The Fight Over Avastin

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:

Indeed, House Republicans are promising to make Avastin an issue during next week’s hearings on the reauthorization of FDA’s user-fee funding provisions. House Energy and Commerce Committee Chairman Fred Upton says he has “grave” concerns about FDA’s review of the data on Avastin, the Wall Street Journal reports, and aides are saying that either he or another member will raise those concerns at Thursday’s hearing.

Read the referenced Wall Street Journal article here.  Stay tuned.  If indeed the full FDA precludes usage of Avastin for the treatment of breast cancer, it will present many questions for the manufacturer, which will undoubtedly know that doctors may still be prescribing it for use as a treatment for the disease.  Of course, manufacturers of all sorts of drugs know that their medication is prescribed off-label, but this will be a much higher profile case than most.  Will that knowledge hurt the manufacturer if any defects are alleged?  We will have to wait and see.  Preemption is always a good argument in drug cases, but what preemption would there be if the FDA did not approve the drug for use for this particular disease?

South Carolina Wins $327 Million from Drugmaker in Unfair Trade Practices Suit

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. 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.

Psychotic Rage: Drug Side-Effect or Detoxification Byproduct?

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.

Botox Maker Hit with $200 Million Punitives Award, But Award Subject to State’s Cap

A federal court jury in Richmond, Virginia, recently ordered drugmaker Allergan, Inc. to pay a staggering $212 million to a 67-year old man who said he suffered brain damage as a result of receiving Botox injections to treat cramps and tremors in his hand in 2007. Ray v. Allergan, Inc., 3:10-cv-00136 (E.D. Va. April 28, 2011). The plaintiff reportedly alleged in his suit that Allergan failed to warn him that Botox injections could trigger an autoimmune reaction that could cause brain damage. He alleged that the injections caused severe medical complications which resulted in total disability and $643,800 in medical costs. He reportedly alleged in his complaint that the drug left him “frequently confused or disoriented,” and that Allergan did not sufficiently warn doctors or patients of the possibility over fear of losing sales. reports that the jury’s award includes $12 million in compensatory damages, and an additional $200 million in punitive damages. Botox is Allergan’s top-selling drug, accounting for $1.42 billion in sales last year alone, which was 29 percent of the drugmaker’s revenue. Perhaps the jury thought that such huge numbers in revenue justified a huge punitive award. Interestingly, however, by Virginia statute, the punitive damages award will be capped at $350,000. The statute further provides that although the jury is not to be made aware of the cap, the trial court is to reduce the award in accordance with that law. Allergan’s spokeswoman has said the company has not yet decided whether to appeal the verdict, but if it does, attorneys for the plaintiff plan to “attack the constitutionality of the cap.”

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 Seeks Billions in Suit for Alleged Deceptive Marketing of Drug

A Spartanburg, South Carolina judge is set to decide how much money Janssen Pharmaceutica, Inc., a Johnson & Johnson subsidiary, should pay the state for what the jury found to be deceptive marketing by the company of its antipsychotic drug Risperdal. Last month, a jury agreed with attorneys for the State of South Carolina that the drug manufacturer had violated the state’s Unfair Trade Practices Act by sending misleading letters to approximately 7,200 South Carolina doctors downplaying the links between Risperdal and diabetes. South Carolina law provides for potential penalties of $5,000 for each offense, and since attorneys for the state argued that every single prescription, sample box or “Dear Doctor” letter written since the 1990s may constitute a violation of the law, the number could reach into the billions of dollars.

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, 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.

The cost of preventing pre-term births: questions of ethics, public policy, and potential liability

Here’s the good news: a new drug called Makena manufactured by a company called KV Pharmaceutical was recently approved by the FDA for the treatment and prevention of pre-term births. But the approval has not come without controversy, as reported by media outlets all over the country. [For additional coverage, see here and here]. The problem? The drug, which must be administered by a shot once a week for about 20 weeks, was running about $20/dose prior to the approval. After the FDA gave the drug a nod, however, the price shot up to $1,500/dose. We’ll do the calculation for you: that’s $30,000 over the course of one pregnancy. [Note: the FDA has no control over pricing.] Now, the company has since reduced the price of each dose to $690, as reported by NBC, which would reduce the total price tag to $13,800.00. Nevertheless, the March of Dimes decided to end its relationship with the company.

