Verdicts & Reversals · 2008-02-11 12:15

The establishment of the Vaccine Injury Compensation Program (VICP) was preceded by a series of lawsuits against pharmaceutical companies by which plaintiffs sought remedies for neurological harm sustained by their children after administration of the diphtheria-pertussis-tetanus (DPT) vaccine. By 1985, hundreds of lawsuits had been filed against vaccine manufacturers. Most were settled out of court; however, a handful proceeded to trial, and resulted in widely varying outcomes.

Negligence Without Defect — Toner v. Lederle

Toner v. Lederle was brought on behalf of a child who developed transverse myelitis and became paralyzed in 1979, after administration of the diphtheria-pertussis-tetanus (DPT) vaccine Tri-Immunol, manufactured by Lederle Laboratories. The plaintiffs were represented by Kenneth L. Pederson and Curtis Webb of Twin Falls, Idaho; the defendants by Robert J. Koontz of Boise, Idaho. The suit was filed in an Idaho state court in 1982, then removed to federal court and tried before a jury in 1985.

At the time the DPT vaccine in question was administered, Tri-Immunol was the only pertussis vaccine licensed by the Food and Drug Administration (FDA) for use in the United States, and only one other case of transverse myelitis had ever been reported in connection with it. Another DPT vaccine, Tri-Solgen, had been developed in the 1950’s by Eli Lilly Company; although it was associated with fewer local reactions than Tri-Immunol, it did not differ with respect to severe reactions. In 1972, the FDA refused to certify Tri-Solgen as safe and effective. Lilly subsequently stopped manufacturing Tri-Solgen, and the FDA subsequently refused to relicense the formula to other manufacturers. At the time that the Tri-Immunol vaccine was administered to the Toner child, a new, less reactive DPT vaccine had been developed and licensed in Japan. Although Lederle was engaged in its own efforts to develop an improved DPT formula, these efforts had not yet borne fruit.

The jury concluded that the vaccine administered to the child was neither defective nor unreasonably dangerous, and that it was fit to serve its intended purpose. However, the jury simultaneously concluded that the pertussis component of the vaccine had caused the child’s paralysis, found Lederle negligent due to its failure to develop a safer alternative to Tri-Immunol, and assessed damages of $1,131,200.

Lederle appealed the decision, arguing that the jury instructions failed to recognize that certain drugs have unavoidable risks but must nevertheless be marketed and used to protect the public health, and that the jury’s rejection of the strict liability claim was fatally inconsistent with its finding that the company was negligent in the manufacture or distribution of the vaccine. Since the appeal raised both questions of federal and state law, those questions were considered by both the Idaho Supreme Court and the U.S. Court of Appeals for the Ninth Circuit. The appeal was heard by Circuit Judges Eugene A. Wright, J. Blaine Anderson and Anthony M. Kennedy (who was subsequently appointed to the U.S. Supreme Court).

The appeals court recognized its obligation, “when faced with a claim that verdicts are inconsistent… [to] search for a reasonable way to read the verdicts as expressing a coherent view of the case.” On September 16, 1987, the court ruled that “the law and the instructions required the jury to examine the case from two different points of view,” and that, albeit apparently inconsistent with its dismissal of the liability claims, the jury’s determination of negligence was reached in accordance with Idaho law.

In the Court of Appeals’ final opinion, Justice Kennedy addressed a significant dilemma revealed by the case:

“Were we charged with deciding whether jury verdicts are the most sensible way of allocating risks and costs regarding vaccines that have been proved beneficial, we might well design a different method. The question, however, is one of Idaho law. The Idaho Supreme Court enforces the traditional tort system, leaving for its legislature any comprehensive reform. We must defer to this state law determination.”

Unavoidable Risks — White v. Wyeth

White v. Wyeth, filed in the Ohio Court of Common Pleas in 1985, alleged that the DPT vaccine was the proximate cause of a child’s seizure disorder and developmental delay. The plaintiffs were represented by attorneys Gary Kabat, Jonathan Sobel, Allen McDowell, Boyd McDowell, and Anthony Colantoni; the defendants were represented by Albert J. Knopp, Mary M. Bittence, Richard Bartelt, Peter A. Tomaras, Edward Madeira, Michael Scott, Caroline West, and Hedy Powell. Defendants in the suit originally included the child’s pediatrician and her employers, The Kaiser Foundation Health Plan of Ohio, Inc. and The Ohio Permanente Medical Group, all accused of medical malpractice. However, prior to trial, the plaintiffs voluntarily dismissed the malpractice claims, rejected Wyeth’s settlement offer, and proceeded with their case against the vaccine manufacturer.

