November 20, 2009
DAVID RIVARD, AS ADMINISTRATOR OF THE ESTATE OF LINDSAY M. RIVARD, DECEASED, AND DAVID RIVARD AND DIANE RIVARD, AS THE PARENTS AND NATURAL GUARDIANS OF LINDSAY M. RIVARD, DECEASED, PLAINTIFFS-APPELLANTS,
AMERICAN HOME PRODUCTS, INC., AMERICAN CYANAMID COMPANY, AND LEDERLE LABORATORIES, A DIVISION OF AMERICAN CYANAMID, DEFENDANTS-RESPONDENTS.
On appeal from Superior Court of New Jersey, Law Division, Bergen County, No. L-8470-01.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued September 30, 2009
Before Judges Wefing, Grall and Messano.
Plaintiffs appeal, pursuant to leave granted, from an order entered by the trial court. After reviewing the record in light of the contentions advanced on appeal, we reverse.
The matter has a complex background which must be set forth in some detail to adequately analyze the parties' contentions. This is the second time these parties have been before this court; we take the initial factual background from our earlier opinion, Rivard v. American Home Products, Inc., 391 N.J. Super. 129 (App. Div. 2007). Plaintiffs are the parents of Lindsay Rivard, who died in 1999 at the age of seven from a brain tumor diagnosed the year before her death. Id. at 139. Lindsay had received four doses of Orimune, an oral polio vaccine manufactured by defendants. She received her last dose in June 1997, and her tumor was diagnosed in November 1998; she died in October, 1999. Ibid. Plaintiffs filed suit in October 2001, alleging that the polio vaccine Lindsay had received had been contaminated with a monkey virus identified as SV40, which led to her brain tumor and subsequent death. Ibid.*fn1 In our earlier opinion, we summarized the development of Orimune.
In the early 1960's, the federal government licensed three manufacturers to make and market "live polio vaccines" from the material created by the developer of the first oral polio vaccine, Dr. Albert Sabin. The government granted one of these licenses to defendants American Cyanamid and its Lederle Laboratories.
Historically, the three types of polio virus, Type I, II, and III, were treated with different vaccines. Graham v. Am. Cyanamid Co., 350 F.3d 496, 500 (6th Cir. 2003), cert[if]. denied, 541 U.S. 990, 124 S.Ct. 2040, 158 L.Ed. 2d 495 (2004). In 1963, however, the federal government granted defendants a license to manufacture and sell a "trivalent vaccine" which worked against all three types of polio virus. Ibid. Defendants developed this vaccine and began distributing it, from the early 1960's until 1999, as Orimune, the vaccine at issue in this appeal. Ibid. See Campagna v. Am. Cyanamid, 337 N.J. Super. 530, 535-39 (App. Div.) (providing a comprehensive review of the development and licensure of the vaccine), certif. denied, 168 N.J. 294 (2001).
Orimune was derived from the original strains of polio virus that Dr. Sabin had developed. To derive the vaccine, defendants took a small amount of Dr. Sabin's strains and neutralized those strains for SV40, which was known to be in the Sabin strains. The neutralization process did not remove SV40 but instead was designed to destroy the virus's ability to infect living cells. The parties, in this case, vigorously contest whether neutralization of the original Sabin polio virus strains with SV40 antiserum sufficiently removed the virulent form of monkey virus from the resulting vaccine.
In any event, to make the vaccine, defendants then multiplied the polio virus contained in the small amount of the original neutralized strain in cultures of monkey kidney cells. The resulting virus was then harvested and pooled with others derived in similar fashion to form a larger volume that was designated as a "seed" to be used in vaccine production.
Defendants then took a small volume of seed, multiplied that virus by again inoculating it into cell cultures of monkey kidneys, harvesting the resulting virus and pooling several harvests of the same type of attenuated poliovirus together into a monopool. Monopool volumes of all three viruses where then "combined" into the trivalent "bulk vaccine lot," which defendants called Orimune.
