New York Personal Injury Lawyer Blog

In a front page story in the February 20, 2010 edition of the New York Times, Gardiner Harris reported on confidential FDA reports which have recommended that the diabetes drug Avandia be removed from the market. Apparently, FDA studies have determined that if diabetes sufferers had taken another drug, Actos, approximately 500 heart attacks and 300 cases of heart failure could have been avoided. Avandia, also known by its clinical name Rosiglitazone, is prescribed to patients with Type 2 diabetes. This apparently dangerous drug was linked to a shocking 304 deaths worldwide in the third quarter of 2009, according to a study by the Institute for Safe Medication Practice, a drug safety group

Two FDA researchers, Dr. David Graham and Dr. Kate Gelperin, concluded that "Rosiglitazone should be removed from the market." There is a significant conflict over what should be done with Avandia. Naturally, the manufacturer, GlaxoSmithKline, is claiming that the reports of cardiac problems as a result of Avandia use are not scientifically definitive and require further study. Senators Charles Grassley, an Iowa Republican, and Max Baucus, a Montana Democrat, who have overseen the FDA study, are sharply critical of GlaxoSmithKline, stating that the company should have alerted patients many years ago of the potential cardiovascular risks of Avandia, thus offering patients the opportunity to take a less dangerous drug for their diabetes. But as early as 2003, according to the Senate investigation, GlaxoSmithKline and the FDA were aware of a GlaxoSmithKline study in which diabetics who used Avandia had substantially more heart problems than those given placebos!

Several years back, Avandia was one of the top selling drugs in the world, but after a 2007 study by a Cleveland Clinic cardiologist suggested cardiac risks from Avandia, the FDA got involved, and sales of the drug took a dive. Mr. Harris also reports that GlaxoSmithKline executives attempted intimidation tactics to prevent independent physicians from notifying patients or other doctors that Avandia posed serious heart risks to diabetics, who die from heart problems 66% of the time. In one egregious example, in 1999, University of North Carolina professor John Buse gave presentations at scientific meetings suggesting that Avandia caused heart problems. As a result, GlaxoSmithKline executives complained to his supervisor and warned of potential legal action against Dr. Buse in an effort to keep him quiet. Dr. Buse ended up signing a document prepared by GlaxoSmithKline agreeing not to publicly discuss his concerns about Avandia. The report mentions another similar incident of intimidation of University of Pennsylvania investigators.

Continue reading "Diabetes Drug Avandia Blamed For Heart Problems" »

At The Law Office Of Mark A. Siesel in White Plains, New York, we represent many clients who are seriously injured as the result of using a dangerous or defective product or machine. Frequently, by the time they come to our office, several days or weeks have passed since the accident occurred, and valuable evidence may no longer be available or has been discarded by the owner of the product.

Thus, if you have suffered injury due to a dangerous product or device, you should do the following whenever possible:

1. Take photographs of the machine, from several angles, and in good light if available;

2. Obtain the manufacturer's name, address (and phone number if on the machine);

3. Write down the model number, serial number and any other information that is on the machine;

4. Get copies of any operating manuals, instructions or paperwork that accompanied the product upon purchase;

5. Attempt to obtain any service records for the machine, or the names and addresses of any companies that serviced the machine;

6. Obtain records of any modifications or changes that have been made to the device or product over the years.

6. Document your injuries by taking photographs immediately after the accident;

7. Secure the names, addresses, phone numbers and e-mail addresses of any witnesses to your accident;

Often, it will not be possible to obtain all of the above items when the machine is old and records are lost or discarded. However, it is vital to the success of a New York defective products case to have as much information as possible to identify potential defendants including manufacturers, distributors, retailers, repair or service companies and suppliers. The manufacturer or distributor can be responsible for many different dangers, including defective design of the product, negligent manufacture of the product, failure to properly maintain the device, improper or lack of safety labels or warnings, and failure to recall products which have a known defect or flaw.

Continue reading "New York Dangerous Products--A Primer" »

Last week, a federal advisory panel of the Food & Drug Administration (FDA) voted 20-17 to recommend a ban of Percocet and Vicodin, two very popular painkillers, due to their damaging effects on the liver. Percocet, also known as Oxycodone, and Vicodin, another name for Hydrocodone, are controlled substances due to their addictive nature, and combine a narcotic with high dosages of acetaminophen, a painkiller found in such medications as Excedrin, Tylenol and Nyquil.

