After 18 months, Mauriello recognized he lacked the resources to fight Lederle on his own and brought on litigator Jerome Edelman, who assigned the case to his son Marty, fresh out of Brooklyn Law School. The senior Mr. Edelman passed away in 2000; the junior Mr. Edelman has worked on the case since the early 1980s. “You can only have one of these cases in your career,” Edelman said.

About six years ago, Edelman asked Morelli, of Morelli & Ratner, a fellow past president of the state Trial Lawyers' Association, to join the team and serve as lead counsel at trial. Morelli's firm, including associate Arthur L. Salmon III, also oversaw a new front in the action, a negligent manufacturing claim, which was added to allegations of defective warnings and required additional discovery.

J. Peter Coll has handled the case for Lederle virtually since its inception, first as a partner at William “Wild Bill” Donovan's now-defunct litigation powerhouse Donovan Leisure Newton & Irvine, and today as the head of a team from Orrick, Herrington & Sutcliffe. Coll, who has argued before the New York Court of Appeals and the U.S. Supreme Court, has served as national counsel for Lederle Laboratories in DTP (diphtheria, tetanus and pertussis whooping cough) vaccine actions. Over the course of his career, his client roster has included numerous top pharmaceutical companies, as well as the late Yankee centerfielder Mickey Mantle.

Coll successfully represented Lederle in a federal court case filed by a man who contracted polio from his granddaughter, who had received Orimune in November 1979, six months after Mr. Tenuto was infected. The 2nd U.S. Circuit Court of Appeals ruled in that case, Plummer v. Lederle Laboratories, 819 F.2d 349 (2nd Cir. 1987), that the warnings given by Lederle were adequate as a matter of law and that the plaintiff had not established that defective warnings were the proximate cause of his condition. Following a series of corporate transactions, Lederle itself is now part of Wyeth Pharmaceuticals, which recently signed an agreement to be acquired by Pfizer.

Edelman attributes the Tenuto case's longevity to the demands of discovery and the pharmaceutical industry's “reflexive” refusal to settle, a product of the industry's relative might. “Their defense,” Edelman said, was “taking every opportunity they can to push every button they can.”

The disparity in resources between Orrick and Edelman & Edelman was never more obvious, Edelman said, than the night he ran into Coll at a restaurant. After Edelman introduced Coll to the one or two other attorneys on his Tenuto team, Coll motioned to the extra-long tables pushed together to accommodate his firm's Tenuto team.

Vaccine 'Epidemic'

At trial, Morelli argued that Lederle's vaccine, Orimune, was an unreasonably dangerous product and that Lederle failed to warn doctors of the risks of “vaccine-associated paralytic polio.” According to the Centers for Disease Control, between 1980 and 1998 ' at a time when more than 300 million doses of the vaccine were distributed ' 144 people in the United States contracted polio via a vaccine, including 86 vaccine recipients and 51 “contact” recipients. In underdeveloped countries, the rates have been much higher: Several small outbreaks have forced entire communities to receive high-dose vaccinations.

Since 2000, all U.S. vaccines administered have used inactivated viruses, reducing the risk of contact-associated polio to zero. Beginning in 1962, Morelli told the jury, Lederle knew it had a problem. The company may have helped end the polio epidemic ' he likened the company's role to the person who takes the lid off a jar after another loosens it ' but had begun a second one, the “vaccine polio epidemic,” as he called it. “There was this incredible failure to warn,” Morelli said in the interview last week at his office in New York City. “We took the warning label and ripped it to shreds.” Schwartz did not warn the Tenutos that Mr. Tenuto's recent hand surgery had made him susceptible to infection from the vaccine, because Lederle had not properly warned him of such risks, Morelli argued.

The plaintiffs also asserted that the particular batch of vaccine Diana received exceeded the federal “reference standard” for whether it could be safely disseminated to the public, Morelli argued.

FDA Approval

The defense contended, among other things, that Mr. Tenuto's disease represented an unavoidable risk of Lederle's efforts to cure the world of polio. “This case challenges ' Orimune, a product that ' eradicated polio in the United States, in the Western Hemisphere and hopefully some day, in the world,” Coll told the jury during his closings.

