Judge Tells FDA to Make a Plan B for Teen Use of Morning After Contraceptive Drug

The AP reports that a federal court judge has dealt the Food and Drug Administration (FDA) a stinging rebuke over its handling of the approval process for the Plan B morning-after pill during the Bush administration. The Plan B drug, sold by Barr Pharmaceuticals (acquired by Teva Pharmaceutical Industries), is a contraceptive pill that "reduces the chance of pregnancy if taken within three days after sex."

According to U.S. District Judge Edward Korman's ruling, politics improperly infected the agency's decisionmaking when it "repeatedly and unreasonably" delayed issuing a decision on the drug. The AP further quoted the judge:

"Korman's ruling said the FDA in several instances had delayed issuing a ruling for suspect reasons and on two occasions took action only to facilitate the confirmation of acting FDA commissioners whose confirmations had been held up by the repeated delays.

'These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned decision-making,' Korman said. 'Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use.'"

As a result of the findings, the judge has ordered that the Plan B drug be made available to 17-year-olds without a prescription, in the same manner that the medication is currently available to women over the age of 18.  Noteably, the court also left untouched various constitutional issues raised in the case.

According to the AP, the FDA had argued in court filings that "politics played no role in the agency's decisions." However, the evaluation of the drug has been plagued by reports of politics and/or religion affecting the entire process. Despite the 30 days that today's order gives the government for compliance, a government attorney has indicated that the agency is "studying the decision and evaluating options". At the same time, it also remains to be seen what effect, if any, the change in administration plays in a further review of the drug.

• AP: Judge orders FDA to let 17-year-olds use pill
• District Court's Opinion (FindLaw)
• Reuters: US court tells FDA to rethink Plan B contraceptive
• FDA Drug Approvals Index (FDA Center for Drug Evaluation and Research)
• FDA Overview (provided by Goldenberg & Johnson, PLLC)
• Washington Post: FDA Approves Plan B's Over-the-Counter Sale
• Washington Post: FDA Official Quits Over Delay on Plan B
• 60 Minutes: The Debate Over Plan B: Did Religion Play Role In An FDA Decision? (CBSNews.com)

Twitter Trials: Juror Johnathan's Tweets Cause $12 Million Verdict Appeal; Reporter Tweets a Federal Trial

Though they still grapple with tools like computers, cameras and microphones, courts have recently faced a new technological problem: what to do about Twitter. While a $12 million jury verdict in Arkansas is threatened by one of the juror's in-trial tweets, a federal court in Kansas recently made headlines for allowing a reporter to cover a trial with Twitter. These cases illustrate the good and the bad in any tool used for communicating what goes on in a trial, and why reporters twittering could be good, while juror twittering is bad. 

Twitter is a social networking tool that allows users to post messages (or "tweets") to a website that displays updates which other can track. It is being used in more and more settings (you can tweet this blog entry, for example, with the buttons to the left). One setting posing potential problems, however, is the courtroom.

In Arkansas, the AP reports that Stoam Holdings and its owner Russell Wright have appealed a recent loss of a $12 million jury verdict in part based on the fact that a juror was allegedly tweeting during the trial. Stoam Holdings is purported to be one of many "Stoam" ventures by Mr. Wright used to bring in investment dollars. Two former investors alleged the operation to be a Ponzi scheme instead of legitimate investment in Wrights plans to manufacture "stoam," a material combining the insulating power of foam with the strength of steel.

Evidently, the case against Stoam prompted "Juror Johnathan" (Johnathan Powell of Fayetteville, Arkansas) to post twitter messages including, "oh and nobody buy Stoam. Its [sic] bad mojo and they'll probably cease to Exist, now that their wallet is 12m lighter." Bad mojo indeed. An attorney for Mr. Wright and Stoam Holdings have filed a motion seeking a new trial on the theory that Juror Johnathan consulted outside information and communicated with outside people about the trial.

