New York Legal Blog

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.

Continue reading "Dennis Quaid's Twins Almost Die From Massive Overdose Of Heparin" »

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The United States Citizenship and Immigration Services USCIS acknowledged that due to a huge increase in applications for green cards and citizenship in July of 2007, the average waiting time for legal residency and citizenship is now 18 months. The surge in applications in July of 2007 (7 times more than the average month), which resulted in the increased waiting time from approximately 7 months to 18 months, was due to applicants submitting their papers just before the almost 50% increase in fees on July 30, 2007.

The USCIS has been under fire for not anticipating and planning for the huge increase in applications last July, although they did hire 750 additional agents for the sole purpose of working on applications. Michael Aytes, the associate director of domestic operations of USCIS has pledged that the agency will keep its promise made at the time of the increase: that in return for the higher fees, by 2010, applications for U.S. citizenship will be processed within 5 months, and petitions for green cards will be handled within four months.

This writer is somewhat skeptical about these optimistic predictions from the USCIS, but we will give the agency the benefit of the doubt and hope that these 750 extra officers will make the difference once the July 2007 surge in applications is two years behind us.

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Posted In: Dangerous Products , Immigration A to Z

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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.

Continue reading "U.S. Supreme Court Now Considering Protecting Drug Manufacturers From Lawsuits" »

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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 Riegel decision should send a chill down the spine of citizens in this country who believe that the civil justice system is vital in the effort to require manufacturers to ensure that their products are safe for the public before they are placed on the open market.

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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.

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