Access To Justice

Plavix is getting a “black box” warning to its label from the US Food and Drug Administration (FDA) because the popular blood thinner can be less effective in some patients, potentially putting them at greater risk of heart attack and stroke.

Patients with cardiovascular disease are prescribed Plavix (clopidogrel bisulfate) to reduce formation of blood clots, which can lead to stroke, heart attack and death.  The boxed warning – the FDA’s strongest caution — highlights the diminished effectiveness of Plavix in patients who have a genetic variation that inhibits their ability to metabolize the drug.

The FDA says that patients with this genetic variation have reduced functioning of a certain liver enzyme and thus cannot metabolize the drug to convert it to its active form. It is estimated that between 2 percent to 14 percent of Americans are poor metabolizers. These patients represent about 14 percent of Chinese, 4 percent of blacks, and 2 percent of whites, according to Bristol-Myers Squibb and Sanofi-aventis, which jointly market the drug. The FDA says genetic tests can identify if a patient is a poor metabolizer.

Patients should not stop taking Plavix unless told to do so by their doctor. Always consult your physician before making any changes to your medications.

As always, Sokolove Law is here to help protect your rights.

News developments that we’ll be keeping an eye on at Sokolove Law:

Recall Redux: More than 400,000 Odyssey Minivans and Element small trucks will be recalled by Honda due to brake problems. Honda’s recall advisory says the company received driver complaints of “brake pedals that feel “soft” or that gradually exhibit a pedal height that gets lower (closer to the floor) before the vehicle stops.”

The Associated Press reports that the voluntary recall will involve 344,000 Odysseys and 68,000 Elements from the 2007 and 2008 model years. The story says the problem involves a device in the electronic stability control system called a vehicle stability assist modulator that can develop an air bubble that may cause a loss of braking ability.

The National Highway Traffic Safety Administration said no deaths and just three crashes with minor injuries have been traced to the problem.

Older ER patients often receive one or more medications that may be inappropriate for adults who are over the age of 65. That’s the key finding of a study by the University of Michigan that looked at a sample of about 470,000 emergency room and outpatient clinic visits, corresponding to a national estimate of about 1.5 billion total visits. Potentially inappropriate medications were administered to nearly 19.5 million older patients, or 16.8 percent of eligible emergency visits from 2000-2006. The study recently appeared in Academic Emergency Medicine.

Pain relievers and antihistamines are among most common drugs used in emergency visits,  despite their risks in those over age 65. Ten medications accounted for 86.5 percent of potentially inappropriate medications prescribed in the nation’s emergency rooms. The five most common ones were promethazine, ketorolac, propoxyphene, meperidine, and diphenhydramine. Two of these – promethazine and ketorolac – accounted for nearly 40 percent.

The study suggests that older ER patients ask for a list of all drugs prescribed at the ER before going home or to a bed in the hospital. The list should include information on the possible side effects of those medicines.

At Sokolove Law, we’re here to help.

Thousand of anxious homeowners will be watching the proceedings in a New Orleans courtroom as a bellwether trial involving tainted Chinese drywall gets underway there.

The test case before U.S. District Judge Eldon E. Fallon is “part of a national consolidated litigation of more than 2,000 cases,” writes Tampa Bay Online.  As such, it likely could set a precedent for the handling of such claims, which is why homeowners with potentially defective drywall in their residences are awaiting its outcome.

Chinese drywall used in new home construction and renovations in the United States has been associated with the release of toxic sulfur compounds that can cause extensive damage to residential wiring, air conditioning and other electrical appliances, as well as potential health risks for homeowners. It is estimated that defective drywall may have been used in as many as 100,000 homes nationwide, particularly in Florida.

Tampa Bay Online also reports that last week Florida officials asked the Federal Emergency Management Agency (FEMA) to provide disaster relief to homeowners impacted by bad drywall. The agency said it would review the request.

Last month, Toyota recalled more than 400,000 2010 Prius and other hybrids for braking issues.

Now the question arises: Does the Prius also have an accelerator problem? Acceleration issues with a number of Toyota models led the automaker to recall millions of cars in January.

