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John Hopkins

Isn't it reasonable to ask for caution?

» Written by // May 12, 2011 // ,


The recent news about the Food & Drug Administration’s (FDA) actions in connection with hip implant manufacturers demands the question: why wasn’t the action being ordered required before the hip implants were placed on the market?

The answer is that the FDA’s order to 20 device makers to study the effects of heavy metals, like cobalt and chromium, and their effect on humans was something that manufacturers should have done before placing hip implants on the market. The FDA is now ordering the study to involve patients who have already had the hips implanted, but that is simply because “the deed is done”.

The FDA relies heavily, right or wrong, on the representations of medical device manufacturers and the studies they conduct. The FDA examines the data produced by the manufacturers but the FDA has neither the personnel nor the funding to conduct their own independent studies. Instead, the FDA relies on the truthfulness of the manufacturer who, after all, should know and understand the potential risks of the very device they have manufactured.

So, why would medical device manufacturers rush their product to be implanted in unsuspecting patients?

Money.

It is not entirely a pure profit issue. Manufacturers typically have products in development and testing for lengthy periods of time and their investments have a long shelf life even before they can be sold.  Manufacturers are denied the use of the money invested; they earn no return on that money; and they often have independent investors and stockholders to whom they must answer. They are sometimes denied the ability to begin developing the next best “widget” because of funds tied up in product development. So, they sometimes rush to production.

Sometimes it is a profit issue.  Manufacturers see a particular product in development as having significant potential to generate high sales and, thus, large profits. They cut a corner here; they cut a corner there; and, all of a sudden, they have sent a dangerous product into the market.

In the case of hip implants, the FDA spokeswoman, Karen Riley said, “There is not enough scientific data to specify the concentration of metal ions in a patient’s body necessary to produce adverse systemic effects.”

Is heavy metal concentration from leaching of cobalt and chromium ions into the human body something that manufacturers could have and should have anticipated and tested for? Of course they should have. Why didn’t they?

Money. Profit. Shelf life of investments.

Any one of these business motivating factors may have caused it. Did they mean to hurt people? Unlikely. They simply allowed the need to market overcome their need for caution and good judgment.

The FDA action involves 20 manufacturers, including: Johnson & Johnson (Depuy), Biomet Inc., Stryker Corp. (SYK) and Zimmer Holdings Inc. (ZMH).

Perhaps sometimes these manufacturers forget they are not manufacturing “widgets”, they are manufacturing parts of peoples’ lives.


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