As for the defective manufacture claim, Coll noted, “[Diana] received either lot 3-452 or lot 3-453. Each of those had been tested by Lederle. Each of them passed all tests conducted by Lederle and then had passed all FDA tests and been approved for release by the FDA.”

Regarding the failure-to-warn, he added, “Each of those lots contained the same package insert and that insert had been approved by the FDA ' The package insert warned of contact polio and it tells the doctor to inquire about the immunization status of household contacts.”

Procedurally, Lederle also asserted pre-emption ' the company could not be sued in state court, it contended, because a federal agency, the FDA, had exclusive jurisdiction to regulate the vaccine. The U.S. Supreme Court had never addressed the pre-emption issue ' until, in a great coincidence, the middle of the Tenuto trial.

About halfway through the month-long trial, Justice Maltese ' the case's fourth judge ' interrupted the proceedings. A decision had just come down in Levine v. Wyeth. The judge printed out copies of the 80-page ruling and everyone read the holding together: State lawsuits serve as a complement to federal actions, not an obstruction, the 6-3 majority ruled. (Somewhat coincidentally, Levine involved the same defendant as the present case, Wyeth.)

In his closings, Morelli told the jurors he would understand if they held only Lederle liable, and not co-defendant Schwartz's estate. “I'm not sure the warning [label] was good enough for him to do anything with it,” Morelli said. The jury apparently agreed, finding Lederle 100% liable for Mr. Tenuto's condition.

For Mr. Tenuto, much has changed in the three decades between his diagnosis and the verdict. He aged from 31 to 61. He lost his job and, unable to work, spent more than 20 years volunteering at a hospital. His marriage broke up, and his ex-wife died. His three daughters are now adults ' the youngest, Diana, recently turned 30. Mr. Tenuto is now a grandfather, twice over.

“It's still going to be hard,” Mr. Tenuto told reporters after the verdict came in. “The money will come in handy to pay for health [care] and things I need.”

Lederle's attorney, Coll, declined to comment. Doug Petkus, a spokesman for Wyeth, said the company is “exploring our appellate options.” The company also disputed Morelli's claim of a “vaccine-associated epidemic.”

“Mr. Morelli's assertion about cases of vaccine associated paralytic polio is baseless,” Petkus said in a statement. “While there are a few reported cases that occasionally appear, you cannot lose sight of the millions who've been saved from the ravages of polio thanks to immunization. The oral polio vaccine (OPV) is universally credited with eradicating wild polio from the Western Hemisphere and is still used today in eradication efforts in other places in the world.”

Mark Fass is a reporter for the New York Law Journal, an Incisive Media sister publication of this newsletter in which this article first appeared.

In May 1979, Elizabeth Tenuto brought her 5-month-old daughter, Diana, to a Staten Island, NY, pediatrician for her second dosage of an oral polio vaccine. A month later, Ms. Tenuto's husband, Dominick, contracted polio, apparently by touching Diana's stool while changing her diaper. Now, three decades after becoming permanently paralyzed, Mr. Tenuto has won a $22.3 million verdict in New York state court against Lederle Laboratories, the giant pharmaceutical company he claims negligently manufactured the vaccine Orimune and failed to warn doctors adequately of its dangers.

The Case

The court action brought by Mr. Tenuto and his wife, Tenuto v. Lederle Laboratories, 001134/1981, finally went to trial in February before Supreme Court Justice Joseph Maltese. After Mr. Tenuto's lead trial counsel, Benedict Morelli, finished summations, Lederle offered $10 million to settle. Mr. Tenuto's lawyers, who had advanced approximately $500,000 in costs over the years, encouraged him to reject the offer. Morelli said in an interview that, after having stood within a few feet of the jurors for three weeks, he was confident of how they would rule. “You need the money,” Morelli said he told his client, “but before that, you need vindication.”

The jury deliberated for one day before awarding Mr. Tenuto $17.5 million for past and future pain and suffering, and $5 million for lost earnings and medical and rehabilitation expenses. The award is $7.5 million greater than the largest Staten Island verdict listed in the database of VerdictSearch, an Incisive Media affiliate of LJN's Product Liability Law & Strategy.

