Invokana Heart Attack Risks Highlighted in New Lawsuit

By Emily Cox
Invokana heart attack risks
flickr/Ian McKellar

A new lawsuit indicates that Johnson & Johnson and its Janssen Pharmaceuticals unit concealed significant Invokana heart attack risks.

Mitchell Greenbaum filed the complaint August 28 in the Northern District of Ohio. He indicates that he suffered a heart attack six months after starting treatment with Invokana for diabetes.

According to his complaint, Greenbaum began taking Invokana in early 2016. In August 2016, he was stopped at a traffic light and suffered a myocardial infarction, or heart attack. Consequently, Greenbaum suffered hypoxia, necessitating resuscitation and causing permanent injuries that have led to a loss of consortium with his wife, Maria Greenbaum, among other serious consequences.

Greenbaum alleges that the drug manufacturers actively withheld Invokana heart attack risks from the public and medical community to protect its bottom line and profited immensely from this intentional concealment at the peril of diabetes patients. The complaint notes that when Invokana first received FDA approval in 2013, federal regulators ordered a study that showed that there were significant heart attack risks. However, J&J and Janssen never added new warnings to the drug’s label.

“Janssen Defendants had a duty to the public and the Plaintiff to manufacture, formulate, design and create a drug which would not adversely increase the risk of cardiac arrest in users, especially given the fact that some users foreseeably may have a prior history of hypertension,” the lawsuit states. “Janssen Defendants failed to recognize the risk of increased clotting and cardiac arrest, or intentionally chose not to recognize said risk, which constitutes both negligence and intentional misconduct.”

Health Concerns Beyond Invokana Heart Attack Risks

Invokana (canagliflozin) is a new-generation type 2 diabetes drug. It hit the market in March 2013 as the first member of a new class of diabetes medications called sodium-glucose cotransporter 2 (SGLT2) inhibitors. These drugs work in a unique way to eliminate excess glucose through urination by altering normal kidney functions. However, thousands of patients have come forward due to a number of life-threatening side effects from the drugs.

In December 2015, the FDA required J&J to add new diabetic ketoacidosis warnings to Invokana, indicating the medication increases the risk of this serious condition that usually requires emergency treatment to avoid life-threatening injuries. Before this update, the Invokana warnings didn’t alert patients about the importance of getting immediate medical attention if they experience abdominal pain, fatigue, nausea, respiratory problems, or vomiting.

In May 2017, the FDA mandated Invokana warning labels regarding the risk of leg and foot amputation. Manufacturers of other similar diabetes drugs maintain that this risk is unique to Invokana alone.

This past month, the FDA released a statement that SGLT2 drugs carried elevated risks for Fournier’s gangrene, a rare flesh-eating genital infection. The condition has resulted in at least one death so far among those taking these medications.


Toyota Recalls 1M Vehicles Due to Electrical Fire Risks

By Emily Cox
Toyota Recall
flickr/Mike Mozart

Toyota announced Wednesday that it is recalling around 1 million of its Prius and C-HR compact SUV vehicles due to concerns that an exposed engine wire could short circuit and cause fires.

The Japanese vehicle manufacturer indicates the problem affects 2016-2018 Prius and C-HR models. Owners will be able to take their vehicles to Toyota dealerships to have the faulty wires repaired.

The issue stems from “an engine wire harness which is connected to the hybrid vehicle power control unit,” Toyota said. “A portion of the wire harness could contact the cover at this connection and wear over time, causing an electrical short circuit, which can generate heat.”

“If sufficient heat is generated, there is an increased risk of a vehicle fire,” the company added.

When vehicle owners bring their vehicles to dealerships, the manufacturer indicates that the wire harness will either be “replaced with a new one that includes a protective sleeve” if a “wire core is exposed,” or the dealership will simply apply protective tape to the harness assembly if the core is not exposed.

Toyota estimates that the recall will affect approximately 1 million vehicles. Roughly 800,000 of these, including all the C-HR model compact SUVs, were sold in Japan, Europe, and Australia. The recall will also affect about 192,000 Prius’ sold in the US.

