Access To Justice

Loyal readers know that I blog a lot about dangerous drugs.  That’s because at Sokolove Law, we see many cases each year involving people who are injured due to side effects, interactions, or other complications resulting from prescription and OTC medications.

So what should we do to avoid these risks?  Of course, the best answer is the same advice you get in almost all pharmaceutical advertisements, “Talk to your doctor before taking any medication.”

But what happens if your doctor isn’t up to speed on the risks or side effects of the latest drugs? The answer is that what your doctor doesn’t know, could hurt you.

I came across a post on the Science Blog that offered a nice analysis of the challenges facing physicians. Here are a few tidbits:

•    In an eight-hour shift a general practitioner can see over 30 patients.

•    Drug trial protocols, study interpretations, and communication of trial results are all falling far short when it comes to supplying unbiased, accurate and discernable information to the nations’ healthcare practitioners.

•    Evaluating the seven-year period from 1998 to 2005….The number of serious side effects and deaths caused by FDA-approved medicines has nearly tripled.

To summarize: Doctors today carry increasingly heavy patient loads, interpreting clinical drug trial results is complicated, and it just isn’t possible for many physicians to adequately research and inform all patients of the potential risks associated with an ever-expanding universe of pharmaceuticals.  The result is a spike in harm caused by serious drug side effects.

So what are consumers to do if they can’t count on their doctor to have all the answers, all the time?  Well, the FDA is moving to implement changes that will improve the clinical trials process for drugs, including a new database containing all clinical trials of every FDA-approved drug. The agency is also beefing up its regulation of pharmaceutical advertisements.

Beyond that, I’m thinking of changing my advice:  Talk to your doctor, but also do your own research.  There is a wealth of information available on drug interactions and side effects from the FDA.  Check out their website at www.fda.gov for more information.

Finally, if you believe you have been harmed by side effects from medication, you may be entitled to compensation.

The Wall Street Journal Health Blog had an eye-opening post recently about kids’ prescription drugs. The post noted that spending on drugs for kids rose nearly 11 percent last year, the most for any age group, according to an annual drug trend report by Medco Health Systems (a leading pharmacy benefit manager).

Medco’s analysis of pediatric medication use found that one in four children covered by health insurance took at least one prescription medication to treat a chronic condition. The use of anti-psychotic, diabetes and asthma drugs grew the most over the past nine years.

The Journal’s angle was that this rise in drug spending was part of an overall trend toward increased health care costs.  That’s an important point. But my gut reaction to this report comes from a different perspective:  Why are kids taking so many prescription drugs? And are we sure they are all safe and appropriate for children?

To be fair, the Journal points out that some of the spending jump had to do with increased H1N1 flu vaccinations, “but that built on a base of increasing use of prescription drugs in children due to obesity, diabetes and other health issues that used to be largely the province of the middle-aged.”

Let’s be clear. If we are detecting and treating conditions such as obesity and diabetes earlier than ever, that’s a good thing.  But at the same time, government regulators need to ensure that our children are not being exposed to  pharmaceuticals that have not been adequately evaluated for their use. To do anything less is simply a prescription for trouble.

Take the recent coverage of anti-psychotic drug use for children, which I wrote about here.   In that case, the Food and Drug Administration stepped in to order further study because the agency was concerned about possible side effects on children. It’s a perfect example of how regulators need to be particularly vigilant about understanding the risks of powerful drugs and their side effects on children.

At Sokolove Law, we have always had an appreciation of the power of new medicines  to prevent illness and to improve the quality of life.  But we are also aware of the potential dangers posed by these drugs when their use is not fully understood by doctors, or properly regulated by the government.

We’ve seen the effects of this lack of vigilance in the faces of countless victims over the years.  If you or a loved one has suffered side effects from dangerous drugs, you may have legal rights.

Prescription drug ads do a great job telling us about all the wonderful things a product can do–relieve pain, prevent disease, manage chronic conditions. But as the music swells and we see healthy vibrant patients enjoying their lives, there’s usually a subtle voiceover that warns of potentially harmful side effects or drug interactions. That warning is often repeated in ridiculously small print that flashes across the screen so fast it’s barely readable.

