Carissa Galvez has a genetic mutation that affects her cerebral spinal fluid. When she was 15, a pediatric neurosurgeon installed an experimental 2-valve shunt into her back and head to help drain the fluid. Our Houston medical device injury attorneys mention that the experimental medical device seemed to help Ms. Galvez live a normal life up until a few weeks ago.
A few weeks ago, something began to malfunction with the experimental 2-valve shunt. Ms. Galvez began to feel ill. She began to vomit frequently and have severe headaches. Her blood pressure went up.
Her mother took her to the hospital. The pediatric hospital where Carissa Galvez received the shunt can’t help her because Carissa is now an adult. The pediatric neurosurgeon who installed the experimental shunt has since retired and no one can reach him. No other doctors in her state are familiar with the experimental 2-valve shunt to help her. And so Ms. Galvez remains hospitalized, shaking and writhing from the pain of her condition that no one can treat. The shunt can’t be removed. (Source: Christine LaCroix, khou.com, 10/5/12)
Ms. Galvez’s condition illustrates the dangers of experimental medical devices and medical devices that have not been approved for patient safety by the FDA. The Houston medical device injury attorneys emphasize that if something goes wrong with the experimental medical device, patients have few or no options for correcting or removing the malfunctioning or defective device.
Sometimes a medical device company will encourage surgeons to experiment with an untested and unapproved medical device in order to create a track record that the company can use to market the device. This is what occurred with the Synthes company’s Norian XR bone cement.
When the Norian XR product began to cause patient complications and even fatalities, Synthes tried to keep the problems quiet. But the company’s attempt to make an end run around the FDA’s approval process and market an unsafe medical device has now led to federal prison sentences for several company executives. The unprecedented step of imprisoning the executives has served as a wake up call to other medical device companies and their executives.
Patients like Carissa Galvez are often desperate to try anything that can give them hope in dealing with a debilitating and painful condition. Our Houston medical device injury attorneys understand that these patients and their families rely on their doctor’s knowledge and concern as well as a belief that the system protects them from unscrupulous marketing practices and use of unsafe, inadequately tested medical devices. They often learn too late that their trust was misplaced.
Patients and their loved ones that have been harmed by unsafe or defective medical devices could be eligible for full financial recoveries for their expenses and losses related to use of the unsafe medical devices. Their financial damages could cover the value of their pain and suffering as well. Sadly, no monetary award will take away that pain and suffering. But holding those responsible for their pain and injury accountable could help prevent others from being similarly harmed.
If you or your loved one have been injured by a defective medical device and you have questions about how you could hold those responsible for your pain financially accountable for their actions, contact our experienced Houston medical device injury attorneys for a free and confidential legal consultation. We could provide you with your available legal options based upon the specific facts and circumstances of your case. Let us help start you down the road to recovery. Call or email the Houston medical device injury attorneys at Denena & Points today for your complimentary case evaluation consultation.a