Acetaminophen is combined with different narcotics in at least 7 other prescription drugs, and each of these drugs would be banned if the FDA takes the advice of its panel. Vicodin is prescribed more than 100 million times per year in the United States, according to the study, and patients who take these potentially dangerous drugs often need progressively larger doses to obtain the same pain relief.

In 2005, Americans bought 28 billion doses of products containing acetaminophen. Although it is effective in treating headaches and reducing fevers, even recommended doses can cause liver damage. More than 400 people die and 42,000 are hospitalized in the U.S. every year from overdoses according to the panel. One panel member, an associate professor of medicine from Duke University Medical Center, noted that: "We're here because there are inadvertent overdoses [of acetaminophen] which are fatal, and this is our opportunity to have a big impact."

Continue reading "U.S. FDA Panel Recommending Ban Of Vicodin And Percocet" »

In a great decision for victims of dangerous drugs throughout the United States, on March 4, 2009 the Supreme Court upheld a Vermont state court decision awarding 6.7 million to a woman who suffered permanent injuries from an anti-nausea drug. The case involved a Vermont resident who developed gangrene after a botched injection of the drug, which tragically resulted in the amputation of her hand and lower arm. The tragedy was compounded by the fact that the plaintiff was a musician, and lost her livelihood due to her injuries.

The physician's assistant who performed the injection used a highly risky intravenous push technique, which allowed the drug to enter an artery, rather than the intravenous drip technique, the much safer method in which the drug is injected into liquid already flowing into a vein. Allowing the drug to enter the artery causes immediate and irreversible gangrene. Wyeth's lawyers requested that the Supreme Court set aside the verdict, attempting to rely on the fact that they had complied with FDA labeling requirements. (In a case last year against medical device manufacturers of heart defibrillators, stents, and artificial hips, the Court had ruled that federal law and FDA scrutiny prevented product liability lawsuits in state courts). However, in a decision written by Justice John Paul Stevens, the elder statesman and most liberal member of the Supreme Court, the justices determined that Wyeth's warnings were insufficient and should have made abundantly clear the dangers of serious injury if the drug was injected improperly.

The decision to allow state damage suits will undoubtedly cause manufacturers to use greater care in the production and labeling of their products. We would also expect a revisiting of last year's decision protecting device makers, which seems somewhat inconsistent with the Court's welcome decision protecting the public this week.

Continue reading "U.S. Supreme Court Delivers Blow to Pharmaceutical Industry" »

The tobacco giant Phillip Morris was ordered to pay 8 million dollars this week to Florida widow Elaine Hess, whose late husband Stuart Hess died of lung cancer at age 55 in 1997. A jury in Fort Lauderdale awarded compensatory damages of 3 dollars and a whopping 5 million dollars in punitive damages, obviously convinced that Philip Morris knew that the cigarettes they marketed and sold are a dangerous product but that the company was more concerned about profit than safety.

Philip Morris USA announced that they would appeal the verdict, certainly to be expected after a major verdict against the tobacco giant in the first of what will likely be thousands of cases in Florida. Back in 2006, the Florida Supreme Court threw out a 145 billion dollar jury award in a dangerous product class action suit filed in the early 1990's on behalf of 8,000 sick smokers. Undoubtedly, the Hess verdict will encourage the families of those 8,000 smokers to pursue their cases as well.

Compensatory damages are awarded for injuries including pain and suffering, lost earnings, loss of enjoyment of life, and medical bills. These type of awards are more likely to be upheld by an appellate court. Conversely, punitive damages, which as the name suggests, are imposed to "punish" the defendant for intentional or malicious conduct, are frequently either reversed or substantially reduced by higher courts on appeal.

Continue reading "Philip Morris Hit With 8 Million Dollar Verdict" »

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.

Continue reading "U.S Supreme Court Deals Large Blow To Big Tobacco" »

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.

Continue reading "Heath Ledger's Accidental Drug Overdose Part Of Growing Trend" »

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!

Continue reading "Expired Tires Causing Needless Deaths And Serious Injuries" »

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" »

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.

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" »

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.

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.