Dallas Personal Injury Lawyer Blog

Pfizer recalls 1 million packets of US birth control pills - Dallas, Texas

US pharmaceutical giant Pfizer on Tuesday recalled one million packets of birth control pills over a packaging error that could put women at risk of unintended pregnancy.

The pills, about half of which were the brand name Lo/Ovral-28 and the other half were generic norgestrel and ethinyl estradiol tablets, may be improperly arranged so that inactive pills are taken at the wrong time in the monthly cycle.

"An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence," Pfizer said in a statement.

"As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy."

The pills were manufactured and packaged by Pfizer in New York state and commercialized by Akrimax Rx Products under the Akrimax brand name in the United States.

Each packet is supposed to contain 21 active tablets and seven inactive pills.

For more information call 214-855-0034 or go to www.injurylawyerdallastexas.com.

Toyota Issues Recall For Steering Problem That Could Cause An Accident - Dallas, Texas

Toyota Motor Corp. said Wednesday it is recalling about 550,000 vehicles worldwide — mostly in the United States — for problems that could make it harder to steer.

The recall affects 447,000 older vehicles in North America, and another 100,000 in other parts of the world.

The latest recall is due to the possibility that the outer ring of the engine's crankshaft pulley may become misaligned with the inner ring, causing noise or a warning signal to light up, the company's U.S. sales unit said in a press release. If the problem isn't corrected, the belt for the power steering pump may become detached from the pulley, making it suddenly more difficult to turn the steering wheel.

Toyota has received a total of 79 reports about the defect dating back to 2007, said Toyota spokesman Dion Corbett. There have been no reports of accidents or injuries related to the problems, he said.

In the United States, the automaker is recalling 283,000 Toyota brand cars:

• 2004 and 2005 Camry, Highlander, Sienna and Solara
• 2004 Avalon
• 2006 Highlander HV

It's also recalling 137,000 Lexus vehicles:

• 2004 and 2005 ES330 and RX330
• 2006 RX400h

Toyota will mail owners a notification to make an appointment with an authorized dealer to have their car inspected once replacement parts have been produced in sufficient quantities.

For more information, call 214-855-0034 or jonathan@theleblanclawfirm.com or go to www.injurylawyerdallastexas.com

FDA Restricts Cholesterol Drugs Zocor and Vytorin Due to Muscle Injury - Dallas, Texas

 

 

The Food and Drug Administration (FDA) on Wednesday restricted the use of high doses of the cholesterol-lowering drug simvastatin, which is sold in generic forms and under the brand names Zocor and Vytorin, because of concerns over muscle problems associated with the drug.

The agency recommends that no new patients start taking the highest dose, 80 mg, of the medication. However, those who are already safely taking that dose may continue to do so.

Statins, which lower cholesterol by inhibiting its production in the liver, are among the most commonly prescribed drugs in the U.S. Recent studies have shown that the medications can lower the risk of having a heart attack or dying from heart disease, but the drugs have also been linked to serious side effects.

The statin Baycol (cerivastatin) was recalled in 2001 after users reported elevated rates of muscle injury similar to the ones that led the FDA to restrict use of simvastatin. Concerns about simvastatin and its potential to cause muscle-weakening, known as myopathy, emerged last March when the FDA issued warnings about the risk.

If you need legal help regarding these drugs, call us at 214-855-0034 or jonathan@theleblanclawfirm.com or go to www.injurylawyerdallastexas.com.

 

If You Used Nexium and Had A Fracture, You Should Contact a Lawyer - Dallas, Texas

 

Nexium is a proton pump inhibitor manufactured by AstraZeneca that is used to reduce the symptoms of gastroesophageal reflux disease, otherwise known as heartburn. A British study published in the December 2006 issue of the Journal of the American Medical Association found prolonged and/or heavy use of Nexium increases the risk of hip fractures in individuals over 50 years old. Nexium works by blocking the enzyme in the stomach wall that produces stomach acid. The reduction of stomach acid can make it harder for the body to absorb some nutrients including calcium, which can lead to weakened bones and fractures.

As a result of this debilitating hip fracture side effect, Nexium can be considered a defective drug. Often drug companies are negligent and do not fully inform doctors and patients about these side effects. AstraZeneca may be required to compensate individuals who have suffered hip fractures due to Nexium.

If you have used Nexium and had a fracture, you should contact us at 214-855-0034 or jonathan@theleblanclawfirm.com or www.injurylawyerdallastexas.com

 

FDA Further Restricts Avandia Due To Risk of Heart Attack and Injury - Dallas, Texas

 

The U.S. Food and Drug Administration (FDA) is informing the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs.

The new restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS)—a program FDA may require to manage serious risks of marketed drugs. The restrictions are based on data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone. The decision to restrict access to rosiglitazone medicines was made on September 23, 2010.  

FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products.

The REMS, called the Avandia-Rosiglitazone Medicines Access Program (PDF - 3MB),² limits the use of rosiglitazone medicines to:

• Patients already being successfully treated with these medicines.
• Patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

Healthcare providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines. After November 18, 2011, rosiglitazone medicines will no longer be available through retail pharmacies. Patients who are enrolled in the Avandia-Rosiglitazone Medicines Access Program will receive their medicine by mail order through specially certified pharmacies participating in the program.

