Will Johnson & Johnson Get A Consent Decree?

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bill-weldonThe possibility that the FDA may take more severe action against Johnson & Johnson may be more likely. After all, the agency last month issued a 483 enforcement report, which detailed all sorts of problems at the healthcare giant’s Las Piedras facility in Puerto Rico, mostly to do with quality control and following written procedures (take a look).

Yet some violations cited were also found in a previous 483 report stemming from FDA inspections at the same facility last January and February. Being a repeat offender, especially after being warned not to do so amid multiple and serious manufacturing issues at this plant and another in Fort Washington, Pa., does not bode well for Johnson & Johnson.

Consequently, “we see increased risk of a consent decree or seizure, either of which could effectively stop (at least temporarily) product manufacturing at and shipment from Las Piedras,” writes Larry Biegelsen, a Wells Fargo Securities analyst in an investor note this morning. He adds that one of his consultants figures there is a 50 percent chance that a mandatory or voluntary decision to stop production and shipment is possible. Now, 50 percent may be ambivalent, but the risk is not low.

What are the implications? Well, there would be another stain on the once-venerable Johnson & Johnson reputation, possibly more lost jobs and a notable financial hit. Biegelsen points out that Las Piedras produces most - possibly 60 percent - of the over-the-counter meds for the US McNeil Consumer Healthcare unit, which he estimates should chalk up sales of $2.3 billion next year.

But if the plant is out of commission, that means $1.38 billion in revenue would be lost in 2011, and that does not include the possibility that Fort Washington will remain offline. You may recall that the Pennsylvania facility was shuttered earlier this year amid the recall of tens of millions of bottles of OTC meds, some of which were found to contain metallic flecks or too much active ingredient. Bottom line: a 2 percent hit on companywide sales and 6 percent to 7 percent reduced earnings per share.

For the moment, this remains theoretical. But given the shellacking Johnson & Johnson is taking, perhaps the board will ask ceo Bill Weldon to share the pain and accept a lower bonus this year or return a portion of his salary. Why should only employees and shareholders suffer? In the absence of any public statements, such notions will not be known until the proxy statement is circulated next spring. There is not much time between now and then, though, for Bill to get things right.

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  1. wait - what?! they’re still shipping product from Puerto Rico? jeezum crow!

  2. So Ed, where is the poll about whether or not we think that J & J will be hit with a consent decree?

  3. They should, but they may be “too big to fail.”

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