Toyota Continues to Face Serious Problems

Wednesday’s announcement comes on the heels of Toyota announcing that it is recalling nearly 20,000 2012 Avalons for potentially defective seatbelt buckles that could cause the airbag not to deploy correctly.

In August, a jury slammed the company with a $242 million verdict, finding that the defective front seats of a Lexus caused two small children’s serious injuries in a rear-end collision and that Toyota carried most of the blame for their skull fractures and traumatic brain injuries.

A putative class action of owners also sued Toyota in February over claims that certain Prius models have a defect that presents serious risks of stalling while traveling at high speeds, potentially causing accidents.

In January, Toyota announced it was adding several hundred thousand vehicles to the ongoing recall over faulty Takata airbags. The ensuing fallout of which has dragged Takata Corp. into a protracted bankruptcy.


High-Risk Heart Devices Receive FDA Approval Despite Scarce Scientific Evidence

By Emily Cox
heart devices
flickr/Christopher Mance

A new study confronts significant issues with medical device approval in the US, underlining more than a dozen instances federal regulators approved heart devices under its “Priority Review” process that were later found to be dangerous and ineffective.

JAMA Internal Medicine published the study August 27. University of California San Francisco School of Medicine researchers found that the FDA relied on studies with little scientific evidence to establish cardiovascular devices were safe or even effective before approving them through its “Priority Review” program.

The report analyzed randomized clinical trials manufacturers performed to provide evidence for premarket approval from the FDA for heart devices. Researchers found that, as devices move through the Priority Review program, the quality and thoroughness of scientific evidence to justify approval of products is not known, let alone evaluated.

The researchers evaluated evidence manufacturers provided federal regulators for 14 high-risk cardiovascular devices that received FDA approval under its Priority Review program between 2007 and 2017. During that time, federal regulators approved a total of 29 devices under the fast-track program. Of these, 14 were high-risk heart devices. Manufacturers used a total of 18 studies to support that these devices were safe and effective.

The findings indicate that none of the 18 studies were double-blind trials. This research benchmark is generally considered essential for high-quality data. At least 13 of the studies used surrogate end points. Furthermore, none of the studies were large-scale, enrolling only an average of 500 patients.

Heart Devices Point to Regulatory Failings

In total, the FDA convened nine safety expert advisory panels to review the effectiveness and safety of the heart devices. Four of these panels found that the devices were safe. However, they did not find the devices were effective in treating the cardiovascular problems at issue. But, regulators pushed the devices through anyway. For 13 of the 14 devices, the FDA asked for post-approval studies for further information.

As of May 23, 2018, there have been two Class I and 13 Class II recalls for six of the heart devices. Earlier this year, Medtronic heart implants, which were among the products covered in the recent report, were recalled because of defects that stopped the devices from providing life-saving shocks.

Study authors warn that the majority of the recalled heart devices received approval based on a single nonrandomized, non-blinded study. They are calling for regulators to make some changes to Priority Review during premarket approval.

“To lower the odds of recall the new program should demand high-quality pre-approval data, larger scale studies, and longer followup,” researchers wrote.

Study Authors Call for Regulatory Changes

The push for high-quality research for approvals stands diametrically opposed to the FDA’s recent efforts to make medical device approvals ever easier and faster. This year the FDA also announced an action plain to spur innovation by further streamlining the premarket and post-market process.

Bringing devices to market faster along with the integration of the premarket and post-market processes only deepens already substantial concerns that patients will pay the ultimate price for devices coming to market through a rushed and ineffective approval process.

Consequently, researchers are calling for the FDA to take action to ensure that post-market studies are completed within a specified time limit. This way, if any problems are revealed, like those that could warrant a recall, the post-market study might help pick up these problems before a significant number of patients are harmed.