For more information about legal representation regarding Avandia, call 214-855-0034 or e-mail jonahtan@theleblanclawfirm.com or go to www.injurylawyerdallastexas.com.

 

Bassettbaby Drop-side Cribs Recalled Due to Risk of Injury-Dallas, Texas

 

Bassettbaby has announced a recall of about 90,000 drop-side cribs in cooperation with the Consumer Product Safety Commission (CPSC).

The cribs' drop side can malfunction, detach, or otherwise fail, causing part of the drop side to detach from the crib. When a drop side partially detaches, it creates a space between the drop side and the crib mattress. A baby or toddler's body can become entrapped in the space, which can lead to strangulation and/or suffocation. A child can also fall out of the crib. Drop-side accidents can also occur due to incorrect assembly and age-related wear and tear.

Bassettbaby and the CPSC are aware of 18 reported incidents in which drop sides malfunctioned or detached from the crib. No injuries were reported. In one of the incidents a child became entrapped between the mattress and the drop side. In three of the incidents children fell out of the cribs. The firm also received 154 reports of drop-side hardware breaking during shipment, assembly, or use.

The recalled cribs are wood with a metal mattress support and have a drop side with external plastic hardware. The cribs were sold in a variety of finishes. A label is attached to the footboard or headboard with the names "Bassettbaby" or "Bassett Furniture Industries, Inc.", as well as the model number, production date, and other information. On some older models the manufacturer's name appears on a separate label. For a complete list of the models included in this recall, visit the CPSC's website.

Non drop-side cribs are not included in this recall.

The cribs were sold at children's product stores and other retailers nationwide and online from January 2000 through August 2010 for between about $200 and $500. They were made in China, Croatia, Slovenia, Taiwan and Vietnam.

For more information about dangerous baby products, go to www.injurylawyerdallastexas.com or call 214-855-0034.

Medical Instrument Maker Must Pay For Wrongful Death of Patient - Dallas, Texas

A jury assessed $8.5 million in damages against a Johnson & Johnson subsidiary whose medical instrument was alleged to have been responsible for a surgery's fatal result. The suit was filed by the wife of Michael Bush, who died May 31, 2004 — three weeks after undergoing a stomach-stapling bariatric procedure. Bush's widow claimed that her husband's suture line popped and allowed a fatal leak of gastric fluids. She contended that the sutures' failure was a result of a defect of a surgical stapler that was manufactured by Ethicon Endo-Surgical Inc. She claimed that the stapler produced U-shaped staples that were prone to failure. The defense blamed Mr. Bush's death on pneumonia, but the jury blamed the gastric leak and the stapler.

 

For more information regarding wrongful death claims in Texas, go to www.injurylawyerdallastexas.com or call 214-855-034.

Toyota Recalls More Cars Due to Steering Problems In Texas And Nationwide

Toyota announced a new recall on Thursday involving some 412,000 Avalons and Lexuses in the United States for steering problems. The recall is the second announced this month by the Japanese automaker.

Some 373,000 of the recalled cars are 2000-2004 model year Toyota Avalons. The vehicles' steering interlock system can develop a crack which can expand, making it hard to unlock the steering system when the cars are parked. In rarer cases, the steering wheel can become locked when the cars are moving.

In addition, 39,000 Lexus luxury LX 470s from model years 2003 to 2007 are being recalled because of a different steering problem. If the car hits a pothole or other large bump and then makes a hard turn, there’s a risk that over time the steering column will become disengaged, making the car unsteerable.

Toyota says it's aware of six reports of steering problems with Avalons, including three unconfirmed minor accidents and no injuries. Lexus says it is aware of one report of a steering problem and no related accidents.

"If [customers] have any concerns they should take their car to the dealer or call the customer experience center," says Brian Lyons, a spokesman for Toyota.

All affected Avalon and Lexus owners will be mailed recall letters in mid- to late-August. The Japanese automaker says it will replace the steering column bracket on all affected Avalons, and install a new component to keep the steering column in place on all Lexuses free of charge.

On July 2, the Toyota announced that it would recall some 138,000 Lexus vehicles in the US due to a valve problem in the cars’ engines that, according to reports, the company had been aware of for almost two years. That announcement came the same week that Toyota said it would expand the number of product-quality field offices in the US and add four months to its product development time, allowing for increased quality control.

In mid-July, Toyota acknowledged for the first time that sticking accelerator pedals and faulty floor mats were involved in a small number of the sudden acceleration problems that led to recalls involving some 8.5 million vehicles earlier this year. But the carmaker said it was not close to drawing firm conclusions from its investigation of 2,000 affected vehicles. An investigation by the National Highway Traffic Safety Administration is ongoing.

The Japanese automaker paid a record $16.4 million fine to the commission in April for failing to inform the agency of the pedal problems for four months.

For more information regarding Toyota and defects, contact an attorney at 214-855-0034 or go to www.injurylawyerdallastexas.com

Avandia Drug More Dangerous Than Thought, Can Lead to Death and Injury In Texas

 
The popular diabetes drug Avandia may be far more dangerous to patients than reported in a study touted by the drug's manufacturer, according to a strongly worded report posted Friday by the Food and Drug Administration.

