Opinion
1134/81.
Decided February 17, 2010.
The plaintiff was represented by: Benedict Morelli, Esq. of Morelli Ratner, Martin Edelman, Esq. of Edelman Edelman, P.C. and Louis Mauriello, Esq.
The defendant Lederle Laboratories was represented by Stephen Foresta, Esq. and J. Peter Coll, Jr., Esq. of Orrick, Herrington Sutcliffe, LLP andby Roger W. Yoerges, Esq. of Steptoe Johnson, LLP. Defendant Estate of Leroy Schwartz, M.D. was represented by Rosary A. Morelli, Esq. of Heidell, Pittoni, Murphy Bach, LLP.
This decision incorporates this court's oral pre-trial and trial decisions along with the written post trial Order dated October 28, 2009, which denied the defendants' motions to set aside or reduce the jury verdict of $22.5 million dollars.
This 1981 case has a long and contentious history which has been ruled upon by the New York Court of Appeals and the Appellate Division, Second Department four times. Amongst other issues it involves a national issue of whether under the "supremacy clause" of the U.S. Constitution, state trial courts are preempted from hearing product liability and failure to adequately warn of risks claims against pharmaceutical companies that are regulated by the U.S. Food Drug Administration (FDA). During the course of this trial, the United States Supreme Court answered that question in the negative in Wyeth v. Levine.
Tenuto v. Lederle Laboratories, et al., 90 NY2d 606 (1997).
Tenuto v. lederle Laboratories, et al., 207 AD2 541 (App. Div 2d Dept. 1994); 234 AD2 284 (App. Div. 2d Dept. 1996); 253 AD2 493 (App. Div 2d Dept. 1998); 276 AD2 550 (App. Div. 2d Dept. 2000).
U.S. Const. Art. VI, cl. 2.
Wyeth v. Levine, 129 S.Ct. 1187 (2009).
Facts
The underlying facts of this case were summarized by the New York Court of Appeals in their 1997 decision which follows:
Id. 90 NY2d at 607 et seq. (1997).
"In May 1979, based upon advice from (defendant) Dr. Schwartz, plaintiffs Dominick and Elizabeth Tenuto presented their five-month-old daughter to him for a second dosage of an oral poliomyelitis vaccine manufactured by defendant Lederle Laboratories, trade named "Orimune." Orimune and other similar oral vaccines consist of three live but weakened strains of the polio virus. Although the pharmaceutical manufacturer had rendered the viruses incapable of producing paralytic disease in a person receiving the vaccine, they cause the production of antibodies which will resist an attack by a wild or virulent polio virus. Typically, oral polio vaccines are administered to infants during their first year of life.
While an oral polio vaccine of live viruses has significant clinical advantages over the alternative, original method of polio vaccination (discovered by Dr. Jonas Salk) involving injection of a vaccine containing killed or inactivated polio virus strains, oral vaccines carry certain unique risks. . . . [O]n a rare but statistically predictable basis, the live viruses lodging in the infant recipient's gastrointestinal tract may grow and revert to virulent form. When those wild viruses are later discharged from the infant's bowel in excretion or from the mouth in saliva, contact with the feces or saliva by the child's adult caretakers may result in infection and, in the case of vulnerable adults (i.e., unvaccinated or where immunization has weakened over time), may result in paralytic polio.
The foregoing risk of parental "contact" polio derived from oral vaccination of a child, has been known since 1961. By the 1970s, United States governmental health officials were recommending that consumers be advised of the risks as well as benefits of oral polio vaccines. Accordingly, as of 1977, defendant Lederle Laboratories included in its Orimune package insert some description of the risks and the recommendation, also reproduced in the Physician's Desk Reference, that such danger be communicated to the parents when an infant is to be orally vaccinated, so that suitable precautions can be taken. The insert also warned against injection of the vaccine directly into the bloodstream.
Plaintiffs also have alleged in their cause of action against Lederle Laboratories that the manufacturer's warnings inadequately conveyed the severity of the risk.
Plaintiffs allege that Dr. Schwartz, although informed that Mr. Tenuto was about to undergo elective surgery, never inquired as to whether he had previously been vaccinated against polio nor advised plaintiffs of the risk of incurring contact polio and of the precautions necessary to prevent exposure, particularly in light of the surgical wound which would result from the immediately impending surgery of Mr. Tenuto.
As a consequence, in caring for his daughter following his operation, Mr. Tenuto was exposed to virulent polio viruses. Within 30 days of the infant's vaccination. Mr. Tenuto began to exhibit the symptoms of paralytic poliomyelitis and was then hospitalized and diagnosed as afflicted with that disease. His polio has rendered him a permanent paraplegic. . .
The Tenutos subsequently brought this action against Dr. Schwartz and Lederle Laboratories, based on Mr. Tenuto's personal injury and his wife's derivative losses. Dr. Schwartz moved to dismiss the claims against him on the ground that they were based entirely on a failure to obtain the statutory informed consent mandated by Public Health Law § 2805-d — claims which would not lie because Dominic and Elizabeth Tenuto were not his patients. Supreme Court (Justice Amman) agreed and granted Dr. Schwartz's motion. The Appellate Division affirmed for the same reason."
207 AD2d 541 (App. Div. 2d Dept. 1994).
The New York Court of Appeals unanimously reversed the Appellate Division, Second Department and the Supreme Court (Amman, J.) ruling that:
"[T]he courts below too restrictively read plaintiffs' allegations contained in the complaint, bill of particulars and other papers. A statutory cause of action pursuant to Public Health Law § 2805-d was not the only cognizable legal theory upon which plaintiffs' allegations rested (citations omitted). Both expressly and by fair implication, plaintiffs have alleged that Dr. Schwartz owed them a duty of care based on common-law principles of ordinary negligence and malpractice. That duty, claimed by plaintiffs, consisted among other things, of complying with the recommendation of the vaccine manufacturer to warn plaintiffs of their personal health risks from the vaccination of their infant daughter, to assess the particular vulnerabilities of plaintiffs to those risks and to advise plaintiffs of precautions to avoid or minimize them. The Court of Appeals concluded, under the circumstances of this case, that a duty of reasonable care extended to plaintiffs despite the absence of a direct doctor/patient treatment relationship between them and Dr. Schwartz. . ."
"[T]he imposition of a duty upon Dr. Schwartz to have warned these plaintiffs and advised them to take precautions if, as plaintiffs allege and their proof may establish, administration of oral polio vaccine to an infant creates a well-recognized danger to parents of incurring contact polio, particularly to a parent of special vulnerability as claimed here. . ."
Id. at 614.
"[D]r. Schwartz knew or should have known that his comprehensive services necessarily brought into play the protection of the health of plaintiffs, who relied upon his professional expertise in providing advice and other forms of medical services (citations omitted) . . . Indeed, if Dr. Schwartz had no responsibility to pass on warnings regarding the dangers associated with the administration of this vaccine, then the duty of the manufacturer to inform doctors of such risks would be meaningless."
Id.
