Medical device makers pressured to foot bill in wake of recalls

Posted by Sarah Showard | Oct 23, 2012 | 0 Comments


The dramatic increase in recent years of medical device recalls and resulting litigation has put a financial burden on the insurers, who are, in turn, forcing manufacturers to share the costs. Experts are looking at the 2010 recall of St. Jude Medical's Riata defibrillators as the next battleground between insurers and manufacturers.

The Food and Drug Administration has advised nearly 80,000 Americans with the Riata defibrillator implants to get imaging tests to see whether wire insulation has eroded – tests that could add up to $45.3 million for all patients. Some insurance companies are reluctant to cover the costs of the procedure for patients, which could trigger lawsuits. St. Jude is paying for the initial test under its warranty in such cases, which experts say is a wise move.

“It would not be in device makers' best interest to balk at paying these costs,” said one analyst. “In the end, they do have to stand behind their product and these products do sometimes fail.”

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About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Women's Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorney, and has been representing plaintiffs since 1990. Sarah has a son, Benjamin, who recently graduated from The Gregory School and will attend ASU in the fall, with future plans to attend law school and eventually join Showard Law Firm. In her spare time Sarah enjoys horseback riding and spending time in Sonoita with her husband Peter.


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