We’re so familiar with this practice that these ads have become fodder for comics and cocktail parties alike.

That may be about to change. In a notice published in the Federal Register, the Food and Drug Administration is proposing new regulations for TV prescription drug ads. The FDA says that the changes are meant to ensure that information about potential drug side effects is presented in a “clear, conspicuous and neutral” manner. The new regulations are an extension of the Food and Drug Administration Amendments Act of 2007, which first required the warnings in ads and allowed the agency to set more specific regulations.

It’s a very positive step. Side effects and drug interactions are no laughing matter. And while pharma companies should be free to advertise the benefits of their products, the intent of the law was to require them to also clearly warn consumers about the risks.

The FDA is soliciting comments about the new rule until June 28. If adopted, it will be an important step in making sure that pharma companies live up to the spirit, not just the letter of the law.

Zinc in denture cream and BPA in plastic drinking bottles.  Both are recent examples of why government regulators need to work harder to protect consumers from potentially toxic chemicals.

The New York Times had a great story on this subject recently. Among other things, the article made the point that the U.S. has had relatively weak regulation of potentially toxic chemicals compared to other developed nations. It led with the tale of GlaxoSmithKline’s Super Poligrip. The pharma giant sold the popular denture cream for more than a decade before pulling it off the shelf this year due to mounting evidence (not to mention lawsuits) that the product may cause zinc poisoning in users.

We posted info on the possible dangers of denture cream here, and I talked specifically about it here.

The Times story offers a good narrative of how the manufacturer resisted changing the ingredients or pulling the product even as studies emerged that pointed to the potential risk zinc poses in denture cream. The Super Poligrip saga underscores the fact that stronger regulations are necessary to ensure that the U.S. does not trail the pack in its response to toxic chemicals in consumer products.

Help may be on the way.  The Congress is currently set to update the Toxic Chemicals Control Act, and the Environmental Protection Agency launched an initiative last December to strengthen its chemical management program. It’s high time.

In the meantime, if you or a loved one has been hurt because of exposure to toxic chemicals, you may be entitled to compensation.

We’ve all had the experience of buying a product and taking it home only to find that it didn’t work properly.  So what do you do when that happens? Typically, the product will have some kind of warranty entitling you to repair, or even replacement, depending on the circumstance.  In the case of expensive items, consumers will often purchase an extended warranty to be sure they are covered for the long term.

Well, what if the product that isn’t working is part of your body?  According to a recent article in The New York Times, if you have a hip or knee replacement, chances are the orthopedic device inserted in your body is not covered by a warranty at all. If it fails and needs to be replaced, you could end up picking up the tab.

According to the Times report:

“The million or so artificial hips and knees implanted each year in the United States…are normally not guaranteed. Instead, the costs of replacing implants that fail early because of design or mechanical problems — devices that sell for as much as $15,000 each — are largely paid by Medicare, insurance companies and patients.”

What’s worse? The Times writes:

“Orthopedic producers may sometimes even profit from the failures because they sell the replacements at full price.”

My colleague Marc Stern recently posted about the problems with artificial hips, including some manufactured by DePuy Orthopedics, a division of Johnson & Johnson.   Patients have run into very serious health issues because of metal-on-metal artificial hips that fail and must be replaced.

The Times story highlighted the plight of an Alaskan man whose artificial hip manufactured by DePuy failed after only three years (it’s supposed to last 15 years).  The cost to replace his hip was $50,000.  DePuy has not offered to pay those costs.

Here’s my point:  Products from coffee makers to cars come with warranties.  Clearly, the manufacturers are prepared to stand by their work. Shouldn’t we require orthopedics manufacturers to do the same?

It’s the first major reform of its kind in 50 years. No, it’s not the sweeping health care reform bill that passed Congress last month. I’m referring instead to a planned and much needed overhaul of U.S. food safety regulations.