Meanwhile, in Wichita, Kansas, last week U.S. District Judge Thomas J. Marten allowed a reporter to use Twitter to cover the trial of six alleged gang members. As noted by CBS News, the reporter, Ron Sylvester, a reporter from the Wichita Eagle, routinely uses Twitter in state courts, but being allowed to do so in federal court was rare. (His tweets can be found here.) The reason is that different courts have their own rules about what sorts of devices can be used during proceedings. Many federal courtrooms ban cameras, microphones and computers.

As CBS News' technology analyst Larry Magid argues, tools like Twitter should be allowed for reporters. If what happens in most trials is public information, tools that allow faster dissemination of this information should not be prohibited.

One might ask, then what wrong with Juror Jonathan's tweets? The answer: he was a juror. Just like courts have rules limiting what reporters can do during a trial, they have rules covering what jurors can do. The Washington County Circuit Court is no different. As the court's clerk told Northwest Arkansas Morning News, jurors are typically instructed not to communicate with outside people or consult outside information about the trial.

Time will tell if this will become the Twitter mistrial, but as if we needed a reminder, Juror Johnathan stands for the lesson: Just Say No to Juror Tweeting.

• Police departments keeping public informed on Twitter (CNN)
• How to be a better tweeter (CNET)
• The Amount And Value Of Twitter Traffic (Washington Post's Tech Crunch)
• Stoam Scam Nets $12.6 Million Judgment (The Morning News)
• Courtroom Procedure (provided by The Gierach Law Firm)

Anna Nicole Smith Death Brings Charges for Howard Stern, Doctors Sandeep Kapoor and Khristine Eroshevich

More than two years after former playmate Anna Nicole Smith's death on February 8, 2007, CNN reports that her "longtime partner" and attorney Howard K. Stern and Dr. Sandeep Kapoor were arrested on Thursday on charges "of conspiring to furnish drugs before her death in 2007." According to CNN, Smith's psychiatrist, Dr. Khristine Eroshevich, is also going to face charges and authorities said they expected her to turn herself in on Monday.

Anna Nicole Smith's name has certainly not been scarce in legal news the past couple of years with legal disputes over everything from custody of her daughter Dannielynn, to probate and estate battles and disputes over where she was to be buried, but the latest criminal charges are a twist that has surprised even some in media circles.

So what was the alleged scheme? CNN related California Attorney General Jerry Brown's description:

"The doctors and Stern devised a plan to use a fake name so that Smith could be prescribed 'thousands of pills'...

'She was obviously addicted,' Brown said. 'These doctors had a medical obligation to prescribe medicine in a professional way. Evidence will show this did not happen.'"

The complaint against charged Stern, Kapoor, and Eroshevich "with eight felonies, including conspiring to furnish controlled substances, unlawfully prescribing a controlled substance and obtaining fraudulent prescriptions from June 2004 to January 2007". The list of drugs allegedly furnished by the doctors to Stern (who then gave them to Smith) was quite lengthy and included such controlled substances as Ambien, Dilaudid, methadone, and Xanax. Anna Nicole's autopsy report had found that she had died due to an accidental overdose from a combination of drugs.

Since their arrest, Stern and Kapoor have since posted $20,000 bond and are out on bail. The question likely on most people's mind is why it took so long for charges to be filed in the case, but at this early stage police have given no indication as to the reason. A FOX News article noted that, even early on, there were certainly red flags about an excessive amount of prescriptions drugs in the case:

"according to an Associated Press report, investigators found 11 prescription medications in her hotel room the day she died. More than 600 pills — including about 450 muscle relaxers — were missing from prescriptions that were no more than five weeks old when she died, and most of the drugs were prescribed in the name of Howard K. Stern, her lawyer-turned-companion. And actually, none of them were prescribed in Smith's name."

However, any answers to the timing of the investigation and charges will have to come from police as there a variety of reasons why earlier suspicions and investigations of Eroshevich, and also of a highly suspect fax from Eroshevich to Kapoor requesting "a laundry list of drugs", did not lead immediately to charges. Although there are risks to delaying a criminal prosecution, such as vanishing defendants and witnesses or increased "memory problems", authorities usually prefer to have all their ducks in a row before bringing charges against a criminal defendant. It could be that prosecutors simply had to wait until they felt they had the strongest case to proceed with.