Martin Edelman, who has been on Mr. Tenuto's team from nearly the case's onset, said he was not joyous when the jury announced its findings, but rather “relieved” ' the case has been on his calendar his entire legal career. “This isn't a case,” Edelman said. “It's a crusade.”

Is It Really Over?

However, the case likely is not yet over. Lederle insisted at trial that it had done nothing wrong in its handling of the vaccine, which was approved by the U.S. Food and Drug Administration (FDA); both Morelli and Edelman said they expect the company to appeal.

Polio was officially eradicated from the Americas in 1994. However, litigation continues with regard to the risks posed by the oral vaccine developed by Dr. Albert Sabin, which was long the drug of choice in the campaign against the disease.

Filed in 1981, Tenuto v. Lederle Laboratories is the oldest ongoing non-guardianship case in New York City, according to the Office of Court Administration. Much of the case's first two decades were consumed by motions, discovery and appeals, including a half-dozen rulings in the Appellate Division, 2nd Department. In 1996, the 2nd Department affirmed the dismissal of the case against the Tenutos' now-deceased pediatrician, Leroy Schwartz. Tenuto v. Lederle Laboratories , 234 AD 2d 284. The Court of Appeals reinstated the case the following year. “We have concluded,” the unanimous panel held in the frequently cited Tenuto v. Lederle Laboratories , 90 N.Y.2d 606, “that a duty of reasonable care extended to plaintiffs despite the absence of a direct doctor/patient treatment relationship between them and Dr. Schwartz.”

The Attorneys

Mr. Tenuto's first attorney was Louis Mauriello, a Staten Island solo practitioner who, as he put it in a recent interview, “signed [Tenuto] up when he was in the iron lung.” After 18 months, Mauriello recognized he lacked the resources to fight Lederle on his own and brought on litigator Jerome Edelman, who assigned the case to his son Marty, fresh out of Brooklyn Law School. The senior Mr. Edelman passed away in 2000; the junior Mr. Edelman has worked on the case since the early 1980s. “You can only have one of these cases in your career,” Edelman said.

About six years ago, Edelman asked Morelli, of Morelli & Ratner, a fellow past president of the state Trial Lawyers' Association, to join the team and serve as lead counsel at trial. Morelli's firm, including associate Arthur L. Salmon III, also oversaw a new front in the action, a negligent manufacturing claim, which was added to allegations of defective warnings and required additional discovery.

J. Peter Coll has handled the case for Lederle virtually since its inception, first as a partner at William “Wild Bill” Donovan's now-defunct litigation powerhouse Donovan Leisure Newton & Irvine, and today as the head of a team from Orrick, Herrington & Sutcliffe. Coll, who has argued before the New York Court of Appeals and the U.S. Supreme Court, has served as national counsel for Lederle Laboratories in DTP (diphtheria, tetanus and pertussis whooping cough) vaccine actions. Over the course of his career, his client roster has included numerous top pharmaceutical companies, as well as the late Yankee centerfielder Mickey Mantle.

Coll successfully represented Lederle in a federal court case filed by a man who contracted polio from his granddaughter, who had received Orimune in November 1979, six months after Mr. Tenuto was infected. The 2nd U.S. Circuit Court of Appeals ruled in that case, Plummer v. Lederle Laboratories , 819 F.2d 349 (2nd Cir. 1987), that the warnings given by Lederle were adequate as a matter of law and that the plaintiff had not established that defective warnings were the proximate cause of his condition. Following a series of corporate transactions, Lederle itself is now part of Wyeth Pharmaceuticals, which recently signed an agreement to be acquired by Pfizer.

Edelman attributes the Tenuto case's longevity to the demands of discovery and the pharmaceutical industry's “reflexive” refusal to settle, a product of the industry's relative might. “Their defense,” Edelman said, was “taking every opportunity they can to push every button they can.”

The disparity in resources between Orrick and Edelman & Edelman was never more obvious, Edelman said, than the night he ran into Coll at a restaurant. After Edelman introduced Coll to the one or two other attorneys on his Tenuto team, Coll motioned to the extra-long tables pushed together to accommodate his firm's Tenuto team.

