Eli Lilly And Thimerosal
JOSEPH COUNTER and THERESA COUNTER, Individually and as Next Friend of JOSEPH ALEXANDER COUNTER
IN THE DISTRICT COURT
23RD JUDICIAL DISTRICT
WATERS & KRAUS, LLP
C. Andrew Waters
State Bar No. 20911450
F. Leighton Durham III
State Bar No. 24012569
3219 McKinney Ave., Ste 3000
Dallas, Texas 75204
THE LAW OFFICES OF
SEAN PATRICK TRACEY
State Bar No. 20176500
1100 Louisiana, Ste. 3075
Houston, Texas 77002
Table of Contents
II. Lilly’s No-Evidence Motion is Premature Because Adequate Time for Discovery Has Not Passed and Lilly Has Not Provided Discovery as Agreed..........................5
III. Lilly Incorrectly Asserts that It Never Owed Jac Counter a Duty of Care............................................6
A. Facts Underlying Plaintiffs’ Claims Against Lilly....................7
i. Eli Lilly in the 1920’s and 1930’s: The Search for Profitable Drugs.....................................7
ii. 1927 - 1928: A New Product..............................8
iii. 1929 - 1930: A Successful Plot............................8
iv. The 1930’s: Confirmation of the Hazards of Thimerosal/Merthiolate and Lilly’s Promotion for Use as a Vaccine Preservative ..........................12
v. The 1940’s: Additional Recognition of Potential Hazards, Especially for Sensitive Persons............................14
vi. The 1950’s: Lilly Begins to Market Thimerosal as a "Non-Toxic" Product and Promotes the Product For Use in the New Polio Vaccine...................16
vii. The 1960’s: "Can We Really Say this Product is Non-Toxic?".........................................18
viii. The 1970’s: Lilly Lies to the FDA in a Bid to Avoid Regulation.....................................19
ix. 1976: One Example of Lilly’s Efforts to Convince the Public that Thimerosal is Safe...........................20
x. The 1980’s: The FDA Recommends a Ban of Thimerosal......21
xi. 75 Years of Conduct Designed to Increase Profits, Without Regard to Safety.................................22
B. Standard for Determining Whether Lilly Owed Jac Counter a Duty of Care........................................22
C. Lilly Owed a Duty to Jac Counter.................................23
D. Lilly is Also Liable for Fraud and Conspiracy......................28
IV. Conclusion and Prayer.............................................30
COME NOW, plaintiffs and file this response to Eli Lilly and Company’s Supplemental Motion for Summary Judgment. Plaintiffs would respectfully show the Court as follows.
Joseph Alexander Counter ("Jac") suffers from autism caused by a mercury-based preservative known as thimerosal, which was intentionally and unnecessarily added to several pediatric vaccines Jac received as an infant. Manufacturers used thimerosal to package vaccines in multi-dose containers. Jac’s parents, Joseph and Theresa, brought this suit on Jac’s behalf and in their individual capacities, alleging that each defendant is liable for causing Jac’s injuries under theories of strict products liability, negligence, misrepresentation, fraud, and conspiracy, among others.
In its motion for summary judgment, Eli Lilly and Company ("Lilly") argues that it cannot be liable to plaintiffs under any theory because it did not manufacture or distribute the particular thimerosal product at issue. In essence, Lilly contends that it did not owe plaintiffs a duty of care. As an initial matter, Lilly’s motion is premature because it has not fully answered plaintiffs’ discovery requests as it agreed to do in a Rule 11 agreement. As such, the Court cannot address Lilly’s motion until adequate time for discovery has passed.
However, if the Court addresses Lilly’s motion, it should be denied because the basis for Lilly’s motion is fundamentally flawed. Lilly’s liability does not arise from the manufacture or distribution of thimerosal, but from its own activities in manipulating the medical literature and concealing the dangers of thimerosal that proximately caused Jac’s autism. Because Lilly could easily foresee that its conduct would endanger individuals injected with thimerosal, it owed a duty under Texas law to children such as Jac to take reasonable precautions to avoid such injuries. Lilly’s conduct was also fraudulent, and its conspiracy with others to hide the dangers of thimerosal makes Lilly liable for Jac’s injuries. Consequently, Lilly’s motion for summary judgment should be denied.
II. Lilly’s No-Evidence Motion is Premature Because Adequate Time for Discovery Has Not Passed and Lilly Has Not Provided Discovery as Agreed
First, Lilly’s motion is premature because adequate time for discovery has not yet passed. There is no dispute that discovery is not complete because the discovery period does not end until January 24, 2003. The rules of civil procedure make clear that a no evidence motion for summary judgment is not properly brought under Rule 166a until after there has been "adequate time for discovery." Tex. R. Civ. P. Rule 166a(i). Further, the drafters of Rule 166a, in authoritative comments "intended to inform the construction and application of the rule," specifically instructed that:
A discovery period set by pretrial order should be adequate opportunity for discovery unless there is a showing to the contrary, and ordinarily a motion under paragraph (i) would be permitted after the period but not before.
Tex. R. Civ. P. Rule 166a, Comments (emphasis added).
In addition, Lilly has not yet provided vital discovery that it agreed to produce in a Rule 11 agreement. Exhibit 1. Lilly alleges that there is no evidence to support plaintiffs’ allegations after 15 months of discovery, but is still withholding the information plaintiffs would need to respond to Lilly’s motion. The length of time a case is pending is irrelevant if the party moving for summary judgment is stonewalling discovery.
