October 5, 2009

Botox Sues for Right to Promote Off-Label Use of Drug

Allergan Inc., the makers of Botox, and it's sister product, Botox Cosmetic, are bringing a lawsuit against the United States, the FDA and it's commissioner, Margaret Hamburg, as well as the Kathleen Sebelius, secretary of Health & Human Services.  The suit alleges that the country's current stance concerning off-label use of drugs is unconstitutional.

A doctor can legally prescribe a medicine to treat an illness even if that medicine is not approved for that purpose.  This is a so-called off-label use.  While this practice is legal, drug companies are not allowed to "push" off-label uses to doctors. 

Drug companies, obviously find this unfair.  They argue, that if a drug works to treat an illness they should be able to promote it even before they have proceeded through the countless clinical trials needed in order to gain approval from the FDA.  The basis of their argument - Free speech!

Allergan's complaint claims the FDA "has promulgated a series of overlapping and interlocking regulations that combine to render unlawful virtually all manufacturer communication, through any avenue, to any audience, about the lawful off-label use of a prescription drug."  Furthermore, "the inability to share such important information proactively with the medical community violates the First Amendment and potentially diminishes the quality of patient care."

I think the First Amendment argument is a novel approach.  The Courts, however, have often limited free speech if necessary for the greater good.  One could argue that the FDA is already hopeless in combatting the power of drug companies, and this lawsuit is an attempt to cripple the FDA which serves an important and valid purpose for the general public.

A victory for Allergan clearly creates a slippery slope for drug manufacturers who will be able to enter a product into the market for one purpose and then promote it for countless others without the safeguards created by the FDA.
October 2, 2009

Musicians - Obtain a Mechanical License to Legally Use Other's Material

I am often asked: Can I legally record and distribute a cover song? And if so, how?

The answer is a mechanical license.  These licenses are paid and distributed to the artists who own the intellectual property that you are covering.  This is the only legal way to record and distribute material that is owned by another artist or musician.  So, if your band is planning on covering the The Clash for your demo or CD, be sure that you are not setting yourself up for a lawsuit.

Many retailers, both in store and on-line, will refuse to carry music if they believe the necessary licenses are missing.  This is because they open themselves up to a lawsuit for selling bootlegged music.  The license fees are relatively low and well worth the expense to avoid a lawsuit.

My office can help you obtain the necessary licenses so that you can sell your music with confidence and get your independent CD into the stores.   Call for a free consultation today.
September 29, 2009

An Economic Argument Against the Death Penalty

Personally, I abhor the death penalty for a number of ethical, political, and philosophical reasons.  Fortunately, I practice in two states that have abolished the practice, so it is not a day to day concern of mine.  That said, here is an interesting editorial from the NY Times making an economic argument to abolish the death penalty nationwide.
September 25, 2009

Coyote Ugly Sued

In the world of interesting injury lawsuits comes one from cu for blogTennessee.  A college student is suing the Coyote Ugly Saloon, made famous by the movie of the same name and known for women dancing on top of the bar, after she fell off the makeshift dancefloor striking her head.

I would be quite astonished if this was the first time the bar was sued for such an event.  The situation does present interesting liability questions.  According to the plaintiff, she was encouraged to climb on to the bar by employees of the club.  She claims to have fallen because the bar top was slippery with drinks.  So it sounds like a great liability claim until we consider that she is a college student in a bar.  I'm going to guess that defense will argue she was bombed.  Then again, all the more reason for the employees to keep her from dancing on the bar.

Here's wishing her a quick recovery.
September 23, 2009

Another Interesting Article on the Medical Malpractice Debate

The NY Times published this piece by David Leonhardt, which I believe does a great job of avoiding the emotion of the subject and examining the matter on the facts alone.  Tort reform is on everyone's lips as we discuss changes to our health care system, but there is no valid reason why.  Our health system is a mess for a number of reasons, the least of which is the plaintiff bar.  Mr. Leonhardt cites economists who say:
The direct costs of malpractice lawsuits -- jury awards, settlements and the like -- are such a minuscule part of health spending that they barely merit discussion...

...All told, jury awards, settlements and administrative costs -- which, by definition, are similar to the combined cost of insurance -- add up to less than $10 billion a year. This equals less than one-half of a percentage point of medical spending.

I have made the point in previous posts, that very few medical malpractice cases are accepted by attorneys and/or go to trial.  The high cost of a lawsuit and the difficulty in proving medical malpractice prohibits excessive lawsuits.  Mr. Leonhardt supports my opinion:
After reviewing thousands of patient records, medical researchers have estimated that only 2 to 3 percent of cases of medical negligence lead to a malpractice claim.

Contrary to the perception of some, we do not have a court system backlogged with frivilous medical malpractice lawsuits which are causing the death of our health care system.  The number of cases and costs attributed to medical malpractice litigation is astonishingly low in comparison to the total cost of our health care system.