Insys Prosecutors Push Back Against Expert Witness Disqualification

By Emily Cox
Insys Prosecutors
flickr/Bryan Furnace

The founder of Insys and several former top executives at the opioid company are accusing a doctor of double-crossing them by agreeing to testify for the federal government in an upcoming racketeering trial after meeting with the pharmaceutical company’s attorneys on multiple occasions. Consequently, the company is moving for the court to disqualify the expert from testifying; however, the federal government fought back Tuesday, saying that the doctor should still be able to take the stand for Insys prosecutors.

The government retained Dr. Christopher Gilligan as one of numerous pain management experts to possibly testify against Insys’ founder, billionaire John Kapoor, and his predecessor as CEO, Michael Babich, who Insys prosecutors allege created a fraudulent speaker program to conceal illegal kickbacks for doctors to prescribe the powerful Schedule II narcotic Subsys and illicitly boost sales. According to Insys executives, Gilligan met with their attorneys several times before the government retained his assistance. The executives further assert that Gilligan learned confidential information about their case and defense strategy during these meetings.

However, Insys prosecutors pushed back Tuesday, telling District Judge Allison D. Burroughs that the court should allow Gilligan to testify, arguing that the information he learned from defense lawyers wasn’t significant enough to substantiate an agreement of confidentiality.

“The lack of any confidentiality agreement is a telling factor, which weighs heavily against the defendants’ claims,” the government stated in its opposition. “The defendants do not assert that they advised, or even requested, that Dr. Gilligan keep his interactions with counsel confidential.”

“Despite that omission, defense counsel claim that they ‘repeatedly’ held ‘privileged calls and meetings’ with the witness during which they shared confidential information,” prosecutors continued. “That experienced counsel failed to contemplate the need to simply request confidentially from a possible expert strongly suggests confidentiality was simply unnecessary.”

Insys Prosecutors Opposition to Expert Disqualification

Gilligan, who the government has retained in other cases, told Insys prosecutors about his meetings with defense counsel when the government first reached out to him in July. According to Gilligan, defense lawyers asked him about off-label marketing and if he had prescribed Subsys. Prosecutors argue that these lines of discourse do nothing to tip the defense’s hand. Furthermore, if they do, then the defendants should have exercised more caution.

“This court should not reward the defendants’ failure to protect whatever confidential information they believed they needed to protect, particularly from a doctor whom the government has previously called upon,” the opposition stated. “Such a ruling would be contrary to the interests of justice.”

Insys prosecutors conceded that confidentiality isn’t exclusive to having an agreement. However, they added that it is ““also true that this court can reject any assertion that it is objectively reasonable to believe that a confidential relationship existed where experienced counsel, from respected law firms, failed even to mention confidentiality in five different meetings with the witness.”

Insys Executives Motion to Disqualify

The defendants’ motion to disqualify indicates that Gilligan met with their lawyers repeatedly, discussing confidential case strategy with them. Gilligan informed them that he had not spoken about the case with the government, saying he would be open to acting as a defense witness. In May, Gilligan notified them that his employer would not allow him to serve as a witness in the case and even offered to help find a replacement.

After discovering that the government had named Gilligan as a potential expert, the executives tried to figure out what happened. They said they informed the government about their past involvement with Gilligan and asked for assurance that the government would drop him as an expert witness. According to the defendants, the government told them that it would not communicate with the doctor until the court settled the matter. However, the government wrote in a Friday letter that an assistant US attorney had spoken with the doctor five days before its expert witnesses’ disclosure deadline and that Gilligan had told the government lawyer he had previously met with the defendants’ attorneys.

The Insys prosecutors included a footnote in Tuesday’s filing, saying that they would have no further contact with Gilligan until the court decided on the motion. If the court opts to remove Gilligan as a witness, prosecutors requested 60 days to locate a replacement.

Insys Racketeering Indictment

The Insys indictment claims that at least nine doctors and one nurse took bribes to distribute the fentanyl-based spray. The company organized parties or intimate meetings to disperse these payments, cloaking them as speaking events to people who did not need it to treat breakthrough cancer pain, which is the only FDA-approved use for Subsys. Company executive Michael J. Gurry and Babich reportedly directed the Insys call centers to fraudulently tell insurance companies that patients needed the spray to get them to cover the prescription cost.

