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Archive for June, 2005

IOWA MAN SUES FORD, TEXAS INSTRUMENTS, AND DUPONT CLAIMING FAULTY ELECTRICAL SWITCH CAUSED FIRE THAT KILLED HIS WIFE AND BURNED DOWN HIS HOME

Thursday, June 30th, 2005

After calling 911, 74-year-old Darletta Mohlis died attempting to escape from her burning house. Now, her three children and husband, Earl, are suing the Ford Motor Company in a wrongful death action claiming a faulty cruise-control deactivation switch on Mr. Mohlis’s 1996 Ford F-150 pickup truck caused the fatal fire.  

In its ongoing investigation of fires linked to faulty cruise control shut off switches in Ford vehicles, CNN has already reported that despite the fact that Ford is aware of 16 million 1992 to 2003 vehicles at risk, only slightly over one million have been recalled.

The switch (manufactured for Ford by Texas Instruments) costs $20.57 and has already being linked to 559 fires reported to the National Highway Traffic Safety Administration (NHTSA). Many of these fires have completely destroyed the vehicle. In this case, however, Mrs. Mohlis died when her entire house burned down after the family pickup truck caught fire while parked in the garage.

The fires are spontaneous and often occur when the ignition switch is off and the key removed. This is because Ford designed the switch to remain on or “hot” at all times. When a crack develops in the film (supplied by Dupont) separating the brake fluid from the electrical circuit, the leak will cause a fire.

Since May 1999, Ford has recalled a total of 1,071,000 vehicles in two separate recalls. CNN reports, however, that a document it has obtained shows Ford is aware that it installed a total of 16 million of the switches between 1992 and 2003 in the following vehicles:

•    Mark VII/VIII from 1994-1998
•    Taurus/Sable and Taurus SHO 2.3 L 1993-1995
•    Econoline 1992-2003
•    F-Series 1993-2003
•    Windstar 1994-2003
•    Explorer without IVD 1995-2003
•    Explorer Sport/Sport Trac 2002-2003
•    Expedition 1997-2003
•    Ranger 1995-2003

In March 2005, the NHTSA opened an expanded investigation into more than 3.7 million of these vehicles. Ford, however, has chosen not to recall all of the vehicles arguing that the switch has performed well for years in most vehicle models.

As a result, Ford has limited their recalls to those models “with an increasing fire rate report.” A recent recall notice was clear as to the risk, however.  Ford stopped using the switch last year in favor of a new design.
In the case of the Mohlis family’s truck, inspections of the truck and fire scene have been performed by two experts hired by the family’s attorney, officials from the NHTSA, and inspectors from Ford.

The family’s experts, an electrical engineer and a certified fire investigator, believe the switch caused the fire. Ford claims the fire started elsewhere and spread to the truck and the switch had nothing to do with the fire. The NHTSA has made no public statement as to its investigation or findings.

Mr. Mohlis states the truck had been parked in the garage and shut off for four days before the fire.

WARNING LABELS FOR RITALIN AND CONCERTA TO BE STRENGTHENED BY FDA IN RESPONSE TO REPORTS OF ADVERSE PSYCHIATRIC AND CARDIOVASCULAR SIDE-EFFECTS

Thursday, June 30th, 2005

Methylphenidates (generic) are a class of drugs used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The most common forms of the drug are Ritalin (made by Novartis) and the long-acting version known as Concerta (made by Johnson & Johnson).

These drugs, along with amphetamines like Adderall, Adderall XR, and Strattera, are widely prescribed for the treatment of ADHD. Last year, 7.8 million prescriptions for Concerta and 2.5 million for methylphenidate were written in the United States alone.

While these drugs appear to be effective, they come with relatively serious warning labels. In fact, the FDA posted the following Alert on February 9 in response to Health Canada’s suspension of Adderall XR sales due to a concern about reports of sudden unexplained deaths in children taking both Adderall and Adderall XR.

“FDA ALERT [2/9/2005] – Sudden Deaths in Children
Health Canada has suspended marketing of Adderall XR products from the Canadian market due to concern about reports of sudden unexplained death (SUD) in children taking Adderall and Adderall XR.  SUD has been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, including Adderall and Adderall XR.  In addition, a very small number of cases of SUD have been reported in children without structural cardiac abnormalities taking Adderall.  At this time, FDA cannot conclude that recommended doses of Adderall can cause SUD, but is continuing to carefully evaluate these data.”

