Working for Justice and Compensating People Injured by Defective Pharmaceutical and Medical Devices
Every year, thousands of Americans are hurt or killed by dangerous and defective pharmaceutical products or devices. These drugs and devices can cause serious side effects ranging from diabetes to heart attacks to birth defects and even death. The Centers for Disease Control & Prevention (CDC) reports that pharmaceutical drugs kill more than 40,000 people each year.
How does this happen? The medical industry in the United States is highly regulated. The U.S. Food & Drug Administration (FDA) must approve pharmaceuticals and medical devices before they are put on the market for consumer access. Despite these safety measures and precautions in place for consumer protection, medications and medical devices can still cause injury. The CDC reports that over 50% of drugs in the American marketplace have potentially dangerous and damaging side effects.
In comparison, most medical devices do not need FDA approval before it is placed into the market. Medical devices can go through two different FDA processes to get a medical device onto the market.
- 510(k) process: A medical device can go through an abbreviated FDA clearance process called the 510(k) process. This abbreviated process does not require studies and hearing about the product’s safety before it is placed on the market. Instead, the new medical device can be placed onto the market using the 510(k) process if the new device is substantially similar to another device already on the market. In this situation, the medical device is cleared to be placed on the market, not approved to be placed on the market.
- Premarket Approval: All Class III devices, which are high risk devices, are required to use the Premarket Approval (PMA) process. In the PMA process, the medical device manufacturer must provide the FDA with sufficient valid scientific evidence to assure the FDA that the device is safe and effective. This means that the medical device manufacturer provides the FDA with studies showing safety and effectiveness. In addition, a hearing may also take place to determine whether the product should be placed on the market.
The medical devices and pharmaceuticals may cause problems whether the FDA approves the medical device or pharmaceutical or simply clears the medical device. The manufacturer or medical company may simply be unaware of the defect which can cause injuries. In addition, there can be situations where the company was aware of potential complications and suppressed this evidence in order to push the product onto the marketplace.
There are three major claims involving dangerous products:
- Design defect claims are defects in the design of the product itself. The defect is faulty from the very beginning, and to prove this, one must show that a change in the design could have prevented the injury. Most states require this proof to include showing there is a safe alternative design. In these claims, an injury would have occurred regardless of how perfectly the product was manufactured.
- Manufacturing defect claims are a claims where the defective product does not meet the specifications laid out during design. In a manufacturing defect claim, it does not matter that all possible care was taken during the manufacturing process – it just matters if a defect was made during the manufacturing process. A manufacturing defect can include the use of cheap, subgrade material, faulty machinery, or poorly trained employees. Generally this is an unplanned defect which occurs in only a small percentage of product produced according to the particular plan.
- Failure to warn claims occur when a manufacturer does not provide proper warning to consumers. Generally, the manufacturer should warn the consumer of all of the potential dangers that could be sustained from using the product. This is especially true for products that could not function without some inherent danger or risk (for example, kitchen knives needing to be sharp). This is only applicable when the manufacturer knew or should have known about the risk.
Karen Beyea-Schroeder has represented injured plaintiffs in some of the largest and most successful actions against pharmaceutical companies in recent years. Contact us now for your free evaluation.