Because monkey kidney cells were utilized in the production of the vaccine, after neutralization of the Sabin strains, plaintiffs also argue that by utilizing this technique, even though an approved Food and Drug Administration (FDA) production method, defendants further added SV40 to the vaccine.
Federal regulations required that tests be performed on the vaccines at various production stages. Graham, supra, 350 F.3d at 501. Regulations required that "[e]ach seed virus [as contrasted with the Sabin strains] used in manufacture shall be demonstrated to be free of extraneous microbial agents." 42 C.F.R. § 73.110(b)(3)(4) (1962). See In re Sabin Oral Polio Vaccine Prods. Liab. Litig., 743 F.Supp. 410, 420 n.16 (D. Md. 1990) (stating that § 73.110(b)(3) "applies only to seeds"), aff'd, 984 F.2d 124 (4th Cir. 1993). In addition, the regulations required testing to ensure that each viral harvest was SV40 free. See 42 C.F.R. §§ 73.113(d), 73.114(a)(5) (1962). Nevertheless, several courts have already concluded that at times in the past defendants and the government breached some of the pertinent federal regulations by releasing vaccines which exceeded the reference vaccine in neurovirulence. See, e.g., In re Sabin Oral Polio Vaccine Prods. Liab. Litig., 763 F.Supp. 811, 829 (D. Md. 1991), aff'd, 984 F.2d 124 (4th Cir. 1993); Campagna, supra, 337 N.J. Super. at 538-39.
[Id. at 140-42.]
During the process of developing a trivalent vaccine, defendants identified the Sabin polio vaccine master seeds, grown from the Sabin strain, by name, such as, "Master Seed Material for SOM Type I" or "Sabin Original Material Type III." The master seeds were used to produce monopools of each type of virus, Type I, II, or III, and lots of that virus type were derived from the monopools. The record contains the following description of the process: "The 'off-shoot' Sabin polio virus seeds [were] given names and numbers to identify when they were manufactured and how they were used in the vaccine dose manufacturing process," such as "Seed 45B51." The "off-shoot" polio virus seed stock was used to grow billions of more polio viruses for vaccine production. Defendants, who are no longer engaged in producing the vaccine, maintained the seed materials in deep freeze storage.
In 2003, plaintiffs sought and obtained an order precluding defendants from any physical contact with those preserved samples, specifically identifying the master seeds, working seeds and monopools that were used during the time period when Lindsay received her doses of Orimune. Thereafter, the parties engaged in the lengthy process of conducting an inventory of the polio vaccine materials that defendants had in storage. Once that inventory was completed, plaintiffs requested and received scores of vaccine samples for testing by their experts. Each vaccine sample produced for plaintiffs was divided into thirds, with one-third distributed to plaintiffs' experts, one-third to defendants' experts, and one-third to defendants.
During the course of discovery, plaintiffs produced an expert's report that tests on Lindsay's tumor found the presence of SV40 DNA. Rivard, supra, 391 N.J. Super. at 139. Plaintiffs also produced an expert's report that Lindsay's tumor cells contained SV40 while adjacent non-malignant tissue did not which, according to the report, was "powerful evidence that the virus played a role in the causation of the tumor." Ibid.
In our earlier opinion, we wrote the following about these reports.
It is clear, at the very least, that defendants' Type III vaccine initially included infectious SV40 beginning with the master seeds, and that the Type I and Type II vaccines tested positive for SV40 beyond neutralization; that for some period following development of Orimune defendants were permitted to place into the stream of commerce, with the government's permission if not its outright encouragement, vaccines which did not meet the standards of purity; and that while none of the tested monopools or trivalent bulks from which Lindsay's vaccination could have been produced tested positive for SV40, plaintiffs' experts have questioned the reliability of those tests.
At least one of plaintiffs' expert witnesses has opined that the applicable regulations required the manufacturer to demonstrate its product was free of extraneous microbial agents, and that defendants failed to meet those regulations.
The expert further stated that SV40 continued to be present in defendants' vaccines and in the ones which Lindsay received. In one instance, for example, defendants' historical records noted some extraneous virus in a monopool that defendants admit had been used in Lindsay's vaccine. [Id. at 150-51.]
