Unbelievably, yet another illness is being blamed on the headline-making <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">Triad alcohol wipes that were most recently in the news for the federal health investigation of a 66-year-old man whose death has been potentially linked to the recalled wipes.
Now, MSNBC, as part of its continuing investigation, reports that a three-year-old twin, Myles Massey, suffered a bacterial infection that has left him severely brain damaged; his brother, Henry, continues to develop normally. Myles is unable to speak and walk, has significantly limited use of his left side, suffers from mental delays and cerebral palsy, and cannot feed himself, relying on a feeding tube, said MSNBC. Myles’ many issues are blamed on the rare Bacillus cereus infection that struck him just after he was born on September 1, 2007.
The amended lawsuit in this case alleges that the bacteria that struck Myles originated with contaminated Triad alcohol prep pads, said MSNBC. Triad Group of Hartland, Wisconsin and its sister company, H&P Industries Inc., have been added to the defendants in the Masseys’ medical malpractice suit. The lawsuit alleges that the tainted wipes caused Myles’ “devastating systemic injuries,†said MSNBC.
In addition to Myles’ illnesses, 9 deaths, 11 infections, and about 250 other “problems†have been connected to Triad and H&P. We’ve also reported that, following raids; seizures; at least six lawsuits; complaints of serious illnesses; failed inspections; a number of massive recalls for tainted alcohol wipes, swabs and other medical products; and, worst of all, the illnesses and fatalities reported, to date, H&P and Triad recently said a permanent injunction filed by the FDA is an important step toward building their medical products business.
The firms have been accused of manufacturing and distributing alcohol products that were allegedly tainted with deadly bacteria and which have led to serious reactions in already compromised patients. The dangerous bacteria linked to the products—Bacillus cereus and Elizabethkingia meningoseptica—can lead to rare and deadly infections.
MSNBC noted that its ongoing investigation revealed the FDA was aware of contamination and sterilization problems going back to 2009 and involving the alcohol prep pads and other products, noting that it remains unknown how long the FDA was aware of Bacillus cereus problems because the agency “heavily redacts inspection documents.†Regardless, said MSNBC previously, some redactions challenged by the Milwaukee Journal Sentinel revealed that the FDA documented the pathogen in “a multi-week inspection that†initiated last November. FDA officials finally admitted to senators Michael Bennet (Democrat-Colorado) and Lamar Alexander (Republican-Tennessee) that it should have taken “stronger action sooner,†wrote MSNBC previously.
When the FDA completed an inspection of the facility in March, multiple violations of cGMP requirements, including continuing problems with the air handling system, failure to adequately investigate drug products that did not meet specifications affecting the majority of the products manufactured at the facility, and failure to take the proper measures to ensure the quality of incoming components were revealed. The FDA previously asked H&P to stop manufacturing and distributing; it did not comply. H&P finally shut down operations shortly after the U.S. Marshalls descended on the plant.
The Masseys first filed their lawsuit in December 2009, blaming shoddy infection control at Evergreen Hospital Medical Center in Kirkland, Washington, where the twins were born. The hospital recently checked and discovered the alcohol wipes used in its neonatal intensive care unit were made by Triad. Also named in the lawsuit are the companies that repackaged and distributed the tainted wipes, including Harvard Drug Group (does business as Major Pharmaceuticals) and Cardinal Health 110, Inc. Evergreen remains named as do the hospital workers involved in Myles’ case, said MSNBC.
