Tire Defect Lawyer Houston wins Aging Tire Tread Separation Case
Did the manufacturer of your tires warn you about the dangers of driving on aging tires? Probably not.
The manufacturers want you to believe that a tire’s age means nothing. But studies have shown how age-related wear weakens a tire, greatly increasing the risk of blowouts, tread separations, and other tire failures. Especially in hot climates, our tire defect lawyer Houston warns that tires age and weaken quickly.
Henry Garza was lucky. He managed to bring his Mazda MPV van back under control and survive the tread separation of his aging Firestone Affinity tire on I-10 in Houston. Mr. Garza had been traveling on the left inside lane of 4 lanes of busy I-10 traffic when he felt a vibration in the steering wheel of his Mazda van. He began to try and ease his speed downward so that he could pull over and try to determine the source of the vibration.
But his aging Firestone tire, 9 years old, had other ideas. The tread on the right rear tire came apart, pulling his van sharply to the right. Mr. Garza heroically managed to keep his van from crossing over the other 3 lanes. He avoided crashing into and injuring anyone else, but in struggling to bring the vehicle under control at highway speeds, he slammed into the concrete highway barrier, severely fracturing his own hip.
The Intense Injuries and Expenses from the Tire Tread Separation Crash
Mr. Garza was an elderly man, and a severe hip fracture was not a minor injury. He underwent hospitalization for the fracture, during which time he suffered a major heart attack. He ended up saddled with almost $175,000 in medical bills and called on tire defect lawyers Houston Tony Denena and Chad Points for help.
Denena Points, PC filed a lawsuit on Mr. Garza’s behalf against Bridgestone Firestone North American Tire LLC. The lawsuit claimed that Mr. Garza’s Firestone Affinity tire was defective and needlessly vulnerable to tread separation because it did not contain a full nylon cap, a tire feature proven to help prevent tire tread separations.
Basically, Firestone had failed to include a proven safety feature when it manufactured the tire that caused Mr. Garza so much pain, injury, and expense. Firestone had also failed to warn Mr. Garza of the inherent dangers in using an aging tire. Denena Points, PC’ arguments and convincing evidence won the case and a confidential settlement from Firestone on Mr. Garza’s behalf.
Get Proven Experience and Success on your Side for Your Tire Tread Separation Injury Claim: Contact a Tire Defect Lawyer Houston at Denena Points, PC for a Free Legal Consultation
Get in touch with us at 281-369-4363 or through our online contact form. We’ll be happy to meet with you and discuss your specific case. We can help you understand your legal options and evaluate your potential for a full financial recovery after your needless injuries. You have no obligation to hire an attorney. And we don’t charge you attorney’s fees unless we in your case for you. Learn more about the no-risk contingency fee basis on which we take our cases. Watch our video.
Financial Recovery for Fatality when Seatbelt Unlatches in TX Wreck
The Houston defective product attorneys at Denena Points, PC were pleased to be able to win a strong financial settlement for the bereaved family members of a 42-year-old mom killed in tragic rollover wreck when her seatbelt unlatched and she was thrown from her vehicle. The mom was part of a 3-vehicle caravan. She was driving her four children in the family SUV, a Ford Expedition, near Kountze, Texas when she lost control of the vehicle.
She lost control when she swerved to avoid crashing into a large BBQ pit that fell out of the vehicle in front of her. The Ford Expedition flipped over several times and the mom was ejected from the SUV. She suffered severe trauma injuries to the head and torso and died shortly following the tragic wreck.
Houston Defective Product Attorneys Aggressively Pursue the Family’s Claim based on Design Defects in the Ford Expedition
The grieving family members filed a lawsuit against the car dealer and manufacturer. They claimed that Ford had known of the high rollover risk posed by SUVs, but had not provided adequate protection to vehicle occupants in the event of a rollover wreck when they designed the Ford Expedition. Ford’s design defects failed to account for the major dangers of high-risk rollover wrecks: vehicle ejection, seatbelt performance, and roof crush. SUV rollovers cause about 12,000 head injuries and 3,000 spinal cord injuries each year.
