Sokolove Success Blog – Our Perspective on Legal News that Matters

Popular medications for treating cholesterol and ulcers have popped up on the latest list of potential drug safety risks released by the Food and Drug Administration (FDA).

It’s no surprise to us that cholesterol drug Zocor continues to come in for FDA scrutiny. We’ve seen our share of rhabdomyolysis cases here. In June, the agency issued a safety alert regarding the risk of severe muscle injury — including rhabdomyolysis — for patients who take the 80 milligram dose of Zocor, the highest dosage approved.

Also making the FDA’s list are Omeprazole products (think Prilosec). According to the FDA there is a risk that these ulcer medications could lead to hypomagnesemia, or low magnesium levels in the blood. Levels that are too low are only a big deal if you’re one of those people who like their muscles, nerves, and enzymes functioning properly.

Other drugs flagged by the FDA include: pain treatment Nucynta (convulsions, hallucinations, and serotonin syndrome), birth control implant Implanon (convulsions), anemia drug Feraheme (serious cardiac disorders), and Afinitor (Hepatitis B reactivation).

The FDA releases its list four times a year to keep the public informed of early investigations into potential drug side effects. As we’re all aware, a drug’s appearance on the list does not mean that FDA has concluded that the drug is unsafe. However, we will continue to monitor adverse effects related to these and other drugs on this list. Let me know if any of these strike your interest or if you would like to explore them further.

More news you don’t want to miss from this week:

Study: Diet Drug Meridia May Boost Heart Risks
Dead Soldiers’ Parents Sue Insurer Over Benefits
Mammography Problems at Medisound, Inc. in Kissimmee, Florida
Questions Loom Over Drug Given to Sleepless Vets

High blood pressure isn’t healthy for you. But could the cure be worse than the disease?

That’s the question now in front of the Food and Drug Administration (FDA), which is currently evaluating data from two clinical trials in which patients with type 2 diabetes who took the blood pressure medication Benicar (olmesartan) had a higher rate of heart attack, sudden death or stroke compared to patients who used a placebo.

The FDA is currently conducting an ongoing safety review of Benicar and cautions that it has not definitively concluded the medication increases the risk of death.

Benicar belongs to a class of drugs called angiotensin II receptor blockers (ARBs). These drugs are widely used to treat hypertension, heart failure, and to prevent kidney failure in diabetics. Other drugs in the class include Micardis (telmisartan), Cozaar (losartan), Diovan (valsartan), Avapro (irbesartan), and Teveten (eprosartan). Approximately 82 million prescriptions for ARBs were written in 2009.

Shortly after the FDA’s announcement last month, the findings of a new study published in the medical journal The Lancet Oncology concluded that ARBs are associated with an increased risk of cancer.  According to Medpage Today, researchers at Case Western Reserve School of Medicine in Cleveland found that in a meta-analysis of nine published studies, ARBs were associated with a “modest but statistically significant 8 percent increase in the relative risk of a new cancer.” However, no increase in the risk of dying from cancer was found.  Researchers caution that further study is needed to draw conclusions about the risk of cancer associated with each drug in the class.

While regulators and scientists work to collect and sift through the evidence, Sokolove Law will continue to investigate reports of cardiac death and/or cancer relative to Benicar and other antihypertensive drugs.

Experience matters. So seasoned professionals like Bill Rivell are a key reason why Sokolove Law fields the best business development team in the legal marketing industry.

Bill’s extensive knowledge of our highly successful case generation model grows out of a 10-year career here at Sokolove Law. During that time, Bill has served both as a product manager, where he helped optimize marketing campaigns and case intakes, and as a case screener, where he honed his relationship-building skills and his ability to recognize fact patterns that can yield successful cases.

Bill is a passionate champion of our co-counsel firms. You’ll find Bill working hard at next week’s AAJ 2010 National Convention in Vancouver. He’ll be doing what he does best: meeting with co-counsel firms and potential new co-counsel to explore upcoming opportunities, to understand their needs, and to share all the ways that Sokolove Law works to grow their practice. Don’t hesitate to drop Bill a note if you want to connect in Vancouver.

One of the great strengths of Sokolove Law’s business development team is the passion and depth of experience its members bring to bear on everything that touches our co-counsel firms. How deep is our bench and its commitment to you?

Meet Business Development Manager Christina Kritharas. In her current role, Christina concentrates on developing relationships with co-counsel and prospective co-counsel firms. But if you’ve worked with Sokolove Law, odds are you’ve worked with Christina. She has been with the firm for 20 years in a variety of roles, which gives her a deep understanding of how plaintiffs firms operate.

A consummate marketer, Christina has also been at the forefront of co-counsel communications at Sokolove Law. Her past projects include development of our Legal Marketing Roundtable series and a syndicated client newsletter that was licensed to plaintiffs firms nationwide.

Look for Christina at the AAJ 2010 National Convention in Vancouver next week.  She’ll be on-site throughout the event to meet with Sokolove Law co-counsel firms and potential new co-counsel to discuss current campaigns and explore upcoming opportunities. She’d love the chance to meet and exchange ideas with you.  Send Christina an email if you want to get together during the convention.

