A class action lawsuit has been filed against two major health care companies – Therasol and United Health Care Services – in what is called the Theranostics Class Action Lawsuit against Theraputex, Inc. and Walgreens Boots Alliance, Inc. According to the class action lawsuit, Theraputex and Walgreens knowingly sold the Therasol hand dryer machine with the incorrect blood analysis method. According to the class action lawsuit, Theraputex and Walgreens placed the faulty blood test on the market long before it was able to prove effective results. The plaintiffs state that they only purchased the home dryers from the stores if they were told that the test could be trusted and used for accurate measurement of human blood pressure. The class action lawsuit further states that the FDA and attorneys general “have known or believe that Theraputex and/or Walgreens intentionally deceived the American public by failing to provide evidence-based support for the claim that their defendant products provide reliable blood pressure measurement.”

Attorneys General from Maryland and California is now being involved in the Theranostics Class Action Lawsuit. Apparently, the attorneys general feel that the manufacturers were aware that the product was defective, yet sold the products anyway. Additionally, the attorneys believe that the companies failed to properly document the development, manufacturing, and distribution of the defective product. The attorneys state that their investigation shows that Theraputex and Walgreens did not take reasonable precautions to ensure the accuracy of the blood pressure testing devices. In addition, the FDA previously found that Theraputex and Walgreens did not properly document the development, manufacturing, and distribution of the defective product.

The Theranostics Class Action Lawsuit further states that the FDA failed to protect patients by requiring that manufacturers make sure the devices meet certain safety standards prior to selling them. According to the FDA, it is “not necessarily unusual for companies to modify their methods without obtaining FDA authorization.” However, the FDA also stated that the risk of harm posed by the modified methods to the blood-analysis process is not substantial enough to outweigh the convenience of a low cost blood-pressure monitor. FDA, like other regulating agencies, is limited in its ability to fine companies that fail to comply with the regulatory laws.

Plaintiffs claim that the Theranostics Class Action Lawsuit is unjust because the FDA lacks sufficient data to determine whether the Theraputex and/or Walgreens products provide adequate protection to patients. These patients may ultimately suffer unnecessary and unwarranted pain and suffering because they rely on these devices to measure their blood-pressure levels. These patients may also face undue financial losses because they need to undergo expensive blood tests in order to prove or disprove the accuracy of the blood-testing results that the company’s blood-testing devices provide. Therefore, this class action lawsuit seeks monetary damages for the pain and suffering endured by the patients who signed waivers agreeing that they would be held harmless for results obtained by the Theraputex and/or Walgreens blood-testing devices. Additionally, plaintiffs seek damages for emotional distress, loss of wages, and medical expenses suffered by the patients.

The blood test class action lawsuit further claims that the FDA’s failure to approve Theraputex was based on an inadequate investigation of the safety of the drug. As previously stated, the FDA has acknowledged that the Theraputex blood tests “should not have been approved for distribution.” FDA did, however, find that there were unanticipated risks inherent in using the Theraputex blood tests due to the fact that the FDA did not approve them for use until November of 2021. According to the FDA, it is currently “reviewing the details of the case” in order to determine whether the Theranostics Class Action Lawsuit should move forward.

Plaintiffs in this Theraputex Class Action Lawsuit claim damages for injuries, loss of wages, medical expenses, and mental anguish as a result of the defendants’ negligence in manufacturing and distributing Theraputex and its related sterile blood collection devices. The FDA has acknowledged that it does not possess the statutory authority to regulate cosmetics, including blood tests, and that the courts must determine what scope the FDA has when determining if a product is defective or whether the manufacturer was negligent. Thus far, the courts have determined that the FDA’s authority to regulate cosmetics products is limited to cosmetics that are for use by those who are under the age of 18, and that the FDA must show “a likelihood of the harm a reasonable person would suffer under the particular circumstances” in order to prove that the manufacturer was at fault for the defendant’s negligence. The court will determine if the FDA’s authority to regulate Theraputex was exceeded in this case.

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