Houston defective product attorneys Chad Points and Tony Denena proved the family members’ claim that defects in the design of the Ford Expedition and the driver’s seatbelt restraint system caused the mom’s tragic death. Their careful presentation of the evidence and qualified expert testimony showed that the Ford Expedition was difficult to handle and unstable in foreseeable emergency evasive maneuvers like the one experienced by the deceased mother, and that the SUV’s occupant restraint system and roof structure failed to offer appropriate protection and containment during rollover wrecks.
Design Defects caused the Seatbelt to Unlatch in the Rollover Wreck, causing the Fatal Injuries
Specifically, the family claimed that the seatbelt buckle had a tendency to unlatch during accidents and impacts and that this defect led directly to the ejection, injuries, and death of the mother driving the family’s Ford Expedition that day.
Ford of course tried to deny everything and put the blame back on the deceased victim. But careful investigation and technical analysis by engineers can determine when a seatbelt tends to unlatch under accident conditions. And so Ford agreed to pay the victim’s family members a financial settlement for the needless loss of the children’s mother.
Our Houston defective product attorneys point out that the most common defect that causes seatbelts to fail is inertial unlatching. This happens when a seatbelt suddenly becomes unlatched and releases you from its safety restraint. It happens because of a “false latch” problem when your seat belt might have looked, sounded, and felt like it was securely latched, but it was not. The false latch problem causes its greatest dangers during high-speed impacts and rollover wrecks: then, you might get suddenly ejected from your vehicle during a crash.
Learn More about Seatbelt Defects, What Kind of Defects Cause Seatbelt Failures, and What you can do after an Unlatching Seatbelt Harms you or a Family Member
Click here to read this article by our Houston defective product attorneys. And if you or your loved ones get injured in a dangerous rollover accident and you need help, don’t hesitate to contact us for a free, no obligation legal consultation. We can help. And we’re available anytime through our online contact form or by phone at 281-369-4363.
Goodyear Dunlop Agrees to Settle with Victim’s Son in Tire Defect Case
Tony Maglitto was riding in the back seat of a Toyota Tundra pickup truck driven by his brother. A defective Goodyear/Dunlop Grand Trek tire on the truck experienced a sudden tread separation as they were driving down busy I-10 in Baytown, Texas.
When the tire lost its tread, the Toyota Tundra became uncontrollable and left the roadway to end in a catastrophic rollover. Mr. Maglitto was ejected from the pickup truck when it flipped over, as often happens in rollover accidents. He suffered severe brain injuries and chest trauma from the impact and died from his injuries.
The tires on the Toyota Tundra were the original equipment Grand Trek TG35 P265/70R16 tires. Mr. Maglitto’s surviving son chose Chad Points as his tire defect lawyer Houston. In the lawsuit, Goodyear/Dunlop claimed the tire wasn’t defective. But the company had also manufactured other Grand Trek tires that had nylon wraps around the treads of the tire as well as belt edge wedges designed to prevent sudden tread separations like the one that happened in Mr. Maglitto’s case.
The tires on the Toyota were defective: they contained neither safety feature – neither the nylon wrap around the tread, nor the belt edge wedges to hold the layers of tread in place. The design of these tires lacked the safety features of other versions of the tire, and were therefore defective.
Mr. Maglitto’s son wasn’t the only plaintiff claiming these particular tires were defective. There were other plaintiffs with other cases and other lawyers. Significantly, those plaintiffs and their lawyers all chose Chad Points to take the depositions from Goodyear/Dunlop and their witnesses in the case, and to write the briefs and argue the case to the court handling the tire defect claims.
Goodyear/Dunlop knew what it was up against with our successful tire defect lawyer Houston. The tire manufacturer tried to keep the plaintiffs’ qualified expert witnesses from testifying about the tire defects. Again the plaintiffs and their lawyers chose Chad Points to handle the dispute because of his significant knowledge and long-term experience successfully handling tire tread separation cases. The judge ruled that our qualified expert witnesses could testify.
Chad Points of Denena Points, PC had the proven ability in winning tire tread separation cases and his ability came through again for Mr. Maglitto’s bereaved son. During negotiations with Chad Points, Goodyear/Dunlop agreed to settle with Mr. Maglitto’s son, but requested that the amount of the settlement be kept confidential. Manufacturers do not like to have the large amounts of settlement agreements disclosed for fear that they will encourage other injured victims to come forward and make claims for the harm they’ve suffered because of their products.
