Erin Brockovich, the consumer advocate who filed a multimillion case against Pacific Gas and Electric Co for groundwater contamination, had blamed preemption laws in her fight against birth control implant Essure. Brockovich had been leading a campaign to have the Bayer Corp-owned drug removed from the market due to concerns about safety.
Brockovich told ABC News that the Food and Drug Administration (FDA) gave Essure a preemption status when it was approved in 2002. This would exempt the manufacturer from tort claims arising from their use of the product.
"Preemption is not about the Essure women - it affects all consumers. If someone had a medical device installed, there's no recourse for victims, and the company is protected. If there's a problem, the company gets a pass, because they have preemption. It dawned on me the consumer didn't know. The women didn't know that this existed," Brockovich said.
Bayer acquired Conceptus, the maker of Essure in April 2013 for USD 31 per share or a total of USD 1.1 billion. Last year, Conceptus was able to generate net sales of USD 141 million. It posted adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of USD 28.2 million in 2012.
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