Lederle's 1975 Orimune Packet Insert
ADVERSE REACTIONS:
***
Paralytic disease following the ingestion of live poliovirus vaccines has been reported in individuals receiving the vaccine, and in some instances, in persons who were in close contact with subjects who had been given live oral poliovirus vaccine. The rare occurrence of "vaccine related cases" were considered "compatible" with vaccine induced risk where certain epidemiological criteria incubation, clinical and laboratory values, could be judged compatible with vaccine as a cause. It has been estimated that the risk of vaccine induced paralytic poliomyelitis is about one chance per million doses.
The estimated risk of vaccine-induced paralytic disease occurring in vaccines or those in close contact with vaccinees is extremely low. However, the "risk" should be considered by the physician and such information should be conveyed to the parent(s) at the time of vaccination. Those parents of a vaccinee who have not had previous polio vaccinations should probably be considered among those adults as subject to increased risk of exposure and in this special situation, in the judgment of the physician responsible, protection may be needed for these intimate contacts.
Notwithstanding the duty to warn the parents of Diane Tenuto of the risks of incurring contact polio recognized by the New York Court of Appeals, the defendant, Estate of Dr. Leroy L. Schwartz, M.D., maintained in the medical malpractice and negligence causes of action against him that the standard of care was not to warn parents of the risks because they were too remote.
At trial, Dr. Jeffrey Brown, a board certified pediatrician, was called as an expert by the Estate of Dr. Schwartz. Dr. Brown testified that it was not a standard of care to warn the parents of infants about to receive an oral polio vaccine of any risks of contact polio. The reason he gave was that those risks were too remote and because it was more important to innoculate the children rather than alarm the parent-child care givers of such a remote risk. Dr. Brown testified that the risk of contact polio was one in one million, as outlined in Lederle's 1975 polio vaccine packet insert. Moreover, the Pediatrician's Guide known as "The Red Book" listed the risk at one in ten million. The jury apparently adopted Dr. Brown's argument because it did not find Dr. Schwartz liable for his failure to warn the parents of the risks of contact polio.
Neither this court nor the parties can assume that had Dr. Schwartz been given the more expansive warning in the June 1979 packet insert that he still would not have warned the parents of the risks of contact. Since he was found not to be negligent for not giving the existing warning, no one can predict what he would have done with greater warnings. Consequently, that does not demonstrate a lack of proximate cause as the defendant, Lederle contends.
Pre-Trial Motions
On the eve of trial, after the jury was selected, and beyond the time to make summary judgment motions, the defendant, Lederle, filed yet another motion for summary judgment pursuant to CPLR § 3212 to dismiss the plaintiff's complaint. The defendants claimed a lack of subject matter jurisdiction because state courts are preempted from hearing the plaintiff's claims, that the defendant manufacturer of a U.S. government approved oral polio vaccine (OPV) violated the federal regulations promulgated by the U.S. Public Health Service and later the Bureau of Biologics, the predecessor to the U.S. Food Drug Administration that governed aspects of the production, testing and release of the polio vaccine. The defendant asserted that this court was preempted by The Food, Drug Cosmetic Act, from ever hearing any claim that Lederle Labs breached FDA regulations, which is solely a federal matter under the "supremacy clause" of the U.S. Constitution, and this court cannot entertain a state claim, which purports to be in conflict with federal statutory and regulatory requirements.
21 USC § 337[a].
U.S. Const. Art. VI, cl. 2.
21 CFR § 630.16(b)(1) and 21 CFR § 630.17(b).
This court orally denied the defendant's motion for summary judgment to dismiss the plaintiff's claims as being preempted by federal law, regulations and the supremacy clause of the U.S. Constitution. This court found that the defendant's claims were not only tardy, but that those claims have always been subsumed in the arguments that the defendant violated duties to the plaintiff, which may be found in federal law and federal regulations. This was not a new theory of the plaintiff's case. Common law duties of manufacturing a product that is fit for use or fit for its intended purpose, to include pharmaceutical products and vaccines, play a pivotal role in protecting health and welfare of the state's citizens, which is not in conflict with the federal law and regulations.
Post Judgment Motion
The defendant, Lederle Laboratories, a Division of American Cyanamid Company (Lederle), the manufacturer of the oral polio vaccine, has moved for an order pursuant to CPLR Rule 4404, to set aside the jury's verdict of $22.5 million and enter judgment in favor of Lederle on both of the claims against it or, in the alternative, to grant Lederle a new trial. Lederle has also requested that, in the event this court does not set aside the verdict or order a new trial, the jury's award should be reduced consistent with jury awards for comparable injuries in the Second Department. More specifically, Lederle argues:
At the beginning of the trial, it was stipulated not to amend the original caption. However, the American Cyanamid Company, to include Lederle Laboratories, was acquired by the American Home Products Corporation in 1994 and in 2002 it changed its name to Wyeth Pharmaceuticals, which since the verdict in this case is now a division of Pfizer, Inc.
1. That the negligent manufacturing claim is preempted by federal laws and regulations;
2. That the warnings claim was not a proximate cause of the plaintiff's injury; and
3. That allowing the jury to consider punitive damages and other errors prejudiced Lederle's defense.
On October 28, 2009, this court denied the defendant's post trial motion in its entirety after having reviewed arguments of counsel and the following documents submitted to include Defendant's Notice of Motion, Defendant's Memorandum in Support of Motion, Plaintiff's Memorandum in Opposition, and Defendant's Reply Memorandum. This decision and order memorializes the court's reasoning.
Vaccines, especially ones that contain an attenuated or live virus, as was the case here with the oral polio vaccine, are inherently toxic or dangerous substances. However, the manufacturer of such vaccines has a common law duty to ensure that such vaccines are produced in such a manner not to increase the risk of harm in the user and those foreseeable persons who may come into contact with the vaccine or its byproduct. The common law duty to warn of the dangers of vaccines cannot be obviated by mandates that all children be vaccinated in order to attend elementary and secondary schools.
Now, as part of their post trial motion, Lederle argues that the jury findings of negligent manufacturing should be set aside because the violations of the Code of Federal Regulations (CFR) sections with reference to the manner in which the polio virus was to be tested was preempted by federal law. Therefore, any violation of the CFR should not have been presented to a New York State court and jury to determine whether the manufacturer, Lederle, complied with those federal regulations before releasing the polio vaccine for distribution and use. Lederle also argued that if this court ruled to keep the case then the court, rather than the jury, should have interpreted the regulation to determine whether there was a violation.
Lederle, further argued that even if this court allowed the jury to ascertain whether there was a violation of the regulation, the testimony of the plaintiff's expert, Dr. Michael Sulzinski, a professor of biology and virology should not have been admitted concerning the regulation because the defense experts, Dr. Joseph Quinnan, a former FDA official, and Dr. Mary Ritchey, a former Lederle Vice-President, were more qualified than Dr. Sulzinski and that the vaccine administered to Diana Tenuto complied with the regulations. Moreover, Lederle argues that any violation of the regulation did not create an increased risk of harm to the plaintiff.
The defendant Lederle's second argument is that the plaintiff's inadequate warnings claims fails as a matter of law because no reasonable jury could have found that the package insert in this case was inadequate in any relevant respect. Moreover, Lederle asserts that there was no proximate cause sufficient to connect Lederle's package insert to the plaintiff's contraction of polio.
