December 2007 Archives

The following appeared first over at our friends at Sports Law Blog. http://sports-law.blogspot.com/

In 1986, Congress passed the Anti-Drug Abuse Act which, among other things, mandated sentences for offenses involving crack cocaine to be 100 times more severe than for crimes involving powdered cocaine. Many have seen this disparity in sentencing guidelines as reflecting the similar disparity in the way the law treats the poor and the not so poor. Whether true or not, crack cocaine is typically associated with urban neighborhoods while powdered cocaine is seen as the drug of choice in the Hollywood hills and townhouses of Manhattan.

What does this have to do with Sports Law?

A major impetus for the Anti-Drug Abuse Act was the death earlier that year of Len Bias, the University of Maryland basketball star and number one pick of the Boston Celtics. Bias reportedly died of a cocaine overdose.

And today, the Washington Post is reporting the tragic story of Willie Mays Aikens, the former Kansas City Royals first baseman noted for being the only player in baseball history to hit two homeruns in a game twice in the same World Series. In 1994, Aikens was sentenced to 15 years in prison for possessing 64 grams of crack cocaine, about the weight of a candy bar; to receive a similar sentence for possessing powdered cocaine, one would need to be caught with more than 6 ½ kilos or more than 14 pounds.

Aikens has become the symbol of what many see as the unequal treatment of the poor and minorities in America’s judicial system. As he told the Post, "The disparity, as far as I'm concerned, is totally wrong. This took me away from my family. My girls were 4 and 5 years old when I was sentenced. Now they're 18 and 19."

Aikens is not scheduled to be released from the federal penitentiary in Jessup, Georgia until 2012.

Alan Milstein

     On January 7th, the United States Supreme Court will hear argument on whether lethal injection as a means of execution constitutes cruel and unusual punishment. Because of that pending matter, executions across the nation have been stayed since September 25th, though Texas hurried to perform the last one before the deadline when Judge Sharon Keller disgraced the judiciary by refusing to accept the late papers of the defendant's attorneys because, she said, "We close at 5."

    More than 3300 inmates currently sit on death row units across the country, though this year there were only 42 executions, a thirteen year low.

Alan Milstein 

Said the Rev. Charles Williams, president of the National Council for Community Empowerment, a civil rights group: "We are an African-American community that has been treated like guinea pigs." 

A New Jersey Chancery Court in Garcia v. Healthnet of New Jersey, Inc sent shockwaves through surgery offices when it held that a surgeon’s referrals of patients to an Ambulatory Surgery Center (“ASC”) he or she owns runs afoul of the New Jersey’s Codey law prohibition against self-referrals.  It is common practice (not only in New Jersey but throughout the country) for surgeons to own ASCs with other surgeons and for those surgeon owners to perform their surgeries at the ASC.  This model is cost effective, efficient and promotes quality. The Centers for Medicare and Medicaid Services("CMS")  recognizes the model in a safe harbor to the federal anti-kickback statute. The New Jersey Medical Board has acknowledged in advisory letters, under a limited factual setting,  that a surgeon owned ASC is an extension of his or her practice.  

             While this court decision has created uncertainty and concern in the health care community, New Jersey regulators should soon adopt regulations clarifying that such a referral is not a violation of Codey.  That is the right result, not only legally but also for patients and their health care providers.  For many years the Board has been working on draft amendments to its corporate practice of medicine regulations which, among other changes, would have clarified the model everyone believed to be permissible.  The Board has likely taken its time publishing the amendments in order to “get it right.”  Because of the lack of clarity and gaps inherent in the Codey law, “getting it right” is imperative.  Hopefully the court’s recent ruling will not accelerate the process at the expense of New Jersey finally achieving clarity in its regulation of the corporate practice of medicine and of self-referrals.  In view of all the other issues impacted by Codey and the present Board regulations, the ASC question is an easy one for the Board. 

Thomas J. Tamburelli 

       Zoloft is the most widely prescribed antidepressant in the United States, with 32.7 million prescriptions written in 2003. Though the drug was never approved for children nor ever shown to be effective for childhood depression, as much as 10% of the sales of the drug are for adolescents. In 2004, the Food and Drug Administration ordered Zoloft and other antidepressants to carry “black box” warnings — the government’s strongest warning short of a ban — about an increased risk of suicidal and violent behavior in children.

The case should wrap up on Wednesday with closing arguments and a jury verdict. During his testimony, Chase talked about the genesis of his hit show: He said he wanted to create a "satire of American corporate life" and wanted to explore the business practices of the criminal enterprise system:"I never understood the money," he testified, "Who keeps the records?"

Governor Jon Corzine on Monday signed legislation that eliminates capital punishment as a sentence in New Jesey and replaces it with life in prison without parole. At the same time, he commuted the death sentences of the eight men presently on death row at New Jersey State Prison in Trenton.

The Governor announced:"These commutations, along with today’s bill signing, brings to a close in New Jersey the protracted moral and practical debate on the death penalty." 

New Jersey, which had not executed any prisoner in the 25 years since the death penalty was reinstated, thus becomes the first state to legislatively repeal the death penalty since 1965 and also the first since the U.S. Supreme Court reauthorized capital punishment in 1976.