• AP: Anna Nicole Smith's boyfriend, doctor posts bail
• CNN: Anna Nicole Smith's boyfriend Howard Stern, doctors charged
• Felony Complaint Against Stern, Kapoor and Eroshevich (FindLaw)
• FOX News: Ex-Boyfriend-Lawyer, Doctors Charged in Anna Nicole Drug Case [Interview Transcript]
• FOX News: Dr. Manny: Finally, Justice for Anna Nicole?
• FOX News: The Truth About Anna Nicole Smith's Doctors
• AP: Anna Nicole Smith's estate seeks high court help (Google News)
• Anna Nicole Smith Litigation (FindLaw)
• Smith's 2006 U.S. Supreme Court Case (FindLaw)
• Autopsy Report: Broward County, Fla. Medical Examiner
• Drug Crimes Overview and Links (provided by Ronald E. Smith, P.C.)

Nancy Braus Texas A&M Bonfire Case Extinguished by Supreme Court: Loss of Consortium Ruling Left Untouched

The Supreme Court today ruled that it will not hear the case brought by Nancy Braus, the mother of a student injured in the Nov. 18, 1999 collapse of a ceremonial log pile that killed 12 people and injured 27 at Texas A&M University. She had sued school officials and others, claiming loss of consortium based on the injuries sustained by her son Dominic Braus in the collapse.

The AP gave some background to the case, noting that:

"The 90-year-old bonfire tradition was suspended after the 1999 collapse of the 59-foot-high, wedding cake-like stack of more than 5,000 logs. An A&M commission blamed the collapse on flawed construction techniques and the lack of adequate supervision of students assembling the stack."

However, the court below had rejected Nancy Braus' action based on a 2003 Texas Supreme Court decision which found that a "parent does not have a claim which can be asserted against those alleged responsible for the injuries to an adult child", or, in legal terms a "filial loss of consortium" claim.

Loss of consortium claims are often brought in cases involving the loss or severe injury of a family member and are based on the loss of love, affection, protection, emotional support, services, companionship, care and society that can occur when a family member is injured. Although loss of consortium claims often involve the death or severe injury of a spouse, consortium is defined not only as "the right of one spouse to the company, affection, and assistance of and to sexual relations with the other," but also as, "the right of a parent or child to the company, affection, and assistance of the other."

However, states vary on whether, and to what extent, they allow the latter "filial consortium" claims involving parents and their children. In cases involving the wrongful death of a child, most states allow the parents to recover consortium damages. On the other hand, if a child is only injured, most states do not allow recovery of such damages. Still, a number of states such as Florida and Massachusetts, do allow parents to recover on consortium claims for injuries to a child.

Today's Supreme Court order simply refused to hear Nancy Braus' case, and thus, it remains in the hands of the states to determine how they deal with filial loss of consortium claims, one way or the other.

• AP: Court refuses to hear Texas A&M bonfire case
• KBTX: Bonfire Injury Case Dismissed
• CBS11: A&M Settles Decade-Old Bonfire Lawsuit
• The Texas Appellate Court's Opinion
• Wrongful Death - An Overview (provided by Robert K. Rainer, PC)
• Loss of Consortium Definition (FindLaw)

Review Sites Under Fire: Useful Consumer Tools or a Plague of Unfairness to Businesses and Professionals?

Most people have used an online consumer review site at some point, whether it be to check out what others thought about the latest gadget, a new restaurant down the street, or obtaining the services of a professional, such as an optometrist, dentist, lawyer, doctor, plumber, etc.. The proliferation of review sites online has made it pretty easy to find somebody's take on just about any consumer product or service need in existence.

However, recently there has been some backlash at various review sites by the businesses and/or professionals being reviewed. The AP reports that some doctors have even taken the unusual step of getting their patients to sign waivers preventing them from posting negative comments online.