This is not a new issue for drug companies, or for the people who need the drugs they manufacture. As KV Pharmaceutical pointed out to The Washington Post, the company is spending approximately $200 million developing the drug and having it approved by the FDA.

This is not atypical for the pharmaceutical industry; research and development are very expensive. In order for the company to stay in business and keep finding and manufacturing drugs that are of use to the public, the company should be entitled to recoup those costs and make a profit. But what duty do these companies have to the human race in general? This question can be posed not only to KV, but to the manufacturers of drugs used to treat cancer and other life-threatening conditions. What responsibility do these companies have to all people, and not just the people who have insurance that is willing to pay for these drugs, or others who can open their wallets and foot the bill themselves? It’s a chicken-and-egg problem that doesn’t seem to have a clear answer. For now, there are companies like Ther-Rx, a division of KV, which has developed a program for women who cannot afford the cost of Makena. The company also indicated it might be willing to develop a cheaper generic version.

Even more interesting from our point of view is the potential legal liability companies risk. The Washington Post indicated that “outside experts said the FTC could sue KV if it concludes the company is illegally impairing competition.” A Washington Post article on the subject interviewed an antitrust lawyer on the subject:

“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.

King of Torts Dethroned

Stanley Chesley, a class-action plaintiffs’ lawyer who became rich and famous for collecting billions of dollars for his clients in various lawsuits throughout his career, is now facing disbarment, the possibility of paying back $7.5 million in fees, and, arguably worse, a “professional death sentence.” The so-called “Master of Disaster” reportedly built his career around a simple strategy: swoop in after a disaster, round up as many clients as possible, and launch a “legal assault” against as many of the deep-pocketed bad guys as possible. How might one who follows such a business model go astray? He allegedly got greedy, with conduct his hearing officer called “shocking and reprehensible” behavior related his keeping far more than his share of a $200 million product liability settlement in Kentucky.

The case at issue was a 1998 class-action lawsuit involving the now withdrawn anti-obesity drug fen-phen, which consisted of more than 400 plaintiffs and was pending in Kentucky’s Boone County. The Wall Street Journal Law Blog reports that Chesley was not initially involved in the litigation, but at some point “muscled” his way into the case and strong-armed the attorneys into sharing fees with him in exchange for his “expertise” in handling class actions. Apparently, though, those attorneys did not notify the plaintiffs of the new arrangement.

The suit eventually resulted in a $200 million settlement with the maker of fen-phen, of which the plaintiffs’ lawyers reportedly kept tens of millions of dollars more than permitted. Of the total settlement, Chesley reportedly received a $20 million fee for his helping settle the case, including a reported additional $4 million for convincing the sitting judge to increase the attorneys’ take on the settlement to 49 percent. That judge later resigned from the bench when it was discovered he allegedly took financial benefit from the settlement in a secret deal.

Of the four plaintiffs’ attorneys involved in that case, three faced criminal charges of fraud and conspiracy. Two were sentenced to 25 and to 20 years in federal prison. As reported at Overlawyered, at the time of those guilty verdicts, it was a mystery as to why Chesley was not similarly charged. Despite that omission, Kentucky’s trial commissioner recently issued his opinion that Chesley should lose his Kentucky law license permanently and return more than $7.5 million in fees collected in the settlement.

Drugmaker’s Decision to Halt Production of Drug Threatens U.S. Death Penalty System

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.

