Articles Posted in Dangerous Products

The United States Supreme Court ruled this past Monday that smokers may sue tobacco companies for fraud in the marketing of “light” cigarettes. In a surprising 5-4 decision considering the conservative, pro-business nature of the Court, the Supreme Court determined that several Maine residents had been deceived by Altria and Philip Morris USA into believing that light cigarettes deliver less tar and nicotine to smokers than regular cigarettes. Although it is true that the light cigarettes do have less tar and nicotine than regular cigarettes, smokers apparently compensate for the difference by taking larger puffs, smoking more cigarettes or inhaling more deeply.

The plaintiffs sued Philip Morris under the Maine Unfair Trade Practices Act, claiming that they had been injured by the deceptive advertising and marketing of cigarettes such as Marlboro Lights. The Supreme Court had to decide whether the plaintiffs had the right to sue at all considering the Federal Cigarette Labeling and Advertising Act, which was enacted in 1965 and required tobacco companies to place warnings on their packaging and advertising. The federal law had prohibited the states from making their own similar laws as to smoking and health based on the United States Constitution’s Supremacy Clause, which states that when there are conflicts between federal and state laws, federal laws must prevail. The majority opinion, written by Justice Anthony Kennedy, determined that the Cigarette Labeling and Advertising Act was intended to prevent states from making their own laws about health problems from smoking, not to pre-empt laws such as Maine’s which establish a general responsibility not to deceive consumers.

Naturally, the four judges in the minority, Scalia, Roberts, Alito and Thomas, sided with big business in claiming that that the Maine statute was essentially an attempt to get around the federal statute, and was instituted only to regulate smoking and health, not the deceptive business practices of Philip Morris. In a major victory for plaintiffs around the country, the decision will allow dozens of similar lawsuits to proceed in other states. Hopefully, the case will also start a trend by which ordinary Americans will be successful in holding corporations accountable for their dangerous practices.

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Deaths such as actor Heath Ledger’s drug overdose from a mixture of medications have soared since the 1980’s according to a study published in The Archives of Internal Medicine yesterday. The authors studied 50 million death certificates since 1983, and found that there were more than 224,000 fatal medication errors, including mixing prescription drugs with alcohol and street drugs. Astonishingly, deaths from medication mistakes at home have risen 700 percent from 1983 to 2004, with 1,132 deaths in 1983 and 12,246 in 2004.

This huge increase in fatalities is attributable to several factors, including the widespread home use of prescription medications like Oxycodone, (which 25 years ago was much more likely to be prescribed in hospitals than for home use), people sharing prescriptions, patients ignoring the risk of mixing alcohol with prescriptions, and as in the case of Heath Ledger, the mixing of medications which are contraindicated. The huge increase in deaths is highest among people in their 40’s and 50’s.

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There was a shocking and sobering story on the ABC’s 20-20 program several weeks ago. Tires sold throughout this country in stores such as Sears, Wal-Mart, and Goodyear have expiration dates, and become dangerous after 6 years regardless of whether they have ever been placed on a vehicle and put in use. Despite this fact, and the tire manufacturers and retailers’ knowledge that unused tires are dangerous after several years, they are routinely sold as new to unsuspecting consumers, often with tragic results.

The headline story was that of 19 year old Andy Moore, who was driving his family’s van on a graduation trip to Canada with a friend. Although the tires on the van had been purchased 4 years earlier and appeared to be in good shape, they were in fact 9 years old, and very dangerous. The accident was caused when the tread on one of the tires literally peeled off, Andy lost control of the vehicle, and Andy and his friend were killed in the accident. Apparently, as in numerous cases across the country, the tires on the Miller van had been sitting on the retailer’s shelves for years, looking new, but drying up and becoming increasingly dangerous.

The 20-20 story was very informative in showing consumers how to tell the expiration date on these dangerous tires. At the very end of the series of numbers along the side of the tires, are numbers such as “414” or “4202”, for example. The first number, “414”, means that the tire was manufactured in the 41st week of 1994! The second number, “4202”, signifies that the tire was made in the 42nd week of 2002. One commentator noted that the tires are “like ticking time bombs on people’s cars”, and in England, unlike the United States, dealers are now warned to stop selling any tires that are six years old or older. 20-20 found 12 year old tires being sold as new in a New Jersey Sears, a 7 year old tire sold as new in an Indianapolis Wal-Mart, and 9 year old tires sold in a San Francisco Goodyear store. In one instance, the salesperson acknowledged that the tires were old to the 20-20 narrator, and suggested that the tire should be used as a spare tire only!

