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Dow Chemical Company v. Mahlum

12/31/1998

rted by the record. First, the sixth material that was omitted in the report on five silicone materials is a substance identified only as "Z-4141," and the Mahlums do not contend that Z-4141 is contained in Dow Corning's breast implants. Thus, its effects, whether harmful or not, have no bearing on the Mahlums' claims. Second, there is no evidence to suggest that Dow Chemical (via Dr. Rowe or otherwise) played any part in creating the second report. The evidence thus indicates that Dow Chemical had no role in attempting to hide the effects of "Z-4141."


The Mahlums also cite the 1970 pathology report prepared by a Dow Chemical scientist, Dr. Gary L. Sparschu, as another link establishing Dow Chemical's undertaking to ensure the safety of silicone gel breast implants. This study injected rats, male and female, with different doses of DC 360, intraperitoneally and subcutaneously. The pathological results showed traces of the silicone fluid throughout the animals' bodies, including the bone marrow. The male rats in one group showed decreased liver weights, and the female rats in another group had decreased brain weights. The report concluded, however, that " hese findings do not appear to be associated with treatment because the effect is not dose related." An inflammatory reaction was not associated with the deposition of DC 360 in the organs. Again, given that the Mahlums do not assert that Dow Chemical performed any of its tests negligently, and that this report found no significant dangers of DC 360, we are left only to speculate as to how this report also should have raised an alarm for Dow Chemical to publish this information.


In a letter from the independent laboratory, Food and Drug Research Laboratories, Inc. (FDRL), to Dow Corning in 1964, FDRL submitted a revised proposal on certain polysiloxane studies pursuant to Dow Corning's modifications "as well as conversations with Dr. V. K. Rowe at the Gordon Research Conference recently." This is the only link connecting Dr. Rowe, and therefore Dow Chemical, to the 1964 polysiloxane dog studies performed by FDRL for Dow Corning. In 1964, FDRL began conducting a long-term (2 years) study of silicone migration (including that of DC 360 when injected) in animals and the extent to which the compounds remain in animal tissues. FDRL reported its results to Dow Corning in 1968.


In 1967, a second two-year study of miniature implants in dogs was performed by the same independent testing laboratory for Dow Corning. The evidence linking Dow Chemical to this study was that Dr. Rowe was one consultant among several who recommended that the study be done. These FDRL studies show that Dow Corning was not relying on Dow Chemical's alleged undertaking as having established the safety of silicone gel breast implants.


The Mahlums conceded that Dow Chemical properly executed the tests that it performed for Dow Corning. Instead, the Mahlums alleged that Dow Chemical was negligent in failing to recommend further studies to ensure that silicone fluids could safely be used in its breast implants. The record, however, shows that Dow Chemical did make such a recommendation regarding Silastic implants. In 1967, Dr. Rowe recommended, presumably in his role as an advisor, to Dow Corning's product safety committee that long-term testing of miniature implants in dogs be conducted to establish the safety of Silastic implants. In response to this recommendation, Dow Corning commissioned the 1967 FDRL long-term study.


In summary, proof at trial identified a series of tests that Dow Chemical performed for Dow Corning at Dow Corning's request. Dow Chemical performed these studies and reported them to Dow Corning. There is no proof suggestin

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