Lederle's third major point was that this court erred in allowing the jury to determine whether punitive damages were warranted in this case, because such a consideration was prejudicial to the defendant, notwithstanding the fact that the jury answered that punitive damages were not warranted. Lastly, Lederle argues that it is entitled to a new trial because the
court should have elaborated its instruction to the jury that "a vaccine is by its nature inherently an unsafe product" to include a statement that oral polio vaccine can cause vaccine associated polio in rare instances and that it is only when the manufacturer increases that risk by making the product defectively or providing insufficient warnings, that it can be held liable.
Federal Preemption
"Preemption is a doctrine holding that certain matters are of such national character and importance that federal laws governing such matters should preempt state laws on the same subject. Stated generally, the judiciary has employed various factors in determining whether Congress intended to entirely preempt or occupy a particular field of law: (1) the aim and intent of Congress as revealed by the statute itself and its legislative history; (2) the pervasiveness of the federal regulatory scheme as authorized and directed by the legislation and as carried into effect by the responsible federal administrative agency; (3) the nature of the subject matter regulated and whether it is one which demands exclusive regulation in order to achieve a uniformity vital to national interest; and (4) whether, under the circumstances of the particular case, state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress."
98 ALR Fed. 124.
The defense relies upon the language of Chapter 21 of the U.S. Code Section 337 which states in part. . ."all such proceedings for the enforcement, or to restrain violations of the this chapter (Food, Drug Cosmetics Act) shall be by and in the name of the United States." In essences, the defendant claims that persons injured as a result of a violation of the safety regulations promulgated by the FDA cannot pursue state common law claims in product liability or failure to adequately warn of risks of the product.
"As a general rule preemption may be "express" or "implied." In the drug and medical device arena, the clearest example of express preemption is in § 360k(a) of the Medical Device Act of 1976, which reads:
No State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement —
(1) which is different from, or in addition to, any requirement applicable under [the MDA] to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under [the Act]." [emphasis added]
The United States Supreme Court in the case of Medtronic, Inc. v. Lohr concluded that, "[n]othing in § 360k denies [a state] the right to provide a traditional damages remedy for violations of common law duties when those duties parallel federal requirements. Even if it may be necessary as a matter of [state] law to prove that those violations were the result of negligent conduct, or that they created an unreasonable hazard for users of the product, such additional elements of the state-law cause of action would make the state requirements narrower, not broader, than the federal requirement. While such a narrower requirement might be "different from" the federal rules in a literal sense, such a difference would surely provide a strange reason for finding pre-emption of a state rule insofar as it duplicates the federal rule. The presence of a damages remedy does not amount to the additional or different "requirement" that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing requirements under federal law.'" Here, however Orimune is a vaccine not a device.
Medtronic v. Lohr, 518 US 470 [1996].
Id, at 495. (Emphasis original)
The defendant, manufacturer has cited to Buckman Co. v. Plaintiff's Legal Committee , where the U.S. Supreme Court held that plaintiffs' claims of "fraud-on-the FDA" conflict with the FDA's responsibility to police fraud. Moreover, "fraud on the FDA claims" would also cause applicants to fear that their disclosures to the FDA, although deemed appropriate to the Agency, will later be judged insufficient in State courts."
Buckman Co. v. Plaintiffs Legal Committee, 531 US 341, [2001].
Id., at 356.
While Buckman involved a medical device rather than a drug, the court concluded that the potential for confusion, and conflict may support a finding of preemption. But, the plaintiff here has not asserted fraud on the FDA. "The FDA issued a regulation stating that it "believes that under existing preemption principals, FDA approval of labeling under the act, whether it be the old or new format, preempts conflicting or contrary state law."
Federal Register, Vol 71, No 15, Jan. 24, 2006.
During the trial of this case, the U.S. Supreme Court had pending before it the case of Wyeth v. Levine, which examined whether a state court jury may find negligence against a pharmaceutical manufacturer for a drug previously approved by the FDA. The New York Attorney General, as one of 43 state Attorneys General in an amici brief in favor of the plaintiff/respondent, in Wyeth v. Levine argued that state courts should not entertain the amorphous concept of "implied" federal preemption in deciding claims of consumers injured by prescribed pharmaceutical drugs. By signing on to the amici brief, Andrew Cuomo, Esq., the New York Attorney General, outlined the position of the State of New York on the issue of preemption. Only Congress should express when state causes of action are preempted by federal statutes or regulations, not the Food Drug Administration, as Wyeth claimed in that case and persists in claiming in this case.
Brief for Amici Curiae, 129 S. Ct. 337 (2008).
While this case was being tried, the long awaited decision in Wyeth v. Levine came down from the U.S. Supreme Court on March 4, 2009. In Wyeth v. Levine, the U.S. Supreme Court held that state law failure to warn claims against a pharmaceutical manufacturer were inadequate and that such state common law claims were not preempted because the existing warning in the drug packet insert was approved by the federal Food and Drug Administration (FDA). The court went on to hold that the FDA approved labels were not the maximum level of warnings necessary, but merely the minimum and that state common law may impose a higher duty to warn. This may be especially true when the manufacturer as disclosed in this case was aware that there existed an increased risk by taking an oral polio vaccine in that at least 8-10 persons per year were contracting contact polio. With that knowledge, Lederle, the manufacturer neglected to enhance the warnings to health care providers that were administering the Sabin oral polio vaccine, which was a live virus as opposed to the Salk attenuated or dead polio virus vaccine.
129 S. Ct. 1187 (2009).
Prior to the U.S. Supreme Court's decision in Wyeth v. Levine, this court ruled pre-trial that the claims of the plaintiff were not precluded by federal law and that the plaintiffs would proceed to trial. Ironically, since 1977, two years before the plaintiff contracted polio, Lederle had an application in with the FDA to enhance the warning on the oral polio vaccine. However, it took two years for the FDA to approve the label change which occurred in June of 1979, the very month that the plaintiff was positively diagnosed with the polio virus. At the request of the defendant, that fact and the June, 1979 packet insert warnings were not presented to the jury because this court ruled that it was a post incident correction, which would be too prejudicial to present to the jury.
However, there were other means of disseminating a warning to the physicians who prescribed and administered the vaccine, namely through drug sales representatives who routinely visit doctors' offices hawking new and improved drugs and distributing free samples to doctors, as well as through written warning notices that are occasionally sent to doctors and hospitals known as "Dear Doctor letters," which outline a new finding or warning before the federal FDA gets around to reviewing and approving a change in a drug packet insert.
The implied federal preemption argument espoused by the defendant was not recognized by the Supreme Court in Wyeth v. Levine, nor is it the policy of the Executive Branch. On May 20, 2009, President Barrack Obama issued a Memorandum which reminds federal agency heads of the principles of federalism and preemption expanded upon in a 1999 Executive Order of President William J. Clinton entitled Executive Order 13132 (August 10, 1999) "Federalism." President Obama's Memorandum states in part that:
Barrack Obama, Memorandum for the Heads of Executive Departments and Agencies (May 20, 2009).
Executive Order 13132 (Aug. 10, 1999, Federalism).
1. Heads of departments and agencies should not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation.
2. Heads of departments and agencies should not include preemption provisions in codified regulations except where such provisions would be justified under legal principles governing preemption, including the principles outlined in Executive Order 13132.
3. Heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under applicable legal principles governing preemption. Where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation.
Id., Memorandum.
Both the U.S. Supreme Court and the President's policy memorandum should make it clear that unless the Congress expressly preempts a field by specific legislation, state common law claims of negligence, products liability and failure to warn claims may still be handled in state courts.
In order to encourage pharmaceutical companies to manufacture vaccines and not be concerned with vaccine associated injury claims, in 1986, Congress enacted the National Childhood Vaccine Injury Act (NCVIA). The Act provides for a federal no fault system for compensating vaccine associated injuries and deaths. It established a National Vaccine Court within the U.S Court of Federal Claims, which is primarily administered by Special Masters. Persons injured by vaccines administered after 1986 must proceed through the administrative system that the Act established as a prerequisite to filing a civil action. The Act, however, imposes no such requirement with respect to persons injured as the result of vaccines administered prior to the effective date, such as the plaintiff who was injured in 1979. The plaintiff was eligible to participate in the new system, but chose not to do so.
42 USCA §§ 300aa- 1 et seq.
Motions to Preclude Plaintiff's Expert Witnesses
The defendant, Lederle Laboratories, moved pre-trial and again during the trial pursuant to The New York Civil Practice Law and Rules (CPLR) § 3101(d) to preclude the testimony of plaintiff's three experts: Joseph Pagano, M.D., Michael Sulzinski, Ph.D. and Lawrence Steinman, M.D. The reasons proffered for such preclusion or limitation of testimony were:
(1) to exclude certain expert testimony that a) impermissibly usurps the court's role to interpret and determine questions of law; and b) fails to provide any foundation to connect alleged violations of regulation or licensing requirements and the injuries suffered by plaintiff as required by establishing proximate cause; and (2) to direct plaintiff to limit his presentation of cumulative expert testimony to ensure that any point of opinion will be adduced one time only and through only a single witness.
Before the hearing on the motion, defendant, Lederle, made a tardy summary judgment motion to preclude the same three expert witnesses disclosed by the plaintiff to the defendants that were proffered. The three witnesses were proffered to state that the defendant violated certain federal regulations and procedures, which proximately caused the plaintiff's development of polio after he had contact with his infant daughter's feces, who was administered the oral polio vaccine that contained a live virus. The basis of that argument was that the subject matter was preempted by federal law and that the experts were not competent to give such testimony.
One of the plaintiff's proffered experts was Dr. Joseph Pagano, whose curriculum vitae (CV) disclosed that he obtained his Doctor of Medicine degree from Yale University in 1957 and has been on the faculty of the University of North Carolina, School of Medicine from 1973 to the present in various positions relating to microbiology, immunology and cancer. The plaintiff's CPLR § 3101 notice of expected expert testimony from Dr. Pagano is contained in part in Appendix 1A.
The second disclosed plaintiff's expert was Dr. Michael A. Sulzinski, who obtained his Ph.D. from Cornell University in 1984 and who has been a professor of biology, specializing in biochemistry, cell and molecular biology at the University of Scranton in Pennsylvania since 1990. Prior to becoming a full time professor, Dr. Sulzinski was a Senior Research Scientist at Roche Diagnostic Systems of Hoffman-LaRoche, Inc. in Nutley, New Jersey for over three years. Prior to that from December 1984, after he received his Ph.D., until March 1987, he worked as a Molecular Biologist for the defendants, Lederle Laboratories, American Cyanamid Company in Pearl River, New York. Dr. Sulzinski's CPLR 3101(d) notice of expected testimony is contained in part in Appendix 1B.
Lastly, the plaintiff noticed that he would call Dr. Lawrence Steinman, who received his Doctor of Medicine degree at Harvard University in 1973. After graduating from Harvard Medical School, Dr. Steinman served as a Fellow at the Weizmann Institute of Science studying chemical immunology from 1975-1977 and was a Visiting Fellow at the National Institute of Health. He completed a residency in pediatric and adult neurology at Stanford University Hospital in 1980 and was board certified as a Neurologist by the American Board of Psychiatry and Neurology in 1984. Dr. Steinman remained at Stanford as a Medical Professor ever since. He is currently the Chair of the Stanford University Program in Immunology. Dr. Steinman's CPLR § 3101(d) notice of expected testimony is contained in part in Appendix 1C.
It cannot be disputed that the three expert witnesses proffered by the plaintiff all had superior education, training, experience and knowledge in their respective fields and consequently, each of them was qualified to testify in accordance with their expected testimony. The three noticed expert witnesses were permitted to present testimony as outlined in the Notice of Expert Testimony provided they did not overlap each other. The area of federal regulation in overseeing the development, testing, manufacturing and distribution of polio vaccines was beyond the experience of a typical juror and consequently, the expert witnesses were permitted to testify about them to educate the jury, as the triers of fact, which would be helpful in formulating the facts to decide the issues of liability.
The expert witnesses were permitted to opine that if a violation occurred, it could generally cause polio, and each was able to make a causal relationship between the general cause and a specific violation that occurred in this case. Plaintiff's three experts on causation were permitted to testify as to the specific causation of polio in the plaintiff.
Notwithstanding Lederle's assertion in their post trial memorandum, this court did hold a hearing outside the presence of the jury as to the qualifications of Dr. Sulzinski, who was the witness that was going to address the issue of the interpretation and application of the federal regulation in question. After that hearing this court determined that based upon Dr. Sulzinski's education, training, experience and knowledge, that he may testify. Dr. Sulzinski was a Westinghouse Scholar in high school, which in turn gave him a scholarship to Penn State University where he majored in bio-chemistry, cell and molecular biology, and was number one in his graduating class. He went on to Cornell University to complete a Ph.D. where he primarily studied plant viruses which he claims are similar to animal or human viruses, which he also studied. Upon obtaining his Ph.D. he was hired by the defendant Lederle Laboratories in 1985. Amongst other things, Dr. Sulzinski tested the virulence of feces of persons exposed to Type III polio six years after the plaintiff, Dominick Tenuto, contracted Type III polio from the feces of his daughter. He first became aware of the testing protocols contained in the federal regulation when he studied them to prepare for his interview with Lederle. Now Dr. Sulzinski teaches those testing protocols contained in the federal regulation in his virology class at the University of Scranton to pre-med students who are working with the polio virus.
TR 1069 to 1123.
Clearly Dr. Sulzinski was fully familiar with the regulation in question, notwithstanding his modest comment on cross examination that he does not consider himself an expert on the regulation. Indeed, experts on the content of a regulation may be the authors and those that teach it. Persons who apply the regulation must do so in conformance with it. Accordingly, Dr. Sulzinski was allowed to testify about the protocol in the regulation.
Ultimately the jury determined that both general and specific causation were present in this case. Interestingly, in their post trial motion the defendant Lederle only sought to strike the testimony of Dr. Michael Sulzinski, mainly because he stated he was not "an expert" on the regulation of which he was most familiar and teaches as part of his course in virology. In accordance with the pre-trial oral order the plaintiff divided the presentations by the three expert witnesses. Ironically, Dr. Joseph Pagano, who testified about the history of polio, with whom the defendants apparently have no post trial challenge, could have, in accordance with his expert disclosure, presented the same testimony as Dr. Sulzinski, the former Lederle employee, whose testimony the defense wants stricken from the record.