In favor of limiting online reviews, the AP noted one argument that:

"'Consumers and patients are hungry for good information' about doctors, but Internet reviews provide just the opposite, contends Dr. Jeffrey Segal, a North Carolina neurosurgeon who has made a business of helping doctors monitor and prevent online criticism."

Segal's North Carolina company, Medical Justice, provides doctors with a standardized waiver agreement to present to patients. Those patients who decide to sign agree not to post online comments about the doctor, "his expertise and/or treatment", whereas those who decline can be advised to seek medical services elsewhere.

Not surprisingly, operators of review sites tend to view the matter quite a bit differently, as exemplified by statements made by John Swapceinski, co-founder of RateMDs.com:

"They're basically forcing the patients to choose between health care and their First Amendment rights, and I really find that repulsive," Swapceinski said.

He said he's planning to post a "Wall of Shame" listing names of doctors who use patient waivers.

The fact of the matter is, however, that businesses or individuals suing consumer review Web sites face an uphill battle. Web sites are protected under federal law against being sued for publishing third-party content. Specifically, Section 230 of the Communications Decency Act provides that: "No provider or user of an interactive computer service shall be treated as a publisher or speaker of any information provided by another information content provider." This doesn't provide sites with blanket immunity for whatever gets thrown up on them, of course, but when it comes to a third-party individual's own, honestly expressed opinions online, it's pretty close.

Because the intent of Congress in passing the law was "to promote the continued development of the Internet and other interactive computer services and other interactive media," and "to preserve the vibrant and competitive free market that presently exists for the Internet and other interactive computer services, unfettered by Federal or State regulation", lawsuits against the operators of review sites often don't get very far and can just be a drain on a business's financial resources.

Lastly, if a review site's users are anonymous, as is the case with RateMDs.com, this can make it an even tougher task to try and pursue legal action for a negative online review, even if the professional/business has some kind of waiver agreement (RateMD.com has refused to take any reviews down based on waivers). However, what seems clear at this point in the development of the Web, is that a growing number of people are starting to ask whether the value being placed on free speech online should begin to give way to some push toward online responsibility. On the other hand, hopefully, we won't have to start signing waivers before getting served our dinner out!

• AP: Docs seek gag orders to stop patients' reviews
• San Francisco Chronicle: Dentist sues over negative Yelp review
• Washington Times: D.C. bar fights consumer Web site
• San Francisco Chronicle: Web 2.0 defamation lawsuits multiply
• What does a person have to prove to win a slander or libel claim? (provided by The Law Offices Of N. Trey Pettlon, III)
• East Bay Express: Yelp and the Business of Extortion 2.0
• The Huffington Post: Is The Yelp Controversy Overblown? (www.huffingtonpost.com)
• Solidifying Immunity For Interactive Computer Service Providers Under the Communications Decency Act (FindLaw)

Model Monika Zsibrita Says Not a Gold Digger, Gets Lawsuit Against Chris Rock Unsealed: Did Rock Open Up This Can of Worms?

The L.A. Times reports that model-turned-stay-at-home-mom, Monika Zsibrita, has had her civil lawsuit against Chris Rock unsealed by a court. The Times summed up the decade-long background leading up to this case as follows:

"It's been more than a decade since Chris Rock and a shapely blond model struck up a conversation over Sunday brunch at the Four Seasons in Beverly Hills. The relationship that followed was brief -- two dinner dates -- but there seems to be no end to the fallout from the liaison.

The second date led back to Rock's hotel room, which led to sex -- he has said he was separated from his wife at the time -- which led to a paternity suit, then tabloid headlines, an allegation of rape, the hiring of private investigator Anthony Pellicano [of wiretapper to the stars fame/infamy], two DNA tests, a confidential settlement, testimony before a federal jury and, on Thursday, the revelation of a new civil suit."

Yes, after more than 10 years, the Zsibrita would like to make it clear, particularly to "those in her native Hungary", that she's no gold digger and would like to get her side of the story out there for all to see. So what is her side of the story? The lawsuit, which was filed in August 2008, claims "breach of contract and a host of other charges", but the L.A. Times notes "its overarching theme is that the comedian known for his caustic humor is, as Zsibrita called him in a conversation after the hearing, 'a monster'", and she "accuses him of first raping her, then siccing a criminal private investigator on her and finally raining potshots on her on Howard Stern's radio show."

