FDA and Congress Investigate Contamination and Other Problems at Johnson & Johnson

As a defective medication lawyer, I have closely watched the continuing reports of problems with drugs manufactured by McNeil Pharmaceuticals. In January, I wrote about the unsettling recall of products made by McNeil Pharmaceuticals, a unit of Johnson & Johnson. That recall involved over-the-counter medications that many of us know well, such as Tylenol, Rolaids, Motrin and St. Joseph Aspirin. Now, the FDA has issued a new recall for commonly used infants’ and children’s medications that McNeil produces, such as Tylenol, Motrin, Zyrtec and Benadryl.
Initially, the FDA said that the products involved in the current recall could have stronger concentrations than they were supposed to, or they could contain inappropriate inactive ingredients or tiny particles. Just a few days later, we began to see more damning reports, alleging quality and security lapses at McNeil’s Fort Washington, PA, manufacturing plant. A routine FDA inspection of the plant found that raw materials for the infants’ and children’s medications were contaminated with Burkholderia cepacia bacteria, which is often resistant to common antibiotics. The Center for Disease Control says that the bacteria can be harmful to people with weakened immune systems or chronic lung disease. The FDA was concerned that the contaminated materials could have been used in the products that were recalled, although McNeil says that its tests of those products did not show contamination. The FDA and McNeil both say that the chance of harm from using these products is remote, but they advise customers to stop using the recalled drugs immediately.
Unfortunately, McNeil has not given consumers a lot of reasons to trust its word. The earlier McNeil recall involved medications that had a “musty” smell and that gave consumers stomach pain, nausea, vomiting and diarrhea. It was suspected that the drugs were tainted with 2,4,6-tribromoanisole (TBA), a flame retardant and pesticide used in shipping pallets. The most disturbing part was that McNeil waited at least a year, rather than the legally required three days, after receiving complaints about the medicines before it fulfilled its duty to report the problem to the FDA. In the current case, McNeil appears to be equally unable or unwilling to meet its reporting duties; the FDA has faulted it for failing to report the contamination or recall lots of tainted medicines. And infants and children have less-developed immune systems than adults, so contaminated drugs could put them at serious risk of illness. We still don’t know what those “tiny particles” are that McNeil initially cited as the reason for the recall, but there have been over 40 consumer reports to the FDA about dark flecks in the medications.
Now, the House Committee on Oversight and Government Reform plans to hold hearings to investigate McNeil and the FDA. As a pharmaceutical liability attorney, I would recommend that consumers who have been harmed by these contaminated drugs ask questions too, including ones about their legal rights in situations like this. Drug manufacturers have a legal duty to warn consumers and the FDA about risks that their products might pose, such as the risk of bacterial contamination that could cause infection. If McNeil knew about problems and kept them quiet, and consumers took their contaminated medications and became sick, those consumers could sue McNeil to recover all of the costs their illnesses.


The defective medication lawyers at the Lowe Law Firm help people who have been hurt by contaminated drugs. If you or someone you love have been seriously harmed by a prescription or over-the-counter medication, we can advise you about recovering compensation from the company that caused your injury. Drug companies have made headlines over the past decade for selling medications that were unsafe to use, sometimes knowingly, or unethically pressuring doctors to prescribe pricey drugs to patients for whom they are not appropriate or FDA approved. In essence, this puts profit above the safety of patients. The law recognizes that you should not have to bear the costs of such an injury on your own if they were imposed upon you through no fault of your own, and we can help you set things right. In a lawsuit, you can recover payments for medical treatment and compensation for pain and suffering, loss of quality of life and past and future lost wages.
If you have been hurt by a defective medication, please call the Lowe Law Firm for a free consultation, toll-free, at 1-877-678-3400 or contact us through our Web site.