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Abbott Didn't Recall Drug That Allegedly Blinded 8 Until a Year Later

An horrific lawsuit in which eight people were blinded after Abbott Labs (ABT) allegedly sold a bacteria-infected cataract drug can move forward, an appeals court ruled, opening the way for lawyers to figure out how the incidents happened. The case is a reminder of the oddly lax attitude Abbott's optical drug unit has displayed when consumers have been blinded by its products in the past.

The case was brought by eight residents of Mexico who had cataract surgery performed by a surgeon in that country with 25 years of experience. After their surgeries in 2007, infections rapidly set in. Their eyes became red, filled with runny pus, they suffered fevers, nausea, and vomiting. Three had to have their eyes removed completely; the other five were completely blind in the affected eyes, the suit claims.

The surgeon had used Abbott Medical Optics' Healon product in the operation, an injectable solution that relaxes the pupil and allows surgeons to manipulate the eye without damaging it. He sent some unopened tubes of Healon to a lab for testing and found that they were infected with bacillus cereus, which causes bacterial endophthalmitis. Abbott denies the claims.

The Abbott unit (formerly known as Advanced Medical Optics), however, did not recall Healon in 2007. Instead, the recall occurred a year later in October 2008.

That recall was repeated a few months later in 2009 because the company had not accounted for all the outstanding stock of Healon that were on the market. Sixty-six adverse events, mostly infections, were reported in association with that recall.

Abbott has a history of moving slowly. In 2007, when it recalled its Complete MoisturePlus contact lens solution, it failed to report eye infections leading to blindness for more than a year. The company's unusual excuse was that it thought it did not have to report the problems because the lens solution was not approved to prevent those infections. And even when the recall happened, Abbott was criticized for not advertising it widely enough.

The ruling in the current case suggests that the plaintiffs may have manipulated the Mexican court system in order to bring its case in the U.S., where Abbott is based. If the California federal district court handling the case allows it to proceed in the U.S., a lawyer for the plaintiffs said, he intends to conduct discovery to find out why Abbott waited a year after the Mexican surgeries to recall Healon.


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