In our earlier opinion, we considered three discrete issues: whether plaintiffs were required to proceed first in the federal court before litigating their claims in state court,*fn2 whether the trial court erred when it denied the defendants' motions for summary judgment, and whether certain of defendants' documents were not discoverable under either the attorney-client privilege or the work product privilege. Id. at 139. As to the first issue, we held that to the extent plaintiffs sought damages for Lindsay's death, their claims first had to be presented under the federal procedure but that their claims for punitive damages and loss of services could proceed in state court. Id. at 156.*fn3 We also upheld the trial court's denial of summary judgment to defendants and remanded the matter to the trial court. Id. at 156-57. With respect to the discovery issue, we set forth guidelines for the trial court to follow in considering defendants' claims of privilege. Id. at 153-56.
Following our remand, defendants filed a motion seeking a return to them of all vaccine samples in plaintiffs' possession.*fn4 Defendants asserted that the samples had been delivered to plaintiffs for purposes of testing in conjunction with the litigation, that plaintiffs had completed their testing in the Rivard matter, and that no further testing was needed in the Gannon and Moreno matters in light of the trial court's grant to defendants of summary judgment. Defendants agreed to maintain the samples for return to plaintiffs in the event this court were to reverse defendants' summary judgments.
Plaintiffs resisted this motion, contending that the fact that defendants had been granted summary judgment in Gannon and Moreno did not preclude plaintiffs from continuing to prepare their cases in the event this court reversed those summary judgments. Plaintiffs stressed that no conditions had been imposed when the samples were delivered to them for testing; they noted also the fact that defendants no longer produced this vaccine and had not demonstrated any need to have the samples returned at that juncture.
After hearing argument on defendants' motion, the trial court entered an order on July 1, 2008, which directed plaintiffs to supply defendants with a "detailed listing of the vaccine samples and materials that are currently in the possession, custody or control of Plaintiffs (including Plaintiffs themselves, Plaintiffs' counsel, Plaintiffs' experts, Plaintiffs' agents, and anyone else acting on Plaintiffs' behalf)." The order directed that the list "include the location where each vaccine sample is being stored, the identity of each sample, and the remaining quantities of each sample." The order barred plaintiffs from conducting any further testing on the samples and directed them to preserve the samples in the same condition and in the same location as they were on the date the motion had been argued. Finally, it directed plaintiffs to return all the samples to defendants "at the conclusion of this action."
On July 15, 2008, plaintiffs delivered to the trial court and defendants a forty-one page listing of the vaccine samples they had received, dividing them into various groupings. It identified each sample, the date it was received and the amount originally delivered. It noted that the samples were stored at three different locations, referred to as "A", "B", and "C." Plaintiffs' counsel explained in his covering letter that the samples stored at locations "B" and "C" were either under the control of plaintiffs' counsel, were stored by plaintiffs' expert Dr. Michael Sulinski, or had been distributed to plaintiffs' expert Dr. Adrienne Butel at her laboratory for testing. He noted that the samples indicated as being at location "A" were being stored by non-testifying consultants and asserted that the identity of those consultants was privileged information. He further explained that defendants could determine the quantity of the remaining samples by subtracting the amount used for testing, as detailed by the experts in their reports, from the amount originally delivered by defendants.
When defendants protested that plaintiffs had not complied with the court's order, plaintiffs filed a motion on July 21 to alter or amend its terms. They contended that it would be unduly onerous to compel them to measure the amount of vaccine remaining in each identified sample and that to do so would pose an unnecessary risk of damaging the samples because the process would require thawing and refreezing each sample. They again asserted that the identify of those consultants who would not testify in this matter was confidential and that to compel them to disclose the location of the samples held by these consultants would necessarily reveal their identities.
