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.

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.

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.

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.

Sokolove Law will be in the thick of things during the five-day convention, from our Annual Co-Counsel Event to a session on “Increasing Your Practice Ethically Through Social Networking” presented by our General Counsel Gabe Miller. But our core mission, as always, will be to connect with our co-counsel and prospective co-counsel to understand the needs of your business and to share what’s new at Sokolove Law.

Leading that charge will be Marc Stern, Vice President of Business Development for Sokolove Law.  Marc directs our top-notch business development team and has overall responsibility for establishing and managing relationships with law firms who stand to benefit from Sokolove Law’s deep marketing expertise. Marc’s own extensive experience in developing, leading, and executing “B2B” strategies for organizations such as Fidelity Investments, The Kessler Group and Aliaswire has helped to shape Sokolove’s innovative B2B strategy.

Marc will be on-site throughout AAJ’s 2010 Annual Convention to engage with co-counsel and potential co-counsel about how Sokolove Law’s business model helps firms achieve their goals and to explore new potential opportunities to work together.  Shoot him an email if you want to meet in Vancouver next week.

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.

So I read with some interest a recent piece on this subject in the Legal Intelligencer by Joel Rose, a management consultant to law firms.  Rose’s article dealt with the topic of law firm retreats, and he argued that a retreat could be a very effective management tool to accomplish many purposes.

I agree. A change of venue can help jumpstart a change in thinking. Why? Being out of the office levels the playing field and gives everyone a chance to contribute and be heard. And leaving the day-to-day distractions of work behind—even for a brief time–is an effective way to get leaders to think outside of the box and dream. Finally, it’s been my experience that people simply behave differently out of the office.

But like Rose, I think that retreats have to be done right – and for the right reasons — particularly in challenging economic times. A retreat really isn’t supposed to be a day at the beach – even though you may be staying near one.

First and foremost, the retreat must serve a specific purpose.  Rose says it could be as simple as asking the partners to take a step back to think longer-term about the firm’s objectives, or it could be to gather the firm’s leadership to tackle a specific problem. Both are good reasons to forcibly wrest the partners from the shackles of their client work to briefly come together to make important decisions.

But retreats can serve another important purpose and that is to force leadership to think critically about the evolution of their industry and to develop strategies and tactics for how a particular firm or company can respond to those changes.

At Sokolove Law, for example, we’ve made good use of short and highly focused retreats on a number of fronts: to bring key leaders together, to hone strategy to better serve the changing needs of our co-counsels, and to set high expectations for the execution of that strategy. (We’ve recently had two successful retreats with subsets of our staff for exactly these purposes.)

Whatever your reason for calling a company retreat, Rose says that good planning and execution are the keys to a successful outcome.  This includes setting a focused agenda, having the right people in the room, making sure that there is a session leader who can get the most out of the assembled group, and setting a clear plan for implementing recommendations and action plans coming out of the session.

If you follow these practical steps, I think you will find that the company retreat is nothing to run away from.

Missouri’s new exam will focus on key US legal principles and drop the state-specific questions, according to a story in the St. Louis Post-Dispatch. Committees with both the American Bar Association and the National Conference of Bar Examiners have signed off on the plan’s benefits. The state expects to offer the new test in February 2011.

This movement in favor of a uniform bar exam is an important step in the right direction. Legal groups have long pushed for uniformity in the bar exam, now administered through a multi-state test coupled with individualized state exams. Advocates say a single licensing test will allow attorneys who pass it to have more latitude in where they can practice. Standardized exams are already the norm for other professionals such as architects and doctors.

The Post-Dispatch story includes a nice breakdown of this emerging trend, noting that “five to ten other states could be on board in the next few years.”

Adoption of a uniform bar exam has been a long time coming and it’s a positive change.  But there’s more to do. My hope is that this development could also help open the door to uniformity for all of the professional rules that now govern the practice of law.

Rules on professional responsibility (for example, regarding conflicts of interest and legal advertising) vary widely by state.  This has important consequences.  First, it makes being a truly national law firm (as Sokolove Law is) difficult, since it is a challenge to keep track of changing rules in 50 different jurisdictions let alone attempt to comply with them.  The effect is that competition is stifled to the detriment of the clients.

It also doesn’t make a lot of sense. To be sure, professionals in other fields must be licensed by the state in which they wish to practice, but this is often easily accomplished by proving passage of nationally accepted standardized tests (for example, the medical boards) and sufficient professional competency (usually demonstrated through experience, and lack of a disciplinary record).  The same should hold true for lawyers.

Uniformity and standardization both in the requirements for admission to the profession, and in the rules governing it, should be a goal all lawyers can agree on.

Disagree?  Show Me… (pun intended) why I’m wrong.

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.

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.