In our video below, Lieff Cabraser SUV rollover accident attorney Fabrice N. Vincent discuss how even when rollovers represent only 3% of US highway vehicle accidents, that 3% includes almost 1/3 of all accident deaths on US highways.

SUV Rollover Lawsuits: SUV Safety Flaws Explained

To learn more about this case, please visit our SUV rollover page.

The complaint charges that Simply Thick and the other defendants failed to properly thermally process and test the safety of the infant food thickening agent SimplyThick, recommended for use by parents with premature infants.

Ms. Addonizio was instructed by hospital staff to add SimplyThick to her daughter’s formula. Within days after her initial discharge, the infant’s health rapidly deteriorated. On May 13, 2010, the child was having trouble breathing and she was rushed to the emergency department at the Weill Cornell Medical Center.

Despite having been discharged from the hospital in good health just 9 days before, Ms. Addonizio’s baby was diagnosed with the life-threatening condition called Necrotizing Enterocolitis (“NEC”).

NEC is a rare disease in children who have been discharged from the hospital. It causes inflammation and death of intestinal tissue. NEC has a mortality rate of 25%, meaning it kills 1 out of every four victims. NEC can cause severe life-long impairment in children who survive it.

During surgery, doctors found that there were spotty areas along the entire length of the infant’s intestine. As removal of the entire intestine was a last resort, the infant’s intestines were instead put in an ostemy bag (a silo outside of her body).

Following the initial surgery, her condition continued to deteriorate until on May 18, 2010, despite the danger involved with additional surgery, Ms. Addonizio consented to additional surgery to save her daughter’s life. During the second surgery 18 centimeters of the infant’s intestine was removed.

Despite the success of the second surgery, the infant’s treatment course during the ensuing six months was excruciating and complicated. In total, the infant spent over four months in a critical care unit and seven weeks in rehabilitation recovering from her injuries allegedly caused by SimplyThick. She returned home finally on November 12, 2010, when she was just shy of 8 months old.

Simply Thick Recall

A year after Ms. Addonizio’s daughter was born and given SimplyThick, the U.S. Food and Drug Administration (“FDA”) warned that SimplyThick may cause NEC and that the product should not be fed to prematurely-born infants. Soon thereafter, the FDA conducted an inspection of Thermo Pac, LLC’s Stone Mountain, Georgia, facility, where SimplyThick was manufactured, and found numerous problems at the manufacturing plant.

As alleged in the complaint, based on the facility inspection, the FDA found that Thermo Pac, LLC failed to properly thermally process acidified food, including SimplyThick, in a manner sufficient to destroy microorganisms dangerous to public health. The FDA also found bacillus cereus, a type of bacteria, present in twelve of thirty samples of finished SimplyThick product that it tested.

On June 4, 2011, the FDA announced that Simply Thick, LLC, was recalling SimplyThick manufactured at the Stone Mountain processing plant.

Legal Assistance for Parents with Infants Suffering from NEC

Lieff Cabraser is representing parents across America whose infants have suffered severe injuries allegedly due to SimplyThick. Visit our SimplyThick case page to learn more about the SimplyThick recall lawsuits.

The industry was shaken in 2005 by disclosures that Guidant, a major maker of heart defibrillators, had not warned doctors about a potentially fatal flaw in its products. Subsequently, Guidant and other device makers promised to set up independent medical advisory boards, to quickly investigate malfunctions in their products and to alert doctors to potential problems.

The issue of opting to conceal from doctors and the public any flaws in their medical device instead of carefully scrutinize every patient death to see if there was a defect that could kill or injure other patients has resurfaced in how St. Jude Medical has handled disclosures about a problem component, a wire — or lead — that connects a defibrillator to a patient’s heart.

As the New York Times explains,

Last month, an outside researcher, Dr. Robert Hauser of Minneapolis, released a study indicating that short-circuits and other failures of the St. Jude lead might have played a role in some 20 patient deaths.

His report followed several studies showing that the lead, called the Riata, was also prone to another malfunction, a tendency for internal wires to break through the protective outer coating and cause electrical problems like unintended shocks in some patients. An estimated 128,000 patients worldwide still use the Riata lead, which the company stopped selling in late 2010.

St. Jude executives, including the chief executive, Daniel J. Starks, quickly reacted to Dr. Hauser’s report by unleashing a public relations campaign aimed at discrediting the study’s accuracy and Dr. Hauser. But left unanswered amid the noise was the question: how closely had St. Jude been examining those deaths for signs pointing to a broader problem involving the Riata lead?

Unfortunately, the reaction of St. Jude executives — seeking to deflect attention and scrutiny of alleged safety flaws with its product — fits a pattern within the medical device industry. In October 2007, Medtronic issued a recall of its Sprint Fidelis heart lead.

The device is a thin electrical cable that connects an implanted defibrillator to a patient’s heart which were implanted in over 200,000 patients. When the lead fractures, the defibrillator can fail to send a needed electrical jolt, and the patient can die. Or, as occurred repeatedly, the defibrillator sends repeated, massive shocks, which themselves can be fatal.

The first reports of patients suffering unnecessary shocks and problems with the Medtronic heart lead came years earlier from the investigatory work of Dr. Hauser and his colleagues at the Minneapolis Heart Institute. They published a report finding that the Sprint Fidelis Lead was more likely to fracture than other types of leads, met with Medtronic to voice their concerns, and advised the FDA of those concerns.

