Access To Justice

Psychotropic Drug Use by Nursing Homes Draws Fire

by James Sokolove on Mar.19, 2010

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.

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Plavix Hit With FDA’s Toughest Warning

by Sokolove Staff on Mar.17, 2010

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.

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Sokolove Daily Roundup

by Sokolove Staff on Mar.16, 2010

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.

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Chinese Drywall Trial Opens

by Sokolove Staff on Mar.15, 2010

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.

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Radiation Redux

by James Sokolove on Mar.12, 2010

Last October, we told you about a case where 206 patients were suing LA’s famed Cedars Sinai Medical center because of accidental overdoses of radiation they received during medical imaging there.  Now, as more and more reports emerge about possible radiation overdoses, the Food and Drug Administration (FDA) is getting involved.

The FDA recently announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. According to the FDA:

“These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.”

In addition, according to the Miami Herald, a medical imaging trade group announced last month that it would begin installing safety controls on scanners to prevent overdoses.  The controls will “alert machine operators whenever a machine’s settings exceed recommended levels.”

I also recently came across an article in The New York Times that referenced a number of additional radiation overdose incidents.  In Missouri, a hospital said it had overradiated 76 patients during a five-year period because radiation equipment had been set up incorrectly.  In Florida, a similar problem resulted in:

“77 brain cancer patients’ receiving 50 percent more radiation than prescribed in 2004 and 2005.”

To be sure, it is good news that the FDA is involved and taking a closer look at regulations and other safeguards to prevent these overdoses.

Like all medical technologies, advanced medical imaging devices may hold the promise to better diagnosis and health care outcomes. However, these are powerful machines. If not set up correctly or deployed by under-trained technicians, the risks to patients are real.

We’ll be following this story for further developments.

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Toyota Prius: Questions On Possible Sudden Acceleration

by Sokolove Staff on Mar.11, 2010

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.

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Fosamax Causing Bone Fractures?

by Sokolove Staff on Mar.10, 2010

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.

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Sokolove Daily Roundup

by Sokolove Staff on Mar.05, 2010

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.

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Sokolove Daily Roundup

by Sokolove Staff on Mar.04, 2010

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.

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Unconstitutional Caps

by James Sokolove on Mar.03, 2010

I’ve written before about a number of initiatives around the country to put caps on medical malpractice awards, and why such initiatives don’t make much sense for consumers.

When last we left these proposals, the Illinois Supreme Court had delayed issuing a ruling on whether the caps were constitutional in that state.  In February, the court issued its ruling overturning the state’s medical malpractice law and holding that caps on liability damages were unconstitutional.

Essentially, the Court’s decision reverses a 2005 state law capping non-economic damages—such as pain and suffering—for physicians at $500,000 and hospitals at $1 million.

The Court based its decision on a case that arose from Cook County, LeBron v. Gottlieb Memorial Hospital, involving the severe disability of a young girl, Abigaile Lebron.

The New York Times had a nice write up on the ruling here.

I’ve argued ad nauseum that caps on medical malpractice do not make any sense.  As I said back in December:

“The bottom line is this:  Damages compensate victims who have suffered because of someone else’s negligence, but they also force the system to be careful.  Doctors are more careful because they don’t want to get sued.  I think that’s a good thing.  Careful doctors are better doctors.  Our medical system has become better because of medical malpractice law, not in spite of it.”

Kudos to the Illinois Supreme Court for a sound decision.  Here’s hoping other states follow their lead.

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