Study Linking Childhood Vaccines with Autism a "Fraud"

By now, we’ve all heard The Associated Press report that the 1998 study conducted by British doctor Andrew Wakefield, from which he concluded from his study of 12 children that a link existed between the MMR (mumps, measles, rubella) vaccine and autism, has now been renounced and regarded as “a fraud” by Britain’s preeminent medical journal. The British Medical Journal (BMJ) condemned Wakefield’s work, claiming that he intentionally altered data to produce false results. The original publisher of Wakefield’s study, The Lancet, retracted the article last year, following which the British General Medical Council stripped Wakefield of his license to practice medicine.

As we previously reported here, the U.S. Supreme Court heard arguments recently in a case that likely will have significant implications for hundreds of pending lawsuits against vaccine makers, the vast majority of which allege a causal link between childhood vaccines and autism. The BMJ’s recent denunciation of Wakefield’s study certainly should play a significant role, too, in the disposition of these pending suits. According to a recent report in The Chronicle Herald, past investigations into Wakefield’s study revealed that his study received funding from lawyers who were suing vaccine manufacturers and that Wakefield, who had developed an alternative to the MMR shot, stood to gain financially if the leading vaccine was dropped from use.

Unfortunately, Wakefield’s bogus study has already caused some significant damage. In spite of the fact that numerous, more expansive studies found no causative link between childhood vaccines and autism, hundreds of thousands of parents–mostly in the U.K. and U.S.–have forgone vaccinations for their children. Not surprisingly, this has led to significant outbreaks of various preventable diseases, most notably those of measles and whooping cough. In 2010, California broke a 55-year-old record for the number of reported cases of whooping cough. We here in South Carolina also have seen a significant rise in the number of cases of whooping cough in recent months.

Although the recent exposure of Wakefield’s fraud brings good news to the scientific community, it seems as though the damage has been done. Though fraudulent, Wakefield’s study certainly was successful in raising long-lasting skepticism over vaccines.

Jury Orders Drugmaker to Pay $257 Million to State for Improper Marketing Practices

A Louisiana jury in mid-October issued a $257.7 million verdict against Janssen Pharmaceutica, Inc. and its parent company, Johnson & Johnson, finding that the drugmaker misled Louisiana doctors about possible side effects of its antipsychotic drug Risperdal. See Caldwell ex rel. State of Louisiana v. Janssen Pharmaceutica, Inc., 04-C-3967, 27th Judicial Court, St. Landy Parish, Louisiana. Businessweek reports that the basis of the suit, which was initiated by the state’s attorney general, was that J&J officials wrongfully touted its drug as superior to competing antipsychotic drugs and attempted to minimize its links to diabetes.

The state’s case was based on claims that J&J and Janssen sent 7,604 “Dear Doctor” letters to Louisiana medical providers and made a total of 27,542 sales calls, in which company representatives claimed that Risperdal was safer than competing antipsychotic drugs such as Eli Lilly’s Zyprexa and AstraZeneca’s Seroquel. (See our previous post here, where we took a look at the litigation involving claims that AstraZeneca failed to warn users of the diabetes risks associated with its antipsychotic drug.) The state’s local NBC news affiliate reported that J&J’s statements were in violation of the state’s Medical Assistance Programs Integrity Law (MAPIL), which requires that the attorney general protect medical assistance programs from companies that engage in fraud, misrepresentation, or other improper practices to obtain payments for which they are not entitled.

According to an article at Law360, which explores a bit of the history of lawsuits against J&J involving improper marketing practices, the jury in the present case issued penalties of $7,250 for each of J&J’s 35,542 alleged violations of the MAPIL, which amounted to one of the largest verdicts in the history of the state. Patrick Morrow of the Opelousas law firm of Morrow, Morrow, Ryan and Bassett, which actually tried the case on behalf of the state, said of the verdict: “You can’t come into Louisiana and disseminate false and misleading information.”

Although J&J has denied any wrongdoing in connection with these claims, this verdict certainly will have a lasting impact on the way drugmakers market their products to doctors and medical professionals.