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How Do Dangerous Drugs and Medical Products Reach the Market?

One would assume that with the technology that exists in our world today that it would be impossible for a pharmaceutical drug or medical product to pass the approval process and still pose a danger to the public.

FDA stamped approval, Gilreath Defective Medical Products and Pharmaceuticals article

No matter how advanced our world becomes, there is always the chance for human error to creep in; however, human error is not the only major issue. Pharmaceutical drugs are a major money making business, and many companies are willing to forego safety procedures in the name of the almighty dollar.

According to ExpertLaw, in recent years there has been a huge rise in lawsuits due to dangerous drugs and medical products. How exactly do so many products that ultimately result in high risk and dangers to the public make it to the market in the first place?

Risk for Patients

The risks these dangerous drugs pose vary in degree of severity.  Some of the drugs can present serious health risks to an individual or can even be fatal.  Tainted medical devices can create major problems for someone that has received the product as well.  Implanting a faulty medical device can mean the person has to endure another surgery to obtain a proper functioning device. Some examples of these defective devices include bone graft treatments, artificial hips, pacemakers, heart valves and knee joints. Another surgery can be dangerous or unsuccessful, especially depending on the age of the individual.

The Possibility of Human Error

A manufacturing company must first find the benefit and need for their drug or medical device through rigorous testing.  The testing process involves many lab tests and animal testing from which the results must be sent to the Center for Drug Evaluation and Research (CDER) in the form of an IND (investigational new drug). The CDER will look for effectiveness, quality, and safety of the drug.  This process usually involves many individuals, allowing the chance of human errors to multiply.

Forgoing Safety Procedures

Another big reason that failures occur is the fact that some companies will forego safety procedures in order to save a few dollars.  The costs are staggering when it comes to developing patents and obtaining government approvals.  Waiting on the approval can literally take years off the life of a patent and allow generic versions of the drug or medical product to make their way into the market. 

“This can create a significant temptation to hide negative information about a potentially lucrative drug or device, so as to obtain government approval and to bring the product to market,” writes ExpertLaw.

Also, drug companies lobby hard and create pressure on the FDA to approve products.  Drug Watch discusses how influential Big Pharma is on the FDA and in the whole of the medical market. 

“Big Pharma” is the nickname given to the world’s most influential and vast pharmaceutical industry and its trade group. These companies make billions of dollars per year by selling drugs and medical devices. Big Pharma has a huge influence over the pharmaceutical and medical device industry and contributes heavily to the annual budget of the FDA, which is the company responsible for regulating drugs and devices manufactured by these large corporations.

Tennessee pharmaceutical liability attorneys are here to help individuals through a stressful and unfairly complicated process, assisting them in getting the compensation they deserve.

If you or a loved one have been affected by a dangerous medical device or drug, it is in your best interest to contact an experienced lawyer who is familiar with handling these types of cases. 

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