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Abbott Labs Makes Costly Mistake as FDA Targets Cybersecurity Deficiencies

The Food and Drug Administration (FDA), after a previous warning in 2014, threatens legal action against Abbott Labs if the company fails to address safety and security issues in implanted cardiac devices sold by St Jude Medical – a recent subsidiary acquired by Abbott Labs. The internet of things takes a much more serious tenure when it’s a medical device compared to your fridge!

The company recently purchased St. Jude Medical, which makes implanted cardiac devices that have been the subject of cybersecurity concerns. A warning letter issued by the FDA gives Abbott Labs 15 days to submit a plan to address errors in the products’ design that could allow hackers to tamper with the settings and drain the batteries of the devices, which were thought to have contributed to the cause of a death. Many of the cybersecurity concerns first came to light after medical device security research firm MedSec submitted a report outlining a variety of alleged security flaws in St. Jude products to investment firm Muddy Waters Research (MWR). MWR subsequently publically announced the product design failures while short-selling St. Jude Medical’s stock in order to capitalise on the expected market response.

As the public increases its awareness of cybersecurity issues it becomes apparent that a failure to adequately consider these issues – as a day to day function of operating a business or prior to the acquisition of a new business – can result in significant damage to a company’s bottom line. The recent short-selling by MWR indicates the necessity for cybersecurity considerations to form central in a company’s business model, otherwise risk having its inadequacies called out in a public forum. And we are not even thinking about what litigation liability risk these sorts of issues might raise.

Copyright 2017 K & L Gates


About this Author

Cameron Abbott, Technology, Attorney, Australia, corporate, KL Gates Law Firm

Mr. Abbott is a corporate lawyer who focuses on technology, telecommunications and broadcasting transactions. He assists corporations and vendors in managing their technology requirements and contracts, particularly large outsourcing and technology procurements issues including licensing terms for SAP and Oracle and major system integration transactions.

Mr. Abbott partners with his clients to ensure market leading solutions are implemented in to their businesses. He concentrates on managing and negotiating complex technology solutions, which...

Giles Whittaker, KL Gates, corporate transactional lawyer, outsourcing intellectual property attorney

Mr. Whittaker is a corporate and transactional lawyer with a focus on technology, outsourcing and intellectual property (IP). He advises on a broad range of technology and broadcasting transactions, including procurement, implementation, IP licensing and commercialisation. Mr. Whittaker also provides regulatory advice regarding privacy, data retention and website content.

Mr. Whittaker joined K&L Gates in 2016 and has gained experience in the Corporate M&A and Complex Commercial Litigation and Disputes teams.