When you take a weight-loss pill, you expect to lose a few pounds. But losing your liver? That’s not part of anyone’s diet program.

The Food and Drug Administration (FDA) thinks so, too, which is why it recently alerted consumers to the risk of potential liver damage from diet drugs Xenical and Alli. Both products, which contain different strengths of the active ingredient orlistat (Xenical at 120 mg and Alli at 60 mg) are designed to promote individual weight loss by blocking the absorption of dietary fats, thereby reducing caloric intake. The agency is requiring Xenical, a prescription obesity drug, and Alli, an over-the-counter weight loss supplement, to carry new warnings about rare but severe liver injury associated with their use.

The FDA based its warning and label revision on a completed safety review of orlistat that identified 13 reported cases of severe liver injury, one of which occurred in the U.S. and involved Alli. Of those cases, two patients died from liver failure and three required liver transplantation. In August 2009 the agency announced that it was reviewing adverse event reports of livery injury among orlistat users, which included prescription Xenical and over-the-counter Alli. According to the FDA, between 1999 and October 2008 the agency received 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat. All but two incidents took place outside the U.S.

Despite these reports and the new warnings, the FDA cautions that a definitive link between orlistat and severe liver injury has not been established.

More than 40 million people worldwide have used either Xenical or its non-prescription counterpart Alli, which together have racked up millions of dollars in sales. Up until now, these weight-loss aids have been best known for their unpleasant gastrointestinal side effects, which include oily discharge and uncontrollable bowel movements.  But liver damage? That’s far more than any consumer should be expected to bargain for in the quest to lose weight.

Sokolove Law is continuing to investigate claims of serious liver injury associated with both Xenical and Alli.  If you’re interested in working with us to identify and develop these cases, drop me a line.

Remember Inspector Gadget, the technologically enhanced police detective who used devices such as a helicopter coming out of his hat or a rapidly extending arm to fight crime? Now, some surgeons have themselves become “Doctor Gadgets” by using advanced robots in the operating room to help conduct surgeries.

The Wall Street Journal (subscription required) reported recently about a surgical robot used at a New Hampshire community hospital.   The da Vinci robot (named after the artist and original Renaissance man) has been billed as a medical breakthrough which promises to make surgeries far less invasive.  The robot, which consists mainly of complex lasers and cameras, allows doctors to operate through small incisions to avoid the need to open large cavities such as the abdomen.

The Journal piece notes that the robot became a symbol of health care reform when President Barack Obama was photographed trying his hand at one of the devices during a visit to a clinic in Cleveland.  But what stuck out for me in reading the article was that Obama symbolized somebody with absolutely no training trying to use the complicated robot.

In fact, isn’t that always the case with technology?  It seems to advance faster than we learn how to harness it.

Surgical robots are highly sophisticated devices that require specialized training and extensive experience to master.  In fact, the Journal reports that surgeons with extensive robotic experience say that it takes as many as 200 surgeries before a doctor is proficient in using the machine, a usage rate that is harder for specialists at small hospitals to achieve.  And that’s troubling since the article’s main point is that these surgical robots are being marketed to hospitals as a tool to increase revenues and smaller hospitals are susceptible to that pitch.

Like lots of advanced medical products and techniques, there’s little doubt that robotic surgery can be a promising medical advancement.  But it can also lead to harm: one patient had to undergo four additional procedures due to a medical error that occurred during robotic surgery, according to the Journal article.

As patients’ advocates, we are forced to ask some hard questions about the use of this medical technology:

•    Is there too much competitive pressure to adopt robotic surgery because of its impact on a hospital’s bottom line?
•    What is the appropriate amount of training before a doctor really knows how to handle this technology safely?
•    And of course, are patients knowingly being put at risk?

We will continue to ask these and other tough questions as we watch the use of this new medical technology unfold in the OR.

As Congress contemplates far-reaching reform of Wall Street and the unscrupulous practices of some of its large financial institutions, attention should be focused on the unacceptable risk that these banks took and the lack of federal regulation that made it possible.  But while we look at the big picture, we should also keep our eye on some of the lesser known yet equally egregious practices engaged in by some major players in the financial industry.

A good example is forced placed (or “lender-placed”) insurance.  When a homeowner takes out a mortgage, the bank rightly requires the borrower to adequately insure the home.  The bank wants to make sure that its collateral is protected.   In the event that a homeowner allows the policy to lapse, the lender has the right to force place an insurance policy. Sounds reasonable, right?

Not exactly. Some lenders have taken advantage of this contractual right and turned it into a predatory practice. For example, a lender may hook up with a chosen insurance company or an affiliate firm to force place these policies on borrowers. These unilaterally imposed policies often provide less coverage to homeowners at a cost of up to several times the market rate for a competitively sought policy.

What’s worse is that in some instances lenders may force place policies even when the homeowner has adequate insurance coverage and has provided proof of it to the lender.

Consumers are understandably fighting back.

In January 2008, three affiliates of Countrywide Financial Corp. were hit with a proposed class action accusing them of forcing their own insurance on Florida borrowers who were already properly insured.

