Drug manufacturer GlaxoSmithKline won a significant ruling this week in the Third Circuit of the United States Court of Appeals in Colaccio vs. Apotex. SmithKline, the manufacturer of the anti-depressants Paxil and Zoloft, defended two separate state tort claims that the manufacturer failed to warn of the risk of suicide from taking the drug. Plaintiffs product liability suits failed. 

In a split decision, the Third Circuit ruled that federal regulatory law pre-empted state tort law claims in cases against manufacturers of anti-depressants for failure to warn of the risk of suicide.  

Anti-depressants are drugs known as selective serotonin re-upate inhibitors (SSRIs). The drugs block the re-absorption of serotonin into the brain. Serotonin is a natural body chemical that regulates mood, sleep and appetite. By blocking the re-absorption the brain cells get an extra dose of a feel-good chemical. Some experts believe that the increase in serotonin causes a drop in the natural chemical dopamine. Dopamine regulates cognition and behavior.

In 1991 the Food and  Drug Administration (FDA) Advisory Panel showed that there was no causal link between anti-depressants and suicide or violent behavior. However, in 2003 a subsequent FDA panel issued a Public Health Advisory for Paxil, Zoloft and other SSRIs urging health care providers to be on the lookout for worsening of depression and the onset of suicidal behavior in the beginning stages of drug therapy or if dosage amounts change. Although none of the drug trials showed an increase in suicide, the FDA has asked drug manufacturers to issue stronger labels.   However, given the lack of scientific data, strong warnings are not required.

From documents obtained through discovery in the civil jury trials, SmithKline was aware that a small number of people could become agitated or violent while on the drugs. Despite this knowledge, no warning was placed on the label. Experts believe that the drug may cause a side effect known as akathisia. Akathisia causes overwhelming mental and physical restlessness. Some medical experts believe this causes patients to be sufficiently energized to harm themselves or others.

In the recent two cases on appeal before the Third Circuit, one district court held that the plaintiff’s product liability claims were pre-empted by federal regulatory FDA rulings. Another district court ruled the opposite, federal law did not pre-empt a state tort suit. In the majority opinion, the Third Circuit held that the FDA was a regulatory agency specifically mandated to scientifically assess the nature of drugs and the warning required. The court held that state tort law could not pre-empt federal law, and therefore the state suits on the failure to warn could not go forward.

The dissenting opinion argued that in many ways the FDA is an imperfect agency as it receives much of its data from the drug manufacturers. Discovery in state tort lawsuits provides a different way for third parties to raise questions about new and existing drugs. The dissent argued that policing drug companies is helped through tort suits, which act as a companion investigative tool for the FDA. 

However compelling the dissent argument, as it stands, where drug manufacturers are not required to place a warning label on drugs, plaintiffs have no ground for suit on the issue of failure to warn.

Antidepressants account for $14 billion a year of wholesale drug revenues in the United States. When the best-selling and most profitable drug poses a risk of suicide, drug manufacturers have a strong incentive to quash warning claims. Often there exists a clash between the manufacturers marketing tactics and the well-being of the consumer. Regulatory agencies must be above the tactics of drug companies. The pharmaceutical industry is regulated because drugs can cause serious harm and drug companies, with their financial conflict of interest, cannot be relied upon to serve the public interest. 

At this point in the legal field, however, for consumers of anti-depressants drugs it is “buyer beware.”

If you have a product liability claim against a drug manufacturer, contact Robert N. Katz for a free private consultation.    

Former Mitsubishi President, Katsuhiko Kawasoe, was sentenced in Japan last week for professional negligence for his role in covering up defects in Mitsubishi trucks in cars over a three-year period from 1997 to 2000.  Apparently, the auto manufacturer hid defects in its clutch system on several models of trucks and cars.  The defect caused the brakes to fail.  In some cases, occupants were killed in collisions caused by the faulty system.  Wrongful death suits arising from these collisions uncovered the scandal.