Learn 4 Important Steps You could take to avoid Dangerous Tire Tread Separations as You Drive
Click here to read these important tips to avoid tire tread separation from your tire defect lawyer Houston.
Contact Denena Points, PC for a FREE Legal Consultation with a Board Certified Tire Defect Lawyer Houston
We will meet with you face-to-face to discuss the injuries you or your family member received in a tire tread separation accident. You may be entitled to a full financial recovery from the tire’s manufacturer for the harm you’ve suffered because of a defective tire.
You’re under no obligation to hire an attorney. If you choose to hire us, we will aggressively pursue your claim for you. Let Chad Points and Tony Denena put their 15 years of solid knowledge and proven experience behind your claim. Rely on the tire defect lawyer Houston that other lawyers choose to represent their plaintiffs for tire tread separation cases. We won’t charge you attorneys’ fees unless we win your case for you. So call today to schedule your free case evaluation consultation. You can get in touch with us at 281-369-4363 or through our convenient online contact form.
Houston Lawyer’s Strong Evidence convinces Ford to Settle Rollover Claim
Why the Deadly Ford Explorer Rollover should not have Happened
Continued from Part 1. With proper engineering, suspension, steering, design, and safety features, most SUV rollovers are preventable. The lawsuit filed by Houston wrongful death lawyers Tony Denena and Chad Points alleged that Ford had failed in all these respects to manufacture a safe vehicle and the unsafe nature of the Ford Explorer SUV lead to the mother’s needless and untimely death.
The Houston wrongful death lawyers Chad Points and Tony Denena had contended with Ford Motor Company on other occasions regarding the unsafe design of some of its vehicles. Their long-term experience and knowledge enabled them to apply the tactics to counter Ford’s hired guns on the defense that claimed the Ford Explorer was safe and rollovers were the driver’s fault.
Chad and Tony presented evidence to show that ESC systems were both economically and technologically feasible at the time the family’s Explorer was made. And that the technology should have been used as it could have prevented the rollover and the wrongful death of the mother of the family.
In addition, Chad and Tony were able to show that the Ford Explorer was not crashworthy. The SUV’s structure and seatbelt design did not prevent or reduce the severity of injuries as they should have. The Ford Explorer was not only especially prone to dangerous rollovers by its very design; it also lacked the safety features to protect vehicle occupants from the consequences of the rollover. Ford knew about the Explorer’s rollover propensity and lack of crashworthiness for years, but did little to prevent the injuries and fatalities that resulted from these conditions.
A Winning Legal Strategy and Extensive Case Preparation helps a Bereaved Family win Justice from Ford Motor Company
Chad Points and Tony Denena’s strong case preparation and legal arguments convinced the defendants to settle the case before trial during mediation. The parties wanted the amount kept confidential, as is often the case where large manufacturers are concerned. The manufacturers may prefer that the existence of large settlements not be disclosed, as this might encourage other victims injured by their products to come forward and make claims.
The Denena Points, PC strategy for success included qualified expert witnesses in the areas of engineering and vehicle design, mechanical engineering accident reconstruction, and medical biomechanics and forensic analysis. Fatal rollover cases based on the existence of inherent design flaws and vehicle defects are complex, highly technical cases that require extensive preparation and complicated technical, medical, and engineering arguments.
You need Experienced Lawyers with the Resources and Knowledge to Win Your Case
When you have an injury or wrongful death claim based on such an accident scenario, you need experienced Houston wrongful death lawyers like Tony Denena and Chad Points who have the financial resources, legal skill, and ability to bring together the winning elements you need and to prosecute a case to its finish against a determined, well financed large manufacturer who will fight your claim tooth and nail.
Learn more about your SUV and Ford Explorer rollover risks by reading this article from the Houston wrongful death lawyers at Denena Points, PC.
