Where Is the Outrage and the Shame?

Do Americans really care more about see-through yoga pants than defective pills and implants?

By Emil Ciurczak, Contributing Editor

This week I watched a report on TV where there was massive Twitter response to the fact that several lots of exercise leotards/yoga pants, distributed by LuluLemon, were see-through when worn. Tens of thousands of outraged Tweets and Facebook postings were sent around the world. 

The top tax rate for millionaires rises from 33 to 35% and tens of thousands of protesters (none making that much in income) protest in televised events.

Large numbers of birth control tablets were mislabeled, causing some pregnancies, and….cue the crickets. What? No one upset? Apparently, inconsequential (social) instances are either more important or more easily understood, so these incidents get more press than real health risks.

When Ranbaxy Laboratories stopped production of its generic version of Lipitor while it “investigates the issue of contamination in certain lots” (at least 14 lots were recalled) due to glass particles in their tablets. I only read about it in trade journals … the major news media seem to have missed it. Our friends at Johnson & Johnson have been making the news over the past few years as well.

For instance, a New Jersey jury has ordered J&J to pay punitive damages of $7.76 million to a former nurse who blames its vaginal mesh implant for years of severe pain despite 18 unsuccessful repair surgeries.1 A spokesman for the plaintiff’s lawyers said the award adds to $3.35 million in compensatory damages awarded by the state Superior Court jury earlier this week. It’s the first verdict in about 4,000 lawsuits filed against the company, based in New Brunswick, N.J. (J&J says the decision isn’t supported by the evidence and the company plans to appeal). 

In the latest in a string of J&J recalls, the giant’s McNeil unit removed three types of K-Y Jelly from pharmacy and grocery store shelves, and recalled shipments delivered to wholesalers, at the end of January. The company has quietly recalled some of its popular products in order to avert potentially expensive new regulatory reviews. 

In addition, “A court jury in Los Angeles on Friday awarded $8.3 million in damages to man who said he was injured by J&J’s all-metal hip implants, which the jury found were designed defectively.”2 The verdict ended the first case to go to trial of about 10,750 product-liability lawsuits against J&J’s DePuy unit, which manufactured the devices. The jury declined to award punitive damages, but costs will add up. (I must have missed the newspapers the day this was covered.) In addition, in 2010, J&J recalled hip replacements implanted in about 93,000 people because an excessive number needed a second hip-replacement procedure. The recall sparked lawsuits, with some patients alleging that potentially toxic metal particles wore away from their all-metal hip parts, entering patients’ bloodstreams. J&J has since taken hundreds of millions of dollars in charges to cover medical and litigation costs related to the recalled products.

Lost product sales and factory upgrades have cost J&J well over $1 billion. In addition, J& J’s manufacturing operations remain under increased scrutiny from the FDA. So, what “meaningful” actions were taken against those responsible for so many errors? Well, J&J has lowered planned bonuses by 10% for new CEO Alex Gorsky and other top executives. The health products maker cited a “mix of short-term successes and disappointments” last year, including its failure to get many of its recalled nonprescription medicines back into stores as quickly as promised. Wow! Almost a death penalty.

Still, Mr. Gorsky received total compensation worth $8.93 million, up approximately 62 percent from the $5.52 million total he received in 2011 and promoted from vice chairman to CEO last April. 

A brief review of the news brings a daily dose of drug company problems. Problems of quality, in fact, that are not “accidents,” but due to lack of quality systems enforcement. Unfortunately, major corporations (not to just single out J&J) are not getting the press needed for reform (court fines are seen as the cost of doing business). Apparently, the FDA does not have the support (financially or philosophically) of Congress to attack the problems more aggressively. And, worst of all, the public doesn’t have the same passion over life-threatening problems that they seem to have over see-through yoga pants!

Published in the May 2013 issue of Pharmaceutical Manufacturing magazine


References

 

1.     “LuluLemon pants problem,” Today Show, 3/19/2013

2.     USFDA announcement

3.     “Jury Adds $7.8M in J&J Punitive Damages”, Thu, 02/28/2013 - 12:18pm, The Associated Press

4.     “Calif. Jury Awards $8.3 Million in Lawsuit Vs. J&J Over Faulty Hip Implants”,Published March 08, 2013, Dow Jones Newswires

5.     “J&J Lowers Exec Bonuses, Citing 'Disappointments'”, Wed, 03/13/2013, L. A. JOHNSON - AP Business Writer - Associated Press 


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