In August, the short-selling investment firm Muddy Waters and cybersecurity firm MedSec Holdings claimed St. Jude’s pacemakers and defibrillators contained cybersecurity flaws, which caused the St. Paul, Minn.-based device maker’s stock to fall.On Wednesday, St. Jude filed a lawsuit against the companies, alleging they intentionally released false information to manipulate St Jude’s stock.
“Regardless of the way a vulnerability comes to our attention, we take those allegations very, very seriously,” FDA official Suzanne Schwartz, MD, told Reuters. “We are putting all of our focus on making sure that we have an understanding of what these allegations are and do a thorough investigation of the claims.”
Dr. Schwartz said that Muddy Waters and MedSec’s method of pointing out the alleged flaws violated advice the FDA issued in a January draft guidance that encouraged researchers to work directly with manufacturers to address suspected security issues.
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