The U.S. Food and Drug Administration (FDA) recently announced the Class I recall of Medtronic guidewires due to serious safety concerns regarding these medical devices. These guidewires were originally designed to guide catheters along arterial pathways to provide improved flow in these blood vessels and to allow the introduction of stents and other medical devices during cardiovascular procedures. However, a number of incidents have provided evidence that the coatings on the Medtronic guidewires can become detached from the devices and can remain in the patient's bloodstream to create blockages in arterial channels. These blockages can lead to strokes, cardiac arrests and other serious medical issues for patients who have been treated with the Medtronic guidewire product line. Holding Manufacturers Responsible Patients who have been adversely affected by the Medtronic guidewire devices or by any other type of medical equipment or prescription medication may require expert legal help to ensure that the manufacturer provides appropriate compensation for injuries or, in extreme cases, the death of a loved one. Class action suits are often filed to protect the rights of patients and injured individuals who may have ongoing medical expenses associated with damage caused by defective devices or pharmaceutical materials. A qualified class action lawsuit attorney can represent and protect the rights individuals who have experienced injury due to the negligence of the manufacturer and can obtain sizable settlements. Drug Recalls In the pharmaceutical field, recalls are relatively frequent and may be caused by a number of different factors:
- Contamination of the drugs during manufacture or shipping
- Failure to maintain sterile conditions during the production process
- Mistakes in manufacturing that may result in incorrect dosing and wrong sizes
- Defects in the packaging materials
- For oral contraceptives and other sequential medications, failure to indicate the proper sequence of use
- Issues that developed from use over an extended period of time and that were not present or predictable during the initial trials of the medication
For patients who have been negatively affected by any of these issues, finding the right pharmaceutical lawsuit lawyer can be a solid first step toward obtaining the compensation needed to deal with any persistent side effects and to hold manufacturers financially responsible for their failure to protect patient health in the public arena. An experienced drug lawsuit attorney can ensure that the individual rights of the patient are taken into consideration and that these patients achieve the financial settlements necessary to compensate them for their injuries, pain and suffering and other expenses associated with the defective product or product line. The Recall Process Class I recalls are put in place by the FDA to prevent the sale of products that pose a significant potential for serious injuries or death when used as recommended. Other recall classes are used for less severe situations:
- Class III recalls are generally performed for administrative or minor formulary changes and are not considered to present a high risk of injury to patients.
- Class II recalls are more serious and may pose a remote risk of injury or adverse health reactions for some patients.
- Class I recalls involve serious risks to patient health and well-being that require the immediate removal of the product from the consumer marketplace.
To date, at least four instances of patient injury have been attributed to the use of the Medtronic guidewires, qualifying the recall for Class I status. Monitoring FDA recalls can provide added information for patients in managing their health care regimens and maintaining a higher degree of control over their medical treatment. If you or someone you care for has been treated with a product that has been recalled by the FDA for any reason, you may benefit from consulting a specialist in the field of medical injury law to evaluate your case and obtain the maximum compensation for your claim.