Lastly, an adequate time for discovery should be determined "by the nature of the cause of action" and "the nature of the evidence necessary to controvert the no-evidence motion." Specialty Retailers, Inc. v. Fuqua, 29 S.W.3d 140, 145 (Tex. App.-Houston [14th Dist.] 2000, pet. denied). The nature of this case involves highly complex factual issues and requires discovery that will inquire into matters that occurred over years and perhaps even decades. More discovery is needed, and Lilly should comply with its agreements before the Court addresses whether adequate evidence exists for plaintiffs’ claims to reach a jury.
III. Lilly Incorrectly Asserts that It Never Owed Jac Counter a Duty of Care
In the alternative, Lilly’s motion for summary judgment should be denied. Essentially, Lilly contends that it is entitled to summary judgment because it never owed plaintiffs a duty of care. As described below, Lilly purposefully and maliciously altered scientific literature and hid the true dangers of thimerisol in vaccines with full knowledge that children like Jac would suffer mercury poisoning. Lilly owed a duty to exercise reasonable care in its conduct, but failed to do so, proximately causing Jac Counter’s autism. Consequently, Lilly’s motion for summary judgment must be denied.
A. Facts Underlying Plaintiffs’ Claims Against Lilly
i. Eli Lilly in the 1920’s and 1930’s: The Search for Profitable Drugs
From the 1920’s through the 1950’s, and even much later, Eli Lilly, first as vice-president and then as president of the company, was directly involved with virtually all significant decisions related to product development at Eli Lilly and Company. In the late 1920’s for example, during the time when Lilly’s efforts led to the development of merthiolate (Lilly’s tradename for thimerosal), Eli Lilly regularly called and chaired research committee meetings. "Each scientist had his say directly to vice-president Lilly, who often made the necessary decisions."
One of the decisions that Eli Lilly made was to establish fellowships at various colleges and universities that were designed "to increase the friendliness of the faculties of the various universities for our house. Various members of our staff are now very welcome in most of the medical centers." While the fellowship program began earlier in the 1920’s, Lilly arranged to have it expanded in 1928. However, the company only wanted to provide funding through fellowships to scientists who would toe the company line and be sensitive to its concerns:
He (Lilly) urged careful screening of university scientists to be sure that the company was "dealing with a man or men of exceptional ability and trustworthiness."
Morris Kharasch was apparently one of the men that Lilly felt could be "trusted."
ii. 1927 - 1928: A New Product
Eli Lilly’s involvement with the fellowship program paid early dividends with its relationship with Dr. Morris Kharasch, first at the University of Maryland and later at the University of Chicago. Kharasch can be credited with inventing thimerosal, which he referred to as an "alkyl mercuric sulfur compound" that had potential as an antiseptic and antibacterial properties. On June 27, 1927, Kharasch, working in collaboration with Lilly as a result of his fellowship, filed a patent application for the alkyl mercuric sulfur compound, i.e. thimerosal. Exhibit 3 (Exhibit ELI-503). Shortly thereafter, Lilly began to make efforts to develop and market the new product. Exhibit 4 (Exhibit ELI-392FF). The product was about 50% ethylmercury.
iii. 1929 - 1930: A Successful Plot
By October 1929, Lilly recognized that thimerosal had the potential to be a big seller. A decision was made to register thimerosal under the tradename merthiolate; the company had already implemented a strategy for testing and marketing the product.
In 1928, Dr. G.H.A. Clowes, Director of Research of the Eli Lilly Co., assigned Lilly scientists H.M. Powell and W.A. Jamieson the task of completing animal toxicity studies in anticipation of plans to sell the product for human use as an antiseptic and/or antibacterial agent. Exhibit 4 (Exhibit ELI-392FF). Powell and Jamieson performed a series of short-term experiments on animals to ascertain what acute and immediate toxicity might be observed. They made no effort to determine what injuries would results from longer term or lower level exposures.
On July 24, 1930, Powell and Jamieson submitted their results for publication to The American Journal of Hygiene, and their article was published in January 1931. Id. In one section of the published paper, Powell and Jamieson noted:
Toxicity in man. Merthiolate has been injected intravenously into 22 persons in doses up to 50 cubic centimeters of 1% solution. . . The toleration of such intravenous doses indicates a very low order of toxicity of merthiolate for man. This information has been supplied through the kindness of Dr. K.C. Smithburn of Indianapolis who has had occasion to use merthiolate in a clinical way. Dr. Smithburn stated in these cases ‘beneficial effect of the drug was not definitely proven. It did not appear, however, to have any deleterious action when used in rather large doses intravenously when all the drug entered the vein.
Id. at page 306 (emphasis added). As discussed below, Powell and Jamieson’s statements and conclusions were cited repeatedly by Eli Lilly for the proposition that thimerosal/merthiolate had a low potential toxicity if injected into humans. Upon closer inspection, however, it is apparent that Lilly scientists working with Smithburn deliberately manipulated and distorted the scientific process and purposefully corrupted the published scientific literature concerning the toxicity of thimerosal.
