The widening quality problems at Johnson & Johnson are causing concerns as yet another J&J business — at least the seventh — has come under scrutiny. The lapses are hard to reconcile with what once was J&J’s stellar image. Executives at J&J cite the corporate credo, prominently displayed at headquarters, stressing the company’s responsibility to the doctors, patients and parents who use its products.

Animas Corp., the J&J unit that makes insulin pumps for diabetics, is currently being investigated. The Food and Drug Administration has warned Animas that unless it corrects violations soon, it could face fines and other sanctions for selling faulty insulin pumps and delaying disclosures of serious injuries to patients using its OneTouch Ping and 2020 pumps. The FDA ordered Animas to explain by Jan. 20 why it kept selling pumps known to fail and also to submit a plan to rectify its failure to promptly report cases where its device might have caused or contributed to death or serious injury.

In a Dec. 27 warning letter posted online by the FDA, the agency wrote to Animas and J&J CEO Bill Weldon that inspectors found Animas, based in West Chester, Pa., never reported on one complaint about serious patient injury and delayed reporting on two others. Those patients were hospitalized with dangerously high blood sugar, respiratory failure and coma, and a life-threatening complication called diabetic ketoacidosis caused by lack of insulin to break down blood sugar.

The problems follow a string of nearly 30 product recalls announced by New Brunswick, N.J.-based Johnson & Johnson since September 2009, with the latest just three weeks ago. The recalls have included millions of bottles of Tylenol, Motrin and other nonprescription medicines for children and adults, prescription drugs for seizures and HIV, faulty hip implants and contact lenses that stung the eyes. Reasons ranged from contamination with metal shards and glass particles to nauseating odors and inaccurate levels of active drug ingredients.

Insulin pumps, which are about the size of a cell phone, automatically inject small amounts of insulin through a tiny needle under the skin throughout the day to keep diabetics’ blood sugar at a safe level. Patients program the device to inject additional insulin right before a meal or snack, according to the amount of carbohydrates about to be eaten.

An Animas spokeswoman, Caroline Pavis, says that the company did not report the three patient incidents to FDA as required within 30 days because each involved patient was not using the pumps according to directions. In one case, she said, the patient ignored an alarm signaling the cap had come off the insulin cartridge inside the device, preventing insulin from being pumped into the body. She did say that Animas will now report all patient complaints promptly. In a separate issue, some pump keypads for controlling how much insulin is injected were deteriorating prematurely, leading to failures.

Animas decided to go with a new keypad “because it’s more durable,” according to Ms. Pavis. But while Animas was lining up the new keypad supplier, it was still selling the older ones. The FDA has demanded documents about the company’s decision to do that. Companies are required to continuously evaluate a product’s safety over its life span. They should have infrastructure in place to process, review and classify complaints, because they could be indicative of a larger issue with the product.

The recalls have cost J&J $900 million in 2010 alone in lost revenue from products not being in stores, plus millions more for factory upgrades and legal expenses. The FDA and Congress have been investigating the handling of the manufacturing problems as well as the recalls. J&J has said there have been no reports of serious patient harm from the recalled products, although as we have reported, the company is now being sued by a couple alleging their toddler died from taking a “super dose” of defective Children’s Tylenol.

The FDA’s warning letter states that the initial Animas response to the problems cited in the August inspection report was not adequate. Animas was to respond before the January 20th deadline. The letter states that if the company doesn’t promptly correct the violations, it could face seizure, injunction, and fines, and could be denied future contracts from federal agencies.

Source: Yahoo News