Federal prosecutors say Kapoor and Baich hired four sales executives to network with prescribers and launch the plan into action. Alec Burlakoff, Sunrise Lee, Joseph A. Rowan, and Richard M. Simon are the other defendants in the case.

The executives claim the conspiracy is actually a series of perfectly legal marketing strategies that “safe harbors” laws specifically protect. They also argue the indictment fails to sufficiently show that the executives targeted doctors they knew would break the law.

State Farm Agrees to $250M Settlement in Judge Rigging Trial

By Emily Cox
State Farm
flickr/State Farm

State Farm agreed to pay $250 million Tuesday to settle a lawsuit over the insurance company secretly working to help elect an Illinois Supreme Court Justice to overturn a billion-dollar verdict against it.

The deal was overseen by District Judge David Herndon from the bench, ending more than 20 years of litigation on the same day the trial was to begin.

The court had scheduled opening arguments to begin Tuesday, six years after plaintiffs filed the current Racketeer Influenced and Corrupt Organizations (RICO) Act class action, and more than two decades after a group of plaintiffs first came forward against State Farm, alleging the insurer violated policy contracts by refusing to replace crash-damaged vehicle parts with Original Equipment Manufacturer (OEM) parts in favor of less expensive replacements.

In 1997, a jury awarded a class of 4.7 million policyholders a staggering $1.186 billion, including disgorgements and punitive damages. However, the court later reduced this award to $1.05 billion.

Eight years later the Illinois Supreme Court would overturn the verdict entirely. This was done, in part, through finding that the issue of “uniform contractual interpretation” across State Farm policies was never adequately addressed during the class certification stage. However, plaintiffs indicate that State Farm in-house attorney William Shepherd helped coordinate a well-funded effort to get Judge Lloyd Karmeier on the state Supreme Court. Furthermore, experts further allege that the deceit went back more than a decade with the insurance company’s outside counsel in regard to State Farm’s connection to the Judge Karmeier campaign.

State Farm Strides to Get Karmeier on the Bench

Following oral arguments in May 2003, Judge Karmeier, a longtime Illinois circuit judge, won in a close race for a vacancy on the state’s Supreme Court. It was the most expensive judicial election in US history at the time. Several months after he joined the bench, Judge Karmeier cast a decisive vote in State Farm’s favor to get the billion-dollar verdict overturned.

Class action plaintiffs claim that, between the oral arguments and the court tossing the verdict, Shepherd, an in-house lawyer-lobbyist for State Farm’s Bloomington headquarters, along with other State Farm insiders, recruited Justice Karmeier to run, covertly managing his campaign and donor network and concealing millions in donations through various groups, including the US Chamber of Commerce, to win the election for Justice Karmeier so that he could help the company overturn the massive judgement.

“Of course, there was no guarantee for State Farm that the appeal would not be decided before the [Karmeier election in November 2004] but the risk — a $2 to $4 million investment for a possible $1.05 billion return — was sufficiently minimal to make it a worthwhile gamble,” the policyholders’ 2012 RICO complaint stated.

Trial themes were going to include a complex money trail and emails that show Judge Karmeier was being kept up-to-date by defendant Edward Murnane about who was financing his campaign. Murnane was the president of the Illinois Civil Justice League. Shepherd founded this organization as a vehicle for State Farm’s plan.

Rather than face the policyholders’ allegations in court, State Farm reached the settlement just prior to opening arguments were to begin.


McAfee Exposes Medical Device Cybersecurity Weaknesses

By Emily Cox
flick/Fotos GOVBA

McAfee researchers recently hacked into a central patient monitoring station for medical devices to demonstrate potential cybersecurity weaknesses.

The McAfee team performed the demonstration this past month at Defcon, a large annual hacker convention in Las Vegas, Nevada. Researchers simulated a patient whose heartbeat had flatlined to show how they could alter patient vital signs.

