What Happens in a Medical Device Recall?
When a company recalls a medical device, it contacts directly the customers who received the product from them, and takes steps to reach others who need to be notified (for example, by issuing press releases or providing detailed instructions) More
Who Recalls Medical Devices?
In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it does two things:
- Recalls the device (through correction or removal)
- Notifies FDA.
Legally, FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death. However, in practice, FDA has rarely needed to require a medical device recall.
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What Is A recall?
A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.
Examples of the types of actions that may be considered recalls:
- Inspecting the device for problems
- Repairing the device
- Adjusting settings on the device
- Re-labeling the device
- Destroying device
- Notifying patients of a problem
- Monitoring patients for health issues
Sometimes a company may have concerns about a group of products, but it cannot predict which individual devices will be affected. To be on the safe side, the company may recall an entire lot, model, or product line.
A recall is either a correction or a removal depending on where the action takes place.
- Correction - Addresses a problem with a medical device in the place where it is used or sold.
- Removal - Addresses a problem with a medical device by removing it from where it is used or sold.
What is Litigation Law?
What is Litigation Law? It is most closely identified with civil law or tort law and the bringing of lawsuits. Lawsuits are legally authorized controversies that are decided by a court of law, and when one individual sues another individual, they are engaging in litigation law. The purpose of a lawsuit is to remedy an injustice or to enforce a right.
In a lawsuit the parties are known as plaintiffs, defendants, applicants, petitioners and/or respondents, but they are all considered litigants during an ongoing trial. In most, but not all matters, the litigants may represent themselves in a lawsuit. However, when they do retain legal counsel, their attorneys are known as litigators. This is often the wiser choice because litigation law encompasses several difficult and complicated legal procedures which calls for the expertise of a knowledgeable litigator with the skills and experience required to successfully navigate the laws, rules and policies that govern the litigation process.
Although historically litigation has been the more common method used for corporate entities and individuals to resolve legal disputes, alternative dispute resolution (ADR) is increasingly becoming a prevalent option. Unlike litigation, which requires a jury or a judge to make a legal determination when disputes arise, mediation and/or arbitration allows for the parties to talk things out and attempt to resolve the issues without court intervention.
Read MoreCan I Bring A Lawsuit If Injured By A Generic Drug?
No. In 2011, the "conservative" Republican majority on the U.S. Supreme Court voted as a block in PLIVA, Inc. v. Mensing, to grant broad immunity to generic drug manufacturers. Until Congress changes the law, there is no longer any recourse for victims against these drug makers. We disagree with this opinion and encourage our leaders in Congress to quickly pass any laws necessary to provide consumer protection once again. Otherwise, there is absolutely no protection to consumers once a drug patent expires.
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