The trial court heard oral argument and denied plaintiffs' motion and entered an order which defendants interpreted as directing the immediate return of all vaccine samples, wherever held. A series of letters ensued in which plaintiffs sought clarification. Ultimately, the trial court entered an order dated September 10, 2008, which directed plaintiffs to return all the vaccine samples within thirty days. It also directed plaintiffs, within three days, to identify "where each vaccine sample is currently being stored, the identity of each sample, and the remaining quantities of each sample, as well as the location where each vaccine sample was being held [on] . . . July 1, 2008 . . . and the remaining quantity of each vaccine sample [on] July 1, 2008." The trial court denied plaintiffs' motion for a stay of this order, and we then granted plaintiffs' motion for leave to appeal and for a stay.
Appellate courts generally defer to a trial court's disposition of discovery matters, and a trial court's decision with respect to such matters will not be overturned on appeal unless the trial court mistakenly exercised its discretion. Bender v. Adelson, 187 N.J. 411, 428 (2006); Serrano v. Underground Utils. Corp., 407 N.J. Super. 253, 268 (App. Div. 2009). After reviewing this record, we are satisfied that the trial court's order does represent a mistaken exercise of its discretion, and we thus reverse.
In determining whether a trial court's discovery order is a mistaken exercise of discretion, it is appropriate to consider the purpose sought to be achieved by the order, whether the order is an appropriate vehicle to achieve that objective, and the relative harm the parties would experience if the order were upheld or were reversed.
During the course of discovery in this matter, plaintiffs received scores of vaccine samples. The record before us contains no indication that any restrictions were placed upon plaintiffs' use of these samples. No protective order, for instance, was entered under Rule 4:10-3, and no provision was made at the time of the original delivery for return of the samples. The only condition contained in the record presented to us is defendants' original condition that the samples be divided into thirds, with the parties each receiving one-third for the use of their respective experts and defendants retaining possession of the remaining third. Plaintiffs complied with that condition.
Defendants have not put forth any reason why the vaccine samples should be returned to them at this point. They have made no assertion, for instance, that the samples have been improperly stored or handled; they have made no contention that some risk inheres in the samples remaining in their present location for the time being. The only ground they have asserted for the immediate return of these samples is that the samples are their property. We can perceive no reason, however, why defendants' property interests should be permitted to override all other concerns.
These samples were not delivered to plaintiffs for the sole purpose of the Rivard litigation. Rather, it was understood by all the parties that the samples would be utilized in connection with the Gannon and Moreno claims. The merits of the pending appeals in those matters are not before us, and we have no way of assessing the probability or likelihood of one side or the other prevailing in those appeals. We can perceive no sound reason, however, why plaintiffs should be forced to assume the task of returning these vaccine samples to defendants, with the attendant time, cost and risk entailed in such a procedure when the possibility remains that plaintiffs will prevail on appeal, and the samples will then have to be returned to them, involving yet more time, cost and risk.
The trial court included in its order a provision barring plaintiffs from conducting any further testing on the vaccine samples, previously delivered to them, prior to their return to defendants. Because we have concluded that the samples may remain in their present locations, we turn to this restriction.
We are satisfied that the present state of the record does not permit us to rule definitively with respect to this restriction. Part of this uncertainty springs from the fact that the trial court did not give any reasons for imposing this condition, apart from its view that the samples should be returned to defendants. Indeed, it is not clear to us that defendants sought to have this restriction imposed.
We are cognizant that the trial court had more familiarity with the details of the discovery in this matter than do we. There may be reasons not immediately apparent to us which would justify this preclusion. We decline, therefore, to reverse this provision outright.
We are satisfied, however, that it should be modified. We therefore direct that plaintiffs may perform no further testing on the samples remaining in their custody or control without leave of court. Determination whether such leave should be granted will involve consideration of the nature of the testing to be performed, the risk, if any, involved in such testing, and whether the testing involves complete destruction of a particular vaccine sample and, if it does, whether defendants retain the remaining two-thirds of that sample and thus have the ability to meet any information developed as a result of that testing. The fact that summary judgment may have been granted to defendants in the Gannon and Moreno litigation is not, by itself, sufficient justification to preclude all further testing while plaintiffs are still pursuing their appellate rights.