What Powell and Jamieson deliberately failed to include in their published article was the fact that the results of K.C. Smithburn’s "clinical" use of thimerosal were flawed and actually indicated that thimerosal is toxic when injected into humans. Lilly asked Smithburn to conduct research from late 1929 until mid to late 1930 at its clinical research laboratory at the Indianapolis City Hospital, which was a perfect place for the company to test its products, or potential products, on patients. Working closely with Lilly personnel, including Powell, Smithburn was involved with experimental research related to an outbreak of meningococcical meningitis in November 1929. By the time the epidemic ended in April 1930, over 144 persons had been hospitalized, and treated at the Lilly labs, for meningitis. See Exhibit 5 (Exhibit ELI-500).
During the outbreak, Dr. Smithburn, at the request of Lilly, injected the meningitis patients with thimerosal/merthiolate in a series of experiments to determine if it might serve as a possible treatment for the disease. The experiments also served a second purpose, i.e. as a basis for reaching a conclusion that thimerosal was non-toxic.
Lilly attempted to disguise its involvement with these human experiments, presumably for two reasons. First, Lilly wanted readers of the Powell and Jamieson study to believe that the subjects were healthy and therefore that conclusions of non-toxicity were accurate. Second, Lilly knew that the series of human experiments were unethical by their very nature. Lilly chose Dr. Smithburn to perform the actual injections, rather than a Lilly doctor, effectively allowing Lilly to distance itself from its use of human guinea pigs.
In September 1930, Smithburn published an article in the journal of the American Medical Association entitled "Meningococcic Meningitis, A Clinical Study of 144 Epidemic Cases," in which he described his observations during the human experiments of thimerosal on meningitis victims. Exhibit 5 (Exhibit ELI-500). The 144 cases were simply described as cases "from the Lilly laboratories for clinical research, Indianapolis City Hospital." Smithburn provided details concerning the epidemic:
The present epidemic of meningitis in Indianapolis began in November 1929. This report includes cases admitted to the Indianapolis City Hospital between November 11, 1929 and April 1, 1930. One patient was received in November, 52 in December, 22 in January, 44 in February and 25 in March.
While Smithburn did not reveal a specific business relationship with Lilly, it is apparent that H.M. Powell, who had been working on the animal studies, assisted Smithburn by making bacteriologic and serologic studies, with the assistance also of F.G. Jones. Both Jones and Powell were identified as "from the biologic department of the Lilly research laboratories." Under the circumstances, it is apparent that Powell must have known that the Smithburn subjects were suffering from meningitis at the time they were experimentally injected with thimerosal. However, this fact is never mentioned in the published Jamieson/Powell study. It is a critical omission that allowed Jamieson and Powell to conclude that "toleration of such intravenous doses indicates a very low order of toxicity of merthiolate for man."
In his article, Smithburn wrote that "the treatment has remained essentially the same throughout the epidemic." He described the use of thimerosal as an experimental effort to treat the disease. Specifically, he stated that "Intravenous administration of an antiseptic solution was tried and found wanting despite the in vitro activity of the agent." Smithburn also reported that efforts were made to combat infection resulting from positive nasopharyngal cultures. Eventually, Smithburn and the Lilly scientists came up with a procedure to address this source of infection, applying ephedrine sulphate in each nostril followed by merthiolate (1 part per 4000 strength) twice daily. Smithburn noted that after the institution of this therapy no nasopharyngal cultures were positive. However, Smithburn also noted that the treatment was "symptomatic," Id., leading to immediate concerns within Eli Lilly as to the potential toxicity of thimerosal/merthiolate and the injuries it could cause.
An interoffice memorandum dated April 24, 1930 was received by Harley W. Rhodehamal, the Director of Research Development, warning of concerns within the company that the product could cause injury and should not be sold in a stronger version, i.e. 1 part per 1000, or 1 part per 2000. Exhibit 7 (Exhibit ELI-204). The memo, from Charles J. Lynn, one of the Directors at Lilly, related concerns about "our experience with the merthiolate solution. . ." Lynn felt that a stronger version of merthiolate posed an even riskier proposition:
Can we expect to have the stronger ointment and jelly used without the complaint which attended the use of the solution in the same strengths? . . . Our experience with the solution ought to serve as a warning and certainly in the face of that warning we ought not to advocate the use of the stronger products without some pretty definite evidence that we will not repeat our solution experience.
Lynn’s concerns were probably related to the toxic effects observed by Smithburn and confirmed in his article, but Lynn may also have known that Jamieson and Powell planned to publish a fraudulent article designed to misrepresent the safety of the product. Despite Lynn’s warnings, Lilly eventually went on to sell the solution in the 1:2000 and 1:1000 strengths. Exhibit 8 (Exhibit ELI-201). There is no indication that Lynn’s concerns were ever addressed with additional testing.
iv. The 1930’s: Confirmation of the Hazards of Thimerosal/Merthiolate and Lilly’s Promotion for Use as a Vaccine Preservative
On August 18, 1931, Kharasch filed a new patent application in an effort to stabilize merthiolate due to its tendency to acquire "certain burning qualities." Exhibit 9 (Exhibit ELI-504). Those efforts were apparently unsuccessful, for Kharasch and Lilly later applied for a third patent for "organo-mercuri-sulfur compound." Exhibit 10 (Exhibit ELI-505) That patent application again noted the problems repeated earlier by Lynn and Smithburn:
Certain antiseptic and bactericidal . . . compounds, which . . . tend to form disassociation products and thereby both tend to decompose and to lose their effectiveness as antiseptic germicides and tend to develop certain medicinally undesirable properties."
