Strong v. American Cyanamid Co.

• Decision Date: 28 August 2007
• Docket Number: No. ED 87045.,ED 87045.
• Citation: 261 S.W.3d 493
• Parties: Cortez STRONG, Respondent/Cross-Appellant, v. AMERICAN CYANAMID COMPANY, Appellant/Cross-Respondent, and Georgia Santos-Jawaid, M.D., Respondent.
• Court: Missouri Court of Appeals

261 S.W.3d 493

Cortez STRONG, Respondent/Cross-Appellant, v. AMERICAN CYANAMID COMPANY, Appellant/Cross-Respondent, and Georgia Santos-Jawaid, M.D., Respondent.

No. ED 87045.

Missouri Court of Appeals, Eastern District, Division Three.

August 28, 2007.

Motion for Rehearing and/or Transfer to Supreme Court Denied October 9, 2007.

Sustained and Cause Ordered Transferred December 18, 2007.

Case Transferred to Supreme Court January 17, 2008.

Case Retransferred to Court of Appeals September 30, 2008.

Original Opinion Reinstated October 6, 2008.

Thomas P. Germeroth, Saint Louis, MO, for Respondent/Cross Appellant.

Michael D. O'Keefe, James W. Erwin, Dale R. Joerling, Saint Louis, MO, for Appellant/Cross Respondent.

J. Thaddeus Eckenrode, Lisa Hope Chazen, Clayton, MO, for Respondent.

OPINION

GLENN A. NORTON, Presiding Judge.

American Cyanamid Company ("Company") appeals the judgment entered upon a jury verdict in favor of Cortez Strong ("Plaintiff") on Plaintiff's claims of products liability and negligent manufacture. Plaintiff cross-appeals the trial court's denial of his motion to amend the judgment against Company to include prejudgment interest. He also appeals the judgment entered upon the jury verdict in favor of Georgia Santos-Jawaid, M.D. ("Dr. Jawaid"), on his claim of medical malpractice. We affirm in part and reverse in part.

I. BACKGROUND

For several decades, Lederle Laboratories, one of Company's divisions, manufactured Orimune, an oral polio vaccine. In June 1987, Plaintiff received a second dose of Orimune as part of his routine immunizations. In the next few days, Plaintiff experienced weakness in his arms. The weakness subsequently developed into permanent paralysis in his left arm and some weakness in both hands.

Alleging that he contracted vaccine-associated paralytic polio from the polio vaccine, Plaintiff commenced this action against Company, the manufacturer, and Dr. Jawaid, the pediatrician who administered the vaccine. As to Company, among other counts, Plaintiff claimed that Orimune was a defective product and that Company negligently manufactured the vaccine. Plaintiff claimed that Dr. Jawaid failed to warn him of the risks of contracting polio from the live polio vaccine and failed to inform him of the alternative inactivated polio vaccine, which did not carry a risk of causing vaccine-associated polio because it does not contain a live polio virus.

According to evidence presented at trial, trivalent oral polio vaccine is intended to prevent infection from three types of "poliovirus" — Type I, Type II and Type III. The virus strains are "attenuated," or weakened, so that the virus strains can still grow but are not able to cause disease the way a virulent or "wild" strain would. When the patient takes the vaccine, the attenuated virus strains cause a mild infection as the virus grows in the patient's esophagus. This growth stimulates the body to produce antibodies that protect against the disease. The patient should also produce antibodies in the digestive tract and the bloodstream.

To produce the vaccine, Company acquired strain material for the three types of virus, which it used to grow the vaccine for each particular strain. For instance, with Type I, Company obtained the original strain material, called "Sabin Original Merck" or "SOM" from Dr. Albert Sabin in the 1960s. The original material came from a type of monkey that can carry a virus called simian virus 40 ("SV40"). Company neutralized the SOM with an antibody to ensure the next virus generation would not carry SV40. After completing the neutralization process, Company called the material 45B157. According to Company, it generally assigns a number for each step in the manufacturing process so they can trace the development of the material.

Company took 45B157 and harvested it in monkey kidney tissue to expand the amount of material. Upon completion of that step, Company designated the grown material as 701S. From the 701S preparation, Company created another harvest or "passage" to expand the material to create what they called "production seed 45B160." Company used 45B160 to produce additional Type I virus in many different monkeys. After harvesting the material in several monkey kidneys, they pooled the harvests together to create a Type I monopool. The Type I monopool then became the Type I vaccine component of the trivalent vaccine.