Vaccine 'Epidemic'

At trial, Morelli argued that Lederle's vaccine, Orimune, was an unreasonably dangerous product and that Lederle failed to warn doctors of the risks of “vaccine-associated paralytic polio.” According to the Centers for Disease Control, between 1980 and 1998 ' at a time when more than 300 million doses of the vaccine were distributed ' 144 people in the United States contracted polio via a vaccine, including 86 vaccine recipients and 51 “contact” recipients. In underdeveloped countries, the rates have been much higher: Several small outbreaks have forced entire communities to receive high-dose vaccinations.

Since 2000, all U.S. vaccines administered have used inactivated viruses, reducing the risk of contact-associated polio to zero. Beginning in 1962, Morelli told the jury, Lederle knew it had a problem. The company may have helped end the polio epidemic ' he likened the company's role to the person who takes the lid off a jar after another loosens it ' but had begun a second one, the “vaccine polio epidemic,” as he called it. “There was this incredible failure to warn,” Morelli said in the interview last week at his office in New York City. “We took the warning label and ripped it to shreds.” Schwartz did not warn the Tenutos that Mr. Tenuto's recent hand surgery had made him susceptible to infection from the vaccine, because Lederle had not properly warned him of such risks, Morelli argued.

The plaintiffs also asserted that the particular batch of vaccine Diana received exceeded the federal “reference standard” for whether it could be safely disseminated to the public, Morelli argued.

FDA Approval

The defense contended, among other things, that Mr. Tenuto's disease represented an unavoidable risk of Lederle's efforts to cure the world of polio. “This case challenges ' Orimune, a product that ' eradicated polio in the United States, in the Western Hemisphere and hopefully some day, in the world,” Coll told the jury during his closings.

As for the defective manufacture claim, Coll noted, “[Diana] received either lot 3-452 or lot 3-453. Each of those had been tested by Lederle. Each of them passed all tests conducted by Lederle and then had passed all FDA tests and been approved for release by the FDA.”

Regarding the failure-to-warn, he added, “Each of those lots contained the same package insert and that insert had been approved by the FDA ' The package insert warned of contact polio and it tells the doctor to inquire about the immunization status of household contacts.”

Procedurally, Lederle also asserted pre-emption ' the company could not be sued in state court, it contended, because a federal agency, the FDA, had exclusive jurisdiction to regulate the vaccine. The U.S. Supreme Court had never addressed the pre-emption issue ' until, in a great coincidence, the middle of the Tenuto trial.

About halfway through the month-long trial, Justice Maltese ' the case's fourth judge ' interrupted the proceedings. A decision had just come down in Levine v. Wyeth. The judge printed out copies of the 80-page ruling and everyone read the holding together: State lawsuits serve as a complement to federal actions, not an obstruction, the 6-3 majority ruled. (Somewhat coincidentally, Levine involved the same defendant as the present case, Wyeth.)

In his closings, Morelli told the jurors he would understand if they held only Lederle liable, and not co-defendant Schwartz's estate. “I'm not sure the warning [label] was good enough for him to do anything with it,” Morelli said. The jury apparently agreed, finding Lederle 100% liable for Mr. Tenuto's condition.

For Mr. Tenuto, much has changed in the three decades between his diagnosis and the verdict. He aged from 31 to 61. He lost his job and, unable to work, spent more than 20 years volunteering at a hospital. His marriage broke up, and his ex-wife died. His three daughters are now adults ' the youngest, Diana, recently turned 30. Mr. Tenuto is now a grandfather, twice over.

“It's still going to be hard,” Mr. Tenuto told reporters after the verdict came in. “The money will come in handy to pay for health [care] and things I need.”

Lederle's attorney, Coll, declined to comment. Doug Petkus, a spokesman for Wyeth, said the company is “exploring our appellate options.” The company also disputed Morelli's claim of a “vaccine-associated epidemic.”

“Mr. Morelli's assertion about cases of vaccine associated paralytic polio is baseless,” Petkus said in a statement. “While there are a few reported cases that occasionally appear, you cannot lose sight of the millions who've been saved from the ravages of polio thanks to immunization. The oral polio vaccine (OPV) is universally credited with eradicating wild polio from the Western Hemisphere and is still used today in eradication efforts in other places in the world.”

Mark Fass is a reporter for the New York Law Journal, an Incisive Media sister publication of this newsletter in which this article first appeared.