Houston Attorney Wins against Ford in Fatal Explorer SUV Rollover Case
Fatal SUV rollovers occur far too frequently. The relative height of the SUV in relation to a fairly narrow wheelbase makes them inherently less stable than many other passenger vehicles. This makes SUVs more likely to roll over in the event of a loss of vehicle control, tire blowout, or wreck. And most of the major auto manufacturers, like Ford, were slow to make Electronic Stability Control (ESC) systems a regular part of the vehicle’s safety equipment.
The Houston wrongful death lawyers at Denena Points, PC have successfully fought Ford Motor Company in several cases such as the one we describe below where innocent victims were seriously injured or killed due to vehicle instability and lack of crashworthiness.
Contact the Houston Wrongful Death Lawyers at Denena Points, PC if You’ve been injured or lost a Loved One to a Rollover Wreck
If an unsafe ford Explorer SUV or other vehicle has rolled over and needlessly harmed you or your family and you need help, contact us anytime. We provide a free legal consultation to discuss your case and answer your urgent questions and you have no obligation to hire an attorney. We will not charge you attorneys’ fees unless we win your case for you. Call our Houston wrongful death lawyers at 281-369-4363 or fill out our online contact form. We’ll be happy to meet with you face-to-face and help you find your road to financial recovery after the traumatic rollover wreck.
The Deadly Christmastime Rollover Wreck that cost a Family the Life of a Mother
If you have an SUV, your own family might have suffered a serious rollover accident like the one that harmed this family. In December 2003, a Pearland, TX family was returning home from their annual Christmas trip to California in their Ford Explorer SUV. When the SUV began to leave the roadway, the mother driving the Ford lost control of the vehicle as she tried to bring it back under control. The Ford SUV rolled over and the mother of the family lost her life in the crash. The father, also in the front seat, suffered serious injuries.
The injured and bereaved family members chose Houston wrongful death lawyers Chad Points and Tony Denena to represent them in their quest for justice after the fatal SUV rollover. Denena Points, PC, PC filed a wrongful death and personal injury lawsuit for the family against Ford and the dealer that sold the unsafe Ford Explorer to the family.
Continue to Part 2 to read the outcome of the lawsuit.
Failed experimental medical device leaves AZ patient without hope
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
Deadly fungal meningitis outbreak leads to MA co’s steroid drug recall
Houston drug recall attorneys report that the U.S. Food and Drug Administration (FDA) is warning doctors and hospitals not to use the products if a Framingham, Massachusetts specialty pharmaceutical company. The products of the New England Compounding Center in Framingham have been linked to a widespread outbreak of a rare form of fungal meningitis in several states. The fungal meningitis outbreak has so far caused illness in about three dozen people in six states and caused at least five deaths.
While this deadly fungal meningitis strain is said not to be contagious, it can take days or weeks for the symptoms of the disease to manifest in patients. So health officials believe many others might be affected by the outbreak, but have not yet become ill. A fungus found in leaf mold causes this type of fungal meningitis.
Our Houston drug recall attorneys note that the meningitis results in inflammation of the lining of the brain and spinal cord. Symptoms to look for include dizziness, nausea, fever, and severe and worsening headaches. Sometimes slurred speech, difficulty urinating, and difficulty walking might result from the inflammation.
The common factor in all of these recent cases of the rare form of fungal meningitis is use of the steroid methylprednisolone acetate from the New England Compounding Company. And the fungal contamination has been found in a sealed vial of the steroid at the company. But until the cause of the contamination is isolated, the FDA is warning people not to use any of the specialty pharmacy company’s products.
So far three deaths from use of the steroid have been reported in Tennessee, with other deaths in Maryland and Virginia. Illnesses have been reported too in Florida, North Carolina, and Indiana. And reportedly, patents in Texas have come in contact with the steroid also. The steroid was administered in shots for back pain.
The rare form of fungal meningitis is treated by high-dose ant fungal medications that are generally administered intravenously. If you or a loved one have become ill after being treated with the steroid, seek medical treatment immediately and contact our experienced Houston drug recall attorneys at once to learn what you could do to hold the manufacturer of the defective product accountable for your or your loved one’s harm.