In Strong v. American Cyanamid Co., the Missouri Court of Appeals affirmed a jury verdict against American Cyanamid Co. (Wyeth), the same defendants in this case. In Strong, the plaintiff, like Dominick Tenuto, contracted vaccine associated paralytic polio from the Orimune, oral polio vaccine. Strong sued the manufacturer in products liability and negligent manufacturing claims and, like Tenuto, also sued the pediatrician for failing to warn of the risks of the vaccine.
Strong v. American Cyanamid Co., 261 S.W.3d 493 (Missouri Ct. of App. ED, Div 3, 2007).
Like the verdict in this case, the jury in Strong found the manufacturer liable and found for the pediatrician. The Missouri Court of Appeals, after reviewing the defendant's history with the Orimune vaccine, held that the trial court did not err in allowing the jury to determine whether there was a violation of the regulation based upon the testimony of the plaintiff's expert and the defendant's expert, the same Dr. Mary Ritchey, who testified as the company representative of Lederle.
Id. at 515.
Monkey Neurovirulence
The oral polio vaccine administered to Diane Tenuto was a trivalent vaccine that contained a combination of Type I, Type II and Type III attenuated polio virus strains. Plaintiff contended at trial that he contracted Type III polio, and the evidence showed that the Type III component of the vaccine administered to Diana Tenuto was made from either monopool 3-452 or monopool 3-453. The FDA's regulation on neurovirulence testing and its regulation on"consistency of manufacture required that, to be acceptable, a monopool must be one of a series of five consecutively made monopools each of which passed the neurovirulence regulations. Lederle contends that those monopools, together with three others, passed the neurovirulence tests. The plaintiff claims that they did not.
Tr. 1161-1162, 1234.
Tr. 2028.
21 CFR § 630.16(b)(1).
21 CFR § 630.17(b).
The defendant's expert witnesses, Dr. Quinnan, a former FDA official, and Dr. Ritchey, a former Lederle employee once responsible for making decisions about the release of vaccine for the company, testified that the vaccine at issue in this case complied with FDA's regulations in all aspects. The regulations required that each monopool under consideration had to be evaluated and compared with tests on the Reference Attenuated Polio virus in two ways: the intrathalamic test and the intraspinal test. After different groups of monkeys were injected by these two routes of administration, they were sacrificed, and the tissue samples from their brains and spines were observed microscopically by trained pathologists for lesions caused by the polio virus.]
Tr. 959, 2027-2028, 2038.
21 CFR § 630.16(b)(1)(I).
21 CFR § 630.16(b)(1)(ii).
Tr. 902-903, 907-908, 1996-1999.
The FDA developed a neurovirulence scoring system pursuant to which the lesions were assigned a score ranging from "0" to "4", a score of "4" representing nearly total destruction of the cells. These scores, ranging from "0" to "4" were assigned to the lesions seen both at the site of the inoculation (the "severity" score) and at the site distal to the inoculation (the "spread" score).
Tr. 908, 1157.
Tr. 903, 905, 907, 1998-1999.
At the time that the monopools at issue in this case were under consideration, each monkey that was tested intrathalamically was given a "dual" score, representing the severity grade and the spread grade. A monkey with a score of "0-2," for example, would have been assigned a grade of "0" for lesions at the site closest to the inoculation and a grade of "2" for lesions at the site distal to the inoculation. Graded in this way, a "comparative analysis" of the intrathalamic neurovirulence of the monopool under test would be made by evaluating the dual severity-spread scores obtained on the monopool with the historical dual severity-spread scores obtained on tests conducted on the Reference Attenuated Polio virus.
Tr. 1998.
Tr. 910, 1997, 2011-2013.
For intraspinal testing, the "comparative analysis" of neurovirulence between the monopool under test and the Reference Attenuated Polio virus was different, as Drs. Quinnan and Ritchey both explained. In that test, each monkey was assigned a final neurovirulence score that was the greater of the severity and the spread scores. If a particular monkey had been assigned a severity score of "3" and a spread score of "2," for example, then that monkey was given a final grade of "3," which was the greater of the two scores. Graded in this way, a "comparative analysis" of the intraspinal neurovirulence of the monopool under test would be made by evaluating the final neurovirulence scores obtained on the monopool under test with the final neurovirulence scores obtained on historical tests conducted on the Reference Attenuated Polio virus. If the monkey with the highest grade on an intraspinal test of a particular monopool had a final score of "3" — because "3" was the greater of the severity or the spread score — then the neurovirulence of that monopool would satisfy the regulatory standards, as long as one or more intraspinal tests on the Reference also included a monkey with final score of at least "3."
Tr. 910-912, 1997, 2011-2013.
Tr. 955, 2008, 2011-2013.
Tr. 926, 1998-1999.
This scoring system for the intraspinal and the intrathalamic tests are not specified in the federal regulations (nor is any other method of "comparative analysis" set forth in the regulations). The scoring systems were developed by the FDA in the early days of OPV research and revised from time to time thereafter as additional information was interpreted about neurovirulence testing.
See, 21 CFR § 630.16(b)(1)(iii).
Tr. 2009, 2010-2011.
Under the method of performing the "comparative analysis" as described by Dr. Quinnan and Dr. Ritchey, the Type III monopools at issue in this case (3-452 and 3-453) complied with the FDA's regulations. Lederle's and the FDA's intrathalamic test results on these two monopools were unremarkable and not challenged by plaintiff. Likewise, Lederle's and the FDA's intraspinal tests on monopool 3-453 were unremarkable and not challenged by plaintiff.
Tr. 2027-2028.
The FDA's intraspinal tests results on monopool 3-452 included a monkey with a score of "3" assigned both to the site of the inoculation and the site distal to the inoculation (referred to as a "3-3 monkey"). Under the FDA's "comparative analysis" of intraspinal results, the results were acceptable because: (1) that monkey was assigned a final grade of "3," just as a "3-0 monkey" or a "2-3 monkey" would have been assigned a final grade of "3"; and (2) the FDA (and Lederle) had observed many monkeys on tests of the Reference that had severity scores of "3" in some instances and spread scores of "3" in others.
Tr. 935-939.
Similarly, Drs. Quinnan and Ritchey testified that monopools 3-452 and 3-453 complied with the "consistency of manufacture" requirement, 21 CFR § 630.17(b), because they were each one in a series of five consecutively-made Type III monopools (3-452 through 3-456, inclusive), all of which met the neurovirulence requirements of § 630.16(b)(1). As with monopool 3-452, the fact that two of the monopools in the relevant series of five (3-454 and 3-456 had between one and three "3-3 monkeys" on either Lederle's or the FDA's intraspinal tests did not violate the regulations, because those monkeys were given a final neurovirulence grade of "3" pursuant to the FDA's method of "comparative analysis" for intraspinal testing, and both Lederle and the FDA had many monkeys with final scores of "3" in their tests on the Reference over time, either because the monkeys had severity scores of "3" or spread scores of "3."
Tr. 951, 952-953, 959-960, 2027-2030.