Despite knowing the leads were unsafe, complaints filed by injured Sprint Fidelis patients alleged, Medtronic vigorously defended its product and continued to promote its safety and use. Medtronic sent a “Dear Doctor” letter to practitioners asserting that failures may be the result of improper surgical technique and assuring doctors that the Sprint Fidelis Leads performed as well as other Medtronic leads.

Dr. Hauser found the  alleged St. Jude lead defect by analyzing Food and Drug Administration (FDA) data on device malfunctions for reports of death associated with St. Jude defibrillators. He found 9.7 deaths attributed to Riata leads for every 100,000 defibrillator devices, and states that “the figure could be even higher since many reports do not give enough detail to determine the cause of the [defibrillator] malfunction.”

Dr. Hauser states that the alleged defect causes the leads to short-circuit, which can result in failure to defibrillate when the heart beats irregularly. This defect is particularly dangerous because, Dr. Hauser writes, “‘Failure to defibrillate may be the first and only sign of lead failure.’”    According to the Chronicle, St. Jude stopped selling Riata and Riata ST devices in December 2010 because of safety concerns, but “more than 79,000 people in the U.S. and 49,000 abroad still have the implants.”

You can learn more about Fosamax bisphosphonate drug femur fractures.

Currently, the FDA has the authority to disallow a device from entering the market only if “the older device has been ordered off the market by the agency or a court order.” Most companies voluntarily recall defective devices before they are ordered off the market by the FDA. As a result, even if the earlier version of the same implant, defibrillator, or other medical device is found to be defective, a new variation can be brought to market with the FDA’s approval despite the new device suffering from the same design flaw as its predecessor.

For example, the FDA “approved vaginal mesh implants even though some traced their designs to a product recalled by Boston Scientific Corp.” The new bill would give the FDA the power to “reject devices that have designs based on past products that were recalled for safety flaws.”

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, summarized the current approval process to Bloomberg: “‘The challenge now is if there’s a problem, it can get replicated’ through future generations of devices.” Bloomberg reports that the FDA clears an average of 28 devices annually that “cite a predicate known to be recalled.”

Learn more about faulty medical devices and the legal rights of the injured.

Lexi Hazam summarized the charges Evans and Mechaley have brought against DePuy: “DePuy was aware its ASR hip implant was failing at a high rate, yet continued to manufacture and sell the product to unsuspecting physicians and patients.”

The complaint alleges a current failure rate of thirteen percent of all DePuy ASR hip implants. However, evidence indicates that the true failure rate may rise much higher than thirteen percent.

The New York Times recently reported that Dr. Art Sedrakyan, a researcher at Weill Cornell Medical College of Cornell University, used data collected in other countries to predict that “tens of thousands” of U.S. patients will experience device failure in the coming decade.

The National Joint Registry of England and Wales has found a forty nine percent failure rate within six years of ASR hip implantation. 40,000 U.S. patients received DePuy ASR hip implants before Johnson & Johnson’s 2010 recall – in the coming decade, many of these still-young devices may prematurely fail, and the U.S. may catch up to the British forty nine percent failure rate.

In an interview with a Knoxville television station, Lieff Cabraser attorney Todd Walburg stated the Yaris “had not been recalled by Toyota, even though it had the same kind of electronic throttle system as the other vehicles that had been recalled.” The complaint alleges:

“The subject 2008 Toyota Yaris was not equipped with a brake override system, also known as smart-throttle technology. Ironically, earlier models of the Toyota Yaris that were sold in Europe were equipped with the Bosch brake override system. Toyota elected not to use the Bosch brake override system in the vehicles that it sold in the United States. ”

Learn why Toyota is legally responsible for the damage and injuries cause by its cars suddenly accelerating.

Under the Act, if a medical device was approved under the expedited 510(k) process, “which now requires companies only to show their devices are smilar to those already on the market,” the FDA could require post-market studies to determine safety. The FDA could also grant partial device approval for devices approved under the 510(k) process, pending futher saftey studies.

In addition to introducing post-market safety legislation, the Senators have also sent investigative letters to five medical device manufacturers, requesting information on their post-market surveillance of products.

Senator Grassley’s press release states, “Letters were sent to Johnson & Johnson, for its DePuy metal-on-metal hip implant…Medtronic for its Infuse product; Boston Scientific for Guidant’s defibrillators; CR Bard for vaginal and hernia mesh products; and, Zimmer Holdings for its knee replacements.”

Patton and her entire family have suffered from the Fosamax and Boniva prescriptions she has taken since 2001. Patton took Fosamax from 2001 to 2006, and took Boniva from 2006 to 2010. Doctors prescribed Fosamax and Boniva, both bisphosphonate drugs, to slow bone loss and combat Patton’s osteoporosis.

However, long term use of these drugs has actually been found to cause brittle bones and to increase the risk of atypical bone fractures. On December 10, 2010, Patton suffered a subtrochanteric femoral fracture while walking up steps. This aptypical femur fracture has been devasting for Patton and her family. Patton noted, “My husband now does a lot of the work I used to do. The accident changed a good part of my life; it put a lot of extra burden on my family.”

Lieff Cabraser attorney Kent Klaudt announced that Reba Patton and her husband Patrick Patton have filed a lawsuit against Fosamax manufacturer Merck&Co., and against Boniva manufacturer GlaxoSmithKine, LLC. Klaudt said, “Merck and GlaxoSmithKline, as alleged in the complaint, concealed and continue to conceal their knowledge of bisphosphonates’ lack of long-term benefits and dangers to Mrs. Patton and other patients.”

To learn more about Fosamax, Boniva and other bisphosphonate drugs, as well as victims’ rights, visit our Bone Drugs and Femur Fractures information page.