Exhibit 10 (Exhibit ELI-505) (emphasis added).
By 1935, Lilly was selling merthiolate for topical antiseptic use, but significant efforts were ongoing to find other ways to sell the product, and by so doing to enhance Lilly’s profits. In fact, by the 1930’s, merthiolate had quickly become one of Lilly’s most important products. However, Lilly researchers remained under constant pressure to develop new products, or to expand markets for established products such as merthiolate.
While publicly adopting the "non-toxic" conclusions from the Jamieson and Powell 1930 publication, within the company it was recognized and understood that thimerosal/merthiolate remained a toxic substance that could have potentially harmful effects. However, promoting the product as "non-toxic by injection" was critical for promoting merthiolate use in vaccines as a preservative.
In 1935, Lilly received another article published in the American Journal of Hygiene entitled "The Bactericidal and Antiseptic Action of Preservatives Frequently Used in Biological Products, and the Effect of These Preservatives on the Potency of the Products." Exhibit 11 (Exhibit ELI-392S). The article noted Jamieson and Powell’s conclusions regarding non-toxicity, and commented that Jamieson and Powell had specifically promoted merthiolate as an efficient preservative in diphtheria toxoid vaccinations:
[Thimerosal] had been used on [Jamieson and Powell’s] recommendation, in this laboratory since 1931, in a dilution of 1-10,000 in diphtheria toxoid preparations. These preparations were found to be sterile when tested in bulk. The question therefore arose as to whether this preservative could be used with equal success in other types of biological products.
Exhibit 5 (Exhibit ELI-392S), at page 261.
Jamieson and Powell clearly recommended the use of merthiolate/thimerosal as a vaccine preservative. This was undoubtedly a way of expanding the market for merthiolate into a new arena, i.e. vaccines. This was done despite the knowledge that the product was toxic and despite knowledge that the Smithburn experimental studies were fatally (albeit secretly) flawed.
v. The 1940’s: Additional Recognition of Potential Hazards, Especially for Sensitive Persons
In 1941, the Lilly staff received an article entitled "Chemotherapy of Bacterial Endocarditis." The article advised Lilly scientists that merthiolate should never be given more frequently than once in 10 days due to its toxicity and potential hazards. Exhibit 12 (Exhibit ELI-392P(2)). Lilly also sold large amounts of merthiolate to the United States government for use in the war effort from 1941-1945. "Merthiolate was an army standard issue and 22 tank cars of the popular antiseptic were dispatched from (the) McCarty Street (plant) during the war." Due to military regulations, and as a result of the toxicity of the ethylmercury preservative, Lilly was required to label the product "POISON." The "POISON" language was only added to cartons of products in certain instances, as when required by the government, and Lilly continued to fail to warn about known hazards of the product for its non-military sales and for sales related to vaccines. Exhibit 13 (Exhibit ELI-228).
By 1943, Lilly also marketed a merthiolate ophthalmic ointment, as Lilly continued to expand its efforts to sell the product for new purposes. Lilly received an article recommending that the eye product not be used unless "it has been previously demonstrated that the patient is not sensitive to the ointment." The article also recommended "that the package should be labeled to warn the customer that such [sensitivity] tests should be made previous to the use of merthiolate ophthalmic ointment in or around the eye." Exhibit 14 (Exhibit ELI-392D). Receipt of this information confirmed Lilly’s knowledge that thimerosal could be more hazardous to some members of the population that might be more sensitive or susceptible to its toxic effects. Despite that knowledge, on July 27, 1944, an internal memorandum confirmed the company’s intention to double the strength of the merthiolate product from 1:2000 to 1:1000. Exhibit 15 (Exhibit ELI-201).
Throughout the remainder of the decade, Lilly received significant additional information concerning the greater susceptibility to injury for a small percentage of persons. In 1946, the company became aware, by virtue of receiving another scientific article, that sensitivity to thimerosal was capable of causing "a disabling dermatologic complication." Exhibit 16 (Exhibit ELI-392L). The knowledge that their product could cause disabling injury was quickly followed by additional published scientific opinions expressing specific concerns about the dangers of injecting merthiolate. In 1947, the Lilly scientists received an article entitled "The Sensitizing Factor in Merthiolate." Exhibit 17 (Exhibit ELI-392M). The article noted:
No eruptions or reactions have been observed or reported to merthiolate internally, but it may be dangerous to inject a serum containing merthiolate into a patient sensitive to merthiolate.
Id., at page 213. Shortly thereafter, Lilly received another article noting that merthiolate was a commonly used preservative and stating that:
It would seem important to determine whether harm would result following [merthiolate’s] subcutaneous or intravenous injection in skin sensitive individuals.
Exhibit 18 (Exhibit ELI-392i).
By this time, Lilly was well aware that its product was being used as a preservative for vaccines and was being injected into human beings, including infants. Lilly had received numerous articles by 1950 that discussed potential harm from injecting merthiolate into humans, but continued to rely upon the fraudulent 1930 Jamieson and Powell study, with its misrepresentation of the Smithburn experiments. Unfortunately, Lilly’s intentional conduct, in failing to properly test the product and advise the public about its hazards, was to continue for decades.
vi. The 1950’s: Lilly Begins to Market Thimerosal as a "Non-Toxic" Product and Promotes the Product For Use in the New Polio Vaccine
In 1950, Lilly received another article that reviewed merthiolate and other mercurials in an effort to determine potential toxicity as well as effectiveness. Research had continued in this area and in 1950 it was apparent that mercury products like merthiolate had significant toxicity and could cause damage to human tissue cells:
In the last decade, interest in various in vivo types of tests has indicated that the mercurials are ineffective in vivo and may be more toxic for tissue cells than bacterial cells.