Interestingly, it was the latter "potshots" on Stern's show that may have, in part, contributed to allowing the suit to come to public light. Zsibrita's attorney, Neville Johnson, says she first filed the suit under seal "because she did not want to run afoul of the confidentiality agreement contained in a 2000 settlement of the paternity case." He argued further:

"that Zsibrita should not be bound by the agreement because Rock had talked about her during a 2004 appearance on Stern's show. According to a summary of the show included in court papers, the comedian said that his sexual liaison with Zsibrita was consensual and that he had been set up by a Nigerian hustler who was actually the father of her child."

Although there confidentiality agreements can vary widely in type and enforcement, courts will often not allow a party to enforce a confidentiality agremeent when that same party has been the one spilling the beans in public, because they are the ones breaking the agreement. Indeed, the court in this case apparently agreed with Zsibrita and unsealed the lawsuit, rejecting arguments Rock's lawyers made to the contrary when it noted details about their relationship were already all over the Internet.

As a sidenote, this isn't the first time Chris Rock has faced issues arising from a paternity suit. In 2007, FOX News reported that Kali Bowyer of Georgia filed a paternity suit seeking child support for her then-13-year-old son who she claimed was Rock's son. However, although a DNA test in that case established that Rock was not the father, Bowyer didn't accept the result and Chris Rock ended up suing to try to keep Bowyer from talking or writing about her claim that the comedian fathered her teenage son. Unlike the Szibrita case, however, no confidentiality agreement had been entered into by either party and Bowyer argued it would violate her First Amendment rights to forbid her from talking about her own experiences.

• L.A. Times: Model's lawsuit against Chris Rock is unsealed
• N.Y. Times: Comedian, All Serious, Takes Stand
• FOX News: DNA Test Clears Comedian Chris Rock in Paternity Suit, Lawyer Says
• Atlanta Journal-Constitution: Chris Rock fights to keep Ga. woman's claim quiet
• Paternity Center (FindLaw)
• Paternity Tests: Blood Tests and DNA (FindLaw)

Tae Bo Founder Billy Blanks' $30M Legal Malpractice Judgment Roundhouse Kicked Back to Trial Court

An appeals court has rejected a lower court's decision in a legal malpractice case awarding Tae Bo founder Billy Blanks nearly $30 million in compensatory and punitive damages, plus interest against his former attorney, William H. Lancaster, and his law firm, Seyfarth Shaw, LLP.

For those who might have missed out on the numerous TV ads and promo's which were prominent during the late 1990's, Billy Blanks is the guy who developed the fitness routine known as "Tae Bo". Named after both taekwondo and boxing, Tae Bo was both popular (and remains so) and very lucrative. However, as can sometimes be the case, out of success came litigation.

For Billy Blanks, the legal problems arose after his former accountant, Jeffrey Greenfield, ended up becoming his agent and manager while Tae Bo was on the rise. Not one to miss a golden goose, Greenfield convinced Blanks to fire the William Morris Agency, and graciously offered to resign his accounting day job in exchange for a "partnership", wherein Greenfield would oversee all of Blanks' business interests and receive one-third of all of Blanks's income (which would rise to almost half in 5 years). Blanks resisted, but informally agreed to a trial period for Greenfield to prove himself as an agent and business manager.

Luckily, Blanks' wife was not keen on Mr. Greenfield's take or his services, and the relationship soon soured. Not so luckily, however, Greenfield already had over $10 million of Blanks' money. But the Blanks got good news when they were told that Greenfield was not a licensed talent agent at any time during the parties' relationship. This meant that under a California law known as the Talent Agencies Act, Blanks could pursue Greenfield for the money he'd been paid while acting as an unlicensed agent.