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Supplementing our February 29, 2008 post “Blood Thinner Heparin Tied To Several Deaths“, the actor Dennis Quaid appeared on “60 Minutes” last Sunday to reveal every parent’s nightmare: He and his wife almost lost their newborn twins last year at Cedar’s Sinai Hospital in Los Angeles due to a massive overdose of the blood thinner Heparin, manufactured by Baxter International.

The nurses were supposed to give the twins a dosage of “Hep-Lock”, a weak form of Heparin to keep IV lines open. Instead, they gave the twins Heparin in a dosage which Quaid described as “10,000 times the normal dosage”, causing a drug overdose which could have been fatal. Apparently the almost tragic mistake was caused by the very similar blue backgrounds on the vials of Hep-Lock and Heparin. Quaid said that “our kids were bleeding from everyplace they were punctured…it was blood everywhere.”

Shockingly, this same event occurred in Indianapolis a year earlier, which resulted in the deaths of three infants. Despite this fact, Baxter International, being sued by the Quaids in a multi-million dollar defective product lawsuit, did not change the colors of the two vials until after the Quaid twins incident–now, one vial is red and the other is blue, making a mistake by nurses much less likely.

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Following up on our blog “U.S. Supreme Court Deals Blow to Lawsuits Against Defective Products“, the Court heard arguments on February 25 in Warner-Lambert v. Kent, to determine whether drug manufacturers should receive similar protection from lawsuits that the Court handed out to medical device makers earlier in February. Judge Breyer, normally one of the Court’s most liberal justices, gave a strong indication that the Court is heading in the direction of protecting drug makers when he stated: “Who should make the decisions that will determine whether a drug is on balance, going to save people or, on balance, going to hurt people?… An expert agency, [The Food and Drug Administration] on the one hand or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt and don’t see those who need the drug to cure them.”

Seemingly forgetting about the thousands of injured victims of Vioxx, for example, who used a dangerous drug which had been approved by the F.D.A. and nevertheless suffered numerous deaths, heart attacks, and other complications, and without question needed the courts to redress their grievances, it appears that the Supreme Court is now ready to bar lawsuits against drug makers.

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Last week, the U.S. Supreme Court ruled that private lawsuits against medical device manufacturers are not permitted when the device in question complies with federal requirements. Essentially, the Court’s decision in Riegel v. Medtronic is another example of the U.S. Supreme Court’s attack on consumer rights, and will have far reaching negative effects for those who are seriously injured by dangerous and defective products . Charles Riegel received a balloon catheter manufactured by Medtronic which ruptured due to over inflation. He developed a heart block and was forced to undergo emergency surgery to save his life.

The Riegels brought a claim in federal court in New York, which was dismissed by the court, and upheld by the U.S. Circuit Court as being preempted by the Medical Devices Amendments (MDA). The MDA precludes lawsuits against manufacturers where the device in question complied with federal requirements. The problem with the Court’s decision, as noted by Justice Ginsberg in her dissenting opinion, is what if evidence of the product’s defect becomes known after the product has received premarket approval?

The Court stated in no uncertain terms its belief that juries are not capable of evaluating the risks associated with dangerous devices, with such language by Judge Scalia as the following: “The Dalkon Shield failure and its aftermath demonstrated the inability of the common law tort system to manage the risks associated with dangerous devices.” And this quote from the opinion is even more frightening for those who believe in our civil justice system as a means to hold manufacturers of defective products accountable: “A jury on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.”

The Food and Drug Administration announced on February 28 that “potential deficiencies” at a Chinese plant that produces the active ingredient in Heparin, a blood thinner used to treat blood clots during dialysis and after some surgery, is a possible cause of 21 deaths, as well as hundreds of allergic reactions including vomiting, nausea and difficulty breathing. Baxter International, the company which makes the brand of Heparin that is now considered a potentially dangerous product, has announced an immediate recall of virtually all of its Heparin products, which it buys from a Chinese plant known as Changzhou SPL.

Heparin is made from pig intestines. In China and other developing countries, tracing the source of the animals used to make the product can be very difficult. The FDA also acknowledged that other problems which could have led to the manufacture of the dangerous product include the lack of specific procedures outlining removal of impurities, and no records showing the suppliers’ source of the products.

The Food and Drug Administration estimates that over one million multi-dose vials of Heparin are sold per month in the United States, and half of those are manufactured and distributed by Baxter. However, the FDA has provided assurances that there is an adequate supply in the market to meet the demand for Heparin, which clearly is a necessary and lifesaving drug.