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How Do Dangerous Pharmaceutical Drugs Make it to Market?

Posted by Brian K. Herrington | Jul 10, 2017 | 0 Comments

Many people who have been injured by a defective pharmaceutical drug often never consider what their legal options are, because on some level they assume that any drug that makes it to the marketplace must have been proven to be safe. And while the Food and Drug Administration (FDA) does play a significant role in monitoring drug safety and approving drugs to be introduced to the marketplace, defective and/or dangerous drugs do often find their ways to consumers, nonetheless.

The FDA Does Not Conduct Drug Tests

A prevalent misconception is that the FDA itself conducts tests of new drugs, and will only approve the drugs once its own internal tests are completed to satisfaction. The FDA itself does not conduct drug tests, and instead it is the responsibility of the manufacturers of the drugs themselves to determine whether they are safe and then, based off of those tests, submit an application for drug approval to the FDA. At that point, the FDA's Center for Drug Evaluation and Research (CDER) will assign a team of experts, including physicians and pharmacologists, to review the findings of the manufacturer that are submitted to determine whether to approve the drug.

Manufacturers Make Intentional and Unintentional Mistakes in Testing

Because the responsibility of conducting thorough tests of a new drug falls to the manufacturer of the drug, there is clearly an enormous financial incentive on the part of the manufacturer in having its own tests reach a conclusion that a new drug is in fact safe. After all, if the manufacturer determines its own product is unsafe, it stands to lose millions and often billions of dollars by keeping a product out of the marketplace.

Unfortunately, executives at pharmaceutical companies have shown a willingness to overlook safety in favor of profits during the testing process and have taken steps to skew their internal studies towards positive results. In some cases, they have committed egregious acts of fraud to win FDA approval. For example, a major manufacturer of defective IVC blood filters received FDA approval after it apparently forged the signature of a regulatory specialist on an FDA application after she had refused to sign the FDA application until her concerns about safety were resolved. While this situation involved a device rather than a drug, the dynamics and concerns are the same.

Defects May Not Become Apparent Until Later

Even where a manufacturer does complete its testing with integrity, it may simply be the case that a defect in a drug does not become apparent until years later. For all of our advances in pharmaceutical technology, we do not understand everything about how new drugs will affect the human body and thus a dangerous defect may later arise, injuring innocent victims.

In such cases, the law is often on the side of the patients who have taken the defective drug, as manufacturers are strictly liable for injuries caused by defectively designed or manufactured drugs (or where there was inadequate warnings and/or instructions), regardless of what the manufacturers may or may not have known about the safety of the drug when manufactured. Talk to a defective drug attorney about your legal options if you have been injured.

Contact Herrington Law Today Regarding Defective Drugs

Herrington Law in Jackson, Mississippi has become a class action leader because of its constant focus on what matters most: obtaining justice for individual plaintiffs who have been wronged by defendants. We have built strong relationships over the decades with co-counsel across the country, all in pursuit of providing outstanding outcomes for the people who matter most: our clients. Contact us to set up a free consultation today regarding filing or joining a defective drug class action lawsuit.

About the Author

Brian K. Herrington

A proven leader in the legal community, dedicated to obtaining justice for his clients with the highest level of client service. For more than 20 years, Brian Herrington has successfully represented consumers, small-business plaintiffs, attorneys general, and banks in complex litigation and comp...


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