Clark, Love & Hutson, GP

Houston Texas Plaintiff Litigation Law Firm

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.

Can I pursue plaintiff litigation if I am partially at fault?

Personal injury claims often boil down to one thing: negligence. In general, people have a duty to act reasonably given the circumstances. If they don't, and this failure causes another person to suffer damages, they may be held legally responsible.

However, determining fault for plaintiff litigation purposes is not always straightforward. For example, what if you are struck in an intersection by a speeding vehicle, but you were also speeding? Does the fact that you were partially at fault for the crash mean you can never recover damages from the other party? Depending on the circumstances, the answer may be "no." This is because Texas recognizes the laws of contributory negligence.

FDA recalled device used to monitor blood thinner Warfarin

On Feb. 1, 2019 the FDA announced a Class I recall for the test strip produced by Roche Diagnostics used to monitor users of the blood-thinner known as warfarin, Coumadin or Jantoven. These test strips delivered inaccurate results and could lead to serious injury or death.

Texans may be concerned about cancer-breast implant link

It is not unusual for people in Texas to have plastic surgery, and one common form of plastic surgery is breast implants. Millions of women across the globe have breast implants, but this does not mean all implants are safe.

According to the U.S. Food and Drug Administration since 2010 at least 457 women in the United States have suffered a rare and deadly form of cancer that may be caused by breast implants. The cancer at issue is anaplastic large cell lymphoma. Of those who contracted it since 2010, nine lost their lives. The cancer affects cells located near the implants. It appears that more incidents of this cancer involved implants with textured surfaces, instead of those with smooth surfaces.

How long does one have to pursue plaintiff litigation in Texas?

When a person is injured due to another person's negligence, for example due to a car crash, their primary concern may just be regaining their health, so they can return to their normal life. Unfortunately, doing so can cost a lot of money, from medical bills, to missed work to emotional distress. Or, say a business owner entered into a contract that has been breached, causing them to lose the benefit they contracted for and costing them greatly both in money and time. In either of these cases, the harmed party may wish to file a lawsuit. However, a person who wishes to pursue plaintiff litigation should not wait too long to do so. This is because Texas, like all other states, has a "statute of limitations" with regards to civil claims.

A "statute of limitations" is basically the period of time that a person has to file a lawsuit. Once that time period is over, a person is barred from filing a lawsuit, even if they would have had grounds for doing so based on the facts of their case. There are different statutes of limitations based on the type of claim being filed.

When will a defective medical device in Texas be recalled?

When a person in Texas receives an artificial hip, a pacemaker or some other type of medical device implanted in them, they naturally hope for an improved condition following the procedure. Unfortunately, defective medical devices are sometimes used, and until the defect is discovered and reported, will harm those who receive them.

The U.S. Food and Drug Administration is the agency responsible for issuing recalls of defective medical devices. A medical device will be recalled if there is a defect, where the product poses a health risk or when the product is both defective and presents a health risk. The FDA will determine if the product violates FDA requirements or law, and if appropriate will classify the recall, either as I, II or III depending on how dangerous the product is. For example, a Class I recall is issued when there is a reasonable chance that the device could lead to serious health issues or fatalities.

Drugs marketed to Texans on TV may be dangerous

Television commercials advertising prescription drugs are becoming increasingly common. While some of these commercials may seem to be light-hearted or abstract, the fact of the matter is that they aim to increase the profits of the drug manufacturers. A rapidly-told list of all possible side effects can go by so quickly that consumers in Texas and nationwide may not be able to understand just how dangerous some drugs can be.

One might expect that these advertisements follow federal guidelines, but the reality may be much different. One study suggests that many of these advertisements violate federal guidelines and thus may do more harm than good. However, due to a rollback in regulations of these commercials by the U.S. Food and Drug Administration, inaccurate and misleading information can be found in some of these advertisements.

Company keeps secret the presence of asbestos in its products

Many people in Houston have used Johnson & Johnson baby powder and other products made by the company containing talc. However, they may be concerned to hear that, according to a Reuters investigation, since the 1970s Johnson & Johnson continued to manufacture and sell its baby powder product, despite having the knowledge that the talc in the products contained asbestos. These products have caused many to contract terminal illnesses, such as cancer.

Thousands of lawsuits regarding the talc have been filed against Johnson & Johnson. However, the company still claimed that its products were safe for consumers to use even though it knew that the products sometimes contained carcinogenic asbestos. Nevertheless, the company kept this vital information secret from both consumers and regulators.

Common blood pressure drugs pulled due to cancer concerns

Thousands of Americans take blood pressure medication every day. Unfortunately, manufacturers are pulling more and more of those medications from the market because of concerns over impurities found in the medication. According to the FDA, these impurities can cause cancer. Several manufacturers started pulling these medications voluntarily in July. The affected drugs include:

Investigation finds spinal-cord stimulators can be defective

Medical device companies have often promoted the use of spinal-cord stimulators to treat a litany of pain disorders. Considering our nation's opioid crisis, they may seem like a viable option for some Texans. They work by sending electrical currents throughout the spine via a battery that is implanted under the patient's skin and are controlled via an external remote control.

However, a recent Associated Press investigation has reported that spinal-cord stimulators often cause more harm than good. In fact, spinal-cord stimulators rank number three in types of medical devices that cause injuries. The U.S. Food and Drug Administration reports that there have been at least 80,000 spinal-cord stimulator injuries since 2008.

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