According to a report by Reuters, U.S. Rep. Rosa DeLauro said recently that the Congress will pass an overhaul of food safety and send it to President  Barack Obama this year.  DeLauro, who chairs the House’s Agriculture Appropriations Subcommittee, also said her committee will hold hearings to examine whether new trade agreements negotiated by the United States should include food safety provisions.

DeLauro cited recent massive recalls of sausage and salami as underscoring the need for action. The Reuters article also pointed out some alarming statistics related to food safety:

•    Foodborne illnesses cost the United States $152 billion in health-related expenses each year, according to a recent study.

•    An estimated 76 million people in the United States get sick every year with foodborne illness and 5,000 die, according to the U.S. Centers for Disease Control and Prevention.

Meanwhile, food recalls continue to pop up. Just last month, the FDA issued an alert after Salmonella Tennessee was discovered in one company’s supply of hydrolyzed vegetable protein (HVP), a common ingredient used most frequently as a flavor enhancer in many processed foods, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings.

Also in March, Heartland Foods, Inc. announced that it was recalling Coarse Ground Black Pepper because of possible Salmonella contamination. In January and February more than 1.24 million pounds (562,500 kilograms) of pepper-coated salami and other meat products were recalled because they may have been contaminated with salmonella.

Here’s the bottom line.  We have a food safety crisis in this country.  It is high time Congress steps in and takes action. Until it does, too many Americans will be harmed simply because they took for granted the food they picked up off a grocery store shelf.

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.

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.

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.

As someone who’s been involved in numerous lawsuits related to product liability, I can tell you I have seen it all.  But the Toyota recall is about as close to a perfect storm as it gets.  Case in point: Congress is now holding hearings on the matter.

In true lawyerly fashion, let’s review the facts:

•    Start with a company that has built its brand on quality.

•    Add in the largest recall in the company’s history and one of the ten largest of all time, totaling more than 8 million vehicles, 6 million in the U.S.

•    The recalls relate to everything from faulty gas pedals to brakes, all absolutely critical to safety.

•    According to the National Highway Transportation Safety Administration (NHTSA), 34 deaths allegedly were caused by gas pedal problems.

•    Toyota has allegedly been aware of the potential for problems with accelerators as early as 1999, and the NHTSA had been investigating the issue dating back to that period.

So, if I may paraphrase, it sure seems as if Toyota had some serious problems with its product that could potentially be dangerous, and the company chose to be in denial about it.

Now, once the company issued a recall, how it handled the matter was also a case study in what not to do.

•    To begin with there is evidence that Toyota was basically forced into the January 21 recall by the NHTSA.

•    Toyota CEO Akio Toyoda waited almost two weeks to comment on the recall before apologizing and calling the situation a “crisis”.

• Then, U.S. Secretary of Transportation Ray LaHood tells Toyota drivers not to drive their cars, only to later say he “misspoke”.

•    Toyoda says he won’t testify before a Congressional Committee; in the face of a threatened subpoena, he agrees to testify this week.

This brings us to the consequences of all of this mismanagement and lack of candor and transparency.

•    An estimated 44 class-action lawsuits have been filed under state and federal law by the end of last week.

•    Claims could reach $3.6 billion, based on an average loss of $600 per vehicle.

•    There are dozens of other individual lawsuits alleging that Toyota knew of the risk and did not act swiftly enough to correct the problem. Experts say these cases could cost Toyota billions in settlements.

•    At least one wrongful death lawsuit has been filed for $100 million related to the death of a Texas couple.

Toyota had serious problems with some of its product.  Instead of acknowledging the problems early on and taking the appropriate steps, the company chose a strategy that combined benign neglect with the finger-crossed hope that it could sweep things under the rug.  It is a strategy that too many businesses employ when product defects are in question.

The result: numerous lawsuits that will likely cost the company billions of dollars and damage its brand well into the future.

More importantly, what Toyota did was wrong.  It put people at risk to save a buck.  The company valued its reputation and revenue over the safety of customers.

If you’re one of those customers, you can find more information about the recall at Toyota’s website.