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Product Liability

Zimmer Biomet Receives FDA Warning Letter

FDA Warning Letter Zimmer Biomet

On August 24, 2018, Zimmer Biomet received a Warning Letter from the FDA regarding quality violations found during 2016 and 2018 inspections at a facility in Warsaw, IN.

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Bayer to Stop Selling Essure Birth Control Device in US

Essure birth control device

Thousands of women have said the Essure birth control device caused serious health issues. On Friday, July 20, 2018 (just days before the release of The Bleeding Edge documentary), Bayer announced that it would discontinue sales of its Essure permanent birth control device in the United States after December 31. This was welcome news to the many women who have advocated against the device.

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Debilitating Problems with DePuy Synthes Attune© Knee Implant System

Total knee replacement

An estimated 4.4 million Americans are living with artificial knee implants reports Consumer Safety Watch. For about 90% who have a total knee replacement, it is a very successful surgery “relieving the pain, enabling patients to return to work and improving quality of life. However, for some, the procedure is not quite so successful.

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Zimmer Ordered to Pay $2 Million in Hip Implant Case

Zimmer hip implant case

In a March 31, 2017 ruling, Zimmer was ordered to pay more than $2 million to a New Mexico man for a defective hip implant with an “unreasonably dangerous design.”

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FDA 510(k) – aka, Substantially Equivalent

FDA Pre-market approval

Products such as new drugs and complex medical devices must be proven safe and effective before companies can put them on the market.

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Monsanto Roundup Lawsuits Centralized in MDL

Tractor spraying herbicide

In October 2016, a panel of federal judges created MDL No. 2741 to centralize dozens of Roundup lawsuits in one federal court, the U.S. District Court for the Northern District of California under Judge Vince Chhabria.

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Gaining Market Approval for Medical Devices

FDA Market Approval

It is the responsibility of manufacturers to ensure the products they bring to market are safe for public use. While the US FDA reviews the products before going to market, what do medical device manufacturers do to gain market approval?

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FDA Basics You Should Know

FDA in magnifying glass

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

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FDA 101: Product Recalls

FDA 101 Product Recalls

Unfortunately, in recent years, drug and product recalls have become more common. Why? What happens and how does the process work? Who is responsible for making sure these products are adequately tested before hitting the market?

Questions? Our knowledgeable staff is available at (877) 284-6600.

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What is a Hip Replacement?

Hip problems

More and more people turn to hip replacement surgeries to give them back their mobility and to relieve the pain caused by diseases such as osteoarthritis.

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