In January of this year, Law 360 reported on a pending California class action involving as many as 625,000 homeowners who are bringing claims against American Security Insurance Co. for fraud and unfair business practices in connection with forced-placed insurance policies.

We are currently investigating similar claims. If you are pursing these cases or have an in interest in doing so, I’d like to hear from you.

It’s supposed to help with your strep throat, but could a widely used antibiotic instead harm your liver?

Health authorities in Canada think so and have raised new concerns about popular antibiotic Avelox and possible increased risks of liver failure. In March, Health Canada (the Canadian equivalent of the US Food and Drug Administration) notified health care professionals and patients of changes to the labeling information for Avelox in Canada.  A safety review by the agency concluded that Avelox may be associated with the rare but potentially life-threatening risk of liver injury, including liver failure.

Avelox (moxifloxacin) is a prescription drug belonging to a class of antibiotics called fluoroquinolones. According to Bayer, the manufacturer, over 40 million patients worldwide have been treated with Avelox for a broad range of bacterial infections, including respiratory infections.

The Canadian report is not the first sign of trouble for Avelox.  In fact, there have long been concerns about whether fluoroquinolones contribute to tendon injuries, such as those experienced by our Levaquin clients. We have been engaged with these drugs since 2008 when the FDA issued a black box warning for the increased risk of tendinitis and tendon rupture associated with them.  Interestingly, reports of tendon-related issues had been reported for more than a decade, prompting a series of labeling revisions that finally culminated in the black box warning.

The same pattern seems to be emerging with respect to the risk of liver injury and Avelox.  In 2007, Bayer updated the labeling for Avelox in Europe to reflect this risk and sent a “Dear Doctor” letter to European physicians to draw attention to the change in early 2008.  Now Health Canada has stepped in and required the change in Canada.

Yet Avelox labeling remains unchanged in the U.S.  That doesn’t seem to make much sense, and it certainly could open the company up to liability claims should Americans be injured as a result of the product.

We’re continuing to monitor developments with this drug. If you are interested in working with us on cases related to Avelox or other fluoroquinolones, drop me a line.

What if the cost of lowering your cholesterol was excruciating muscle pain, or possibly kidney failure?  Is that a tradeoff you’d be willing to make?

I only ask because some patients are unwittingly making that choice.  The FDA recently issued a warning about the risk of muscle injury for patients who take the highest approved dose of Zocor, a popular cholesterol-lowering medication. Whether you are a gym rat or a couch potato, we’ve all pulled a muscle at some point.  That’s not what we’re talking about here. It’s far worse.

According to the FDA, muscle injury, myopathy, is a known side effect of all statin drugs.  But the warning says patients who are prescribed and use the 80 milligram dose of Zocor run an increased risk of developing muscle injury, including rhabdomyolysis. That’s right: “Rhabdo”.  Remember Baycol? Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and even death.

The risk of rhabdomyolysis is accelerated by potential drug interactions, and there is concern that patients are continuing to be prescribed higher doses of Zocor with other medications that are known to increase the risk despite dose limitations and drug-drug interaction precautions on the drug label. We first began following Zocor in 2008 when the FDA warned of an increased risk of rhabdomyolysis in patients taking this drug concurrently with the heart medication amiodarone.

An estimated 24 million Americans take cholesterol-lowering drugs. And the number is likely to go higher: Last month the FDA approved the preventative use of the cholesterol medication Crestor for millions of people who do not have a cholesterol problem.

We will continue to watch the unfolding announcements about Zocor and other drugs, and will be working with our co-counsel to identify cases where people have been injured.  As always, let me know your thoughts.

There’s something wrong about metal on metal.

Just ask the hip-transplant patients whose so-called metal-on-metal (MoM) artificial hips are causing some real problems.

In the last two weeks, The New York Times had three stories on the problems associated with these prosthetics in some patients, including severe tissue and bone damage.  You can check out the stories here, here and here.

Here’s a brief summary.  So-called MoM artificial hips have come under increasing scrutiny as the result of studies showing that the implants generate metallic debris as they wear causing serious health problems that often require replacement of the implant soon after it was inserted.  The problem is so acute, that many leading orthopedic surgeons have cut back on the use of these types of implants, or stopped using them altogether.

Then on March 9th, DePuy Orthopaedics, a division of Johnson and Johnson, warned that its ASR implant (which the company recently announced it was pulling from the market because of slow sales) in fact had a high early failure rate in some patients.

As if that’s not bad enough, on March 11, Science Daily reported that a new study found elevated levels of the metals cobalt and chromium in the offspring of patients with MoM hip implants.  The study concluded that there is a correlation between cobalt and chromium levels in the mother and those in her infant at the time of delivery.

So in a nutshell:  metal-on-metal is not a good thing.  The metal can grind away at itself causing early failure, and possibly even impacting unborn children if mothers had a MoM hip implanted.  What’s worse, there seems to be some evidence that manufacturers may have known about some of these risks and waited too long to report them, or to pull products from shelves.

We’ll continue to monitor these developments and if legal issues emerge, we’ll be prepared to help people who may have suffered as a result.