While researchers did not perform the demonstration remotely, they warned that it could be done from great distances as long as the hospital’s system is connected to the internet.

The team highlighted the security weakness just ahead of the new McAfee Advance Threat Research Lab’s opening in Oregon. The facility will also be used to demonstrate potential cybersecurity threats to all forms of new technology.

Two years ago, numerous U.S. hospital systems were hacked, infecting their systems with malware that stopped staff from communicating with the computers. The hospitals paid ransom through bitcoin to regain control.

In at least one instance, when a hospital refused to pay the ransom, administrators had to shut down portions of the facility until they could regain control. Consequently, they had to move some of the patients, impacting care.

America isn’t isolated in its vulnerability to medical device cybersecurity risks. Hackers have broken into health trusts in the U.K. and Germany, as well. In most cases, the hospitals end up paying bitcoin ransoms to protect patients in their care. Some hospitals have even hired law firms to buy bitcoin in case hackers hit them with malware, which is becoming known as ransomware.

FDA Action on Medical Device Cybersecurity

In 2016, the FDA issued new guidance on medical device cybersecurity. The document indicated that manufacturers need to detect and monitor potential cybersecurity vulnerabilities in medical devices, as well as research the level of vulnerabilities and risks to patients and establish a protocol for sharing cybersecurity information among manufacturers to limit hacking risks.

The agency indicated that manufacturers should design medical device software with upgrading capabilities to be able to combat newly discovered vulnerabilities for the device’s entire lifespan. The FDA warned that products that cannot be upgraded will become obsolete quickly and put patients in harm’s way. The agency indicates that these measures will allow manufacturers to ensure medical device safety and effectiveness at all stages of deployment and distribution, as well as encourages continuous quality improvement.

Medical Device Cybersecurity Concerns

Medical cybersecurity concerns have been escalating over the past few years as vulnerabilities to healthcare organizations’ record systems and medical devices continue to surface.

Since 2014, the Department of Homeland Security (DHS) has actively investigated at least two dozed cases of probable cybersecurity flaws in hospital equipment and medical devices. According to DHS, if the medical field does not take preventative actions to strengthen its cybersecurity issues, hackers could exploit these vulnerabilities, and patients will pay the ultimate price.

Department of Health and Human Services (DHHS) manager Jason Lay says the medical field’s vulnerabilities are a significant danger. Lay indicates the possibility of hacks to medical devices are an extraordinarily real possibility, saying that hackers could potentially exploit medical devices to gain access to healthcare organizations’ health record systems.

Furthermore, a demonstration at the 2012 San Francisco RSA security conference showed researchers could hack medical devices like insulin pumps from as far as 300 feet away. Researchers further showed how hackers could take control of insulin devices remotely, overriding them to deliver lethal doses of insulin to patients without any notification.

Since the White House issued Executive Order 13536 in 2013, the FDA has worked on improving the medical field’s cybersecurity. The Order called on the private and public sectors to collectively strengthen the gap in cybersecurity infrastructures. In October 2014, the agency issued its first guidance, recommending medical device manufacturers to include strong anti-hack programs during the design stages of development.




Happy Labor Day from Arentz Law Group

Labor Day

Labor Day gives us an opportunity to recognize the invaluable contributions that working men and women make to our nation, our economy and our collective prosperity. It gives us a chance to show gratitude for workers’ grit, dedication, ingenuity and strength, which define our nation’s character.

— Thomas E. Perez

Taxotere MCL Conference Set for October 4

By Emily Cox
taxotere mcl
flickr/Haukeland universitetssjukehus

The newly established Taxotere multicounty litigation (MCL) in New Jersey is hitting the ground running, setting its initial Taxotere MCL conference to get the litigation underway.

Middlesex County Superior Court issued the order August 24, scheduling the litigation’s first Case Management Conference (CMC) for October 4 at 10am.

