As a dangerous medical device attorney, I’ve written twice so far about serious contamination problems in supposedly sterile Triad alcohol prep pads and other products. The products attracted attention after the Kothari family of Texas filed a lawsuit against manufacturer H&P Industries, which blamed a contaminated H&P product for the death of their two-year-old son. Products containing the same bacterium are blamed for disabling heart problems in a Tennessee man and a life-threatening infection in a ten-year-old cancer patient in Colorado. The FDA ordered H&P to stop production March 28, but the company apparently did not immediately comply. Possibly as a result, U.S. Marshals visited the plant April 4 to seize potential evidence, triggering a shutdown.
Products manufactured by H&P have been the subjects of multiple recalls since Harrison Kothari’s death in November. In that case and in several other widely publicized cases, products used to prepare patients for surgery were contaminated with a bacterium called Bacillus cereus, which is not a common hospital-borne infection. The media later discovered that serious problems at H&P’s Wisconsin plant had been turned up as early as July of 2009 and again in early 2010, but the FDA took no serious action. Inspections found plumbing products that could cause contamination, employees handling products without gloves, improperly cleaned and sterilized equipment and a medicine being made without its active ingredient.
It wasn’t clear what triggered the FDA’s request that H&P shut down its operations, but as the Milwaukee Journal Sentinel reported, it is unusual for companies not to comply. An H&P spokesperson said the company was “considering its options” last week. The FDA’s next option could have been to get a court order forcing a shutdown. But on April 4, the U.S. Marshals Service arrived to seize materials at the plant, and H&P voluntarily complied with the shutdown order.
It’s good news for patients that the H&P plant has ceased production, but disturbing to me as a defective medical device lawyer that it took so long to address these problems. As I’ve written before, previous problems included the president of the company authorizing shipments of products even though they failed inspections, a clear breach of safety and possible breach of the law. The FDA also didn’t resume inspections until a Colorado children’s hospital had an outbreak of Bacillus cereus and reported possible contamination to the agency. This inaction by the FDA may have come at far too high a price for the families that suffered a death or illness. Several lawsuits have already been filed in addition to the Kotharis’, and more are expected as more families begin to connect their illnesses with the unsanitary products.
If you believe a tainted or defective medical product is responsible for harming your own family, you should call Carey, Danis & Lowe right away. Based in St. Louis, we represent clients who have lost a loved one or suffered a serious injury or illness because of unsafe, flawed medical products. As this story illustrates, the FDA doesn’t fully protect the American public; problems slip through the cracks, and some of them cause very serious injuries and illnesses. Our pharmaceutical liability attorneys help patients hold the manufacturers legally liable and recover fair financial compensation for their losses, suffering and medical costs. Medical bills can be substantial for people subjected to a catastrophic illness, so these can make a real difference in the lives of victims.
Carey, Danis & Lowe offers free, confidential case evaluations, so you can speak to us about your case and your rights at no further obligation or risk. To set up a meeting, call us toll-free at 1-877-678-3400 or send us an email today.