Dr. Sulzinski was qualified to testify whether a 3/3 score indicates greater neurovirulence than a 3/2 or 2/3 monkey score. Dr. Sulzinski, as a professor of virology, disputed Lederle's contention that single digit scoring was acceptable. He testified that after examination each of the two numbers assigned to a monkey, concerning severity and spread, were important indicators of neurovirulence, and that neither number should be ignored. Dr. Sulzinski claimed that exceeding the reference standard renders a vaccine lot "too neurovirulent" to pass the monkey neurovirulence test.
Tr. 1157-58.
Tr. 1185.
Lots with 3/3 monkeys should have been rejected because they failed to demonstrate "acceptable neurovirulence." It was on that basis that he concluded that lot 3-452 exceeded the standard, and that lots 3-452 and 3-453 were not part of five consecutive monopools that passed. Dr. Sulzinski did not invade the province of the court or jury when he rendered his opinion.
Tr. 1187.
While Dr. Sulzinski did not publish monkey neurovirulence tests and did not personally conduct or pass upon monkey tests, those facts were presented in cross-examination before the jury. In New York, the lack of published writing does not disqualify an expert from testifying. Therefore, this court did not abuse its discretion to permit Dr. Sulzinski's opinions to go to the jury.
Erbstein v. Savasatit, 274 AD2d 445 (2d Dept. 2000); Smith v. City of New York, 656 NY2d 2d 681 (2d Dept. 1997); Khatri v. Lazarus, 225 AD2d 302 (1st Dept. 1996).
This court found the testimony of Dr. Mary Ritchey, to be evasive and not credible on how the monkey tests should be evaluated. The testimony of Dr. Raconiello, from Columbia University, who was presented by the defendants, was not convincing. He in essence stated that the monkey neurovirulence testing which was mandated by 21 CFR § 630.16(6)(1) and 21 CFR § 630.17(b) was of no consequence. Nonetheless, he went on to state that he has used mice to test for neurovirulence which is cheaper than using monkeys. This would appear to be contradictory, for if the testing does not matter, why develop a cheaper method which has never been adopted by the FDA? On cross examination, Dr. Raconiello did testify that the monkey neurovirulence testing is important for human safety and was "the gold standard."
TR 1782.
TR 1744-47.
Therefore, a violation of the testing protocol would result in a less safe vaccine, which would increase the risk of harm to recipients and persons who came into contact with recipients. That increased risk would be a substantial factor in causing Dominick Tenuto to contract polio.
TR 1189-90.
TR 1191, 1993-94.
Inadequacy of Warnings
When Justice William Mastro, the Senior Associate Justice on the Appellate Division, Second Department was a trial judge in Richmond County he ruled on a motion for summary judgment seeking to dismiss this case in 1999. Justice Mastro in denying that motion outlined the history of Lederle's knowledge of the risks of contact associated polio in 1977 based upon the Morbidity and Mortality Weekly Report of October 7, 1977 that was included in the 1979 packet insert.
181 Misc 2d 367
The 1979 Orimune packet insert, which did not go to the jury at the request of the defendant Lederle, states in part:
The risk of vaccine-associated paralysis is extremely small for vaccinees, susceptible family members and other close personal contacts. However, the responsible physician should convey or specifically direct personnel acting his authority to convey the warnings to the vaccinee [or] parent . . . of the possibility of vaccine-associated paralysis propr to administration of the vaccine. When the attenuated vaccine strains are to be introduced into a household with adults who have never been vaccinated, some physicians may choose to give these adults at least two doses of IPV a month apart before the children receive Orimune.
Orimune 1979 packet insert.
Justice Mastro's decision included the following:
The New York Court of Appeals in Martin v. Hacker, reinforced holdings that a drug warning "must convey updated information" and cited, with approval, Baker v. St. Agnes Hosptial, which had earlier held that this "continuing obligation" of a drug manufacturer was two fold. The Baker court said:
Martin v. Hacker, 83 NY2d 1, [1993].
Baker v. St. Agnes Hospital, 70 AD2d at 406
First, it must keep abreast of knowledge of its products as gained through reserach, adverse reaction reports, scientific literature and other available methods . . (s)econd, and equally important, it must take such steps as are reasonably necessary to bring that knowledge to the attention of the medical profession.
Id.
Baker, then went on to describe the "well-known methods by which pharmaceutical manufacturers apprise the medical profession of the dangers of a drug": (1) "the Physicians Desk Reference (PDR), the compendium often relied upon by physicians to obtain knowledge of the proper uses and hazards of drugs"; (2) "so-called "Dear Doctor" letters addressed to physicians"; and (3) "the use of "detail men" who call upon physicians personally to present them with information concerning pharmaceuticals."
Id.
Id.
Id.
From October of 1977, when Lederle knew of the federal government's recommendations regarding vaccination of adults who may be in close contact of children receiving Orimune, until the 1979 Orimune package insert, there is no indication that Lederle took any steps "to bring that knowledge to the attention of the medical profession." Plaintiff also points to another documentary evidence [commonly known as the Nightingale Report] which highlights the risk of close contacts contracting paralytic polio; yet defendant [Lederle] did not promptly revise its package insert or take other steps to indicate that IPV should be offered to close contacts to reduce the risk of contracting contact polio. Clearly this information was available at the time plaintiff's daughter was vaccinated.
Id.
Elena O. Nightingale, M.C. Ph.D., "Recommendations for a National Policy on Poliomyelitis Vaccination", The New England Journal of Medicine, Vol. 297, No. 5, at 249, August 4, 1977.
The same information that was presented to Justice Mastro on Lederle's motion for summary judgment that was affirmed by the Appellate Division, Second Department was also presented to the jury in the trial of this case with the exception of the June 1979 Orimune packet insert.
Tenuto v. Lederle, 276 AD2d 550 [2d Dept 2000].
Therefore, the jury had sufficient information to form the basis for the answers to the following questions that were based on the Appellate Division's decision in Baker v. St. Agnes Hospital:
Baker v. St. Agnes Hospital, 70 AD2d 400, [2d Dept, 1979].
Was Defendant Lederle Laboratories negligent in failing to provide an adequate and complete warning to physicians, by package insert or otherwise, to advise contacts about the risk of contact polio, and how to avoid contracting paralytic polio?
The jury answered "yes".
The jury was also asked: Was that negligence a substantial factor in causing injury to Dominick Tenuto?
The jury answered "yes".
There was sufficient information presented to the jury to find that Lederle knew of the increased risks of contact polio and failed to provide timely, adequate and complete warnings. Accordingly, this court sees no reason to set aside the jury's verdict on that cause of action.
The Court's Rulings
After hearing all of the evidenced presented, this court was of the opinion that the defendant Lederle violated the regulation with reference to the testing protocols. However, rather than directing a verdict on the negligence count, this court allowed the jury to determine whether Lederle violated the regulation, which would not have been negligence per se, as the CFR is not a statute, but a regulation, which under New York law would at best be "some evidence" of negligence.
Now, Lederle claims that this court should have ruled whether there was a violation, rather than leaving it to the jury. Had this court ruled that there was a violation of the CFRs, this court would have directed a verdict on negligence which Lederle undoubtedly would appeal. By allowing the jury to determine whether there was a violation of the CFRs, Lederle had an opportunity to be found not negligent, which put them in a better position, rather than having this court impose its opinion upon the jury and the parties.