The Court is mandating that parties submit a brief statement seven days before the conference, outlining the following information:

  • All company and financial affiliations with the parties and counsel associates participating in the litigation, so the court can easily identify any recusal or disqualification issues early.
  • All relevant actions pending in federal and state courts, as well as their current status.
  • Discovery status
  • Settlement negotiations status, including settlement demands, mediation, and settlement prospects.

New Jersey Superior Court consolidated all the lawsuits pending in the state’s court systems August 15, transferring 353 cases to Middlesex County for pretrial proceedings. The plaintiffs in the Taxotere MCL allege that the cancer drug’s manufacturer actively concealed considerable risks, including permanent hair loss, while grossly overstating the potent drug’s efficacy. Similar New Jersey cases in the future will be filed directly into the Taxotere MCL to maximize judicial efficiency.

Taxotere MCL Background

Taxotere (docetaxel) initially received FDA approval in 1996 to treat aggressive, metastatic breast cancer when other treatment options have failed. However, despite its limited indications, Taxotere is the most commonly prescribed breast cancer drug in the US, often as a first-line treatment even though it is considerably more toxic than equally effective and safer treatments, such as Taxol. An ongoing Qui Tam lawsuit alleges that Sanofi provided exorbitant illegal kickbacks to encourage doctors to prescribe the medication as a first-line treatment, skyrocketing Taxotere to the forefront of the cancer treatment market, while Sanofi raked in the profits – much of which was obtained by defrauding the Medicare and Medicaid.

With about 300,000 breast cancer cases diagnosed each year, Taxotere is the most prescribed drug in its class despite the fact that studies show that less-toxic Taxol is more effective. In 2009, Sanofi made more than $3 billion from Taxotere before losing patent protection.

Taxotere and Permanent Hair Loss

Not only is Taxol more effective and less toxic than Taxotere. It also doesn’t have the same permanent side effects as Taxotere. Studies have linked Taxotere with about a 10 percent occurrence of permanent hair loss. Sanofi knew about this side effect and hid it from its most profitable market – American women.

Sanofi knew about Taxotere’s alopecia risk since at least 2005. This is when the company updated Canadian warning labels to specifically include this risk. Sanofi would go on to update European warning labels in 2012. Somehow, the U.S. must just have gotten lost in the shuffle, because warning labels would not include this warning until the end of 2015. This was more than a decade after Sanofi became aware of a GEICAM study showing that 10 percent of Taxotere patients suffered permanent hair loss. Even the company’s own studies indicated more than a nine percent rate for permanent alopecia occurrence.

Outside of the Taxotere MCL, Sanofi is facing thousands of additional Taxotere lawsuits throughout the county, including nearly 10,000 federal cases that are currently pending in a multidistrict litigation (MDL) that is underway in the Eastern District of Louisiana.


Baby Powder Wrongful Death Lawsuit Says J&J Products at Fault

By Emily Cox
baby powder wrongful death lawsuit

A new baby powder wrongful death lawsuit indicates that a woman developed fatal ovarian cancer after years of using Johnson & Johnson’s Baby Powder and Shower to Shower products and alleges that J&J consciously concealed life-threatening risk factors associated with its seemingly benign talc-based products.

Her husband, Mark Vetrini, filed the Baby Powder wrongful death complaint August 24 in Delaware Superior Court. He is presenting claims on behalf of himself and the estate of his late wife, Vanessa Vetrini, against J&J, Imerys Talc, Rio Tinto Minerals, Inc., and Valeant Pharmaceuticals.

According to the lawsuit, Vanessa Vetrini used Baby Powder and Shower to Shower around her genital area for feminine hygiene purposes for decades. She received an ovarian cancer diagnosis in January 2012 and died from the disease on June 5, 2016. She was only 42 years old. However, the Baby Powder wrongful death lawsuit asserts that the manufacturers knew about the connection between talcum powder and ovarian cancer for decades but deliberately withheld this information to protect brand image at the expense of human lives. The companies even encouraged women to use the product unsafely to increase use and sales.

