On June 29, 2011, a panel of the Food and Drug Administration rejected the drug Avastin for use in the treatment of end-stage breast cancer.  Manufactured by Genentech, a subsidiary of Roche, the drug has been approved for the treatment of other types of cancer, but as recently reported by NBC Nightly News, the panel believed that the drug is not effective, and the side effects too serious, for the treatment of breast cancer.  A final decision will come from the FDA in a few months.

As can be imagined, this action has brought a firestorm of criticism of the FDA.  Because the drug will still be on the market, it will be possible, perhaps, for doctors to prescribe the drug “off-label” for breast cancer, but of course, insurance companies won’t pay for it if it’s not approved for the specific disease for which it is prescribed.

But, as FiercePharma reports, it appears that Avastin will not be dropped from Medicare coverage, no matter what the FDA decides down the road, and the decision could have grave consequences for the FDA down the road:

Earlier this month, the State of South Carolina was awarded $327 million in damages from drugmaker Janssen Pharmaceutica, Inc., a Johnson & Johnson subsidiary, under the state’s Unfair Trade Practices Act for deceptive marketing of its anti-psychotic drug, Risperdal.  The suit alleged that the company had, for years, sent deceptive letters to doctors in which the company downplayed the links between Risperdal and diabetes.  As we previously reported here, South Carolina could have received upwards of $3 billion dollars from the suit, as the State Attorney General argued that every single prescription, sample box or “Dear Doctor” letter written since the 1990s could constitute a violation of the law worthy of a $5,000 penalty.

It was in April that the South Carolina jury found the drugmaker to be responsible.  Only recently did Spartanburg County’s Judge Roger Couch determine the amount that the company would be responsible for paying the state.  Charleston’s The Post and Courier reported that Judge Couch, in his order, wrote that Janssen knew that its drug was associated with health problems and that it intentionally hid those studies.  He said the company “systematically set about in a concerted effort to conceal that information and to manipulate the information available to the public for the purpose of protecting or improving its market share.”

The award reportedly marks the largest penalty for breaking the South Carolina Unfair Trade Practices Act and also represents the state’s largest award in a drug marketing case.  Bloomberg.com reports that on June 3, Janssen officially announced that it will appeal Judge Couch’s order.  It maintains that  company fully disclosed Risperdal’s health risks and that it properly marketed the anti-psychotic medicine.

As we previously reported, this South Carolina case is not the first of its kind.  A Pennsylvania case was dismissed in June, and another case in West Virginia was dropped in December.  A case in Pennsylvania, however, ended with a jury’s awarding of $257.7 million to the state for the drug company’s alleged offenses similar to those addressed in Judge Couch’s recent order.  As with the recent South Carolina verdict, Janssen has appealed the Pennsylvania verdict and maintains it acted properly.

Recently, the estates of Pennsylvania couple, Sean and Natalie Wain, filed a product liability lawsuit against Pfizer in the United States District Court for the Western District of Pennsylvania. The complaint alleged that the pharmaceutical company’s smoking cessation drug, Chantix, caused Wain to experience psychotic rage, shoot and kill his wife, and commit suicide in May 2009. Allegedly, Wain had been taking the drug for one or two weeks prior to the incident.

This action is only the most recent in a long line of Chantix-related claims. Over 100 lawsuits have been filed against Pfizer alleging that plaintiffs or their decedents committed suicide, suffered severe injury attempting to commit suicide, or exhibited unusual behavior after taking Chantix. Besides the consumption of Chantix, there is only one other apparent similarity among the plaintiffs – they were all deprived of cigarettes.

Being deprived of an addiction is difficult even without the alleged side effects of medication. We here at Abnormal Use know this all too well. No phone messages are checked or emails are read at the office until we get our first taste of coffee in the morning. On those rare occasions when that fresh nectar is not immediately available upon our arrival, we get a little angry. Our indignation only escalates as we await the percolation of our precious drink to relieve us of the perils of our temporary detoxification. While we have never reached the level of “psychotic rage,” we have also never been deprived of coffee for two weeks.

According to a study by the Institute of Safe Medication Practices, Chantix was shown to create violent behavior when users first began taking the drug, often before they had completely stopped smoking. The study also noted that the violent behavior ceased for 93 percent of the participants after they quit taking Chantix.

