Daikon Shield

The increase in liability claims is not uniform across all pharmaceutical products. Contraceptives, vaccines, and drugs taken during pregnancy appear to be particularly susceptible to liability claims. The vast majority of all product liability litigation in the health care sector over the past two decades is attributable to two products—the Daikon Shield contraceptive and Bendectin,... 

The Rand researchers concluded that A H. Robins s Daikon Shield contraceptive intrauterine device (IUD) and Merrell Dow s Bendectin antinausea medicine for pregnant women explained the bulk of liability cases for these two... 

The Daikon Shield and Bendectin are both products intended to affect the reproductive health of women in childbearing years. A.H. Robins acquired the rights to the Daikon Shield in 1970. Claims of the device s effectiveness as a contraceptive were based on a 1-year study of 640 women, which showed a 1.1-percent pregnancy rate during the trial period (103). At that time, Federal law did not require FDA approval of medical devices such as the Daikon Shield.11... 

After the Daikon Shield suits forced A.H. Robins into bankruptcy, the courts imposed an April 1986 filing deadline for new claims. By that time, about 320,000 claims had been filed against the firm for injury caused by the Daikon Shield (206). Of the 4,400 claims resulting in litigation, A.H. Robins paid 250 million in out-of-court settlements and another 25 million in punitive awards imposed by 11 juries. As part of its bankruptcy plan, the courts required A.H. Robins set aside another 2,475 billion for unsettled claims (288). 

Withdrawal from the market did not eliminate the potential for the IUD to cause new injuries, since many women kept implanted Daikon Shields in place after 1974. 

An allergic hypersensitivity reaction -generalized itching, erythema and oedema of the eyelids — occurred with Dextran 70 during hysteroscopy for removal of an implanted Daikon shield. No previous exposure to dextran was known to the patient. Dextran was given to prevent anticipated bleeding (34 ). 

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