2018

Defective medical devices: Stay hopeful in the face of adversity

The task feels enormous and overwhelming: Making large and successful medical device manufacturers pay for harm to patients. These companies have access to a well-padded budget and to big name attorneys. How could ordinary Tennessee residents beat these odds and emerge from a lawsuit successfully?

We understand these and other issues surrounding lawsuits centered on defective medical devices. Unfortunately, we also understand why victims give up on their hopes of holding responsible parties to account. When a loss occurs, such as the recent loss of a trial against DePuy hip replacements, it becomes even easier to abandon hope and accept the consequences.

We urge you to look at the big picture. Many people who suffered harm by DePuy’s hip replacements have walked away with a satisfactory legal remedy after seeking justice. Courts have awarded several million dollars in damages to injured victims targeting DePuy over the last few years.

These ordinary citizens seeking compensation for their suffering probably wanted to call it quits more than once. By choosing not to give up, they succeeded on two fronts: they got the compensation award they needed, and they helped hold defective medical device manufacturers to account. This is no small feat, especially for average Americans.

While there is no question that hip replacements have given many people a new lease on life, it does not make up for the long-term suffering and pain some replacements can cause. Holding device makers accountable for design, manufacturing or other defects can return a measure of peace to injured victims and prevent future defects. We invite you to learn more on our blog and elsewhere on our website.

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What is the reporting procedure for defective medical devices?

The research and development teams involved in the creation of medical devices put a great amount of work into each project. In turn, it is safe to assume that the manufacturers of these products attempt to ensure they are safe for patient use. Unfortunately, defective medical devices can pass the development and testing phase and still cause injury to residents of Tennessee.

When a defective medical device does lead to injuries, the reporting process is critical in getting the device off the market and eliminating any further injury risk. This benefits consumers and manufacturers because it protects parties on both sides of the issue.

There are two types of reporting: mandatory and voluntary.

Under federal requirements, mandatory reporters must submit reports involving adverse events associated with devices to the Food and Drug Administration (FDA). They must also make a report if they believe that a death or injury occurred because of a defective device. Examples of mandatory reporters include device manufacturers, importers and medical facilities where devices are used.

As the term indicates, voluntary reporting is not required, but it is a great way for the FDA and for manufacturers to learn about potentially defective medical devices. Anyone can make a voluntary report including doctors, patients, nurses, family members and care providers. The FDA makes it easy to report a possible defect and even offers an online portal people can use for reporting.

It is important to understand that even though a product has been recalled, injured parties can still take legal action against the manufacturer and possibly other parties for any negligent harm the device caused.

Source: U.S. Food and Drug Administration, “Medical Device Reporting (MDR),” accessed April 26, 2018

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Information about the valsartan blood pressure drug recall

You may have heard by now that the Food and Drug Administration (FDA) recently announced the voluntary recall of defective drugs containing an active ingredient called valsartan. These medicines were recalled because some of the drugs contain – or may contain – N-nitrosodimethylamine (NDMA), which could pose a cancer risk to patients.

Medications that control high blood pressure are extremely important to the health and life of patients. As such, it is important for hypertension patients in Tennessee to understand what the recall means. Physicians and the FDA want people to know that the drug itself is not faulty. NDMA contamination during manufacturing is what makes these products defective. Patients taking drugs containing valsartan should not stop unless a doctor tells them to do so and provides them with a replacement drug.

Those who are taking drugs for high blood pressure should look at the prescription label to see if the medicine was included in the recall. If your medication was recalled, contact your doctor right away to make an appointment and – again – continue taking the drug until you acquire a replacement.

So far, there have been no reports of patients in America suffering harm from potentially dangerous medications included in the recall. However, creating a plan of action now in case health problems do arise is a great idea.

An important part of an action plan includes searching for an attorney experienced with cases involving defective drugs. By doing this right now, you will be prepared to pick up the phone and call the lawyer of your choice if you or a loved one suffers an illness or injury linked to this medication.

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Identifying a medical device defect

Physicians and their patients trust medical devices to aid in treating or fixing certain ailments or injuries. When those devices have defects, they can cause additional harm.

Thankfully, it is possible to seek reparations with a medical device claim. One of the key aspects to winning such claims is to show the defective nature of the products, and there are a few ways that devices obtain this designation.

