The Business Of Law

Archive for December, 2009

FDA Keeps Close Eye on Meridia

by Marc Stern on Dec.08, 2009, under Uncategorized

Call it food for thought.

The U.S. Food and Drug Administration (FDA) is reviewing the preliminary findings of a new study of the weight loss drug Meridia.  However, the agency recently released an early communication indicating that certain patients taking the drug may have a higher risk of heart attacks, strokes, and other cardiovascular problems. 

Consumer advocacy group Public Citizen last week asked the FDA to ban Meridia because of the study findings.  The group noted that a total of 84 deaths associated with the drug have been reported to the FDA as of June 2009.

The recent study tested sibutramine (sold under the brand name Meridia) in overweight or obese people with an increased risk for heart problems. The analysis of these data is ongoing and FDA was careful to say that it is making no conclusions about the preliminary findings at this time.

That said, the preliminary analysis suggests that patients using sibutramine experienced a higher number of cardiovascular events compared to those using a placebo. The preliminary data shows that cardiovascular events were reported in 11.4% of patients using sibutramine compared to 10% of patients using a placebo. This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population.

The FDA warned that doctors and their patients should continue to follow current guidelines, which recommend against using Meridia in patients with a history of heart-related health issues. As always, the FDA recommends that consumers should talk to their doctor about whether Meridia is right for them.

We at Sokolove Law will be continuing to monitor the FDA’s review of Meridia, and we’ll bring you any further news as it develops.

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Change is Contagious

by Mike Skoler on Dec.06, 2009, under Uncategorized

Mr. Ivory Tower Law School should be careful, because Mr. Big Law Firm has come down with a serious case of change, and it’s contagious.

As I’ve written before, the economic recession, an outdated business model, and international pressures are combining into a nasty fever for Big Law.  Gone are the first-year associate salaries that would make a Rockefeller blush, gone are the huge bonuses, gone are the stadium boxes and other perks and privileges.  Ashby Jones over at the WSJ Law Blog last week picked up on the fact that this fever is catchy, and that Big Law  just sneezed all over Big Law School.

Ashby’s piece quotes a recent article on the Conglomerate Blog, by Professor Erik Gerding of the University of New Mexico Law School.

Gerding’s piece focuses on the fact, that for years, Big Law has sustained Big Law School.  Specifically, he notes that the business model for Big Law School is basically, many students all paying high tuition.  That model is contingent, says Gerding, on the promise of high-paying Big Law jobs on the back end to help students pay off the tuition.  Less Big Law jobs and lower Big Law salaries means less Big Law School students.

Ashby goes on to theorize that perhaps this change might result in fewer students, and a more practical education at America’s law schools.  Here’s hoping he’s right, and if I may (though as I’ve said, I’m not a lawyer) offer my own suggestions for some changes:

1.  Focus on practice-oriented education.  At the moment, law schools put a nearly singular focus on bar passage, and rightly so, since that’s a prerequisite for practicing law, but don’t let the law schools fool you.  The reason they focus on bar passage is because that’s a key metric on the outside rankings by organizations like US News, etc.  I’d like to see schools focus more on practical curricula such as trial practice, alternative dispute resolution, and research.

2. Emphasize how to run a successful law firm.  For years, the path for law students has been to leave law school and go practice at a big firm.  As a result, the only thing they teach you in law school about running your own law firm is how not to steal your client’s money.  I’d like to see real classes in the business model of a professional organization.  Let’s teach lawyers how to run a law firm, and how to practice law at the same time.

3. Expand access to law school by offering diversified schedules. Simply put, law schools can be a bit uppity.  They resist the idea of a part-time legal education as not worthy of the profession.  Sure some have great evening programs (see Georgetown Law Center, for example), but those are few and far between, especially when compared to the many and varied flexible programs offered by top business schools. I would like to see us encourage more people to attend law school without sacrificing their current careers, or delaying having a family.  Let’s give young lawyers the same flexibility that we give other graduate students.

4. Lower the cost.  This one goes hand in glove with #3 above, and it’s going to get me in real trouble.  Law school does not need to cost as much as it does.  We need to lower the cost, by cutting out overhead that is wasteful and needless, and we need to expand the loan forgiveness programs that allow students to relieve themselves of debt by giving back to the community.  At one point being a lawyer was thought of as public service.  As the industry changes, we should do more to reward young lawyers who are in the profession for something other than the money.

These are just a few of my thoughts, but if the changes happening to Big Law have indeed infected Big Law School, I want it to come back better, stronger and leaner than ever.

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FDA Recall of Ti Synex II Vertebral Body Replacement

by Marc Stern on Dec.01, 2009, under Uncategorized

We are currently investigating the FDA’s Class I Recall of the Ti Synex II Vertebral Body Replacement device manufactured by Synthes USA.

The implantable device is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body.  Failure of the central body component resulting in loss of vertebral body replacement height has been reported in some patients.

Potential adverse health effects linked to device failure include nerve injury, increased pain, spinal compression fracture, failure of supplementary fixation, and/or the need for revision surgery.  If you’re interested in working with us on this case type, please drop me a note.

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