Recent news reports suggest that there may be acceleration issues with the Prius. USA Today writes that there have been two alleged sudden-acceleration incidents involving the vehicles: one in California, where the highway patrol had to assist the driver in stopping his 2008 Prius, and the other in New York, where a woman ’s 2005 Prius suddenly accelerated and smacked into a stone wall.  The alleged incidents occurred as the automaker insisted that its accelerator problems are mechanical and not electronic, according to 24/7 Wall St.

If you or someone you know has been injured by a Toyota recall model, please contact us.

Popular osteoporosis drug Fosamax may increase the risk of broken bones, such as femur fracture, in some women, according to an ABC News report.

ABC is also reporting that the FDA “will look into whether or not a link exists between the use of certain osteoporosis drugs and a particular type of leg fracture.”

Osteoporosis medications like Fosamax – part of a drug class known as bisphosphonates — are meant to strengthen bones.  Doctors prescribe them for the estimated 10 million Americans with osteoporosis, many of whom are women.  Some doctors are now worried that woman who use Fosamax or similar medications  for five years or more may increase their risk of sudden bone breaks.

Fosamax maker Merck told ABC that “a causal association has not been established” between long-term use of the drug and fractures.

However, a small observational study published in 2008 in the Journal of Orthopedic Trauma linked Fosamax to an unusual type of femur fracture. That same year the company was asked by the Food and Drug Administration (FDA) to list femur fractures on the package insert’s list of potential side effects.

A number of studies suggest the benefits of taking a bisphosphonate such as Fosamax outweigh the potential risks for women who face osteoporosis. As always, do not change medications without first consulting your doctor.

News developments that we’ll be watching at Sokolove Law:

GlaxoSmithKline could face billions of dollars in potential liability from personal injury lawsuits stemming from its diabetes drug Avandia, according to a Reuters report.  The news service said that UBS cut its price target for Glaxo and estimated the company’s potential liability to range “below the midpoint of the $1-$6 billion range forecast by legal experts.” Around 13,000 lawsuits have been filed in connection with Avandia.

Last month a US Senate committee released a report saying that Glaxo knew of possible cardiac risks associated with Avandia for years before such evidence became public. Glaxo rejected the Senate report findings and said the drug is safe.

An advisory panel convened by the Food and Drug Administration (FDA) said on Friday that insulin pump problems were more likely the result of user error than device defects, according to Reuters. Insulin pumps are used by diabetics to regulate their blood sugar. A defective pump could lead to improper blood sugar levels, a potentially fatal problem. Earlier this week the FDA said there were problems with the pumps across the industry and called together a panel of outside experts to discuss ways to minimize the risk from defective pumps and to improve how pump makers report and investigate the problems.

Shoppers may want to consult with an FDA recall website before heading out to do the grocery shopping this weekend. That’s because thousands of products containing hydrolyzed vegetable protein (HVP) made by Basic Food Flavors Inc. may be contaminated by Salmonella, according to the federal agency. WebMD writes that so far there have been recalls of 56 processed foods ranging from dips to soup mixes and the list is expected to grow. No illnesses have so far been reported. Concerned consumers can go to an FDA web site to learn about recalled products. The site will be updated as new recalls are issued.

News developments that we’ll be watching at Sokolove Law:

Insulin Pumps Under Scrutiny: The Food and Drug Administration (FDA) said yesterday that insulin pump problems are on the rise and issues with the devices “exist across manufacturers,” according to a Reuters report.

The  FDA did not cite specific manufacturers. However, major pump makers include Medtronic, Roche Holding AG and Johnson & Johnson.  There have been 18 pump recalls in the last five years, according to the FDA.  A document issued by the agency found that there were nearly 17,000 reports of adverse events related to insulin pumps between 2006-2009, including 310 deaths. The reports do not prove a device caused a specific problem.

Insulin pumps are mostly used by individuals with Type I diabetes who require insulin daily to help control their blood sugar. A malfunctioning pump can lead to improper blood sugar levels, a potentially fatal problem.

Reuters reports the FDA will meet with an outside advisory panel on Friday to discuss ways to minimize the risk from malfunctioning pumps and to improve how pump makers report and investigate the problems.