“All of the Defendants have been or should have been aware for nearly forty (40) years of independent scientific studies linking the use of their products to the increased risk of ovarian cancer in women when used in the perineal area,” the lawsuit states. “Despite this overwhelming body of evidence all of the Defendants have failed to inform their consumers of this known hazard.

Baby Powder Wrongful Death and Litigation

Mark Vetrini’s pursuit for justice joins thousands of other Baby Powder and Shower to Shower lawsuits pending against J&J in the nation’s courts.

Over the past few years, numerous of these claims have gone to trial in state courts with many of them ending in multimillion dollar damage awards for J&J’s conscious negligence regarding the health of its consumers and valuing the all-mighty dollar over human life. Despite the massive verdicts, J&J is refusing to be cowed by the overwhelmingly negative response to its defensive measures. The healthcare giant is pursuing appeals in each of these cases and has continued to maintain that it will not offer talcum powder settlements for women who developed ovarian cancer after using its dangerous products.

Vetrini’s lawsuit is pending in Delaware state court. However, thousands of other individuals are also pursuing claims in Missouri state court, as well as the federal court system. The Judicial Panel on Multidistrict Litigation (JPML) has centralized the federal litigation before District Judge Freda Wolfson in the District of New Jersey for coordinated pretrial proceedings to expedite the dissemination of justice for those harmed by J&J’s callous disregard for the health of its consumers. The multidistrict litigation (MDL) works to reduce duplicative discovery and avoid conflicting pretrial rulings that tend to hold up these large legal actions.

If J&J still fails to resolve the litigation after discovery and the bellwether trial process, the company could face thousands of individual trials in courts nationwide. Given jury response in previous trials, this could result in crushing liability for America’s Family Company.

Jury Hits Ford with $4.8M Explorer Defect Verdict

By Emily Cox
Ford Explorer Defect
flickr/Mike Mozart

A Texas federal jury returned with a $4.8 million Ford Explorer defect verdict Wednesday after six days of testimony involving a man whose left arm was severed when his 1999 Ford Explorer rolled over, finding that the type of window glass in the vehicle caused his injuries.

Following four hours of deliberations, the 12-juror panel in Chief Justice Judge Ricardo H. Hinojosa’s courtroom determined Wednesday afternoon that Ford Motor Co. was 90 percent liable for substantial injuries that have left welder Jose Leos-Ortiz unable to work. The jury also found Leos-Ortiz carried 10 percent of responsibility for the incident. The jurors awarded Leos-Ortiz $3.3 million for past damages and $1.5 million for future damages.

Ford Explorer Defect Accident

Court documents indicate that Leos-Ortiz was involved in a one-vehicle accident in June 2009, while he was driving the vehicle on a highway from Brownsville, Texas, to Mission, Texas. Leos-Ortiz’s attorney told jurors that if Ford had installed laminated glass, which is glass between plastic layers to keep broken pieces intact, rather than cheaper tempered class, then the Explorer’s window wouldn’t have shattered on impact. Consequently, Leos-Ortiz would not have lost his arm.

Leos-Ortiz originally filed his petition in the case in June 2011. However, his lawyer indicates the case was slow getting to trial through no fault of the court or Ford. Rather, the delay was the result of a backlogged docket that reset the trial for the case 11 times.

At the time of the accident, Leos-Ortiz was twice the legal limit of intoxication, but his lawyer argued this was irrelevant.

“I got their experts to admit that drunk or sober … this truck still turns over,” he said. “There’s no moral meter on this vehicle.”

As for the 10 percent liability that jurors ascribed to Leos-Ortiz, his lawyer said he argued to the panel that they should assign his client some blame, not because he was intoxicated, but since he hadn’t kept up with maintenance on the SUV that had more than 306,000 miles and still had its original suspension system.

Ford argued in filings that Leos-Ortiz couldn’t bring the lawsuit, because the law barred his claims “”in whole or in part, due to the contributory and/or comparative negligence of plaintiff, in that he failed to exercise ordinary care, caution and prudence to avoid the incident and injuries at issue.”


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