Exhibit 19 (Exhibit ELI-392R).
In that same year, Lilly received an article from the prestigious New York Academy of Sciences entitled "Mercurials as Antiseptics." In the plainest language possible, the New York Academy of Sciences advised Lilly its merthiolate product was hazardous:
[Merthiolate] is toxic when injected parenterally and therefore cannot be used in chemotherapy.
Exhibit 20 (Exhibit ELI-392T).
In 1960, despite repeated warnings and information concerning the toxicity of thimerosal, including scientifically based conclusions that certain persons were more likely to be injured due to their susceptibility, Eli Lilly made a decision to begin promoting the product as "non-toxic" in an apparent effort to increase sales. Exhibit 21 (Exhibit ELI-99).
In the 1950’s, Lilly also continued its efforts to promote thimerosal for use in various vaccines, including Dr. Jonas Salk’s polio vaccine. In an article entitled "The Preservation of Poliomyelitis Vaccine With Stabilized Merthiolate," six Lilly scientists (including H.M. Powell) extolled the virtues of merthiolate and announced that they had "solved the problem of the apparent incompatibility of merthiolate and poliomyelitis vaccine." Exhibit 22 (Exhibit ELI-404A) at page 9.
Trivalent poliomyelitis vaccine produced in monkey kidney tissue culture may be satisfactorily preserved with merthiolate if the trisodium salt of ethylene diamine tetra-asetic acid is added.
Thus, in the 1950’s, as in the 1930’s, Lilly continued its efforts to promote merthiolate/thimerosal as the preservative of choice for new vaccines as they were added to an ever-growing list.
vii. The 1960’s: "Can We Really Say this Product is Non-Toxic?"
On August 16, 1961, Lilly personnel noted in an interoffice memorandum that "under government regulations, certain warning statements were to be added to our labeling for over-the-counter items." Exhibit 23 (Exhibit ELI-29). Lilly’s failure to respond to the new government regulations was entirely consistent with its previous failure to address known hazards and the decision made in 1960 to label thimerosal products as "non-toxic." Exhibit 21 (Exhibit ELI-99). Lilly’s established pattern and practice of deliberately ignoring health concerns and misleading the public concerning the toxicity of merthiolate was to continue throughout the decade.
In 1963, Lilly received more information indicating that injection of merthiolate in vaccines could cause injury and that testing should be completed:
There is another point of practical significance: does the parenteral injection of merthiolate-containing fluids cause disturbances in merthiolate-sensitive patients?
It is known that persons that are contact sensitive to a drug may tolerate the same medications internally, but it seems advisable to use a preservative other than merthiolate for injections in merthiolate-sensitive people.
Exhibit 24 (Exhibit ELI-392H).
Despite its increasing knowledge and understanding of the potential for danger, Lilly made a conscious decision to continue to label its packages of merthiolate as "non-toxic." Exhibit 25 (Exhibit ELI-73); Exhibit 26 (ELI-69).
In August of 1967, a Dr. Jansen confirmed Lilly’s understanding of the inappropriateness of labeling thimerosal "non-toxic" and requested "that they delete the "non-toxic" which appears on the front panel." Exhibit 27 (Exhibit ELI-68). On August 29, Lilly changed the draft label, removing the "non-toxic" language and substituting "non-irritating to body tissues." The marketing department, in response to the concerns of the medical department, still wished to advertise the product as "non-irritating to skin tissues," even though Lilly was fully aware that thimerosal had been shown to be irritating, toxic and to cause cell damage. Exhibit 28 (Exhibit ELI-67).
viii. The 1970’s: Lilly Lies to the FDA in a Bid to Avoid Regulation
In 1972, Lilly received an article that confirmed that its product, used as a preservative in vaccines, caused 6 deaths from mercury poisoning. Exhibit 29 (Exhibit ELI-392K(1)). "The symptoms and clinical course of the 6 patients suggests subacute mercury poisoning."
Shortly thereafter, the FDA required Lilly to provide all the information at its disposal concerning the potential toxicity of thimerosal. Lilly reported to the FDA, in a February 14, 1973 letter, that "as with other chemicals of its generation, information relating to safety and efficacy of thimerosal in animal models is sparse." Exhibit 30 (Exhibit ELI-392). But Lilly went further, advising the FDA that the product was non-toxic and cited the fraudulent Jamieson and Powell study of 1930 as its supporting scientific evidence. Exhibit 31 (Exhibit ELI-392QQ). Despite its knowledge to the contrary, Lilly continued to use the incomplete Powell and Jamieson version of the Lilly/Smithburn experiment to support its conclusions that the product was safe and "non-toxic."
ix. 1976: One Example of Lilly’s Efforts to Convince the Public that Thimerosal is Safe.
On April 27, 1976, Lilly’s Manager of Industrial Sales, W. Orbaugh, responded to a letter from Rexall Drug Company in St. Louis, Missouri. Rexall Drug had been concerned about the potential hazards of merthiolate/thimerosal and had requested, pursuant to the trademark/marketing agreement maintained with Lilly, permission to place the following warning on the product:
Frequent or prolonged use or application to large areas may cause mercury poisoning.