A jury trial was conducted featuring testimony from family members and treating physicians; Dr. Mark Geier served as one of the plaintiffs’ expert witnesses, testifying about vaccine development and manufacturing. The plaintiffs argued that Wyeth knew of a safer alternative design for the DPT vaccine but failed to either develop it or to seek FDA certification, and that the company failed to adequately warn medical professionals that the vaccine could cause severe reactions.

At the end of the trial, the judge ruled that there was no evidence that Wyeth had acted in a malicious, reckless or willful manner, and dismissed the claims for punitive damages and negligence. The court nonetheless sustained the plaintiffs’ strict liability claims. On March 19, 1986, the jury found Wyeth liable for the child’s injuries, and entered a verdict in the plaintiffs’ favor for $2.1 million. Both parties promptly appealed — Wyeth challenging the verdict, and the plaintiffs challenging the court’s failure to include pre-judgment interest in the award.

The appeals court held that the lower court had erred by failing to recognize that Wyeth’s DPT vaccine was an “unavoidably unsafe product” — that is, a useful and desirable product attended with a known but apparently reasonable risk. The court determined that the company had satisfied its obligation to adequately warn of side effects and adverse reactions associated with the vaccine in its package insert directed to the prescribing physician, who functions as a “learned intermediary” between the manufacturer and the consumer. It was also found that the lower court erred by failing to recognize that it would have been illegal for Wyeth to market allegedly “safer” alternative vaccines, when there was no evidence that these alternatives were either “safer” or equally efficacious.

The court dismissed the plaintiffs’ claims for pre-judgment interest, since the defendant had made a good faith effort to reach a settlement prior to trial.

The original verdict was reversed, judgment was entered in favor of Wyeth, and the plaintiffs were ordered to pay the firm’s legal costs. As in Toner, the decision concluded with an acknowledgment of the need for a better way to seek justice and compensation for those individuals who suffer from vaccine injuries.

“One final note. In recognition of the serious and damaging consequences precipitated by the inoculation of unavoidably unsafe drugs (approved by the FDA), the U.S. Congress — to its eternal credit — passed the National Childhood Vaccine Injury Act of 1986.”

The majority of the court found that Wyeth’s liability for the child’s injuries could be determined under Ohio law. They determined that the trial record did not support the plaintiffs’ contention that Wyeth could have marketed the acellular pertussis vaccine at the time in question; rather, the company had abided by the recommendations and restrictions placed upon it by the FDA, which refused to license any new formula before more extensive safety testing was conducted.

Two justices, however, dissented with respect to the reversal of the award to the plaintiffs. They felt that the evidence had indicated that Wyeth could have developed and marketed a less-reactive vaccine at the time in question, and expressed the opinion that their colleagues had “deferred to the marketing decisions of drug manufacturers” in failing to find the company liable for the injuries sustained by the child.

The Preemption Debate — Hurley v. Lederle & Abbott v. American Cyanamid

The issue of federal preemption has been a central subject of controversy in vaccine litigation — that is, whether federal regulations supercede any state laws that might appear to conflict with them.

Hurley v. Lederle arose from a child’s adverse reaction to a DPT vaccine. The case was filed in the U.S. District Court for the Eastern District of Texas, with plaintiffs represented by Marcus A. Pitre, H. P. Wright, and Andrew W. Dodd. The defendants were represented by Richard L. Josephson, Patrick C. Appel, Richard T. McCarroll, Demaris Gullekson, and O. J. Weber. The plaintiffs alleged that Lederle was negligent; that its vaccine was unfit for its intended purpose; that it had failed to properly design the product and to warn consumers of potential adverse effects; and that the company was strictly liable for producing an “unreasonably dangerous product.”

On December 31, 1986, Judge Howell Cobb dismissed all of the plaintiffs’ state law claims for damages and punitive damages based upon inadequate warning/labelings and defective design of DPT, ruling that those claims were preempted by federal law.

