In the first lawsuit over Johnson & Johnson’s “phantom recalls,” Oregon’s Attorney General John Kroger argues that Oregon consumers were left in the dark when the company hired parties to covertly buy up potentially defective Motrin from Oregon stores in 2008 and 2009. The lawsuit asserts that J&J’s decision to pursue a secret recall process, rather than a public recall, violated the state’s consumer protections laws.

The complaint cites many disturbing facts that have come out about the phantom recall. As early as Nov. 20 2008, routine testing by J&J showed that some Motrin caplets did not dissolve correctly. Despite notifying the FDA about the defect on Nov. 26,  J&J made “no attempt to notify wholesalers, retailers, or consumers [about] the defective Motrin® . . . .” to stop its shipment or sale.  Weeks later, after J&J “received price estimates from two companies that specialize in product recalls” for a public recall, J&J rejected this approach, choosing instead to ‘remove the defective Motrin® . . . from the market surreptitiously.”

During the “Phase I” of the phantom recall, J&J hired a company to visit 250 stores nationwide to see if any of the defective Motrin remained on the shelves.  In April 2009, five months after J&J knew it was selling a defective product, the company found only 595 packages of defective Motrin on the shelves of these 250 stores.  Two months later, the complaint suggests, a consulting company was hired by J&J to secretly purchase the remaining Motrin from about 5000 convenience stores. How many consumers purchased and consumed these potentially defective drugs remains unknown.

All in all, J&J’s phantom recall turned up only 41 packages of defective Motrin® leaving “787 [packages of defective Motrin®} unaccounted for in Oregon.” But the number of Motrin packages sold isn’t as significant as the fact that “[a]t no point during the entire process did Defendants alert Oregon consumers or retailers that it had distributed the defective Motrin® . . . .” In fact, it was an employee of the company hired to do the phantom recall that alerted the Oregon Board of Pharmacy, who then alerted the FDA in Seattle.

During this five month process, J&J was communicating with the FDA in Puerto Rico, arguing that because so few of the Motrin were still on the shelves, there was no need to do a recall.

So what will this lawsuit mean?  Regardless of whether it yields some recovery for Oregon consumers, it shines light on some of the big problems that can grow out of a regulatory system that relies upon industry to initiate recalls. As we’ve talked about here, the move to give the FDA recall authority over drugs has gained serious traction, appearing in no less than three bills filed in Congress last year. And now a new straw poll at Pharma Tech shows 90 percent of readers think the FDA should be able to hit the recall button.

Of course, J&J is not the only drug-maker that has tried to hide its dirty laundry. Recent revelations on “60 Minutes” document how GlaxoSmithKline tried to silence their own quality control inspectors. At very least, stronger whistleblower protections are needed.

But these problems may be just the tip of the iceberg. Both the J&J and GSK breakdowns in manufacturing standards happened in Puerto Rico-based operations, and like the Deltex factory shuttered in Texas this week, these U.S. plants undergo regular FDA inspections. But many over-the-counter and prescription drug products are manufactured overseas, in locations that FDA inspects less frequently, and whistleblower protections may be non-existent. Congress just expanded FDA funding and authority to regulate imported food sold in the U.S. Doing the same for drugs is a smart move to protect consumers.

–Wells Wilkinson, Director, Prescription Access Litigation