Act now. You could be eligible for a full financial recovery for the injury and loss you have suffered. But you need knowledgeable and skilled legal help to win your claim against a drug manufacturer. Our track record of more than 14 years of successful recoveries against negligent defendants could be your key to a winning claim in your time of distress. Call or email our Houston drug recall attorneys today to schedule your free case evaluation consultation.
Have you been injured in Texas because of a Stryker medical device?
The Houston medical device injury attorneys at Denena & Points note that Stryker Corporation, like other medical devices, typically seeks to put its medical device products on the market without clinical trials or extensive testing. The bulk of medical devices enter the U.S. market under the FDA expedited approval process. The expedited approval process does not require a manufacturer to engage in testing or clinical trials if it says that its new product is substantially equivalent to a medical device product already on the market.
The FDA expedited approval process saves the manufacturers and the agency enormous amounts of time and money. But the weaknesses in the system have already been show. Surgical mesh repairs of prolapse, for instance, which were predicated upon surgical mesh repairs of hernia, have been shown to not be substantially equivalent after all. The transvaginal surgical mesh repairs have caused serious pain and injury to hundreds of women.
And Synthes, another medical device company, decided to make an end run around the FDA approval process and put its Norian XR product on the market without the required IDE that the FDA required. Our Houston medical device injury attorneys point out that the Norian XR product has since been linked to a number of severe injuries and fatalities.
Some time back, we wrote about a major recall from Stryker Corp. The company pulled its Rejuvenate and ABG II modular-neck stem devices involved in hip replacement surgeries. The metal-on-metal stem and neck could grind together and produce wear and metal flaking linked to a condition called metallosis. Research has shown a high incidence of kidney and bladder disease and failures from the metallosis condition.
And metal-on-metal hip implants have been shown to have failure rates overall. With the Rejuvenate and ABG II recall, Stryker had appeared to try to place the blame for defective product performance with the surgeons that installed the implant and the ill patients with pre-existing conditions like diabetes who required the implants.
In its current recall, Stryker is expanding a Class I recall for certain models of its Neptune Waste Management System. Our Houston medical device injury attorneys emphasize that Class I recalls are the most serious category of recall, indicating the danger of serious injury or death. In this recall, Stryker does not appear to be trying to lay the blame with doctors and patients.
The company does note that their Neptune medical devices do not have required approval from the FDA. And so the FDA has not determined whether these Neptune Waste Management Systems are safe for use or not.
However, actual uses of the product without the required FDA clearance indicate that the medical device product is not safe. Stryker has received at least two reports of serious bodily injury and tissue damage from use of the product. Our Houston medical device injury attorneys caution that at least one use of the product resulted in fatal injury.
The Neptune Waste Management System is a medical device used to collect and dispose of surgical waster fluids. Stryker specifies that instructions for using the product did not specifically warn users against the danger of connecting the Neptune Rover (the high vacuum, high flow device) to a passive drainage tube. And that failure to be precise has apparently caused some patients good tissue and one patient his or her life.
Stryker it seems is telling customers of the product to review revised instructions and educate Neptune users about the warning. Our Houston medical device injury attorneys would suggest that maybe customers abandon use of the product until it has been adequately tested and approved and the FDA has had a chance to determine whether the Neptune medical device is safe or not.
The Neptune medical device products are being marketed illegally as the FDA hasn’t determined their safety and effectiveness. The FDA advises against use of the Neptune medical devices until they can be properly tested and approved by the FDA.
The expanded Stryker recall affects the Neptune I Silver, the Neptune 2 Ultra (120 V), and the Neptune 2 Ultra (230 V). Stryker says that it will cease distribution of these devices until the FDA clears them. We wonder if the company’s adoption of this stance could have anything to do with a deterrent effect resulting from the recent prison terms accorded to Synthes executives who illegally marketed a medical device without proper FDA approval.
Contact the Houston medical device injury attorneys at Denena & Points for a free initial consultation if you have been injured in Texas because of a defective Stryker medical device. Our Texas Board Certified personal injury attorneys have a top tier range of expertise, trial experience, and professional dedication in the field that could help you obtain the full financial recovery you deserve for your serious injury.
We’ve been helping victims and their families that have been hurt by defective medical devices to win their claims against the big manufacturers for over a decade. Let us put our knowledge and skill to work for your benefit. Contact our Houston medical device injury attorneys today for your free case evaluation consultation.
