Clark, Love & Hutson, PLLC

Houston Texas Plaintiff Litigation Law Firm

Plaintiffs prevail in defective medical implant case

Surgical implants can do a lot of good, but if they are defective they can do a lot of harm. Many women in Texas and nationwide have had procedures to place pelvic mesh in their bodies. However, some types of pelvic mesh implants have proven to be defective, leading to painful injuries for patients.

Ethicon, a subsidiary of Johnson & Johnson, has been ordered following a jury trial to pay $80 million in damages to a couple over the company's pelvic mesh product. Of those damages, $30 million were compensatory and $50 million were punitive.

Even FDA cleared medical devices can be defective

When it comes to medical devices, patients in Houston may feel secure if they learn that the device is cleared by the U.S. Food and Drug Administration. However, this security can be misleading. This is because there is a significant difference between a product being FDA cleared and FDA approved.

The FDA regulates prescription drugs, over-the-counter drugs, biologics, medical devices and surgical implants, among other products. If a product is FDA approved, this means that the FDA has determined that the benefits of the product are greater than any known risks that may accompany the use of the product in the way it was intended. For FDA approval, the manufacturer of the product must provide the agency with a premarket approval application as well as the results of the clinical tests of the product. FDA approval is generally required to sell products in the nation that have a significant benefit but also present the potential for significant risks. Class III medical devices, such as pacemakers, breast implants and replacement heart valves must be FDA approved.

Dangerous drug litigation can be complex, but not impossible

Manufacturers of prescription medications have a duty to make sure their products have been thoroughly tested so they are safe for consumers. In fact, the U.S. Food and Drug Administration has testing criteria that drug manufacturers must follow. However, consumers in Houston may be disturbed to hear that even medications that were licensed by the FDA could be defective.

Prescription medication usually have a "learned intermediary" - a person who prescribes the medication or fills the prescription, thus being essentially a person who plays a role in-between the medication being manufactured and the medication reaching the hands of the consumer. This can make determine who can be held liable in dangerous drug litigation complex.

Texans will have more access to information on medical devices

While dangerous medical devices are receiving more attention in the news these days, it can still be difficult for patients in Texas and across the United States to determine whether a medical device they are considering putting in their body is dangerous or has a history of being defective. Americans should be able to depend on the agencies governing medical devices to inform them when a device causes harm. Unfortunately, until recently this has not been the case.

The U.S. Food and Drug Administration (FDA) has stated that it will end a program that had allowed manufacturers of medical devices to keep reports of harm concealed from U.S. citizens. The program, known as "alternative summary reporting" is two decades old but has collected and kept secret thousands of reports of harm caused by medical devices. The FDA plans to open these records to the public within a matter of weeks.

Report: arsenic found in bottled water

You trust that the products you consume are safe from harmful substances. If a product becomes contaminated, the company issues a recall, right? That isn’t always the case.

Consumer Reports reports that the Keurig Dr Pepper company has sold an imported bottled water containing twice the legal limit of arsenic in the United States. The report stated that the Food and Drug Administration (FDA) flagged the product but may have known about the contamination as early as 2013. Both the company and the Mexican government are now investigating these claims.

Texans harmed by dangerous drugs deserve justice

Modern medicine is truly remarkable. It seems as if advancements in the medical world are being made every day. However, it is essential that drug manufacturers thoroughly test their products before putting them on store shelves, to ensure consumers in Texas and across the nation are safe.

Unfortunately, sometimes in a quest to get their product on the marketplace before competitors do, drug manufacturers let dangerous drugs slip through the cracks -- or worse, knowingly leave a dangerous drug on the market. It is essential that drug manufacturers are held accountable in such situations. This is because a dangerous drug can cause a patient to suffer a worsened condition or even death.

What types of medical errors could lead to plaintiff litigation?

We trust that after years of education and training, the doctors, nurses, surgeons and other medical professionals who care for us when we are ill or injured know what they are doing. For the most part, medical professionals in Houston meet their duty of care to their patients. However, they are not perfect, and mistakes are sometimes made. When a medical mistake is made due to the negligence of the medical practitioner at issue, it could lead to plaintiff litigation.

In general, there are several types of medical malpractice to be aware of. For example, mistakes can be made during surgical procedures. The surgeon could operate on the wrong body part or leave an instrument in a patient. These mistakes could alter a person's life forever, leading to a worsened medical condition, pain and suffering and other problems.

Texans need to know that robotic surgery for cancer may be unsafe

It may seem like using surgical robotic devices may be less risky than traditional surgical methods. After all, advances in technology may mean that large incisions and other surgical risks are minimized. However, Texans may be concerned to learn that the U.S. Food and Drug Administration has issued a warning stating that the use of robotic devices in cancer operations may be unsafe.

The FDA stated that surgical robotic devices may increase safety risks and could even lead to poor surgical outcomes for those who undergo operations using these devices. The FDA reviewed recent studies that claimed that there is limited data on the risks of using robotics during cancer operations. Thus, the FDA determined that it cannot properly verify whether robotic devices are an effective way to perform operations on those with cancer.

Settlement reached in Xarelto dangerous drug litigation

Blood thinning medications are often used by people in Texas who suffer from heart diseases and other medical conditions that could lead to blood clots. However, recent legal claims alleged that a specific blood thinner, Xarelto, lacked warnings that the drug could be dangerous.

Drug giants Bayer and Johnson & Johnson recently reached a $775 million settlement that resolved approximately 25,000 claims regarding the blood thinner medication, Xarelto. The plaintiffs in the lawsuits alleged that the companies did not provide an adequate warning that the drug could cause fatal bleeding. Because the companies jointly sell the drug, each will be 50 percent responsible for paying the settlement costs.

FDA addresses policies after defective medical device litigation

In the wake of harm caused by metal hip and knee replacements and vaginal mesh, people in Texas may be concerned about any harmful side effects that may be present in the medical devices they need. Defective medical device litigation has resulted from the damages certain defective medical devices caused, but can anything be done to prevent these devices from reaching the marketplace in the first place?

For the most part, unlike medications, medical devices do not need to be tested on humans before being used by physicians to treat patients, unless the device's failure would obviously threaten the lives of patients. However, the U.S. Food and Drug Administration has elevated the risk level of devices that have been reported to the FDA as causing injuries. As of right now, manufacturers legally only need to demonstrate that the device is substantially equivalent to devices already on the market.

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