The remaining issues to be addressed are the trial court's determinations that plaintiffs must provide an inventory of the remaining vaccine samples and must disclose the location of those samples that had been delivered to plaintiffs' consultants.
We agree with the trial court that defendants are entitled to some form of inventory to assure themselves of the safety and integrity of the samples they have provided to plaintiffs.
Within their briefs, the parties appear to disagree as to the methodology needed to comply with the trial court's order to produce an inventory. Plaintiffs read the order to compel thawing each sample, measuring the remaining quantity and then refreezing the sample. Defendants present two responses: that plaintiffs have not demonstrated why such a procedure is unduly burdensome and that all that is required is a mathematical calculation.
We consider defendants' first response to require no analysis. In our view, to state the procedure is to demonstrate its inherent burdens. As to the second, it would appear that the only dispute between the parties is as to who should perform this mathematical calculation. Plaintiffs assert that defendants can conclude on their own what remains on hand based upon the expert reports they have received, while defendants assert it is plaintiffs' obligation to state what remains following the testing which has been performed.
On this question, we agree with defendants. Plaintiffs urged this method to the trial court although without agreeing to perform it themselves. We see no reason why defendants should have to scour the expert reports supplied to them to match up the testing described against the list plaintiffs have prepared. We perceive nothing unfair in directing plaintiffs to complete that task and to supply the information to defendants and the trial court.
Plaintiffs contend that to disclose the location at which the remaining samples are stored would, of necessity, disclose the identity of these consultants who will not testify at trial. This, they assert is improper. Defendants assert that they seek not to learn the identity of these consultants but to assure themselves that no unauthorized testing has occurred.
Rule 4:10-2(d)(3) provides in pertinent part:
A party may discover facts known or opinions held by an expert . . . who has been retained or specially employed by another party in anticipation of litigation or preparation for trial and who is not expected to be called as a witness at trial only upon a showing of exceptional circumstances under which it is impractical for the party seeking discovery to obtain facts or opinions on the same subject by other means.
The rule is intended to provide protection for the work done by consulting experts who will not testify at trial but who aid the attorney in preparing for trial. Fitzgerald v. Roberts, 186 N.J. 286, 300 (2006). Experts may serve differing functions during the course of trial preparation; the work performed as a proposed expert for trial is subject to discovery while that performed as non-testifying adviser is not. Franklin v. Milner, 150 N.J. Super. 456 (App. Div. 1977). And the manner in which a consultant has performed his or her consulting functions may remove the protection generally afforded by the rule. In re Long Branch Manufactured Gas Plant, 388 N.J. Super. 254, 269 (Law Div. 2005) (noting that "calling someone a non-testifying consulting expert does not mean that he or she is automatically and absolutely shielded from discovery on issues that the party has knowingly injected into the case.").
If, as defendants maintain, their objective is to assure themselves that unauthorized testing has not occurred, there are means to achieve that objective without compromising plaintiffs' right to shield the identity of those with whom they have consulted. To that end, we modify the trial court's order to direct that plaintiffs submit to the trial court, in camera, a list of the locations where all of the vaccine samples previously delivered to them are now stored. That list will note the original quantity of each sample, the amount tested (a quantity revealed by the reports previously supplied by plaintiffs) and the quantity remaining (a process involving a mathematical calculation, rather than the thawing and refreezing otherwise required). Plaintiffs will also deliver to defendants a similar list, containing the calculations we have noted but not revealing the situs of the samples in the custody of plaintiffs' non-testifying consultants. This list will provide a base line which will assure that no further testing occurs without the permission of the trial court while, at the same time, maintaining the confidentiality to which plaintiffs are entitled. It will also provide assurance that the samples are deposited in a facility adequate to maintain the safety and integrity of the samples. It will also obviate the time- consuming and risky procedure of thawing and refreezing these samples to measure the contents on hand.
Reversed and remanded for further proceedings in accordance with this opinion. We do not retain jurisdiction.