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News & Perspective

September 25, 2015

Consequences of Tort Reforms: How Minimizing Negligence Penalties for Defective Products Creates Too-Big-to-Care Corporations

There was a time when corporations cared about their products and the effect they had on the general population. It was a time when companies worked hard to prevent the distribution of defective products; when the system failed and a...

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February 15, 2015

FDA Rejected Cutting Guides Used in Knee Replacements

The OtisKnee device, made by OtisMed Corporation, was not approved by the Food and Drug Administration (FDA) to be used in knee replacement surgeries. The OtisKnee devices were not proven to be safe or effective. OtisMed Corporation distributed and marketed...

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December 16, 2014

FDA Guidance Document Clarifies When Product Changes Establish Need for Recall

The FDA has instituted a final guidance document in order for companies to clearly distinguish a recall from a market withdrawal. Part of the draft version of the new guidance called for reporting of any enhancement of a product, a...

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