Johnson and Johnson (J&J) has been facing some major problems lately connected to pulling 40 types of children’s drugs from store shelves this month after a Food and Drug Administration (FDA) inspection in April found contaminated materials at a manufacturing facility run by the company’s McNeil Consumer Healthcare unit.
FDA officials and a J&J executive testified about the manufacturing problems on Thursday at a U.S. House Committee on Health, Education, Labor, and Pensions hearing. These hearings took an unexpected turn that revealed serious violations and a scathing breech of ethics.
Following the hearings another unit of J&J that produces children’s medicine, Blacksmith Brands Inc., announced a recall Friday of about 100,000 units of four PediaCare items sold nationwide. These recalled items include PediaCare Multi-Symptom Cold, PediaCare Long Acting Cough, PediaCare Decongestant and PediaCare Allergy and Cold.
One resounding theme of all of the happenings surrounding J&J last week revealed that the giant pharmaceutical company’s efforts to restructure and cut costs over the last three to four years resulted in putting children in serious danger. This has further besmirched the already tainted reputation of a company that had a very public recall of their Tylenol products in 1984 regarding tampered products containing poison. This scandal drastically changed packaging standards. Perhaps J&J will once again change the over the counter policies in the US.
PediaCare Recall
Blacksmith Brands said on Friday it was recalling the four PediaCare items because they were made at the same manufacturing facility run by McNeil Consumer Healthcare. Apparently, there have been no reported incidents linked to the recalled PediaCare products, but tiny particles have been found in other products that were made at the McNeil plant, Blacksmith Brands said.
The PediaCare items involved in the recall are:
- PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
- PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
- PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
- PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4
Ingredients used by J&J in some of the 40 varieties of previously recalled children and infant medicines were contaminated with bacteria, according to an FDA report released this month. The report lists more than 20 manufacturing problems at the McNeil plant where the newly recalled PediaCare products were produced.
Tylenol Recall Hearings
The FDA’s principal deputy commissioner, Joshua Sharfstein, told committee members at a hearing on Thursday that McNeil Consumer Healthcare had a “pattern of noncompliance” with good manufacturing practices. He said FDA regulators were considering such punitive measures as “seizure, injunction or criminal penalties.”
The FDA’s criminal investigations office is looking into the matter, an aide said. Dr. Sharfstein said the agency was now working well with J&J and its McNeil unit, but he described a history of troubles getting the unit to fix violations.
The hearing then took a surprising turn into a new controversy that had not been previously revealed to the press. The committee began questioning the lone J&J executive, Colleen Goggins, who oversees J&J’s consumer business, as to why, after the company discovered some defective Motrin products, J&J instructed a contractor to send out workers to buy the entire available product off retail shelves.
Under pressure from the FDA, the company issued a recall of 88,104 packages of Motrin in July 2009. “I don’t think we fully understood what was going on,” Dr. Sharfstein said.
J&J had learned as early as November 2008 that certain Motrin pills wouldn’t dissolve appropriately, thus reducing or completely negating their effectiveness. The company put a hold on lots at its distribution center. Then, instead of issuing a recall, they hired a contractor to sample some of the eight-count packages on store shelves to see if a recall was necessary, according to an FDA PowerPoint document.
The contractor appeared to take their job farther and instructed workers to visit all of the stores “on your schedule to locate and purchase” all of the Motrin eight-count packages, according to a memo shown at the House committee hearing. The memo said “you should simply ‘act’ like a regular customer in making these purchases,” and advised the workers not to talk about a recall.
Goggins told the committee that she didn’t know what instructions had been given to the contractor. She also said that it’s unclear what prompted the contractor to direct its workers to buy up all packages on store shelves, thus neatly hanging the issue on the contractor and leaving them out to dry.
Some on the committee suggested that the lower standards displayed by McNeil have occurred amid J&J’s cost-cutting and consolidation of some functions. Last year, J&J announced plans to cut 8,200 jobs, or 7% of its work force, as part of a broad restructuring that aims to achieve $1.7 billion in yearly savings by 2011. J&J executives also recently moved to standardize compensation across the company.
The consumer business’s overall spending on property, plant and equipment fell to $439 million last year from $499 million the year before. Goggins said the cost-cutting measures didn’t overall quality control at the problematic Fort Washington facility. She said the head count among Fort Washington’s quality staff was flat from 2006 to 2009, while the plant’s quality-control spending during that time rose 17%.
Defective Drug Lawyers
J&J’s consumer business, which includes the McNeil unit and other companies, had $15.8 billion in sales and $2.48 billion in profit. This looks fantastic to shareholders just as long as they don’t actually give their children these products.
As a defective drug law firm, it is our aim to protect consumers from some of the policies of giant pharmaceutical companies to profit off of drugs that they know may be harmful to consumers. Many of these policies result from lack of diligent research and lack of oversight. Other causes stem from irresponsible and dangerous cost-cutting measures the can result in putting the consumer’s health in jeopardy such as the current J&J issue.
Phillips Webster represents consumers and their loved ones in personal injury and wrongful death lawsuits resulting from defective drugs. If you or someone you know has been affected by the serious problems surrounding Children’s Tylenol or PediaCare products it is important to have experienced representation on your side to assure that your voice will be heard and that you receive the compensation that you deserve. Call the defective drug lawyers at Phillips Webster for a free consultation on your legal options.
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