Exhibit 32 (Exhibit ELI-412E).
Lilly responded aggressively, and immediately, ordering Rexall not to add the warning and purposefully misstating the potential hazards of a product it knew to be toxic:
We object to the connection of our trademark with the unjustified alarm and concern on the part of the user which the statement is likely to cause.
We are not aware of any instance of ‘mercury poisoning’ after decades of marketing this product. This is because the mercury in the product is organically bound ethylmercury and has a completely non-toxic nature, not methylmercury.
Exhibit 32 (Exhibit ELI-412E).
In keeping with its continuing disinformation campaign, Lilly, in the 1980’s Physicians Desk Reference, again claimed that the product was "relatively non-toxic", a statement that it had known to be a lie for over 45 years. Exhibit 33 (Exhibit ELI-502).
x. The 1980’s: The FDA Recommends a Ban of Thimerosal
On January 5, 1982, the Food and Drug Administration published its advance notice of proposed rule making regarding thimerosal. Their scientific panel’s opinions and recommendations were the culmination of 5 years of research concerning the potential hazards and safety of thimerosal. The panel concluded that:
At the cellular level, thimerosal has been found to be more toxic for human epithelial cells in vitro than mercuric chloride, mercuric nitrate, and merbromim (mercurochrome).
Exhibit 34 (Exhibit ELI-512). The FDA specifically found that thimerosal was significantly more toxic for living tissue than it was for the bacteria it was supposed to kill:
It was found to be 35.3 times more toxic for embryonic chick heart tissue than for staphylococcus areus.
The FDA scientific panel’s conclusions were clear and unequivocal, focusing on thimerosal’s potential for cell damage and its significant toxicity:
The Panel concludes that thimerosal is not safe for [over-the-counter] topical use because of its potential for cell damage if applied to broken skin and its allergy potential.
It is worth noting that the FDA’s conclusions were published in the Federal Register. Eli Lilly was specifically identified as a party of interest due to its involvement with thimerosal. Id., 47 FR, at 436.
xi. 75-Years of Conduct Designed to Increase Profits, Without Regard to Safety
Without Lilly’s funding of the original Kharasch work through its fellowship program in the 1920’s, its successful efforts to corrupt the medical literature and its extensive promotion and marketing of thimerosal as a vaccine preservative, the product would have never been used in that capacity. The actions of Lilly officers, in concert with Morris Kharasch and K.C. Smithburn, and directed by Eli Lilly himself, were all carefully designed to enhance the marketability of its product and promote sales and profits, without any regard whatsoever for the potential health effects and injuries that it knew would probably result.
As a result, Lilly continues, even at this late date, to profit from its sordid history with a product that it knew it should never have placed in the stream of commerce. Exhibit ELI-501 is an internal memorandum, dated December 16, 1999 that confirms Lilly’s licensing agreements that will earn income from the marketing and sale of thimerosal in 40 nations throughout the third world for many years into the future. Exhibit 35.
While the product has finally been banned in the United States, Lilly continues to benefit from its malicious and calculated efforts to promote the product that began in the 1920’s.
Whether Lilly owed a duty to plaintiffs is a question of law. Joseph E. Seagram & Sons, Inc. v. McGuire, 814 S.W.2d 385, 387 (Tex. 1991). Texas courts apply the risk-utility balancing test to decide whether a common law duty exists. Reed v. Scott Fetzer Co., 990 S.W.2d 732, 736 (Tex. 1998); Greater Houston Transp. Co. v. Phillips, 801 S.W.2d 523, 525 (Tex. 1990). In applying the risk-utility test, the Court must balance the risk, foreseeability, and likelihood of injury against the social utility of the actor’s conduct, the magnitude of the burden of guarding against the injury, and the consequences of placing the burden on the defendant. Smith Kline Beecham Corp. v. Doe, 903 S.W.2d 347, 353 (Tex. 1995); Bird v. W.C.W., 868 S.W.2d 767, 769 (Tex. 1994). The most important factor to be considered is foreseeability. El Chico Corp. v. Poole, 732 S.W.2d 306, 311 (Tex. 1987).
C. Lilly Owed a Duty to Jac Counter
Lilly’s allegation that it never owed plaintiffs a duty of care could not be more inaccurate. It is a basic principle of negligence law that everyone has a duty to exercise reasonable care to avoid a foreseeable risk of harm to others. El Chico Corp., 732 S.W.2d at 311-12. As such, Lilly had a duty to refrain from affirmatively distorting published medical literature and deceiving health regulators and physicians, because doing so created a foreseeable and unreasonable risk that infants would be injected with thimerosal, causing many to suffer from mercury poisoning. Because Jac, and many others like him, experienced injuries that mirrored the concealed results from Lilly’s own studies, their injuries were necessarily foreseeable. Lilly may argue that it could not foresee that pediatricians would rely on its misrepresentations decades later, but Lilly itself relied on the Smithburn study for decades and touted it repeatedly as proof that thimerosal is non-toxic. Furthermore, Lilly never disclosed that Smithburn actually observed a toxic reaction in at least one person injected with thimerosal. In fact, Lilly never took any action to remedy its malfeasance.