“The court finds that the comprehensive and pervasive nature of the Food, Drug and Cosmetic Act (FDCA), the Public Health Services Act (PHSA), and their respective regulations, evidence preemptive intent so strong that it precludes any state law determination that DPT is defectively designed… There are dominant and overriding federal interests in promoting uniformity in the design and manufacture of DPT vaccines… [A] state common law determination that DPT design and manufacture is defective will seriously and irreconcilably conflict with the federal regulatory scheme and the national policies of immunization, adequate production, and supply of DPT. In effect, it will chill the efforts of the federal government to ensure that all U.S. children are immunized and frustrate Congress’ intent in fostering such programs.”

As in White v. Wyeth, the Hurley ruling also concluded that under the “learned intermediary” doctrine, the manufacturer had a duty to warn the prescribing physician only, rather than the patient or his parents.

In his decision, Judge Cobb alluded to the need for the federal government to assume responsibility for compensating children and families affected by adverse reactions to vaccines:

“[T]he court notes that the primary responsibility of manufacturers such as Lederle and Connaught is to comply with the federal regulations regarding the production and marketing of DPT. If these obligations are fulfilled and the DPT vaccine is administered correctly, responsibility for immunization accidents should rest with the official agencies charged with testing, approving and recommending them.”

Abbott v. American Cyanamid was filed in the U.S. District Court for the Eastern District of Virginia in 1985. Plaintiffs were represented by Michael Hersch Gottesman, assisted by Anthony M. Colantoni and six other attorneys; defendants were represented by Lloyd Norton Cutler. As in Hurley, the plaintiffs asserted that the vaccine manufacturer negligently failed to develop a safer vaccine and negligently failed to provide sufficient warnings; the plaintiffs also asserted that the vaccine was unfit for its intended use. In its defense, the manufacturer argued that Congress delegated to the Food and Drug Administration (FDA) the authority to determine vaccine safety, and that such regulation preempted plaintiff’s claims.

On March 9, 1987, judgment was entered in favor of the defendant. U.S. District Judge Claude M. Hilton held that federal food and drug regulations precluded any state law determination that an FDA-approved vaccine was defectively designed. As in White v. Wyeth, the “failure to warn” claims were dismissed pursuant to the court’s determination that the manufacturer’s warnings were indeed adequate, and were appropriately addressed to the physicians who would prescribe and administer the vaccine. In this instance, the plaintiff’s own physician testified that the manufacturer’s warning was adequate.

The Abbott court found that:

“DTP is an integral part of the U.S. national health policy to immunize children against diphtheria, tetanus, and pertussis. The FDA has comprehensively set out DTP vaccine design regulations and has specifically rejected some of the designs which plaintiff desires to have implemented. The DTP vaccine must be made within the FDA parameters as promulgated in [federal regulations]. Since Congress has impliedly delegated to the FDA authority to determine the safety and efficacy of vaccines used in the U. S. pursuant to U.S.C. § 301 et seq., defendant’s motion for summary judgment is granted.”

One year later, the Abbott decision was reversed in full by the U.S. Court of Appeals for the Fourth Circuit. In a decision written by Judge Francis D. Murnaghan, Jr., the appeals court held that with passage of the FDCA and PHSA, Congress did not intend, either expressly or implicitly, to preempt state law.

“Preemption does not follow immediately from the comprehensive federal regulation of prescription biological products. Every subject that merits congressional legislation is, by definition, a subject of national concern. That cannot mean, however, that every federal statute ousts all related state law… When preemption by regulation is considered, courts are reluctant to find preemption by federal regulations when the agency does not make very clear an intent of preemption since agencies normally address problems in a detailed manner. The presumption against preemption is even stronger against preemption of state remedies, like tort recoveries, when no federal remedy exists.”

The court also rejected the federal preemption argument in light of the Childhood Vaccine Injury Act’s provision that petitioners may reject a judgment and subsequently pursue civil remedies. In a concurring opinion, Judge William Wilkins described the newly-enabled National Vaccine Injury Compensation Program as a “no-fault compensation system which in part preempts state law, but largely complements the state tort systems.”