It is not unusual to present facts to a jury to ascertain whether a defendant's conduct violated a statute or, as in this case, a regulation. It appears that the defendant believes that because the regulation in question was lengthy and complicated, the judge should have usurped the role of the finders of fact in declaring this court's opinion that the regulation was violated. Thereafter, this court would have directed a verdict advising the jury to determine any damages proximately resulting from said violation. It must be emphasized that throughout the trial, both sides referenced the regulation, which was put up on a screen in front of the jurors several times. When this court gave its final instructions to the jury, the regulation had been referenced by the attorneys in summation, and each juror was given a printed copy of the regulation which went into the deliberation room with the jurors.
It was the province of the jury to ascertain whether the facts that they found constituted a violation of the pertinent regulations in this case and whether any violation constituted some evidence of negligence. It is the province of the jury to determine whether such conduct or inaction constituted a breach of a duty of care that was a substantial factor in causing the plaintiff's affliction with polio and whether the warnings provided by Lederle were adequate.
If the jury found that Lederle was negligent in the manufacturing of the vaccine because it violated the regulations, which it did, that finding would raise the specter of whether it was reckless in not complying with the regulation and, that perhaps Lederle may have been liable for punitive damages. However, the jury found that any violation of the regulation did not rise to the level of recklessness and they did not award punitive damages. Merely giving the jury the option to find if it desired to consider punitive damages does not taint the jury, as the defendant Lederle suggests.
As to Lederle's other claims of error, they were either not preserved for the record or of no consequence.
This court has not found sufficient reasons to set aside the jury verdict on the law. Jury Verdict Is Not Excessive
The jury awarded the plaintiff, Dominick Tenuto:
For past pain and suffering for almost 30 years from May, 1979 until the verdict on March 19, 2009$12 million
For future pain and suffering for a future life expectancy of 20 years$ 5.5 million
For past lost earning$ 2.5 million
For future medical expenses$ 2.5 million
This was a unique case for which there does not exist comparable facts or awards within this state. Dominick Tenuto has sustained almost 30 years of past pain and suffering before having his day in court. He had physical and psychological injuries as a result of his contracting contact polio. It cost him his job, his marriage and the loss of enjoyment of life. He lives in a small handicapped accessible apartment. He uses a wheelchair to get around and a board to assist him getting in and out of bed. Dominick Tenuto has the knowledge and costs of post polio syndrome, which are starting to manifest themselves and has to endure the rest of his life knowing and feeling that his physical condition will degenerate greatly.
While Dominick Tenuto worked in a back office job on Wall Street, he had a Series 7 license to sell securities. While he did not capitalize on that license in 1979 before he contracted polio, he did however, lose the opportunity to capitalize on his securities license through the Bull Markets of the past three decades. Clearly, the economist's testimony as to lost wages based on his existing salary over 30 years was not excessive, but most conservative.
In conclusion, with 30 years of past pain and suffering with polio, and another 20 years of future pain and suffering, as well as the prognosis of constant care due to the physical and mental conditions of post polio syndrome, this court does not find the jury awards to be excessive.
Conclusion
Accordingly, it is hereby:
ORDERED, that the motion of the defendant, Lederle Laboratories, a Division of American Cyanamid Company, to set aside the jury verdict and enter judgment on behalf of Lederle or, in the alternative, to order a new trial or reduce the jury award is denied in its entirety; and it is further
ORDERED, that the plaintiff's counsel and the Clerk of this court shall enter judgment on behalf of plaintiff in the sum of $ 22,500,000, together with interest, costs and disbursements.
Dr. Joseph Pagano, M.D. Expected Testimony Pursuant to CPLR § 3101(d)
"[T]he documented historical records covering the licensing, testing, and meetings that discussed the significance of the regulatory requirements; the records of testing of various strains and seeds by both the Orimune manufacturer, as well as by other individuals who submitted their strains, and/or seeds, for approval.
Dr. Pagano is expected to give testimony concerning the disease of polio, the three types of polio viruses, how inactivated polio vaccine works, how oral polio vaccine is supposed to work and the historical events that led up to both the approval of what is known as Salk vaccine, and what is known as Sabin vaccine; the tests that were to be performed to insure safety, purity and potency of the oral polio vaccine strains and seeds; why the tests would assist in the evaluation of whether the vaccine could meet the safety standards; the meetings that were held between the vaccine manufacturers and the regulator (then DBS), about the dangers of not complying and/or performing all of the tests; the dangers that were specifically involved with the Type III component; and the danger of virus shed and its propensity to revert to higher neurovirulence. Dr. Pagano is also expected to testify as to the knowledge, generally, in the scientific community about the possibility of contact polio, and the herd effect and shed virus of the live oral polio vaccine.
Dr. Pagano is also expected to give testimony concerning the requirements of the license application and the standard in the industry as to what each manufacturer had to do in order to properly secure a license, including adherence to the regulatory system; the importance and significance of neurovirulence testing and other testing conducted to meet the industry standards, the license standards, and the regulatory application, the safety tests contained in that license application, Dr. Sabin's instructions for the manufacture and testing of the Sabin oral polio vaccine and the regulatory requirements placed upon the oral polio industry by the DBS and later by the FDA; the failure of American Cyanamid to prohibit the use of the Maloney Table in the evaluation and the release of it's Orimune vaccine increased the dangers to contacts of those administered said vaccine; that American Cyanamid should have informed the medical personnel, the scientific community, and the various committees that were charged with the responsibility of reviewing the administration of vaccines to children, about their non-compliance with the regulations and their failure to abide by determinations of courts that there was a lack of compliance with the safety tests; that the aforementioned failures were substantial factors in Dominick Tenuto long acquired paralytic poliomyelitis and of his resultant permanent paralysis."
Appendix 1A
Dr. Michael A. Sulzinski, Ph.D. Expected Testimony Pursuant to CPLR § 3101(d
"The documented historical records covering the licensing, testing, and problems encountered with test results of the components of the Orimune vaccine; the records of testings of Seed 45B85, the Type III seed involved in the within matter; various papers and publications, including advertisements, package inserts, product brochures, questionnaires about the Orimune product that covers the relevant periods herein.
Dr. Sulzinski is expected to give testimony concerning the Sabin Original (SO) seeds, the Sabin Original Merck (SOM) seeds, the licensing seeds, the intermediate seeds, and the working seeds, all of which were part of the final vaccine administered to Diane Tenuto; the tests that were to be performed to insure safety, purity and potency of all of the seeds and all of the monovalent material derived therefrom; the acquisition of the Sabin Original seeds, and specifically about the acquisition of Sabin Original Type III by American Cyanamid, what tests were to be performed and what tests were in fact performed; the meetings that were held between the vaccine manufacturers and the regulator (then DBS and later FDA), about the dangers of the Orimune vaccine, and in particular, the dangers of the Orimune Type III; what occurred when seeds were produced from material including but not limited to all Type III seeds, both those that were approved and those that were never approved.