Moreover, there is no social utility in permitting a company to callously disregard the well being of children so that it can maximize profits through misinformation and deceit. If anything, social values and policy considerations require that companies like Lilly be held financially responsible for the injuries they cause by altering the results of studies that doctors and health regulators rely on in evaluating the safety of a particular drug or its components. Requiring Lilly to refrain from affirmatively deceiving governmental agencies, physicians, and consumers is no more onerous than Lilly’s existing duty to behave as a reasonable, responsible corporate citizen.
Similar duties are recognized throughout the Restatement (Second) of Torts. For instance, section 291 of the Restatement provides:
Where an act is one which a reasonable man would recognize as involving a risk of harm to another, the risk is unreasonable and the act is negligent if the risk is of such magnitude as to outweigh what the law regards as the utility of the act or of the particular manner in which it is done.
Restatement (Second) of Torts § 291. In the present circumstance, absolutely no social utility was created by Lilly’s conduct, but its risk to children was enormous. Thimerosal is merely a preservative that was never used to cure a disease or illness. Only Lilly and the other companies that manufactured and used thimerosal for multi-dose packaging benefited from Lilly’s deceit. Moreover, Lilly could have easily foreseen that doctors and health regulators would rely on its misrepresentations to the detriment of every child injected with a thimerosal-containing vaccine. In other words, Lilly’s conduct was devoid of any redeeming social value and fraught with recognizable risk to infants.
Even more directly on point, § 302 of the Restatement provides that:
A negligent act or omission may be one which involves an unreasonable risk of harm to another through either:
(a) the continuous operation of a force started or continued by the act or omission, or
(b) the foreseeable action of the other, a third person, an animal, or a force of nature.
Restatement (Second) of Torts § 302. Under this section a person is liable for setting into motion a force, the continuous operation of which, ultimately injures another. Id. cmt. c. For example, a person would be liable for damages caused by a fire set on his own property that spreads to another’s land and causes damage. Id. ill. 1. A person is also liable for damages if his conduct creates a situation that is harmless if left to itself but is capable of being made dangerous by the foreseeable acts of others. Id. cmt. d.
In this case, Lilly "started a fire" by affirmatively misrepresenting the results of the Smithburn study. The continued operation of that act, and Lilly’s continued reliance on the false information, ultimately led to the widespread use of thimerosal in vaccines, which caused mercury poisoning in children like Jac. Moreover, even if Lilly’s conduct was harmless, Lilly should have recognized that the other vaccine manufacturers would rely on the Smithburn study to justify the use of thimerosal in childhood vaccines, creating the specific danger that injured Jac. Id. cmt. d.
Finally, the same duty plaintiffs seek to impose on Lilly is recognized in Restatement § 303. That section states:
An act is negligent if the actor intends it to affect, or realizes or should realize that it is likely to affect, the conduct of another, a third person, or an animal in such a manner as to create an unreasonable risk of harm to the other.
Restatement (Second) of Torts § 303. The example provided with this section is directly analogous to the present case. If a candy company enters a float in a parade, from which an employee throws candy into the crowd, the candy company would be liable for injuries caused to a small boy trampled by members of the crowd rushing to gather up the candy. Id. ill. 1. Here, Lilly had every reason to recognize that other vaccine manufacturers would rely on the falsified results of the Smithburn study and Lilly’s continuing misrepresentations (despite their own knowledge of the dangers of thimerosal) to produce thimerosal-containing vaccines. Therefore, Lilly should be liable to the children injured by products sold in reliance on its misrepresentations.
Lilly relies on Firestone Steel Prod. Co. v. Barajas, 927 S.W.2d 608 (Tex. 1996), for its contention that one company is not liable for injuries caused by products manufactured by another company. Reliance on this case, however demonstrates the fundamental flaw in Lilly’s analysis. Barajas was a wrongful death case in which the plaintiffs sued Firestone for negligence, strict products liability, and conspiracy for the fatal injuries Jimmy Barajas suffered when a tire he was changing exploded. General Tire company made the tire, which was mounted on a wheel manufactured by Kelsey-Hayes Company. Plaintiff sued Firestone alleging that the Kelsey-Hayes wheel was a "15 degree bead seat taper wheel design" and that Firestone had originally developed that wheel design. The evidence, however, showed that Kelsey-Hayes substantially modified Firestone’s original design and that Firestone had no connection to the accident other than its original design. Id. at 611. Based on these facts, the court held that Firestone did not owe Jimmy Barajas a duty because "under traditional notions of products liability, the plaintiff must prove the defendant supplied the product that caused the injury." Id. at 614, 616 (emphasis added).
The present case is distinguishable from Barajas on the simple basis that Lilly’s conduct contributed to cause Jac’s injuries, whereas the plaintiffs in Barajas could not point to any conduct by Firestone that contributed to cause Mr. Barajas’ death. Plaintiffs are not seeking to hold Lilly responsible simply because Lilly designed and manufactured a product similar to the one that caused Jac’s injuries. Instead, plaintiffs seek to hold Lilly responsible for its own acts and omissions that it could reasonably foresee would cause the exact injuries that Jac suffered.