Neither would the Hurley ruling survive an appeal. On August 17, 1988, the U.S. Court of Appeals for the Fifth Circuit reversed Judge Cobb’s decision, albeit tactfully acknowledging that it was the result of careful and thoughtful consideration. In a decision written by Judge E. Grady Jolly, the appeals court held that the lower court had erred in determining that federal law preempted state products liability law governing vaccinations. In support of its ruling, the court called attention to the recent establishment of the Vaccine Injury Compensation Program:

“Finally, we believe that any case for preemption is doomed by the National Childhood Vaccine Injury Act of 1986. Although the Act was passed after this case was filed, it is relevant as proof that Congress intends no preemption of the state law liability of vaccine manufacturers. The NCVI Act clearly states that state law remedies apply to the manufacture and sale of vaccines and it even makes recovery easier for injured consumers.”

Unlike the Abbott reversal, the Hurley appeals court let stand the lower’s court’s finding that the “learned intermediary” principle applied to the instant case, and that the vaccine manufacturer had satisfied its duty to the customer to provide adequate warnings of the risks of its product. The case was remanded to the district court

Such rulings would stand for the next eighteen years. The debate over federal preemption would be reinvigorated with the January 2006 promulgation of the FDA’s Final Rule on prescription drug labeling. Whereas in 1988 the agency had not made clear its intent with respect to preemption, FDA regulations now explicitly state that “under existing preemption principles, FDA approval of labeling… preempts conflicting or contrary State law.”

No Reasonable Alternative — Jones v. Lederle

In Jones v. Lederle, the plaintiffs alleged that a DPT vaccination administered in 1979 caused their child to develop a seizure disorder and mental retardation. The plaintiffs were represented by Richard E. Shandell; the defendants by Daniel J. Thomasch and Stephen G. Foresta. A malpractice suit filed against the doctor who administered the vaccine resulted in payment of a substantial settlement to the parents. In 1985, the parents filed a product liability action against the manufacturer in the New York State Supreme Court; the case was later removed to the U.S. District Court for the Eastern District of New York.

At the close of discovery, the defendants entered a motion for summary judgment, requesting dismissal of all claims. After consideration of the evidence and arguments presented by the parties, the court dismissed all claims pertaining to defective manufacture, failure to warn, and breach of express warranty, but let stand the claims pertaining to design defect, negligent design, and implied warranty of merchantability (that is, the implication that a product is fit for its intended use). The court also concluded that state tort laws were not preempted by FDA regulations.

A jury trial was held in late 1991 — six years after the case was originally filed — and featured expert testimony by Dr. Mark Geier, Dr. Mark Thoman and Dr. Leon Charash.

At the end of trial, the defendants entered a motion for judgment as a matter of law, otherwise known as a motion for a directed verdict — that is, an order from the judge presiding over a jury trial, issued if the court finds that no reasonable jury could reach a decision to the contrary. Lederle also moved to exclude the testimony of both plaintiffs’ experts as inadmissible under the Federal Rules of Evidence. Judge Jack B. Weinstein chose to postpone making a decision on the motions until after the jury had completed its deliberations.

The jury returned a $3,250,000 verdict for the plaintiffs, with 25% of the fault apportioned to Lederle, and the rest to the physician who administered the vaccine. Judge Weinstein then ruled on the defendant’s motions. Although the judge was “unimpressed with the qualifications, veracity and bona fides of these experts,” he allowed the testimony of Drs. Geier and Charash to stand. He nonetheless determined that no acceptable evidence was offered to support a jury finding that a safer vaccine was available when the child was immunized. He further ruled that the jury had no evidence to support the plaintiffs’ claims that the scientific knowledge required to design an acellular vaccine existed in 1979; that any vaccine manufacturer was capable of manufacturing such a vaccine at that time; or that such a vaccine could have met FDA requirements for administration to infants.

The court granted the motion for a directed verdict, and overruled the jury. In closing, Judge Weinstein observed:

“The case illustrates some of the strengths and weaknesses of the American system for marketing drugs. Requiring strict proof of safety — both to comply with FDA regulations and to avoid tort liability — slows the availability of new products. The result may well be that dangers will be enhanced during the necessarily extended developmental period. But these results are attributable to the way in which scientists usually solve problems — through incremental, peer reviewed experiments — and to the regulatory system, not to any delict on the part of this defendant.”
“The evidence is essentially uncontested that defendant could not have produced and marketed the safer vaccine that plaintiff’s experts say would have avoided [the child’s] injuries. Once this conclusion is reached, there is nothing left to the case. The warnings were adequate. The production was not defective — it was in accordance with the design. No safer alternative design was available. The vaccine, with its possible drawbacks, saved far more infant lives than it put at risk.”