Mr. Leonhardt does criticize the current system by pointing out that fear of malpractice leads to defensive medicine which is often wasteful.  Unfortunately, there is no solution to combatting defensive medicine.  States that have medical malpractice caps, or other legislation meant to curb litigation, often have similar amounts of spending.  One reason could be that doctors are paid more for doing more, and the excess testing and treatment is as much financial opportunism as it is defensive medicine.
September 16, 2009

Peter Neronha Sworn in as US Attorney in Rhode Island

Former State prosecutor, and fellow graduate of my alma mater BC Law, Peter Neronha was today sworn in as the US Attorney for Rhode Island.  The Senate confirmed Neronha's confirmation on Tuesday with the support of both RI Senators, Reed and Whitehouse.   Neronha became a federal prosecutor in 2002 after spending several years as a Rhode Island State prosecutor.

Best of luck.
September 15, 2009

Another MBTA Accident

Boston.com is reporting that a commuter rail pulling into South Station has been involved in an accident injuring at least 12 people.  Apparently, the conductor pulled the train too far into the station striking the rubber bumper at the end of the line.  Although, the conductor was driving at a low rate of speed at the time of the accident, many passengers were already standing and collecting their bags which presumably caused a number of passengers to fall.  There is no word if any of the injuries are serious.
September 11, 2009

Salmonella Recall in Rhode Island

Kilwin's Quality Confections is recalling all seven ounce packages of chocolate covered peanuts and all bulk chocolate covered peanuts sold in its stores before April 1 because of possible salmonella contamination.  Salmonella can cause serious infections and even death, particularly in children, the elderly and those with weakened immune systems.

No illnesses have been reported to date.  Kilwin's is a Michigan candy retailer with stores in several States.  The Rhode Island franchise is located in Newport.  If you or a loved one has been injured because of this product, contact our office for a free consultation.
September 11, 2009

No One is Free From the Ire of the Recording Industry

Today it appears that the Ellen DeGeneres Show is going to be sued for illegally broadcasting music.  It appears that those quirky trademark dances that Ellen performs which some people, not including this author, find funny, have been performed over music that was not properly licensed.  That's right - a national television show broadcast to millions apparently forgot to obtain licenses and permission to broadcast music. 


When asked why they did not obtain the proper licenses, one of the show's producers allegedly replied we don't "roll that way."  That at least is kind of funny.  Ellen herself was not listed as a defendant in the suit.

September 3, 2009

Musicians - Copyright Your Music!

To begin with the basics of copyright law - An artist is the owner and sole copyright holder of his or her creation.  Copyright protection begins to attach to the work of art the moment that it is created and/or published.  This, however, may be inadequate protection.

By registering your copyright with the United States Copyright Office:

  • You are making clear when your work was created;

  • You are telling the world that this idea, song, image is your creation;

  • You gain valuable legal protections in the courtroom that may be absent without a registered copyright;

  • You are ensured that the Courts will hear your case;

  • You will not have any difficulty presenting evidence as to when your work was created.


A lot of musicians ask me about the so-called "poor man's copyright" in which the author of a work mails the work to himself in a sealed envelope to prove the time of creation.  While there is some merit to this process, there are cases in which the material was not allowed into evidence for one reason or another.  Instantly, the author's entire case was lost.  In some circumstances, registration is necessary in order to bring the suit (in other words, if you don't hold a registered copyright, the courts won't even hear your case).  As such, I would not recommend that any serious musician rely on the "poor man's copyright."

In the age of the internet where a song can be heard and stolen from 3000 miles away, it is imperative that musicians protect their work.  There are two examples of copyright infringement that all musicians want to prevent.  The first is illegal downloading and possession of your material.  The second example is where someone hears your song, lyrics, or melody and "incorporates" it into his or her "creation."

Federal registration of a copyright is the only way to ensure your protection.  It is both easy and inexpensive.  Rest easy knowing that your work is fully protected and concentrate on what you do best - creating music. 

Call my office for a free consultation and we can discuss your options concerning copyright and trademark.
September 2, 2009

Pfizer Settles Fraud Allegations for Astonishing 2.3 Billion!

That's right - 2.3 BIllion. 

The settlement brings an end to numerous civil and criminal filings against Pfizer and subsidiary, Upjohn, regarding the painkiller Bextra which was pulled from the market in 2005, as well as a few other drugs.  As part of the settlement, the corporation will plead guilty to misbranding Bextra with the intent to defraud.

The Dept. of Justice initially brought the charges alleging that Pfizer promoted Bextra for off-label uses that were not approved by the FDA.  The Department also alleged that Pfizer gave kickbacks to doctors to encourage them to prescribe Bextra (a charge that Pfizer still denies).

I'd like to believe such settlements will cause drug companies to re-think the way they rush drugs to the market and promote them to the public, but alas, much like the tobacco companies, such settlements are a small drop in the ocean.  I wouldn't be surprised if Pfizer still made a profit on Bextra despite the settlement.
August 31, 2009

Another Fatal Motorcycle Accident

Sunday, a Westerly man was killed while riding his motorcyle marking the 14th fatality this year in Rhode Island involving motorcycles.  I do not know the details of Sunday's accident, but it is clear that 14 fatalities in this small State is far too many. 