Thus, the FDA has had every reason to monitor adverse event reports very carefully with respect to all of the drugs used in the treatment of ADHD. Of course, an adverse event report neither identifies a side-effect nor confirms one’s existence. It may truly be something to watch or it may simply be an occurrence unrelated to the drug being taken.

Even when a link to a particular prescription drug is not proven, the FDA and the manufacturer often mention these events on the label. Recent high profile drug withdrawals, pressure from consumer advocacy groups and lawmakers, and a move toward greater disclosure of adverse information about prescription drugs have prompted the FDA to be more proactive in terms of identifying and following potential safety problems.

Recently, the FDA has received reports of patients experiencing a variety of psychiatric events while being treated with Ritalin or Concerta. These include hallucinations, suicidal thoughts, psychotic behavior, aggression, and violent actions. (Eli Lilly has reported observing increased aggression and hostility in a small number of Strattera users and has added that information to the U.S. and European label for the drug.)

As a result of these reports, the FDA plans to strengthen the warning labels on Ritalin, Concerta, and all other methylphenidate products and has also asked its pediatric advisory committee to review the matter. The agency has not confirmed any link between the adverse events and the drugs and it has not indicated that a description of the events will be included in the warning. 

Any labeling change, however, is likely to be put off until all ADHD medications are re-evaluated. This would probably not occur until early 2006.

In addition to the possible psychiatric problems associated with the drugs, the FDA is also concerned over reports of cardiovascular problems including hypertension, arrhythmias, chest pain, and tachycardia in Concerta users. As a result, further steps may be taken to investigate these issues by way of data base studies or new safety trials.

JUSTICE DEPARTMENT MAKES IT OFFICIAL ñ THE FEDERAL GOVERNMENT WILL ONLY SEEK A TOTAL OF $14 BILLION IN DAMAGES IN ITS CIVIL RACKETEERING CASE AGAINST THE TOBACCO INDUSTRY

Wednesday, June 29th, 2005

Amid great speculation and controversy as to its underlying motivations, the Justice Department has filed its formal damage request motion in its civil racketeering case against the tobacco industry. The $10 billion for a five-year stop-smoking program and a ten-year $4 billion for an anti-smoking education program is all that is being asked of an industry that stands accused of a decades-long conspiracy of fraud on the public and government agencies. In terms of absolute dollars, it is like asking someone who just burned down an entire neighborhood to pay a $500 fine and another $100 to fund an anti-arson program.   

As previously reported, the manner in which the trial came to an end has raised questions as to just what motivated the dramatic and unexpected last-minute shift in the government’s position with respect to the amount of damages it was seeking in its six-year-old civil racketeering case against the tobacco industry for engaging in a 50-year conspiracy to defraud and addict smokers by intentionally concealing information regarding the dangers associated with smoking.   

For years, the government has pursued the tobacco industry for “a decades-long pattern of material misrepresentations, half-truths, deceptions and lies that continue to this day.” (Excerpt from summation of Associate Attorney General Sharon Eubanks.)
 
The monetary damages the government had always been expected to demand from the industry was based on the extensive testimony of expert witnesses and was anticipated to be a $130-billion, 25-year smoking cessation program along with other penalties and injunctive relief prohibiting tobacco companies from targeting young smokers in their marketing campaigns.

Anti-smoking advocates were all in favor of such a substantial award which they believed would act as a deterrent to future improper conduct as well as provide funding for badly needed cessation programs.  

The tobacco industry and its attorneys fully expected that demand and were concerned about how much of that claim and penalties U.S. District Court Judge Gladys Kessler would impose.

Much of the evidence presented by the government was comprised of highly incriminating internal documents that included written memos from tobacco executives and scientists which described plans to encourage young people to smoke and to keep the public ignorant of the potentially dangerous and addictive nature of cigarette smoke.

This was essentially the same evidence introduced in prior litigation brought by states to recover their costs for the medical treatment of smokers. The industry settled that case for $246 billion.