While this study may appear to be damning for Pfizer, a closer look indicates that it may not be as conclusive as the plaintiffs desire. First, the study was a mere compilation of Chantix adverse event reports submitted to the FDA. By limiting itself to the 78 reports submitted to the FDA and not examining the thousands of other Chantix users, the study lacks the ability to paint a global picture of the drug’s side effects. Second, this was not a controlled research study. The Institute did not gather a representative sample of individuals who wished to quit smoking. They did not study the individuals prior to the consumption of the drug. They did not administer any placebos. This study is far from what one would expect of viable scientific research.Without a controlled environment, the study lacked the ability to factor in third variables. By examining only cases reported to the FDA, at best, the study reveals correlation – not causation. With these limititations, suggesting that it is Chantix, not the process of quitting smoking, which is causing these side effects is premature.

We do not mean to suggest that these plaintiffs did not display violent behavior after taking Chantix. Nor do we suggest that quitting smoking always leads to psychotic rage. Rather, we suggest that we withhold judgment of Pfizer and Chantix before making sure that no other factors are at play. Of course, if making rash conclusions is your addiction, we know how withholding judgment may make you feel.

This is not the first big award handed down against drugmaker Allergan. Last May, we reported here on a $15 million verdict in favor of an Oklahoma doctor who similarly alleged she suffered injury from Botox as a result of the maker’s failure to provide sufficient information regarding possible side effects. In that instance, Allergan vowed to appeal the verdict. It remains to be seen whether in this instance Allergan will take the benefit of Virginia’s punitive damages cap and pay, or whether it plans to similarly appeal the most recent verdict.

South Carolina’s suit is the fourth case of its kind to go to court. We previously reported here on a similar case tried in Louisiana. In that case, the jury awarded a $257.7 million verdict against the drugmaker. The jury found that the company had sent 7,604 “Dear Doctor” letters and made a total of 27,542 sales calls in which its sales representatives claimed Risperdal was safer than competing antipsychotic drugs such as Eli Lilly’s Zyprexa and AstraZeneca’s Seroquel. The Louisiana jury assessed penalties of $7,250 for each violation. Of the other two cases, the Pennsylvania case was dismissed in June, and another case in West Virginia was dropped in December.

As reported by TheState.com, Janssen has appealed the Louisiana verdict, although representatives have reportedly not yet decided whether they will do the same with this latest South Carolina jury verdict. That likely will depend on the dollar number reached by the Spartanburg County judge. We’ll continue to follow this case and report on Judge Couch’s ruling.

“It threatens to extract significant competitive harm on extremely vulnerable pregnant women, and it threatens to significantly inflate health-care costs at a time when controlling health-care costs is a critical national priority,” said David Balto, a Washington antitrust lawyer who worked at the FTC.

This is an issue that will continue to force some tough choices. And, cynical though it may seem, we are certain that litigation about this very issue is inevitable, if not with this drug than with the next one down the line.

Not too long ago, The Wall Street Journal Law Blog reported that drugmaker Hospira, Inc., based in Lake Forest, Illinois, will permanently cease production of sodium thiopental, an anesthetic that is a key component for the lethal injection drug combinations used in capital punishment. Although states can use a different anesthetic in place of sodium thiopental, such a switch likely would have to be approved by courts and potentially state legislatures.

According to an article in The New York Times, Hospira had planned to resume production of the drug this winter at its plant in Italy, as it does not have any domestic facilities capable of producing the anesthetic. The Italian parliament, however, issued an order prohibiting exportation of the drug if it might be used to perform lethal injections. Hospira issued a statement on January 21, 2011, in which it noted the difficulty of “control[ling] the product all the way to the ultimate end user” to ensure it was not used for capital punishment. Given the issues surrounding the product and the challenges associated with bringing the drug back to the market, Hospira decided to “exit the market.”

Last year, a temporary halt in production delayed scheduled executions in California and Oklahoma. As a result of the shortage, pentobarbital, a drug used to euthanize animals, was reportedly approved for use in capital punishment in Oklahoma when the state sought court clearance to use the drug as a substitute. The New York Times reports that the process of approval in many states may take much longer than that provided for in Oklahoma. Specifically, it quotes the executive director of the Death Penalty Information Center, who notes that many states will require formal proposes, public comment, and challenges in court, which is a process that can take months to complete. It is expected, in light of Hospira’s recent statement, that most states will now follow Oklahoma’s lead in seeking similar approvals of the substitute drug.

The news of Hospira’s decision has reignited debates online about the merits of capital punishment. (See here and here, for example). Hospira’s announcement most certainly will cause states throughout the country to scramble for approval of a new drug combination.