Plaintiffs concede that Lilly cannot be liable under a strict products liability theory because Lilly did not manufacture or distribute the thimerosal that was injected into Jac. Houston Lighting & Power Co. v. Reynolds, 765 S.W.2d 784, 785 (Tex. 1988). However, Lilly remains liable to plaintiffs for the foreseeable harm caused by its own conduct. "In products liability actions, Texas law clearly distinguishes between negligence claims based on conduct and strict liability claims based on products." Oasis Oil Corp. v. Koch Refining Co., 60 S.W.3d 248, 252-53 (Tex. App.-Corpus Christi 2001, pet. denied). As the Supreme Court has repeatedly noted, negligence claims look to the actor’s conduct while strict liability actions focus on the condition of the product. Grinnell, 951 S.W.2d at 437; Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 384-85 (Tex.1995). As such, Lilly cannot escape responsibility entirely just because it cannot be held liable under a theory of strict liability.
Admittedly, the Barajas court also stated while considering the Barajases negligence claims that "Firestone conclusively showed that it did not design, manufacture or sell the wheel in question. Accordingly Firestone did not owe a duty to the Barajases." Id. at 615. However, the court was not faced with a situation such as this case where the defendant’s conduct is directly attributable to plaintiff’s injury. Here, Lilly’s actions were a substantial contributing factor to Jac’s injuries, in addition to the inherent danger of the thimerosal products. Therefore, unlike in Barajas, Lilly’s own conduct was a direct and proximate cause of plaintiff’s injuries, which would not have occurred had Lilly met its duty of care. Consequently, Lilly is responsible for Jac’s injuries and its motion for summary judgment should be denied.
D. Lilly is Also Liable for Fraud and Conspiracy
Lilly also argues it never owed a duty under which it could be liable to plaintiffs for fraud or conspiracy. However, Texas common law fraud recognizes that a party’s duty to refrain from injuring people through false statements extends to all individuals who the party has "reason to expect" will rely on the misinformation to their detriment. In Ernst & Young, L.L.P. v. Pac. Mut. Life Ins. Co., 51 S.W.3d 573 (Tex. 2001), the Texas Supreme Court held that to prevail on a fraud claim, a plaintiff must prove that:
(1) the defendant made a material misrepresentation that was false;
(2) it knew that the representation was false or made it recklessly as a positive assertion without any knowledge of its truth;
(3) it intended to induce plaintiff to act upon the misrepresentation; and
(4) plaintiff actually and justifiable relied upon the representation and thereby suffered injury.
Id. at 577. To show that a party intended to induce a plaintiff to act on the misrepresentation, the Supreme Court held that the plaintiff need only show that the defendant had reason to expect that the plaintiff will act in reliance upon the misrepresentation. Id. at 579-80.
Here, Lilly knowingly and recklessly made false material representations to the FDA, physicians, consumers, and the general public regarding the toxic hazards of thimerosal. See supra III.A. In actual and justifiable reliance on Lilly’s misrepresentations, plaintiffs allowed Jac to be injected with an unreasonable and dangerous amount of mercury, which had devastating effects on Jac. Also, Lilly had every "reason to expect" that its misrepresentations would be relied on by doctors, drug companies, and eventually plaintiffs and their pediatricians. In fact, Lilly relied on the same misrepresentations to deceive the public. Therefore, Lilly owed a duty to plaintiffs and can be liable for fraud.
Finally, plaintiffs contend that Lilly, in combination with Smithburn, Kharasch and others, knowingly agreed to conceal the dangers of thimerosal from doctors, patients, health officials, and others relying on the peer reviewed medical and scientific literature. These conspirators took steps toward that goal manipulating the scientific literature and by intentionally concealing vital information regarding the health risks associated with childhood vaccines containing thimerosal. As discussed above, Lilly even defrauded the federal government in furtherance of this conspiracy by relying on Powell and Jamieson’s article to defend thimerosal before the FDA. See supra III.A.viii. Because Lilly, along with all of the other defendants, knowingly participated in the ongoing ruse regarding the safety of thimerosal and took affirmative steps to ensure the true dangers of thimerosal were never discovered, Lilly was part of a conspiracy for which it should be held liable. Tilton v. Marshall, 925 S.W.2d 672, 680-81 (Tex. 1996).
IV. Conclusion and Prayer
Initially, Lilly’s motion for summary judgment should not be addressed because discovery has not been completed and Lilly has not fully answered plaintiffs’ discovery requests as it agreed to do. However, if the Court considers the merits of Lilly’s motion, it is clear that Lilly owed Jac Counter a duty to refrain from affirmatively distorting the scientific literature and hiding the toxic effects of thimerosal. Lilly’s conduct breached that duty and proximately caused Jac’s illness. Therefore, Lilly owed Jac a duty of care, and is liable for the injuries it caused under negligence, fraud, misrepresentation, and conspiracy theories.
WHEREFORE, PREMISES CONSIDERED, plaintiffs respectfully request that the Court deny Lilly’s motion for summary judgment. Plaintiffs also request that the Court grant them all other relief to which they may be entitled.
WATERS & KRAUS LLP
C. ANDREW WATERS
State Bar No. 20911450
F. LEIGHTON DURHAM III
State Bar No. 24012569
3219 McKinney Ave., Ste. 3000
Dallas, Texas 75204
THE LAW OFFICES OF
SEAN PATRICK TRACEY
State Bar No. 20176500
1100 Louisiana, Ste. 3075
Houston, Texas 77002
ATTORNEYS FOR PLAINTIFFS
CERTIFICATE OF SERVICE
CERTIFICATE OF SERVICE
I hereby certify that a copy of the foregoing response to Eli Lilly and Company’s Supplemental Motion for Summary Judgment was served on all counsel of record on August 30, 2002 via certified mail, return receipt requested.
F. Leighton Durham III