Although it might have sounded like an open and shut case, the law firm Blanks hired to pursue Greenfield filed suit in the wrong place and the Blanks missed their deadline to recover the sums they paid Greenfield via the Labor Commissioner. Having no option to go after Greenfield, Blanks instead pursued his former law firm for legal malpractice. This is typically challenging because a plaintiff has to prove both: 1) that the lawyer or firm was negligent; and 2) that had the firm/attorney not been negligent, they would have been successful in pursuing the underlying case and would have recovered damages. However, a jury agreed with Blanks after a lengthy six week trial and awarded him the $10 million he should have gotten from Greenfield, plus $15 million in punitive damages for the firm's misconduct.

However, an appeals court on Friday sent the case back to the trial court because it improperly instructed the jury about how to deal with the contract between Greenfield and Blanks, and also because it should have allowed the jury to decide whether the law firm was negligent (the court decided that issue itself). As a result, it looks like a few more legal kicks and punches are going to have to be thrown before this case is knocked out.

• The California Appeals Court Decision (FindLaw)
• Metropolitan News: Court Throws Out $30 Million Legal Malpractice Award
• Tae Bo creator Billy Blanks wins award in case against law firm (CourtTV)
• Firm hit for $35 Million in Malpractice Verdict (ABA) [PDF]
• Statutes of Limitations: Is Your Lawsuit Timely? (FindLaw)

Dustin Dibble, Drunk Man Who Lost Leg in Train Accident, Awarded $2.3 Million: Runaway train or runaway jury?

For people who get angry when they hear about someone suing for getting burned by their morning coffee, or getting injured undertaking an extreme sport, etc., etc., a story came out yesterday that might add to their frustration.

CNN reports that a Manhattan jury awarded $2.33 million to Dustin Dibble, who lost his leg after drunkenly stumbling onto the path of an oncoming subway train. The story gave the following background, stating that Dibble fell and "landed in the subway tracks after a late night watching a hockey game at a bar with friends April 23, 2006. A downtown N train ran over him, severing his right leg." The conductor apparently mistook Dibble for "an inert object", whatever that might have been.

Although the result in the case might be offensive to some at first sight, the case does bring up some interesting policy questions for debate. For instance, if one were to say that Dibble was entirely at fault, would it have been preferable to have him behind the wheel of a car? It could be (and perhaps was) argued that he was being responsible by taking public transportation instead of driving, in the first place. Alternatively, should he have taken a cab? If so, would he have all the blame if he drunkenly got hit by a cab while hailing it? One response would be that perhaps Dibble should have chosen to stop drinking before he hit a .18 BAC, but in the end these are all issues the jury (composed of our peers) likely faced when making its decision. Sometimes awards that seem incomprehensible at first glance end up, at least arguably, having a more rational basis.

It should be noted that the jury in this case was not entirely unsympathetic to NYC Transit, finding that Dibble was 35 percent responsible for his own injuries and damages, which reduced the award "from $3,594,943 to $2,336,713." In this case, the jury did not absolve Dibble of fault, but it did apparently buy into arguments that the train conductor was trained to stop the train, and had time to do so, when he saw him on the tracks.

In the end, the Metropolitan Transit Authority (MTA) has signalled that it intends to appeal the result, so it looks the suit will keep rolling for a while longer.

• CNN: Drunk man run over by train awarded $2.3 million
• Editorial: You foot the bill: $2.3 million jury award to drunk on subway tracks was even stupider than he was (NY Daily News)
• The famous/infamous "McDonald's Coffee Spill Lawsuit" revisited
• Proving Fault: What is Negligence? (FindLaw)
• Who's at Fault for an Accident FAQ: Can I Recover if an Accident Was Partly My Fault? (FindLaw)

Jury Burns Philip Morris in Stuart Hess Case

In the first phase of a case that may represent the standard for thousands of other similar cases, the AP reported that a jury on Thursday ruled that chain-smoker Stuart Hess's death was caused by his addiction to cigarettes. This ruling represents a serious blow to tobacco giant Philip Morris, which sought to avoid liability in this and related Florida cases.

