Medical Devices

The Role Of Medical Devices In Healthcare

Medical devices play a vital role in healthcare. They include a wide range of products, from elastic bandages and surgical gloves to powered wheelchairs, heart valves, and prostheses.

Medical devices, considered separate from pharmaceutical drugs, must be cleared by the Food and Drug Administration (FDA) before they can be marketed to consumers.

Why Medical Devices Sometimes Lack Safety

In an industry worth approximately $200 billion worldwide and $85 billion in the U.S., there is great incentive for device manufacturers to cut corners. And while corporations profit from devices with questionable safety, it is the recipients of these devices who suffer.

If a medical device caused harm to you or a loved one, the Bart Bernard Injury Lawyers can help. During your free initial consultation you will be informed of your legal rights and have your questions answered by an experienced personal injury attorney. Bart Bernard Injury Lawyers is committed to helping Louisianans injured by unsafe medical devices. Contact us today and find out whether you have a case.

How Common Are Product Recalls?

Presented with sufficient evidence that a currently marketed device or drug poses a health risk, the FDA can decide to issue a product recall, effectively removing it from the market (actually, the FDA doesn’t have mandatory recall authority; recalls are typically voluntary). To give you some idea of how common recalls are, between 2004 and 2011 the FDA reported more than 1,700 drug recalls. From 2005 to 2009, 3,510 medical device recalls were initiated.

What Should I Do If A Devices or Drug That I’m Using Has Been Recalled?

The first thing that you should do if a medical product you’re using is recalled is to contact your doctor. In the case of a drug, the decision to continue or discontinue use will need to be made, while a medical device recall might necessitate a physical examination and testing. If you have suffered harm from the product, or there is a risk of suffering harm, you should talk to Bart Bernard, a product liability lawyer about your legal rights and options.

What is a Class Action Lawsuit? Is it Different Than Multidistrict Lititgation (MDL)?

Both class action lawsuits and MDL involve a group of people who were injured by the same product (i.e. drug or medical device) and seeking claims against the same defendant/s. The main difference (there are many specific legal differences) between a class action suit and multidistrict litigation is that in MDL, individual lawsuits are preserved. They are merely consolidated for the purpose of streamlining pretrial proceedings. MDL typically gives plaintiffs better chance of obtaining compensation for their specific injuries. In a class action settlements and verdicts, plaintiffs may only be entitled to a share of the total compensation. A lawyer can let you know whether there are any ongoing class actions or MDL for the specific product that injured you and if so, which type of lawsuit is in your best interest.

I Have Been Contacted By A Drug or Device Manufacturer. How Should I Respond?

When a manufacturer issues a product recall—for example, a defective hip implant—it may reach out to people who received the faulty hip as part of an initiative to reimburse recipients for out-of-pocket expenses, or some other reimbursement scheme. Caution in dealing with manufacturer reps is advised because you don’t want to sign anything or give a statement that entitles you to less compensation than you deserve. It’s best to have a lawyer review any agreement proposed by a product manufacturer before you agree to it. Under no circumstances are you obligated to sign a release or agree to a manufacturer’s terms.

What Must I Show In Order To Have A Case Against Drug or Device Manufacturer?

You must prove the following in a products liability case:

  • You used the product as intended
  • The product has a design defect, manufacturing defect, or marketing defect
  • You suffered injury or losses from using the product
  • The product’s defect is responsible for your injury/losses

Can I Sue A Party Other THan the Drug or Device Manufacturer

Yes. Other possible defendants in a defective drug or medical device case include your doctor, your pharmacist, a hospital or clinic, a retail supplier or sales representative, and others. As for who you ought to sue, a lawyer should be consulted. Sometimes, a claim against a doctor, for example, might turn into a medical malpractice claim, which is quite different than a product liability claim.

Can I File A Claim If Somebody In My Family Was Killed By A Defective Drug or Device?

A claim filed on behalf of a deceased person is known as a wrongful death claim. In Louisiana, the surviving spouse and children are the first in line to file a wrongful death claim, followed by the decedent’s parents, brothers and sisters, and grandparents. Depending on the circumstances surrounding the wrongful death claim, compensation for the decedent’s medical and burial expenses, as well as compensation for the survivors, can be pursued.

How Long Do I Have To File A Product Liability Lawsuit?

Louisiana’s statutory limitations are among the strictest in the U.S. Following your injury or the discovery of your injury, you have only 1 year to file a lawsuit. In wrongful death claims, a 1 year statutory limitation (beginning when the death occurs) also applies.

I’ve Heard About Some Huge Settlements With Drug Companies And Device Manufacturers. Are These Typical?

There really is no “typical” settlement or verdict in cases against drug/device makers. Each case is distinct in terms of the type of harm a product causes and how many people it affects. A device that is used in thousands of patients and causes serious harm could result in millions, even billions, of dollars in compensation. Bear in mind, however, that in cases involving multiple lawsuits, a settlement is divided among plaintiffs, and not always equally. The terms of settlements aren’t always disclosed, either. Individual multimillion dollar lawsuits are possible, but uncommon. So while you may read a story about a company reaching a multimillion or multibillion dollar deal to settle lawsuits, you’ll want to dig beneath the headlines to get a fuller idea of how compensation is awarded.




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