Synthes’ Norian bone cement and unethical human experimentation in U.S.
Not too many weeks ago, our Houston medical device injury attorneys ran an article on the recall of a bone putty from Johnson & Johnson’s Synthes unit that had a tendency to ignite during surgery, presenting great risk to the patients involved. We just read a horrific expose by Fortune Features of Time Warner Cable News from September 18th covering illegal human experimentation and off-label marketing of a deadly bone cement product by Synthes.
Apparently Synthes, founded as a company in 1958 to pursue the as-yet unexplored field of implant surgery as a therapy for bone disease and injury, sought to do an end run around FDA rules governing medical device products. Just after 2000, the company, under its executive leadership, sought to market a bone cement approved for use in the arm and the skull as a solution for filling compression fractures in the spine.
Under the scheme spearheaded by company executives, the bone cement Norian, branded as Norian XR, would be mixed with another substance to treat Vertebral Compression Factures (VCFs). But our Houston medical device injury attorneys point out that the U.S. FDA explicitly told Synthes that the product could not be marketed to treat VCFs, that the labels must contain specific warnings, and that it should not be mixed with another substance before being injected into the spine. In effect, the FDA specifically told the company that it could not sell the product for spinal repair uses, in which the company saw a huge new market.
Off-label marketing (marketing a product for a use for which it does not have FDA approval and for which its label does not indicate approval) is a common practice in the medical device industry as in the pharmaceutical industry. Indeed, off-label marketing of medical devices is such a common practice that very few people take it seriously or regard it as a real problem.
The FDA had indicated to Synthes that if it wanted to market Norian to treat VCFs, the company would need to seek an Investigation device Exemption (IDE). Under the IDE, Synthes would have to recruit large numbers of patients to consent to testing of the product in a controlled study and at considerable cost. Our Houston medical device injury attorneys understand that the company’s executive leadership apparently nixed that idea. And then decided to quietly recruit small numbers of surgeons to test the product on their patients.
Synthes’ leadership apparently thought that this unethical practice would build a track record of product success that they could use to tout their product and rake in the profits. But unfortunate things happened during these small, unapproved trials. Patients died in mere minutes on he operating table as bone cement leaked into their vascular-pulmonary system and quickly generated large amounts of clotting that blocked arteries and caused blood pressure to plummet.
Our Houston medical device injury attorneys note that many of the patients were elderly people with bone deterioration. Because of their advanced ages, family members did not initially question their sudden deaths on the operating table. Many of these family members only recently learned that an unapproved, defective medical device and corporate greed might be to blame for their family members’ deaths.
Four Synthes executives indicted in the matter pleaded guilty under a misdemeanor provision that usually only results in probation or a small fine. But prosecutors, feeling that the company’s disregard for the public safety was egregious in this matter, actually took the unprecedented step of sentencing these executives to prison.
And the recent Synthes recall about which we wrote several weeks ago involved a bone putty apparently designed to prevent the problem of leakage and bleeding. Designed perhaps to prevent the very bleeding and clotting problem that led to deaths of several patients on whom Norian had been used, this Synthes product instead erupted in flame on the operating table under certain conditions. You can read more about this recent bone putty recall in the article lined to this page.
There’s no question that bone fractures and bone deterioration can be very painful. However, our Houston medical device injury attorneys caution that the treatment of injecting the bone with various cements and putties, at least those made by Synthes, seems risky at best.
The Synthes saga reveals how little some medical device manufacturers really care about public health and well being. Patients and family members of patients who have suffered mysterious pain, injury, or death after surgery should seek the cause of that suffering.
Contact our Houston medical device injury attorneys if you would like a free and confidential legal consultation to discuss your injury case. We’ve been successfully investigating, trying, and obtaining full financial recoveries for injured patients and their families for mare than a decade.
Our goal is to hold defective medical device manufacturers accountable for their callous disregard of public safety and ensure that you get the just financial compensation you deserve after a needless injury or family members’ death. Call or email us today for your free case evaluation consultation.
