Category: Clark Love Hutson

Clark Love and Hutson Law Firm Discuss Changes in Drug Litigation Over the Years

Clark Love and Hutson Law Firm is a nationally recognized Houston based law firm specializing in Defective Medical Device Litigation and has helped hundreds of clients over the years reach a settlement for numerous defective medical devices. The firm has also seen changes in the drug litigation over the years. They have done research on regulation, litigation, and innovation in the pharmaceutical industry and discovered an equation for safety. Pharmaceuticals present a complex challenge. The question itself is not easy to answer unless reference is made to the impact of the federal regulatory process that governs every aspect of the prescription drug cycle and makes reduction of liability risk intrinsic to new drug development. The firm questions, what is the relationship, between regulation, liability exposure, and pharmaceutical innovation? Research is ongoing into the development of new products in challenging categories such as birth control, or that thalidomide, perhaps the most notorious drug in history, is currently being “rehabilitated” for use against such devastating diseases as leprosy and AIDS.

Despite the safety of regulations, the threat of litigation demands constraints. Companies are carrying the heavy costs of litigation and must pay high insurance premiums. Regulation also adds a heavy toll on innovation through high costs. Today the drug development process typically runs 12 years. It is costly and complex. The regulated development phases include laboratory testing, clinical studies of the pharmaceutical profile of a new drug, its effectiveness and tolerability by patients. There are also extensive clinical trials to study the effects of the drug in humans over specified periods of time.

It is true that the U.S. regulatory process and tort liability system significantly affect the cost of drug development and the length of time to market. The only real opportunity for innovation is at the beginning of the 12-year regulatory process. The key benefit of this process is assurance of reasonably safe, effective prescription drugs. Large strides in medical science have occurred in the past few decades despite the constraints of the system. Diseases have been taken out. The diagnosis for patients with diseases such as cancer and heart disease has dramatically improved. Biotechnology guides in a new era of exciting possibilities, including the potential for safer, specifically targeted vaccines. The health of the industry seems to indicate that regulation, and innovation represent a logical equation instead of an impossible triangle. Ongoing medical progress is telling evidence of a system that works.

Clark, Love, and Hutson Discuss the Top Medical Device Malfunctions

Clark Love Hutson

As a whole, American society puts enormous faith in our medical professionals and the medical device industry. While there are numerous regulations to screen new medical devices before they reach the market, the FDA receives hundreds of medical device malfunctions complaints each year. Clark, Love, Hutson is a nationally recognized Houston based law firm specializing in Defective Medical Device Litigation and has helped hundreds of clients over the years reach a settlement for numerous defective medical devices. Below, the Clark Love and Hutson law firm will review some of the most well known medical device malfunctions lawsuits and discuss the associated medical devices.

Metal-on-Metal Hip Implants

An infamous medical device malfunction, metal-on-metal hip implants were first introduced as a new innovative product that would be more durable than the average hip implants and would help younger, more active patients. However, in 2012 the British Medical Journal published an article describing the growing concerns with the all-metal implant. Some of these concerns were based on two metals of the implant (a metal stem inserted into the bone and the metal ball placed above) rubbing against each other and shedding metal fragments within a patient’s body. Many patients reported that these metal fragments would often lead to inflammation, swelling, metal positioning, and severe pain. As of July 2019, 14,000 metal-on-metal hip implant legal cases are still pending across the U.S.

Hamilton G5 Ventilator

The Hamilton G5 Ventilator was distributed from March 2007 to March 2014 throughout the United States and several other countries. After March 2014, the device was recalled after a number of patients suffered severe injury and death after Hamilton G5 Ventilator malfunctions. The G5 ventilator was known to stop working without sounding an alarm when an operator pressed the oxygen enrichment key while attaching the ventilator mask. This step is used to create a seal on the mask. However, if the G5 ventilator malfunctioned, the patient would not receive enough oxygen and could suffocate if a medical professional did not intervene. Like the metal-on-metal hip implants, some patients and their family members pursued litigation, and a number of cases have settled with Hamilton outside of court.

Spinal Cord Stimulator

Since they were first distributed in 2008, the U.S. Food and Drug Administration (FDA) has received over 80,000 injury reports relating to spinal cord stimulators. Originally intended to treat chronic pain, spinal cord stimulators have been known to shock and burn patients. One patient reported being shocked by his stimulator, which caused him to fall down his staircase. In other cases, the spinal cord stimulator has been linked to over 500 patient’s deaths after having the stimulator implanted. Almost half of the spinal cord stimulator recalls have been Medtronic devices; however, Medtronic recall notices have yet to warn of the device’s potential risks. Currently, there are several active cases involving spinal cord stimulators from several different manufacturers.

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