Thus, it came as a complete shock to everyone in the courtroom when the Justice Department lawyers inexplicable scaled back their demand to what amounts to little more than petty cash to the defendants which include Phillip Morris USA; RJ. Reynolds Tobacco Co. and Brown & Williamson (now Reynolds American Inc.); British American Tobacco; the Lorillard Tobacco unit of Loew’s Corp.;  and Vector Group Ltd.’s Ligget Group Inc.

Anti-smoking advocates like William V. Corr, director of the Campaign for Tobacco Free Kids, immediately assailed the government’s unexpected move as “a political decision to take into consideration the tobacco companies’ financial interest rather than health interests of 45 million addicted smokers.” Tobacco analysts and many lawmakers immediately speculated that politics played a role in the decision.

At the request of Rep. Henry A. Waxman and seven other lawmakers, the Justice Department’s Office of Professional Responsibility has opened an investigation into allegations of political interference in the case.

Even the trial judge, herself, questioned the reduction in the demand as suggesting “that there are some additional influences being brought to bear on the government’s position in this case.”

At first, the Justice Department offered had no real explanation for the reduced figure and the members of its trial team declined comment. As more facts surrounding this “mystery” came to light, however, it began to appear that the decision was more the product of politics and favoritism than sound legal analysis.

Less than a month before summations, the Justice Department had filed an extensive legal brief with the trial judge which argued that the $130 billion smoking-cessation program was an appropriate and legally permissible sanction that was unaffected by the recent federal appeals court ruling that determined the government could not seek to force the tobacco industry to pay $280 billion in ill-gotten gains.

Representative Waxman has expressed great concern that a position the Justice Department had confidence in so close to the end of the trial was abandoned to benefit the tobacco industry at the expense of the health of the American people. A group of 50 lawmakers has sent a letter to Attorney General Alberto R. Gonzalez requesting that he not enter into any agreement with the tobacco industry “based on the unreasonably weak demands made by the government last week.”

While the Justice department attempted to justify the decision as a response to the appellate ruling which eliminated a large element of the damages being sought, the May 12 brief had already addressed that point and came to the conclusion that the earlier ruling by the Court of Appeals did not preclude the $130 billion demand.

An additional red flag was also raised by an apparent flurry of internal activity at the Justice Department just prior to the end of the trial. The New York Times reported that senior Department officials flatly overruled the objections of the career lawyers in charge of the case and ordered them to reduce the demand by $120 billion despite the fact that the trial team argued the move was legally unjustifiable and would be viewed as politically motivated.

Robert D. McCallum, the Associate Attorney General who overruled the top two lawyers on the trial team (Sharon Y. Eubanks and Stephen D. Brody) and other political appointees appear to have engaged in efforts to undermine the case.

Significantly, McCallum is a close friend of President Bush from college as well as a former partner in the Atlanta law firm of Alston & Bird, which has done legal work for R.J. Reynolds Tobacco, part of Reynolds American, a defendant in the case.

The New York Times quoted an anonymous source in the Justice Department as stating: “Everyone is asking, ‘Why now?’ Why would you throw the case down the toilet at the very last hour, after five years?” Some lawyers on the trial team reportedly threatened to quit after McCallum’s actions.

As a result of the internal dissention, a lower-level attorney in the Department, who agrees with the lower demand, was reportedly put in charge of preparing the final briefs and the proposed order on penalties.

Other allegations adding to the suspicion that the decision to reduce the demand by $120 billion was anything but justified include what the New York Times calls “the handling of some government witnesses who were asked to alter their written testimony to reflect the department’s concerns.”

One of those witnesses who refused to eliminate part of his testimony was Matthew Meyers, president of the Campaign for Tobacco-Free Kids, stated in an interview that: “To have the lawyers work on a case this long, and then just have the department basically throw it out seems despicable to me.”  
 
Obviously emboldened and encouraged by the collapse of the Justice Department’s previously aggressive stance with respect to damages and penalties, the attorneys for the tobacco industry defendants have now indicated that they will ask Judge Kessler to throw out the entire case claming the government isn’t entitled to any of the remedies it now seeks to have imposed.

Although Judge Kessler has encouraged the two sides to settle the case, all previous attempts to do so failed. This latest turn of events would seem to guarantee the matter will have to be resolved by the District Court and then the Court of Appeals for the Second Circuit.

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