Dr. Sulzinski is also expected to give testimony concerning the licensing of Orimune, the data/information supplied by Lederle/American/Cyanamid given in support of its license application for Orimune, both monovalent and trivalent; the minimum licensing requirements with regard to both the monovalent and trivalent product; the requirements of the license application and the standard in the industry as to what each manufacturer had to do in order to properly secure a license, including adherence to the regulatory system; the importance and significance of the neurovirulence testing and other testing conducted to meet the industry standards, the license standards and the regulatory requirements; the use of the Maloney Table as a substitute means for approving the submission of test results to the regulator; the significance of such results including but not limited to the results that exceeded the reference standard that was contained in the regulatory system, as well as in the license application, and Dr. Sabin's instructions for production of his product; the significance of said meetings that took place in the period of 1962-1963, and thereafter, including up to the 1990s when Orimune was no longer produced and sold for use in the United States; why individuals both recipients and contacts were becoming paralyzed from what was supposed to be a fully attenuated vaccine; how the Maloney Table was utilized by the vaccine manufacturer, and its continued use even after it was ruled to be an illegal and improper means to determine the neurovirulence and safety or oral polio vaccine.
The substance of plaintiff's expert's testimony is expected to be that the Orimune product administered to Diane Tenuto was comprised of three Sabin strains of live polio virus corresponding to the three different types of polio (types I, II and III) and that therefore Orimune was designated a "trivalent" vaccine; that the seeds utilized in preparation of the final product administered to Diane Tenuto in May of 1979, and which resulted in a confirmed paralytic poliomyelitis — CDC evaluated case of contact induced Type III polio in Dominick Tenuto, did not fulfill American Cyanamid's own licensing requirements and/or testing requirements, did not fulfill Dr. Sabin's testing requirements, did not fulfill the Federal regulatory requirements, and the requirements of other vaccine manufacturers who were licensed to sell product during all times relevant herein; that certain "lots" (monovalent pools) were released for use by American Cyanamid even though they knew said lots failed to meet the aforesaid safety standards, and that the only way of releasing these pools was by avoiding critical review of the safety results and releasing vaccines that were outside the regulations as written; that the danger of reversion to higher neurovirulence after the administration of oral polio vaccine was a known danger both prior to and subsequent to licensure and therefore the testing regimen was the sole safety measure that one could rely upon in order to prevent the danger of reversion to higher neurovirulence; said vaccine did not meet the regulatory requirements as claimed by American Cyanamid in its warrants to the administrating medical personnel; that American Cyanamid did not report the full extent of its testing problems to anyone outside of the company except a few chosen individuals who were regulating the vaccine manufacturer, some of whom became employees of the company following their retirement from the regulating agency; that all of the above were substantial factors in Dominick Tenuto having acquired paralytic poliomyelitis and his resultant permanent paralysis."
Appendix 1B
Dr. Lawrence Steinman, M.D. Expected Testimony Pursuant to CPLR § 3101(d
"Dr. Steinman will base his opinions on his training, knowledge, experience, and the literature in the field, a review of the pertinent materials herein, including but not limited to the pleadings, interrogatories with responses, depositions from the within matter and in other polio litigation, trial testimony, exhibits and other materials prepared by American Cyanamid/Lederle — the defendant herein, documents reviewed by Dr. Steinman in other polio-related litigation, the exhibits listed both by plaintiffs and defendants, the exhibits attached to the deposition of Dr. Mary Ritchey in the within matter, Orimune package inserts and those from other manufacturers of the polio vaccine, papers and publications, advertisements, product brochures, questionnaires and materials given to sales personnel of American Cyanamid at all times relevant herein.
Dr. Steinman will give testimony concerning whether information contained in the Orimune package inserts and other warnings issued by American Cyanamid were complete and accurate; whether they property informed physicians who were using the product; the importance of neurovirulence testing and the significance of neurovirulence testing; the various means of communication with physicians utilized by American Cyanamid, including advertisements, brochures, package inserts, the Physician Desk Reference, medical literature, tapes; detail personnel training and what they should have informed physicians about the Orimune product; the duties and obligations of ethical manufacturers of vaccines and drugs; whether physicians would utilize a product that was in violation of safety regulations; the duty of a drug manufacturer/vaccine manufacturer to notify the various medical groups that are making recommendations as the Red Book Committee, the Institutes of Medicine, the American Academy of Pediatrics, and the Immunization Practices Committees of the Centers for Disease Control, etc.; whether the recommendations of Lederle to those various committees fully reflected the information in its and its agents possession; why other alternative regimens and vaccines could have or should have been utilized prior to May of 1979; why the warnings contained in the package inserts leading up to and following May of 1979 were not accurate, complete and fully informative; information known to Lederle that should have been included in the package inserts; the obligation of the vaccine manufacturer to fully inform the administering physician, the patient(s) family and close members were at an increased risk of contact polio; Lederle's failure to inform the vaccine administrators, the public at large and the various committees making recommendations with regard to immunization practice, that its vaccine did not meet the minimum safety requirements as promulgated by the regulatory system and what affect that failure had on administering the vaccine; what a reasonable physician would have done had they been given the full information and a proper warning if he had been supplied with the knowledge that Lederle had up until and including May of 1979; what physicians would have done had they been supplied with the knowledge that Lederle had with regard to its failure to comply fully with the regulations as prescribed.
The substance of Dr. Steinman's testimony is expected to be that Lederle failed to follow proper scientific methods in evaluating the safety of the Orimune vaccine and that the language of Lederle's warnings and package inserts prior to May of 1979 did not contain this information; that the vaccine did not fully comply with Federal regulations and therefore the statements contained in the package insert up until May of 1979 were false and misleading; that Lederle was aware prior to May of 1979 that 53% of its Type 3 polio vaccine would not have passed the Federal standards if they had abided by those standards; that Lederle determined prior to May of 1979 to utilize the Maloney Table, which was not in compliance with the minimum safety requirements for the oral polio vaccine; that Lederle determined prior to May of 1979 to avoid critical review of the safety tests — both the intrathalamic as well as the intraspinal tests; that Lederle should have informed all physicians who utilized the Orimune vaccine of all the above via the Orimune package insert or other direct communication from Lederle to the physician.
Dr. Steinman will testify that the Lederle package inserts and communications prior to May or 1979 were inadequate in that they failed to warn that the live attenuated polio viruses contact revert to a higher degree of neurovirulence during the replication in the alimentary canal of the vaccine; and that the contacts of such children who had with heightened susceptibility to infection or were not fully immunize or who were fully immunized but had immune deficiencies of various types would be at a higher risk for contact polio.
Dr. Steinman will testify that the statements contained in the package insert concerning the risk of vaccine induced paralytic disease in those receiving the vaccine and/or those in close contact with vaccinees were inadequate in that its assessments of said risk was not scientifically valid. The method selected by American Cyanamid utilized a doses distributed system which did not adequately convey and provide a useful basis for determining the risk to either recipients who actually received the vaccine or their contacts.
Dr. Steinman will testify that there were alternative means to prevent and/or diminish the risk of contact polio as was discussed by American Cyanamid among their staff, specifically the use of IPV, but that Lederle never informed the physicians or the public at large as to what steps were necessary to be taken in order to avoid this danger during the time period prior to May of 1979."
Appendix 1C