Pending before the United States Supreme Court is a case involving the issue of whether lethal injection as a means of execution is cruel and unusual punishment and, thus, unconstitutional.

The Maryland Court of  Special Appeals issued an opinion helpful to insureds in Maryland Casualty Co. v. Hanson. The case involved the issue of continuous trigger: whether continuous  exposure or damage constitutes a single or multiple losses such that the more than one insurance policy is stacked or whether the policy’s “limitation of liability” provision concerning repeated exposure or damage as one occurrence limits the available insurance coverage.

Continuous trigger is a relatively new idea in the law and concerns an issue important to landowners where there has been repeated injury or damage over time. Under the theory of continuous trigger, coverage is triggered during any time of exposure: initial exposure, continuing exposure or, in the case of property damage, by manifestation of loss.

In  Hanson, the plaintiffs were children exposed to lead paint at defendant’s property over six years, spanning several insurance policies. The Maryland Court of Special Appeals held that insurance coverage is triggered during all applicable policy periods in a case of continuous exposure and that the insured’s current carrier was on the entire risk.

Maryland Casualty Co. v Hanson. http://www.courts.state.md.us/opinions/cosa/2006/819s05.pdf

Now we wait. Currently pending before the Supreme Court and the Third Circuit are two critical cases involving the issue of federal preemption of state law claims against manufacturers of medical devices and pharmaceuticals.

The Supreme Court case is  Riegel v. Medtronic, Inc. In that case, the widow of Charles Riegel filed suit against Medtronic after the catheter inserted inside Mr. Reigel burst during a coronary angioplasty because it had been inflated beyond the recommended pressure. Medtronic moved for summary judgment on the ground that the state common law claims were preempted by the Medical Device Amendments to the Food, Drug and Cosmetics Act ("FDCA"), 21 U.S.C. § 360k(a).

The Second Circuit affirmed dismissal of the case holding that because the design of the device was approved by the FDA, any state claim alleging faulty design was preempted; only claims alleging negligent manufacturing could survive.

The Third Circuit case argued just a few days ago is Colacicco v. Apotex, in which the widow of a suicide filed suit against the manufacturer of the antidepressant her husband was taking alleging a failure to warn. Like in the device case, the company argued that state law claims should be preempted because they conflict with FDA's approval of the warnings accompanying the drugs.

The wrong decisions in these cases will be a setback to the rights of individuals to seek justice against large manufacturers who have injured them. The history of tort law reflects the fact that government regulators have not always been correct about the safety of the products they have approved. Perhaps the best example is the Thalidomide scandal of the late fifties. Here was a drug approved by the FDA as safe and yet it wasn't and thousands of children suffered severe deformities as a result.

If a product or device is proved defective or unreasonably dangerous, the issue alleged by the plaintiffs in these two cases, it should not matter that the FDA had once thought otherwise, particularly when the basis of such a decision is information supplied by the manufacturer. We will keep you posted.

 

This first appeared at Blog-Bioethics.Net.

The media coverage of the recent termination of the Pfizer torcetrapib clinical trial has been nothing short of startling in this age of aggressive investigative journalism. In short, the stories have been about Money, Money, Money. In announcing the halt of this experiment after a finding that human subjects had died because of their participation, the New York Times announced, “End of Drug Trial is a Big Loss for Pfizer.” Bloomberg broke the story by observing: “Pfizer Shares Drop After Company Abandons Cholesterol Drug.” The Toronto Star had a different take: ‘Drug Failure Cost Pfizer 23 Billion.”

In its front page story, the New York Times further added this remarkable conclusion: “Pfizer will not face the product liability lawsuits that have dogged Merck over its painkiller, Vioxx . . . Patients in clinical trials must sign waivers confirming that they understand the risks they face when they take unapproved medicines in clinical trials.” Do they?.

Why am I skeptical? Money. Money. Money. Pfizer had long touted this drug in meetings with shareholders, actual and potential, as the Mother of all Blockbusters. Could this potential have delayed the end of this experiment, even though some researchers had long warned that such drugs might actually pose more risks than benefits.

Two aspects of this trial, what surprisingly little we know about it, trouble me. First, the experiment took place largely in the offices of thousands of cardiologists across the country. What this means is that the subjects may have been induced to participate by their long trusted physician and signed on not to better mankind (or “Pfizer”) but because they believed their physician thought it was in their best therapeutic interest to do so. This might make the informed consent document neither voluntary nor informed.

Second, Pfizer says the delay in halting the trial was because this was a double blinded experiment with one arm taking Lipitor only and the other adding torcetrpib. Only when the data managing subcontractor removed the blinds were the devastating results revealed.

Call me naïve (I’ve been called worse), but why double blind a study where the data is comprised of good and bad cholesterol numbers? Does anyone believe there could be a placebo response that would raise good cholesterol? I have long advocated that the industry’s reliance on this “gold standard” is not always to eliminate researcher bias or that dreaded placebo response. Sometimes it is to keep subjects and physicians in the game. And if this had not been a double blinded study, could the ongoing results have been known to the physicians and disclosed to their patients earlier?
Alan Milstein

This first appeared at Blog-Bioethics.Net.