Unfortunately, around 3,000 cyclists are killed each year across the country.  Both drivers of cars and motorcyclists need to help bring down this staggering number.  Drivers of cars are unaccustomed to looking for motorcycles or bicyclists.  Often while looking for other vehicles to avoid, a driver's eye can miss a motorcyle or bike.   Unfortunately, a relatively minor car accident can result in a fatal motorcycle accident. 

I am an avid bicyclist myself and know the unique hazards that motorcycle and bicycle riders face.  It is always on us to drive defensively when the rest of the world is innattentive.  If you have been injured while riding a motorcycle, it is important to call an attorney who understands this difference and has experience representing bikers.
August 27, 2009

An Argument Supporting Liability for Future Harm

I first came across this law review article in the Law Professors blog which included an abstract and I decided I had to read the article.   Professors Ariel Porat and Alex Stein have written a compelling argument supporting liability for future harm in tort cases.

Historically, a plaintiff could not be compensated for the "chance" that illness might develop at a later time.  A small example of this is a plaintiff who suffers a concussion in an auto accident.   Obviously, the plaintiff will be compensated for the head injury, but it is well documented that concussions can occur more easily, and with greater severity, after the first one is suffered.  The plaintiff, however, will not be compensated for the increased likelihood that he or she will suffer concussions in the future.

Professors Porat and Stein begin their argument with a relatively recent Supreme Court case, Norfolk & Western Railway Company v. AyresThe plaintiff in that suit contracted asbestosis from exposure to asbestos along the railway.  The plaintiff suffered emotional distress because he was aware that 1 in 10 people suffering from asbestosis eventually develop mesothelioma, a fatal form of cancer.  Even though the plaintiff had not yet developed mesothelioma, the United States Supreme Court in a 5-4 decision, held that the plaintiff was allowed to recover if the distress was proven to be "genuine and serious."

This case, while a step forward, is not far enough because the plaintiff had already contracted asbestosis, a very serious condition.  Common law courts have often allowed recovery for emotional distress stemming from an illness or injury, in this case, asbestosis. 

This article takes the next step and argues for liability for future harm without the necessity of a pre-existing condition.  The authors propose a probability approach where the plaintiff should be compensated for the illness he or she has been exposed to multiplied by the probability of such illness manifesting.

Before I do any further disservice to the authors argument, I will stop and suggest that you read their article in the full.  I was able to download it via SSRN here.
August 24, 2009

Many Providence Day Cares Putting Children At Risk

The City of Providence has almost 500 day care centers, many of which are home day cares located in poor sections of the City.  While it is quite easy to obtain a license, a recent article in the Projo, shows that being licensed is not enough. 

Many day cares were cited or suspended due to issues such as improper ventilation that could lead to carbon monoxide build up, fire hazards, improper electrical wiring, etc.  One house was infested with flies and sickly animals. 

The economic reality is that proper day care is incredibly expensive and home day care offers a cost-effective alternative to a low income family.  Ensuring that the facility is properly licensed and insured is not enough, however.  Parents must carefully examine the facilities where the kids will be spending their time to ensure that they are safe and secure.
August 21, 2009

"Skanks in NYC" Blogger Identified

Any regular reader of this blog is aware that I am fascinated watching the law adapt and adjust to the ever increasing use of the internet and social medial as a form of sharing ideas, communication, and material... legally and illegally.

"Skanks in NYC" was a google hosted blog that existed for the sole purpose of smearing and defaming a model named Liskula Cohen.  A defamation action was filed and the plaintiff convinced the judge to force google to disclose the bloggers information so that he or she would appear in the defamation action.  The blogger was identified as Rosemary Port who used the blog to seek revenge against Cohen for the most common and cliched reasons, a man.  Apparently Ms. Port thought that Cohen had spoken poorly of her to an unnamed gentleman.

Once identified, Cohen has chosen to drop the suit so long as the website is taken down.   This is an important decision that rides the line between privacy, free speech, and civil freedoms.  Ms. Port is shocked that her privacy was disturbed and believes the Court decided wrongly.    Her actions, however, made the decision easier for the Justice.  The blog (which I admittedly have never seen) seems to have no purpose other than to abuse and smear the reputation of Ms. Cohen.   Ms. Port does not qualify as a legitimate reporter, nor is she sharing news with the public.  Her actions cross the line of free speech and she did not deserve anonymity.

I expect to see a number of these cases come up in the future.  It is SO EASY today to besmear and defame a person.  On twitter, myspace, facebook, or Ebay (as in a case I handled in which a buyer was so dissatisfied that she made it her life's goal to destroy my client's business and reputation.)  We may see a flood of defamation lawsuits stemming from social media. 

Long gone is the day when we gathered around the water cooler making snide comments.