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Legal News
FDA Report Finds Serious Flaws with the Manufacture of Children’s Motrin and Tylenol
Thursday, May 6th, 2010A recent FDA report focuses on drug contamination, lack of quality control, and neglect at Johnson & Johnson subsidiary regarding manufacture of Children’s Motrin and other products. Johnson & Johnson’s McNeil unit that produces children’s over-the-counter medicines, such as Motrin, Tylenol, Zyrtec and Benadryl has announced a recall of over forty of its pediatric medications and a temporary shut-down of its main manufacturing plant in response to an inspection report issued by the FDA on Tuesday. This is the fourth recall the pharmaceutical giant has issued since May 2009 for its products and the second in six months for children’s Motrin and Tylenol. Among the more serious findings in the report were that the company did not respond to over 46 complaints received since June 2009 concerning drugs manufactured at its Fort Washington plant. The FDA inspection revealed (CLICK HERE TO DOWNLOAD FDA PDF) over 20 violations of internal quality control procedures at the plant, which resulted in the bacterial contamination of over forty over-the-counter children’s products. The FDA inspection further revealed that raw materials used in the manufacture of drugs tested positive for bacterial contamination, manufactured drugs did not contain accurate dosage, and there were reports of a brown or black substance in the drugs.
Report Shows McNeil’s Disregard for Ensuring Quality and Safety of its Pharmaceutical Products
The FDA report reveals McNeil’s pattern of disregard for the safety of consumers and lack of diligence in reporting known manufacturing problems concerning its products to the FDA . The Los Angeles Times has reported that McNeil knew they had serious manufacturing and quality control problems at another manufacturing plant in Puerto Rico, yet waited over a year to notify the FDA and to fix the problems. Deborah M. Autor, of the FDA has gone on the record stating that, “We had concerns about the company’s failure to investigate and correct quality problems. The company should have acted faster. All companies have a responsibility to ensure high quality, safety and effectiveness of their products and protect consumers.”  McNeil’s failure to  timely respond to complaints about their pediatric medicines demonstrates a frightening indifference to those we love most: our children. The lack of written procedures for production and testing of children’s drugs at the Fort Washington plant, as detailed in the FDA report, paints a disturbing picture of the pharmaceutical conglomerate’s emphasis of corporate profits over consumer safety.
Motrin Has Also Been Tied to Stevens-Johnson Syndrome
Manufacturers of ibuprofen products, such as McNeil, have known since the 1970s that there has been a causal connection between ibuprofen and Stevens-Johnson syndrome and its more deadly form, Toxic Epidermal Necrolysis. Still, the company did not warn of SJS/TEN on the labels of its ibuprofen products until  the FDA ordered them to do so in 2005, when it determined that the mounting evidence of the causal connection between ibuprofen and SJS/TEN had reached a point where a specific warning of the disease on ibuprofen products was required.  Meanwhile, parents continued to give Motrin and other ibuprofen products to their children for common colds and fevers. The resulting drug reaction, SJS, is treated like a critical-care burn injury, because it causes blistering and skin loss of between 10% and 30% of the total skin on a victim’s body. TEN is the more severe form of the same toxic drug reaction: it causes over 30% of the body’s skin to burn and fall off. TEN is lethal for up to 60% of its victims.
The Law Offices of Brian D. Witzer Calls for Better Oversight of Drug Giants
“Motrin is a dangerous and defective product that can have deadly consequences for adults and families. It is about time that McNeil and Johnson & Johnson communicate the dangers of their drugs rather than disregarding FDA findings and sweeping consumer health complaints under the carpet,” Brian D. Witzer stated. “They must be held responsible for their defective manufacturing processes and improperly formulated products.”
The Law Offices of Brian D. Witzer has a long history of fighting big companies and winning. If you, or a loved one have experienced symptoms of SJS due to Motrin or any other drug, contact us for a free evaluation of your case HERE. We have the resources and expertise to help you fight for justice.
Witzer Law Takes Lead in Allopurinol Cases
Wednesday, March 24th, 2010Building on a record-setting verdict in Pasadena, CA (view news here) the Law Offices of BrianD. Witzer has taken the lead in publicizing the dangers of Allopurinol. Without proper education and monitoring of those on Allopurinol by doctors and pharmacists, a simple case of gout or kidney stones can turn tragic. Read more…
Witzer Law Now Accepting Clients Affected by Toyota Recall
Thursday, February 25th, 2010The Law Offices of Brian D. Witzer has the resources and expertise to help you gain justice.
The Law Offices of Brian D. Witzer has gained a sterling reputation as a firm with a history of getting large settlements in difficult cases. As the news reports come in, it has become clear that Toyota waited to recall millions of cars and car parts, even though evidence was mounting of accidents taking place due to defective Toyota parts.
Accidents caused by Toyota’s defective parts/engineering, lack of communication with consumers, and slow reaction time have led many drivers to remain on the road in an accident prone vehicle, Read more…