Company performed essentially the same steps for the Type II component of the vaccine. It began with original seed material from Dr. Sabin which it neutralized to create 45B158. Company grew out 45B158 to create 801S and used the 801S harvest to create production seed 45B162. Like 45B160, Company pooled several harvests of 45B162 together to create a monopool for the Type II vaccine.

Unlike the Type I and Type II components, Company's Type III component in the vaccine at issue in this case did not derive directly from Sabin original material. Instead, Company obtained the strain material from a company called Institut Merieux, which had itself obtained the material from Pfizer, a pharmaceutical company. Company describes the material as "Pfizer material" because Pfizer created it by performing a "cloning implant purification of the Sabin Original Merck." Company designated the material as 45B164. According to Company, it did not neutralize the 45B164 because it was not produced in monkeys. Instead, Company went directly to creating production seed 45B165. As with 45B160 and 45B162, Company used 45B165 to grow out more virus and then pooled several harvests together to create a monopool for the Type III component of the vaccine.

Once Company completed the three monopools, it combined the monopools together with a dilutant to lessen the strength of the vaccine. The large vessel of diluted trivalent vaccine was then divided into smaller vessels, which were used to fill the individual doses Company packaged as Orimune and sold for public use.

At trial, Plaintiff introduced evidence intending to show that in manufacturing Orimune, Company failed to comply with several regulations that specifically govern the manufacture of live oral polio vaccine. In addition to other testimony, Plaintiff offered Thomas Bozzo as an expert to testify about Company's compliance with the polio vaccine regulations.

Initially, Bozzo testified about his qualifications. Bozzo stated that he holds a bachelor's degree in pharmacy and a master's degree in public health from Johns Hopkins University. In order to obtain his master's degree, Bozzo took courses dealing with epidemiology — the causes of infectious diseases, how chronic diseases progress, and biostatistics relating to disease.

Bozzo also testified that he is currently a consultant to biologics pharmaceutical tissue industries, providing advice to such organizations about compliance with FDA requirements. Before becoming a consultant he spent over twenty-one years working for the FDA in the area of regulating biologic products. Before working with the FDA he worked four to five years for its predecessor, the Division of Biologic Standards.

While at the FDA, Bozzo worked as a branch chief or branch director in a variety of areas including those having to do with assuring that products are made according to good manufacturing practices. Bozzo was also a compliance officer. He would take information provided during inspections to analyze products and determine whether or not the information indicates a violation of the regulations or the law. During his last five to six years he was the director of the office of compliance in the center for biologics evaluation and research.

Bozzo did conduct inspections and review inspection reports with respect to Orimune, although he was not specifically involved in licensing Company to manufacture the vaccine or approving the seeds or monopools. However, Bozzo was required to be familiar with the process for licensing manufacturers and others to produce products like Orimune.

Bozzo testified that he supervised the people who drafted the polio vaccine regulations, although he was not personally involved with the regulatory changes that occurred in the nineties. Finally, Bozzo explained he had to be knowledgeable about the polio vaccine regulations, but did not specifically recall instances when he was asked to interpret or apply them with regard to the manufacturing or testing of Orimune. Based on the foregoing, the court accepted Bozzo as an expert over Company's objection.

Once accepted, Bozzo testified about the regulatory requirements governing the production of oral polio vaccine. Bozzo cited three areas where he believed Company failed to comply with the regulations. Specifically, he stated Company violated 21 C.F.R. Section 630.10(b)(4) and (5)¹ and 21 C.F.R. Section 630.16(b)(1) because it did not test the Sabin strains SOM Types I and II and the Pfizer material, as well as intermediate seeds 701S and 801S, for neurovirulence. He also testified that Company violated 21 C.F.R. Section 630.10(b)(3) because it did not test the Sabin strains for extraneous microbial agents. Finally, he testified that Company violated 21 C.F.R. Section 630.12(a)(2), which prohibits the use of monkeys that have been used previously for experimental or test purposes as a source of kidney tissue in the processing of vaccine. According to Bozzo, Company used tissue from monkeys given an experimental foamy virus vaccine to develop materials used to create the Type I seed that was later used in Plaintiff's vaccine.

In its defense, Company presented the testimony of Dr. Mary Ritchey, a microbiologist who worked for Company in the area of vaccine quality control. When asked about the regulations, Dr. Ritchey testified that she disagreed with Bozzo that the regulations required testing of original strain material or intermediate material. She stated that the government was aware that Company did not perform tests on this...