Faulty design

The design of a medical device can sometimes be the root of the issue. Some medical device designs may be faulty from the start or become obsolete over time and as more medical advances occur. It is important for manufacturers and recipients of different medical devices to stay vigilant about the quality of a device and its longevity. For this reason, receiving an annual physical and seeking medical attention at the first sign of any irregular activity may be essential for the health of a medical device recipient.

Manufacturing defect

The U.S. Department of Health and Human Services monitors the safety of medical devices and provides updates on devices that may be dangerous or that are in recall. By law, there are several regulations that govern the manufacture of different products. Particularly when it comes to medical devices, manufacturers must meet strict specifications. A manufacturing defect can occur by a manufacturer not following the design correctly or utilizing improper materials, or by issues with the manufacturing equipment.

Improper marketing

Sometimes marketing campaigns make elaborate claims to spark interest about a product. Though this may seem like a good marketing strategy, it can have negative consequences, especially if the claims are not correct. Manufacturers must be careful to fact check any claims that are made about their products, as well as be very truthful and intentional about the facts they share in regard to the status, function and warranty of a device.

By keeping these things in mind, claimants may be able to support their cases successfully. To aid in the process, it may be beneficial to consult a knowledgeable attorney.

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Determining the viability of a medical malpractice claim

There are many great physicians who work diligently and intentionally to provide the best care to their patients. However, there are also those who cause undue suffering due to neglect.

Thankfully, those patients and their families may seek reparations if they can successfully prove their cases. There are a few important factors in determining if a medical malpractice claim is viable.

Definition

Medical malpractice occurs when physicians do not provide a proper level of care in their professional capacity. The medical malpractice laws provide an in-depth breakdown of the different aspects of medical malpractice. In short, in order to prove it, patients must show that the physician did not meet the reasonable standard of care, either by the means they utilized or by services they did not render.

Damages

The types of damages that parties may seek depend upon the classification of the claimant. When patients file for themselves, they may claim lost wages, medical bills, and more. If the patient dies and the family files, they may seek additional damages, such as loss of life, loss of quality of life, and pain and suffering. Reviewing the law can help claimants to choose the damages that fit their cases.

Evidence

Proper evidence is critical to any malpractice case. Especially in cases where the defense tries to claim that the harm was natural or unavoidable, the right evidence can disprove the defense and solidify the claim. Medical records directly from the physician and the hospital are important in these cases. Photos or video footage, and eyewitness or expert witness testimony may also be beneficial in building a solid case.

These are a few key things to keep in mind when determining if a medical malpractice claim can be successful. For those who believe they have a quality case, it would be best to consult with a knowledgeable attorney and determine the best course of action.

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3 ways health care can harm you instead of help you

When you see your doctor or go to the hospital, you expect a certain standard of care. The basic purpose of the health care system is to safeguard your health and save your life.

Unfortunately, this is not how things always happen. Some of it is due to natural consequences. Not all diseases are treatable, not every surgery is a guaranteed fix and so on. However, sometimes the industry is at fault for preventable incidents due to negligence, errors and omissions. Three common areas in which these occur are as follows.

1. Medical malpractice

Medical malpractice cases can be difficult to prove because not all instances are so cut and dry. A more obvious case may be something such as a doctor performing a medical procedure while intoxicated. A more complex claim may involve something like providing an unnecessary treatment, as you would have to prove the treatment was unnecessary and not a part of the standard care any other doctor would provide. Other acts of medical malpractice include:

  • Leaving equipment inside your body
  • Misdiagnosing or not diagnosing you at all
  • Delaying treatment
  • Administering the wrong type or dosage of medicine

Doctors and surgeons are not the only guilty parties. Nurses and others can also make these mistakes.

2. Harmful drugs

Your doctor may not have made an error in your prescription, but the manufacturer of the drug may have made an unsafe product. Drug companies may have withheld information or not completed enough testing before putting something on the market. Sometimes damaging side effects do not come to light until years later, and the medicine that was supposed to help you ends up causing more harm than the problem it was supposed to treat. You can find a list of recalls through the FDA to find out if this affects you.

3. Defective devices

The amazing strides society has made in technology can be both a blessing and a curse. Medical devices can help someone to walk or breathe, but they can also damage organs and result in infections. You deserve financial compensation for the long-term health consequences from these defective devices.

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