In December 1992, Judge Weinstein’s decision was affirmed by the U.S. Court of Appeals for the Second Circuit.

A Magnitudinous Mistake — Graham v. Wyeth

Graham v. Wyeth Laboratories alleged that the plaintiffs’ child suffered neurological injuries after receiving a whole-cell diphtheria-pertussis-tetanus (DPT) vaccine. The plaintiffs were represented by attorneys Andrew Hutton of Wichita, Kansas, and Ted Warshafsky of Milwaukee, Wisconsin; the defendants by Albert J. Knopp and Alvin D. Herrington. The suit was filed in 1985 and tried two years later before Judge Patrick F. Kelly in the U.S. District Court for the District of Kansas.

During a two-month trial, Dr. Mark Geier and his collaborator, Dr. Arthur Zahalsky, offered key expert testimony in which they asserted that the vaccine was defective and unreasonably dangerous.

“Dr. Geier… testified extensively as to the critical relationship between the toxicity of any pertussis vaccine and the level of endotoxin. The thrust of his testimony was that the higher the level of endotoxin, the greater the danger that any given vaccination would lead to adverse reactions, including those allegedly suffered by Graham. Dr. Geier stated that the “[m]ore the endotoxin, the more severe [the] reaction”. Specifically, Dr. Geier stated that the endotoxin content of Wyeth’s vaccination was 240 micrograms per milliliter — a level four times higher than that of the next most toxic pertussis vaccine made by other pharmaceutical companies and 2400 times higher than the least toxic of the other pertussis vaccines.”

On October 14, 1987, the jury concluded that Wyeth’s DPT vaccine either caused or substantially contributed to the plaintiffs’ child’s neurological problems, and found the defendant negligent in connection with the testing, design and marketing of its product. The plaintiffs were awarded $15,000,000 in damages — an amount that, if paid according to a typical contingent fee arrangement, would translate into over $6,000,000 in fees for the plaintiffs’ attorneys.

On February 2, 1988, Judge Kelly issued a grandiloquent memorandum announcing the establishment of a “Wyeth Laboratories DTP Litigation Library,” containing all of the evidence presented at the trial — pleadings, documents, depositions, written expert opinions or reports, judicial rulings and orders, trial briefs, the trial transcript and all exhibits, court instructions, post-trial motions, and the court’s final order.

Shortly thereafter, in depositions for the cases McLean v. Wyeth, Cavallo v. Wyeth, Cooper v. Wyeth, and Talley v. Wyeth, Dr. Geier testified that Wyeth’s vaccine did not have an endotoxin level of 240 micrograms per milliliter, as he had previously claimed under oath, but a level of 20 micrograms per milliliter. This new estimate represented a twelve-fold decrease from the spectacular figures that were so critical to the success of the plaintiffs’ case, and so damning to the defendants in Graham. During his deposition in Talley v. Wyeth, Dr. Geier commented on the discrepancy:

“That’s right, that one looks like an error of — what we call an order of magnitude error, that is when I did the calculation, I must have missed a zero.”

This admission effectively invalidated Dr. Geier’s testimony regarding endotoxin levels in Graham, and also undermined the testimony offered by Dr. Zahalsky, who had relied upon Dr. Geier’s figures in forming his own opinions. Dr. Zahalsky, too, would later recant many of the claims he offered in Graham, significantly lowering his toxicity estimates for Wyeth’s vaccine in his testimony in Overlay v. Warner Lambert and Knudsen v. Connaught Laboratories.