Mitsubishi hid reports of defects, choosing to secretly repair the cars when brought into dealerships rather than issue a product recall that would have protected consumers.  When news of the cover-up came out, sales plummeted, and company officials were forced out in disgrace.  Subsequently, those officials were charged with professional negligence and criminal violations for falsifying reports and failing to take proper recall measures.

In the United States, the National Highway Transportation Safety Association (NHTSA) has issued its 2007 recall report. Automobile recalls increased in 2007 by thirty percent from the previous year.  Manufacturers issued 588 recalls, affecting almost 15 million vehicles. 

Recalls have increased over the last seven years partly due to the Federal TREAD Act (Transportation Recall, Enhancement, Accountability and Documentation) passed in 2000.  The TREAD Act was enacted after congressional hearings established that recalls of defective tires could have occurred sooner if the NHTSA had obtained reports of tire problems from the manufacturer in a timely manner.  The Act arose in response to the recall of 10 million Firestone tires in 2000.  However, the Act covers only tires. 

Ford Motor Company issued the most recalls in 2007.  Daimler/Chrysler came in second for the total number of recalls.  General Motors and Toyota, both covering a large part of the auto sales market, had a decline in the number of recalls issued.

Ford felt the sting in 2007 when it recalled 3.6 million vehicles for a faulty cruise control switch that lead to fires.  Combined with recalls in past years for the same defect, this was the largest recall ever. 

Volkswagen recalled nearly a million 2007 Beetles for a faulty brake light switch.  Sales of the Beetles fell by thirty percent as well.

Recalls hurt manufacturers directly with unexpected costs and indirectly with a decrease in sales and harm to the overall brand.  However, recalls benefit consumers by identifying problems before accidents occur.  Ultimately, recalls should lower product liability claims. 

In the past, some automobile manufacturers, as the Mitsubishi scandal detailed, put corporate costs over consumer safety.  With strong federal regulation and adherence to safety requirements, hopefully, in the United States, manufacturers will bear the cost of product defects in the recall arena rather than through product liability litigation.

However, if you believe that you may have a product liability claim or if you were in an auto accident that may be related to a product defect, contact the law firm of Robert N. Katz for a free, private consultation.  

 To apply this doctrine in a negligence case, the plaintiff must usually show:

1. That harm would not have occurred without someone’s negligence;
   
2. The “thing” which caused the harm was under the exclusive control of the defendant; and
   
3. There is an absence of a reasonable explanation as to how the harm occurred.

 
Over the course of my practice, many accident victims will tell me that in addition to being hit by a negligent driver of another automobile, their own car failed to protect them in the accident.   For example, the seatbelt did not hold or the airbag did not deploy.   These clients will often question me about adding a product liability suit to the auto accident claim against the negligent driver.

 This week the Georgia Court of Appeals in Millers vs. Ford Motor Company upheld the grant of summary judgment (a motion filed by the defendant that defeats the plaintiff’s case before it ever gets to trial) to the automobile manufacturer, Ford Motor Company. In that case the plaintiffs alleged that the seatbelt and side air bag in their Lincoln Town Car were defective and contributed to their injuries when they were struck by another car. 

 The court held that the plaintiffs failed to show that the seatbelt and side air bag were defective when they left the defendant manufacturer.   The court ruled that mechanical devices sometimes get out of working order without any negligence on anyone’s part.   Also, once a car leaves the manufacturer, the manufacturer no longer has control over the car and cannot be liable for subsequent repairs or tampering with the vehicle. 

In a product liability suit, the plaintiff must show:

1. There was a defect in the product that varied from its intended design;
2. The defect existed when it left the manufacturer; and
3. The defect was the cause of the plaintiff’s injuries.
   

This concept is called “strict liability.”    If the plaintiff fails to meet the burden of proof, the court will likely grant summary judgment, dismissing the case without a trial. 

Product liability suits require a good deal of pre-litigation investigation in order to determine if a truly defective product exists. Plaintiffs must be prepared to show the condition of the car following the purchase (all repairs, alterations etc.) and should usually rely on expert testimony to prove negligent manufacture. After the filing of suit, extensive discovery will be necessary to prove a product defect. Consultation with an attorney will best help you determine if the facts in your case “speak for themselves.”