The analysis by Dr. Thomas Marciniak says the officials overseeing the so-called RECORD study repeatedly submitted sloppy data and failed to follow up on reports of problems in patients -- including reports of patient deaths. He also called the design of the study "inappropriate and biased," in large part because it was not "blinded" -- meaning that GlaxoSmithKline, the maker of Avandia, was aware at all times of which patients were getting Avandia and which were on other medications.

The analysis was posted along with more than a thousand pages of additional documents being weighed by an FDA panel, ahead of a meeting next week when members will debate a series of steps that could include removing Avandia from the market.

Avandia is used to control blood sugar levels in diabetics, but its usage has fallen since a study published in 2007 reported that it raised the risk of heart attacks and other heart problems. That study, a so-called meta-analysis of other studies involving Avandia, found a 43 percent increase in the risk of heart attacks for patients on Avandia compared with those on other medications.

Within weeks, GlaxoSmithKline responded by releasing interim data from the RECORD study, which painted a much more reassuring picture. The study, which involved 4,447 patients and compared Avandia with two older diabetes drugs, metformin and sulfonylurea, found no increased risk of heart problems. Full results were published last year in the Lancet.

However, Marciniak did an intensive review of patient records, and said that in many cases there was missing data, or that investigators failed to follow up on likely cases of heart problems. A slide presentation that accompanies the report is full of biting commentary, such as notes on one patient who died after spending more than six weeks in the hospital. "This patient had no CV [heart] events adjudicated!" Marciniak wrote in red text. "The pulmonary edema was ignored." At the bottom of a five-sentence summary on the patient, Marciniak added, "This brief letter is the total information submitted for this 46-day hospitalization terminating in death!"

In most cases, he wrote, the omissions made the safety data for Avandia look better than it really was. Once he re-analyzed the data, he wrote, it actually shows an increased risk of heart attack -- much like the studies it was meant to refute. Marciniak's view, reflected in a slide presentation for the FDA panel, is that "RECORD confirms and extends the recognized concerns regarding increased heart failure and heart failure deaths with rosiglitazone [Avandia]."

In a statement Thursday, Glaxo's vice president for Clinical Development, Dr. Murray Stewart, said, "Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia and together they show that this medicine does not increase the overall risk of heart attack, stroke or death."

"There's just no evidence of an increase in heart attacks," he added in a phone interview. "What's more, all the clinical trials show no evidence in mortality versus standard of care. They all show decreased mortality."

The RECORD study is the largest of those studies, and the most widely known. In a briefing Thursday, Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, said, "RECORD is the most germane because it is meant to look at cardiological [sic] comparisons between rosiglitazone [the generic name for Avandia] and the standard of care."

Given that, attacks on its credibility are highly charged. "How do they count the adverse events, how do they [investigate] them -- if there are problems with that, it's really worrisome," said Dr. David Nathan, the director of the Diabetes Center at Massachusetts General Hospital.

While Nathan said he's not sure if there is a serious risk, since 2008 the Treatment Guidelines Committee of the American Diabetes Association, which Nathan chairs, has recommended that doctors use medications other than Avandia. Said Nathan, "We took the position that there's just no rationale for using a drug that might be dangerous, especially when other options are available."

If you need legal representation regarding Avandia or more information, go to www.injurylawyerdallastexas.com or call 214-855-0034. 

General Motors Recalling 1.5M Vehicles Over Fire Concern

General Motors Co. said Tuesday it was recalling about 1.5 million vehicles worldwide to address a problem with a heated windshield wiper fluid system that could lead to a fire, its second recall over the issue in two years.

The recall affects several pickup trucks, sport utility vehicles, crossovers and passenger car models from the 2006 to 2009 model years. GM conducted a similar recall in 2008 but came across new reports of fires in vehicles that had been fixed.

GM said it would disable the heated washer fluid system module that could lead to fires. The Detroit automaker will pay owners and those leasing vehicles $100 each since the feature is being disabled.

GM said it was aware of five fires but there had been no injuries or crashes reported. Nearly 1.4 million vehicles are in the U.S. and more than 100,000 vehicles are in Canada, Mexico and other international markets.

"While our analysis shows the number of incidents is very small compared with the number of vehicles on the road, we want our customers to have complete peace of mind," said Jeff Boyer, GM's executive director of safety.

The recall covers the 2006-2009 model year Buick Lucerne, Cadillac DTS, and Hummer H2; 2008-2009 Buick Enclave and Cadillac CTS; 2007-2009 Cadillac Escalade, Escalade ESV and Escalade EXT; 2007-2009 Chevrolet Avalanche, Silverado, Suburban and Tahoe; 2007-2009 GMC Acadia, Sierra, Yukon and Yukon XL; 2007-2009 Saturn Outlook; and 2009 Chevrolet Traverse.

The auto company said customers will begin to receive recall letters later this month but can contact their dealer to make an appointment to have the heated washer system removed. Dealers will remove the heated washer fluid module and reroute washer fluid hoses.