Upon discovering this new information, the defendants promptly filed a motion to vacate the previous judgment and hold a new trial. Judge Kelly denied both of these motions. Upon appeal, the U.S. Court of Appeals for the Tenth Circuit found that Judge Kelly had committed numerous harmful errors and abuses of judicial discretion. These included:

• Improperly precluding critical testimony by one of the child’s treating physicians, and improperly striking relevant, material testimony from two others. All three physicians were of the opinion that the plaintiffs’ child had suffered a stroke prior to her vaccination, and that the stroke rather than the vaccination was the cause of her neurological condition. Judge Kelly, however, prevented all of this testimony from reaching the jury.
• Improperly admitting into evidence an American Medical Association report, described by Judge Kelly as “the smoking gun we have all been looking for.” The judge himself altered the document in a manner that “obscured the purpose and theme of the article,” “distorted the thrust of the Report,” and “could only mislead the jury.” He also prohibited cross-examination about the true purpose of the report, which was to propose the establishment of a federal vaccine injury compensation program, rather than to establish vaccine causation of the conditions described in the report.
• Improperly refusing to vacate the judgment and authorize a new trial after being informed of Dr. Geier’s materially significant calculation error, and the subsequent errors of fact in his testimony and that of Dr. Zahalsky.

The appeals court gave Dr. Geier the benefit of the doubt, assuming that any errors he made were unintentional, and that he must have been unaware of those errors when he testified. Its presumption of good faith notwithstanding, the appeals court concluded that:

“[T]he miscalculations made by Dr. Geier changed the entire complexion of the case. Had the Graham jury been alerted to the correct calculations of toxicity, it may well have taken a different view of the case… Without evidence being adduced as to high endotoxin levels, the case might not have even reached the jury… We are also persuaded that Dr. Zahalsky’s testimony was gravely undercut by Dr. Geier’s failure to analyze his data.”
“The district court found no impropriety or unfairness in testimony of Drs. Geier and Zahalsky even when the deficiencies in their testimony were brought to his attention by Wyeth… We are hard pressed to understand that conclusion in light of the context in which their evidence was presented at trial. Elementary reasoning and our complete review of the trial record reveals that an accurate presentation of the endotoxin level in Wyeth’s vaccine could not help but dilute the total impact of Graham’s case.”

Dr. Geier would later state that his tenfold error of fact had “no bearing whatsoever” on his opinions.

The $15,000,000 judgment was reversed, and the case was remanded to the District Court. Judge Kelly responded to Wyeth’s motion to disqualify him from rehearing the case with expressions of bewildered astonishment that anyone might question his impartiality, or characterize his manner as deferential to the plaintiffs and hostile to the defendants. He insisted that any new trial be held before him again.

The parties to the case entered into a settlement agreement prior to a second trial.

 

Cases cited:

Toner v. Lederle Laboratories, 112 Idaho 328, 732 P.2d 297, 306 (Idaho 1987), cert. denied 485 U.S. 942, 108 S.Ct. 1122, 99 L.Ed.2d 282 (1988).
White v. Wyeth Laboratories, Inc., 40 Ohio St.3d 390, 533 NE2d 748, 755 (Ohio 1988); CCH Prod. Liab. Rep. P12,055.
Hurley v. Lederle Laboratories, 651 F. Supp. 993, 995 (E.D. Tex. 1986) 863 F.2d 1173 (5th Cir. 1988).
Abbott v. American Cyanamid, 844 F.2d 1108 (4th Cir.), cert. denied, 488 U.S. 908 (1988).
Jones v. Lederle Laboratories, 695 F. Supp. 700, 709-711 (E.D.N.Y. 1988), 785 F. Supp. 1123 (E.D.N.Y. 1992).
Graham v. Wyeth Laboratories, 666 F. Supp. 1483, 1497 (D. Kan. 1987), aff’d in pertinent part, rev’d in part on other grounds 906 F.2d 1399 (10th Cir. 1990), cert. denied 498 U.S. 981 (1990).
McLean v. Wyeth Laboratories, Case 86-4077 (W.D. Ark., 1988).
Cavallo v. Wyeth Laboratories, Case 716-507 (Circuit Court of Milwaukee County, Wisconsin).
Cooper v. Wyeth Laboratories, Case 86-1177C (E.D. Miss., 1987).
Talley v. Wyeth Laboratories, Case 87-349-C (E.D. Okla., 1988).
Overlay v. Warner Lambert, Case IP83-1780-C (S.D. Ind., 1986).
Knudsen v. Connaught Laboratories, 691 F.Supp. 1346 (M.D. Fla., 1987).

Comments


  1. Wow!

    I can’t imagine how long it took you to get all of this together.

    Great background, that puts all of this into perspective.

    Joe

    — Club 166    2008-02-11 14:31    #