Deadly drywall? Toxic Chinese drywall may be responsible for several deaths, according to a Scripps Howard News Service analysis of drywall complaints and follow-up inspections handled by the US Consumer Product Safety Commission (CPSC).  The news service writes that eight deaths allegedly linked to toxic wallboard were reported to federal consumer safety officials between June-December 2009. Most involved elderly and young people with longstanding medical problems. However, the CSPC told Scripps there is “no scientific proof of a link between drywall and the deaths.”

Fatal facelift: The Boston Globe reports that cosmetic surgery company Lifestyle Lift is facing a lawsuit alleging that a Massachusetts woman died from a  facelift procedure performed at one of its surgical centers. The suit was filed in Middlesex Superior Court by the deceased woman’s family.

At Sokolove Law, we’re here to protect your rights.

Potential power steering problems with some of its vehicles have led General Motors (GM) to announce today that it will recall 1.3 million cars in North America, including its popular Chevrolet Cobalt, reports The Wall Street Journal (subscription required).

The voluntary recall involves the 2005-2010 Chevrolet Cobalt; 2007-2010 Pontiac G5; 2005-2006 Pontiac Pursuit sold in Canada, and the 2005-2006 Pontiac G4 sold in Mexico, according to GM.

In January, the National Highway Traffic Safety Administration began an investigation into safety concerns with approximately 905,000 Chevy Cobalts after receiving more than 1,000 complaints of loss of power steering assist and reports of 14 crashes and one injury.

GM says the vehicles being recalled are still safe to drive. “After our in-depth investigation, we found that this is a condition that takes time to develop. It tends to occur in older models out of warranty,” said Jamie Hresko, GM Vice President of Quality, in a statement. “While greater steering effort under 15 mph may be required, if the customer experiences loss of power steering assist, it is important to note that the vehicle can still be safely controlled because the customer can still steer the vehicle.”

GM said both a chime will sound and a ‘Power Steering’ message will be displayed when the issue occurs.

GM’s recall comes as automakers face heightened scrutiny in the wake of the Toyota recall of more than 8 million vehicles worldwide for safety defects in accelerator and brake systems.

GlaxoSmithKline’s diabetes drug Avandia is in the spotlight again.

Confidential government reports say the medication can harm the heart and increase the possibility of heart attacks and heart failure in users, according to a recent New York Times (NYT) article. The Food and Drug Administration (FDA) reports say the drug should be removed from the market, writes the Times.

A Senate report quoted by the Times and released over the weekend says that GlaxoSmithKline (GSK) was aware of  possible cardiac risks associated with Avandia for years before such evidence became public.

The Senate report is the result of a two-year inquiry conducted by Sen. Max Baucus, chairman of the Senate Finance Committee, and Sen. Chuck Grassley, the committee’s ranking Republican. The two senators also asked the FDA to describe the steps it has taken to protect patients in an ongoing Avandia clinical trial since the agency has estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007, according a Senate press release.

GSK issued statements rejecting the conclusions of both the Senate and NYT reports and saying the drug is safe.

Avandia (generic name rosiglitazone) is prescribed to treat Type 2 diabetes. In 2007, the New England Journal of Medicine published a study warning of the possible cardiovascular risk of Avandia. Following the study, the FDA issued a warning about Avandia and GSK relabeled the diabetes medicine to flag the risk of heart failure. However, the FDA has allowed the drug to remain on the market.

As always, do not change medications without first consulting your doctor.

Thank you to those who have reached out to Sokolove Law in regards to the advertisements that we run on The Glenn Beck Program.  Some of you have questioned our choice of venue. We would like to take this opportunity to explain how we place our ads and why certain shows may be selected in comparison to others.

Sokolove Law runs its messaging across all sorts of mediums and programs. On network radio, our core audience listens to a lot of talk radio, so that is where we focus as well.  We neither support nor condemn the ideologies or the agendas of those broadcasters.  We understand and respect the fact that the constituency that we are trying to serve has diverse viewpoints and disparate tastes in entertainment.  We are simply trying to be as effective and efficient as possible in getting our message out to those folks.

At Sokolove Law, our mission is to make sure that everyone has access to justice.