Access To Justice

At Sokolove Law, we have seen an increasing number of nursing home abuse cases over the years.  It’s a sad fact that many seniors are seriously injured as a result of abuse right in their nursing home.  Sometimes this abuse is dramatic and results in broken bones and criminal prosecutions. Too often it’s more subtle and comes in the form of neglect, which results in malnutrition, dehydration, or systemic infections from skin sores that lead to more serious issues such as heart failure.

Now, recent news reports are pointing to a different kind of abuse—the use of powerful psychotropic drugs on patients with dementia and Alzheimer’s.

According to a recent front page story in The Boston Sunday Globe, some 2,500 nursing home residents in Massachusetts were given powerful antipsychotic drugs last year that were not intended or recommended for their medical condition.

This practice appears to be fairly widespread. The US Food and Drug Administration have twice issued nationwide alerts about the use of these drugs for elderly patients. In October, the Chicago Tribune identified 1,200 violations at Illinois nursing homes involving psychotropic medications since 2001. Those infractions affected 2,900 patients.

And the problem does not appear to be limited just to the U.S.  In November, a report in the Guardian found that nearly 2,000 elderly patients are killed each year in the U.K. by unnecessary anti-psychotic medication, and as many as 144,000 people suffering from dementia in that country are being given anti-psychotic drugs unnecessarily.

Here’s the bottom line, as reported in the Globe:

“Way too many patients in nursing homes are treated with antipsychotics purely to sedate them or to control behaviors that are difficult for the staff,’’ said Robert A. Stern, an Alzheimer’s specialist and brain researcher at Boston University School of Medicine.

Simply put these drugs may be dangerous, and that may be particularly true when they are given to patients who don’t need them.  The use of antipsychotic drugs on patients with dementia or Alzheimer’s is just another subtle form of nursing home abuse.  If you or a loved one has been the victim of nursing home abuse of any kind, you may have legal rights.  Contact us to find out more.

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.

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.

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.

According to published reports, U.S. drug reviewers are calling on federal regulators to further study the effects of atypical antipsychotic medicines in children.  In a report published earlier this month, the staff of the FDA said a study of the medical literature found a direct link between treatment with atypical antipsychotics and adverse metabolic effects including abnormal weight gain and increases in cholesterol and blood pressure, particularly among younger age groups.

Specifically, the FDA analysis showed increased reporting of metabolic problems with Eli Lilly’s Zyprexa and AstraZeneca’s Seroquel.

The concerns about Zyprexa and Seroquel are just the latest in a long history of potentially dangerous side effects associated with prescription medications.

To me, these reports are extremely concerning.  Back in January, a study in the New England Journal of Medicine suggested that newer, second-generation antipsychotics such as Seroquel might pose heart risks — specifically, a higher risk of sudden death due to cardiac arrest.  Then in April, the FDA found that Seroquel had too many safety concerns to make it a first-line treatment against depression or anxiety disorders.

That’s a lot of concern being raised about one drug in a single year.  Overall it seems that Seroquel — like many drugs — can be quite effective for certain patients. However, for many other patients there are wide reports of dangerous side effects.  More troubling is the fact that these drugs are often prescribed for children.

When you look at the three adverse studies that have come out this year, one wonders whether the FDA has done all the diligence it should to ensure that the drug is safe.  Do we know all we should about the side effects? Or should we expect a new round of research to tell us of even more risks?  Against this backdrop; perhaps the safety of the drug is not the only thing in question, perhaps the credibility and effectiveness of the FDA are as well.

There’s more on the newer class of antipsychotic medications at the U.S. Food and Drug Administration.

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

Oil giant BP was ordered to pay $100 million in damages to contract workers after a federal  jury found that the company exposed the workers to toxic substances at its Texas City oil refinery in 2007, writes the Houston Chronicle. The story says that the plaintiffs alleged exposure to carbon disulfide while working on two refining units. BP said it will appeal the decision.

Tough new rules regarding the use of anti-psychotic drugs are being sought in the wake of a recent Chicago Tribune investigation that found the medications were sometimes used to “chemically restrain” elderly patients in Illinois nursing homes.  The Tribune reports today that health advocates are urging Gov. Pat Quinn’s Nursing Home Safety Task Force to target the problem.

People with pacemakers should think twice before undergoing an MRI scan.  ScienceDaily reports that FDA researchers have found that MRI scans may cause certain cardiac pacemakers to inadequately stimulate a patient’s heart due to the magnetic pulses from the MRI mixing with the electronic pulses from the pacemaker. This lack of stimulation could create a potentially dangerous situation for these patients, according to the article.

Industrial launderer Cintas has agreed to pay $6.5 million to settle a class action lawsuit alleging that it failed to pay a living wage to some of its laundry workers, writes the Associated Press. The tentative settlement provides $3.3 million in back wages and interest for more than 500 Southern California Cintas laundry workers at the company’s Ontario, Pico Rivera, and Whittier locations, according to a Workers United/SEIU press release. Cintas doesn’t admit wrongdoing in the settlement, says the AP.

Recent Recalls: The U.S. Consumer Product Safety Commission (CSPC) and the National Highway Traffic Safety Administration announced that Dorel Juvenile Group is voluntarily recalling about 477,000 Dorel infant car seat/carriers. These carriers were also sold under the Safety 1st, Cosco, Eddie Bauer, and Disney brands. Dorel said it has received 77 reports of the carrier handle fully or partially falling off. At least three injuries to infants have been reported, including a head injury, bumps, and bruises. The product can still be used as a car seat when properly installed, according to the CSPC.

