Wednesday, February 1, 2012

Watch Out for the Stork And for Legal Actions

Ring ring.

"Hello, honey...What's wrong?...You're what?!... But how...Did you forget to take your...Are you sure?...Having a baby is a blessed event, but not now, not for us. How could you let this happen?"

Maybe he's asking the wrong person. Maybe he should ask Pfizer, Inc., how it could let this happen. Perhaps the unexpected bundle is on the way because of  a recall of birth control pills, specifically Lo/Ovral-28 and Norgestrel and Ethinyl Estradiol tablets.

"An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. The cause was identified and corrected immediately."  (http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp#guid=20120131007121en&source=RSS_2011&page=1)

The improper dosages in the pills could lead to unexpected pregnancies, according to Pfizer's news release. "Pfizer has responded rapidly to ensure that its products continue to meet the company’s high quality standards. The safety of patients who take our medicines is our first priority."

Some couples may have new first priorities in a few months. I can't tell how "rapidly" Pfizer announced the recall. I've heard about it on several news broadcasts, so we can hope women who use the product have heard about it too.
 
Pfizer needs to be looking ahead at legal suits and how it will deal with individual cases or a class action. In the meantime, communicators should be communicating openly about the swiftness of the recall announcement, the steps being taken to address the defective pills, and how it is preventing a recurrence. Communications now may not prevent a single couple from taking multi-million-dollar legal action' but it's not going to hurt.
 
"Dr. Manny Alvarez, senior managing health editor of FoxNews.com, said this recall of birth control pills is one of the largest he can remember in recent years. 'If there’s one thing that for years women have relied on, it’s that the sun is going to come out in the morning, you have to pay taxes, and that your birth control pills will work,' he said. 'The efficacy of birth control pills is supposed to be 99.8 percent in preventing pregnancy, especially when women take it as directed.'"  (http://www.foxnews.com/health/2012/02/01/contraceptive-recall-could-put-pfizer-at-risk-multi-million-dollar-lawsuit/)
 
Although Pfizer claims there are no health impacts from the drug, that's immaterial if someone using it gets pregnant.

“'In essence,' (Greg Gianforcaro, a litigation attorney in New Jersey) explained, 'we’re looking at, how do you put a price tag on a child’s education, a child’s upbringing, and other costs – initially, for diapers, then for sneakers, and then 20 years later, college and marriage?...'

"If many women get pregnant as a result of the botched pills, and a class action suit is large enough, Gianforcaro said there is the potential that it could put Pfizer out of business. 'I don’t anticipate that happening here, but there’s always the possibility,' he said."

In case of legal suits, Pfizer has several avenues of defense, such as requiring proof the woman was taking the recalled birth control and claiming pregnancies are part of that .2% rate of ineffectiveness. Strategies need to be formulated now and the communications people need to be filled in so they might craft messages now that will help later.

As with all pharmaceutical recalls, the entire industry must beware. According to Alvarez, "'But again, we’re looking at a drug company that has created more mistrust in the health care system.'”

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