FDA under Congressional pressure due to medical device approval process
The Houston medical device injury lawyers at Denena & Points realize that you might know that most medical devices that get introduced to the U.S. market receive approval under the FDA’s expedited 510(k) approval process. Under the 510(k) expedited approval process, a medical device will receive approval so long as it is “substantially equivalent” to a medical device that already received approval to enter the market. This remains true even if that earlier, substantially equivalent product was recalled for defects still present in the later product. Medical devices approved under the 510(k) process do not require additional testing or clinical trials in human subjects.
The Institute of Medicine in 2011 recommended to the FDA that it replace the 510(k) approval process with a new system. The Institute indicated that the 510(k) process couldn’t properly assure the safety or effectiveness of a medical device before it enters the market. And a study found in the Archives of Medicine determined that fully 71% of dangerous recalled medical devices from 2005 to 2009 received their approvals through the 510(k) expedited approval process.
Earlier this year, Congress introduced a bill that would allow the U.S. FDA to reject a medical device application where that new device was substantially equivalent to a product already determined to be harmful. Yes, it’s shocking that Congress has to introduce additional legislation to give the FDA that authority. It should already have that authority. Our Houston medical device injury lawyers mention that the bill has not yet cleared Congress.
So two Congressmen, Representative Edward Markey (D, Massachusetts) and Senator Jeff Merkley (D, Oregon) have sent a letter to the FDA requesting some answers about the agency’s willingness to assume the additional authority needed to help ensure your safety. These two Congressmen actually don’t ask for much in the way of real change.
They only want the FDA to make changes to the 510(k) database that would indicate the devices that were recalled for design flaws, and include and clearly mark past medical device recalls. The Congressmen would also like the FDA to update the database within 30 days after reviewing a manufacturer’s root cause analysis and determining that a flaw leading to a recall was serious; and to notify the public when a new medical device includes design flaws that led to an earlier product’s recall.
Our Houston medical device injury lawyers note that even if these changes are implemented, the safety of the public remains at risk from medical devices approved under the expedited 510(k) process. And realistically, how many of you would go to the FDA database to check on the design flaw and recall notes relating to a medical device your doctor has recommended? When your health or the life of a loved one is threatened, even a flawed medical device that promises hope likely seems better than no device at all.
The real answer would be to require extensive testing and clinical trails of all medical devices before they reach the market. But manufacturers view both the cost and the time delay required by such testing as prohibitive and a deterrent to research and development.
Ultimately, solutions will continue to be balanced between the medical needs of a population with poor health and the needs of the manufacturers that produce the medical devices and products promised to save them or alleviate their suffering. Yet our Houston medical device injury lawyers strongly believe that some better oversight of the 510(k) expedited approval process is necessary.
As a glaring example stands the transvaginal surgical mesh that has led to so much suffering for so many women. Use of the mesh to repair extensive internal organ prolapses was approved under the 510(k) expedited process based on its substantial equivalency to the mesh used to repair hernias. Our Houston medical device injury lawyers emphasize that even if the mesh itself might have been substantially equivalent, the intended use clearly was not. A prolapse repair is a far more invasive and extensive procedure, with much higher risks, than a simpler hernia repair.
At the very least, some modification of the 519(k) approval process should be made to catch these types of cases where a novel use of a substantially equivalent product deviates so diametrically from the product’s prior use that unanticipated risks and errors could occur. In such cases, the medical device should undergo additional testing and clinical trials relating to its intended novel usage before it is released into the U.S. market and installed in the bodies of unsuspecting patients.
Our Houston medical device injury lawyers have taken some pains to learn about the intricacies of transvaginal surgical mesh prolapse repair in order to help our clients that were injured by the product. In doing so, we’ve acquired an in-depth knowledge of the strengths and weaknesses of the FDA medical device approval processes as well.
If you or a loved one are suffering because of a defective medical device, give us a call to schedule a free case evaluation consultation. Our Houston medical device injury lawyers could familiarize you with the law that applies to your specific situation and help you understand your options for winning a full financial recovery for the harm you’ve received. Money can never replace the health and well being that you’ve lost to a defective medical device. But it can help you meet your future medical costs as you struggle to recover from the injury and your lost wages if you can no longer work. Let our experience and knowledge help you recover.