The jury's decision that Hess did not continue smoking by his own choice was vitally important considering that Philip Morris lawyers had argued that Hess could have quit smoking. A Reuters story noted that the attorney for Elaine Hess, Stuart's widow, said "The next phase is to decide (compensatory) damages and our entitlement to punitive damages," and added "that the jury can assign a percentage of liability to the tobacco company and to the smoker."

Attorneys in the case haven't said how much money they are seeking from Philip Morris but the AP speculated that it would likely be in the millions of dollars.

The reason this case is of particular importance is because it is the first to go to trial since a 2006 Supreme Court of Florida ruling throwing out a $145 billion jury verdict in a class action suit. At that time, the state's high court said that although plaintiffs established that tobacco companies, each of the cases had to be established individually. The AP noted there are about 8,000 other cases that could be affected by a decision, one way or another, in the Hess case.

However, Philip Morris told the press it was not giving up. "'The Hess trial is not over,' said the Richmond, Va.-based company, a unit of Altria Group." Considering the past history of tobacco litigation, particularly with individuals' lawsuits, that could be the last thing someone would expect.

• AP: Jury: Florida smoker died because of addiction
• Reuters: Loss for cigarette maker in Florida smoker trial
• Time: A Big Money Decision Against Big Tobacco
• The Florida Supreme Court's Big Tobacco Decision: Why Neither Side Can Be Very Happy (FindLaw's Writ)
• Florida Supreme Court Decision in Engle v. Liggett Group (FindLaw)
• Time: Tobacco Takes a Hit

Autism MMR Vaccine Cases Decided: No Link Shown

Plaintiffs failed to demonstrate that vaccines "played any role at all" in causing their children's autism and other severe conditions, special masters in test cases ruled today.

The cases in the Vaccine Court Omnibus Autism Proceeding involved autistic children of three families, the Cedillos, the Hazlehursts, and the Snyders, whose conditions, the parents argued, were brought on by early childhood vaccinations. According to a Reuters report, the parents "sought payment under the National Vaccine Injury Compensation Program (VICP), a no-fault system that has a $2.5 billion fund built up from a 75-cent-per-dose tax on vaccines."

A story from CNN indicates that by mid-2008 more than 5,300 cases had been filed by parents who believed vaccines may have caused autism in their children and were seeking payment under the VICP. As a result, there was a high degree of attention on the decisions today.

The special master in the Cedillo case, George Hastings, summarized his findings in rejecting a theory that the cause of a child's autism was a measles, mumps and rubella (MMR) vaccine in combination with other vaccines containing thimerosal (a preservative), stating that plaintiffs:

"failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems."

The government had argued that plaintiffs' claims linking the vaccines with autism were "not supported by 'good science.'" Indeed, in Hastings' own words "[t]he numerous medical studies concerning these issues, performed by medical scientists worldwide, have come down strongly against the petitioners' contentions." Furthermore, the government's experts on the issue were "far better qualified, far more experienced, and far more persuasive" than those offered by the plaintiffs.

These cases were particularly important in setting the bar on the amount of proof required to establish these kinds of autism claims. As noted by the Reuters piece, "Under the program, someone injured by a vaccine does not have to prove the vaccine actually caused his or her injuries.  All they need to do is establish that vaccines sometimes cause that particular condition or injury, as the three test cases sought to prove. The no-fault payout system is meant to protect vaccine makers from costly lawsuits that drove many out of the vaccine-making business." Nevertheless, today's decisions indicate that even with the relative burden of proof lowered under the program, courts will look for solid evidence that vaccines can cause autism.

• Reuters: U.S. vaccine court denies family's autism case
• CNN: Vaccine didn't cause autism, court rules
• Decisions in Today's Autism Cases (U.S. Court of Federal Claims)
• KNOW. . .The Autism - Vaccine Connection (K.N.O.W. Vaccines)
• National Vaccine Injury Compensation Program (VICP) (US Dep't of Health & Human Services)
• CBS: Vaccine-Autism Link Case Goes To Court (CBSNews.com)