We’ll be watching these developments here at Sokolove Law.

An Associated Press article says that the number of reported baby deaths linked to defective Simplicity cribs has risen to 11 total, including a September incident in which a 7-month-old died after part of a crib broke.  The Consumer Product Safety Commission said yesterday that 11 babies have died, according to AP; earlier recall announcements had reported only three deaths.  The recall of Simplicity-manufactured drop-side cribs began in December 2005, writes the AP. Hardware problems have led to more than 2 million being recalled.

Taking antidepressants may  slightly raise the risk of stroke and death in older women who take these medications, according to a new finding from the Women’s Health Initiative study. A
WebMD report says the study found that stroke risk was greater in postmenopausal women who took selective serotonin reuptake inhibitor (SSRI) antidepressants, although their overall risk was still very low.  Older women who took SSRI or tricyclic antidepressants also had a slightly higher risk of dying from all causes, compared to those who did not take the drugs, writes WebMD.

Recent Recalls

Around 22,000 toy dart guns sets are being recalled after an 8-year-old child who chewed on one of the darts died after it became lodged in his throat. The Consumer Product Safety Commission says that OKK Trading, which imported the Action Team play set, is voluntarily recalling the toy, sold at discount department stores nationwide from December 2006 through March 2008.

A nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension, was announced yesterday by The Medicines Company and the Food and Drug Administration (FDA).  The product was recalled due to the potential presence of inert stainless steel particles. The particles could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs, according to the FDA.

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

Grocery chain Albertson’s LLC agreed to pay $8.9 million to settle discrimination lawsuits filed by 168 black and Hispanic workers who claimed they faced racial taunts and graffiti while working in the company’s Denver warehouse distribution center, according to an Associated Press report. The three suits were initially filed on behalf of the workers by the Equal Employment Opportunity Commission. The AP said that Albertson’s maintains that the incidents occurred before it took over the distribution center in June 2006.

Cover Your Ears: Time writes that a unpublished report by German researchers has found that exposure to jet noise increases a person’s  increased risk of stroke, high blood pressure, and heart disease. The study, due to publish in January, reports that women exposed to jet noise have a 93% higher rate of hospitalization for cardiovascular problems (69% for men). Women also are 172% more likely to have a stroke due to jet noise exposure, says the magazine.

San Francisco may become the first US city to require cellphone radiation labels, writes the Associated Press. AP says that San Francisco Mayor Gavin Newsom is pushing legislation requiring cell phone retailers to post radiation levels next each phone in type as large as that advertising the price.

Recall: Atlas Operations, Inc. and the U.S. Food and Drug Administration (FDA) have notified consumers of a nationwide recall of the company’s dietary supplements for sexual enhancement. These products are currently being sold as dietary supplements throughout the United States. The FDA said its lab analyses found that some of the products tested contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making these products unapproved drugs. The active drug ingredient is not listed on the product labels. The undeclared ingredient may pose a consumer health threat because its interaction with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels.

At Sokolove Law, we’re here to help.

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

Radiation from computerized tomography or CT scans performed in 2007 will cause an estimated 29,000 cancers that will result in the deaths of 15,000 Americans, warns a study published in the Archives of Internal Medicine. Two-thirds of the projected cancers will occur in women, one-third in people ages 35-54 at the time of their CT, and 15 percent in children or teens, according to a Reuters article. About 70 million CT scans were done on Americans in 2007.

The U.S. Consumer Product Safety Commission (CPSC) recalled millions of Roman shades and blinds today after receiving reports of several strangulation deaths in young children. CPSC has received reports of five deaths and 16 near strangulations, since 2006, in Roman shades, and three deaths, since 2001, in roll-up blinds. The CPSC and the Window Covering Safety Council are working to provide repair kits for the recalled shades, which were sold by retailers including Wal-Mart, Pottery Barn, Ace Hardware, West Elm, The Land of Nod, and JCPenney.

New Orleans Saints coach Sean Payton will carry the ball in a class-action lawsuit against Knauf Plasterboard Tianjin Co. Ltd., says a blog post at The Times-Picayune. Knauf is a Chinese company that made drywall that is believed to be corroding homes and making people sick. Payton, the suit’s lead plaintiff, was one of the first in Louisiana to link media reports of defective Chinese drywall to his family’s health problems and the failure of electrical and other equipment in his home. It is estimated that at least 550 million pounds of Chinese drywall has been imported into the United States since 2006 — enough to build 60,000 average-size homes.

Resolving Paxil lawsuits has cost GlaxoSmithKline almost $1 billion, according to a Bloomberg News report that cites court records and people familiar with the cases. This figure includes $390 million to settle suicide or attempted suicide cases linked to the anti-depressant drug, and $200 million to settle Paxil addiction and birth-defect cases. Bloomberg says Glaxo declined to confirm the $1 billion figure. Paxil went on the market in 1993.

Nursing home administrators in Illinois may soon face tougher disciplinary sanctions in cases of patient harm in their facilities as state officials push to improve elder safety. The Chicago Tribune writes that administrators are now seldom punished by the state entity charged with licensing them and other professional nursing home staff, despite reports of elder abuse.

Keep those you love protected from harm. At Sokolove Law, we’re here to help.