The general public and many medical professionals rely on editorials, review articles, and research papers appearing in revered publications such as the New England Journal of Medicine, the American Journal of Medicine, and the Journal of the American Medical Association, as their primary source of information for new drugs and devices. The pharmaceutical companies and their sales representatives cannot be expected to provide in-depth scientific analysis because direct-to-consumer advertisements and company sales representatives tend to focus on the positive, while minimizing and sometimes failing to disclose unfavorable information about the product. But, many of these so-called 'scholarly' articles that appear to be authored by prominent academics and medical professionals are nothing more than propaganda produced by the pharmaceutical companies to increase profits.

Medical ghostwriting is not to be confused with collaboration in which a number of people work together in a joint intellectual effort to produce the final article. Medical ghostwriting on the other hand occurs when a person is named and presumed to be the author, but in fact, has done nothing more than allow their name to be affixed to somebody else's work. So who are these people that put aside their pride and produce this unaccredited work? The real authors are none other than medical education companies hired by the pharmaceutical companies to draft the 'scientific' studies and articles.

One such company called DesignWrite proudly claim to blend "scientific and clinical issues with marketing needs." This is the same company that was recently uncovered as the brains behind 26 papers in 18 medical journals dating back as far as 2000, promoting the use of Wyeth's hormone therapy drugs, Premarin and Prempro. An indication of how influential this practice has become is evident from the fact that DesignWrite originated in 1993 with 5 employees, but currently employs 100 people.

Jim Szaller is a Cleveland lawyer who has spent many years fighting on behalf of victims injured by medical devices and drugs dating back to the Dalkon Shield litigation of the 1970s. He spent 4 years going through the documents in the Premarin and Prempro litigation to establish the DesignWrite connection. In that particular case, a McGill University researcher, Dr. Barbara Sherwin allowed her name to be listed as the sole author of an article she acknowledged was written by DesignWrite.1 A second DesignWrite article was attributed solely to Dr. Gloria Bachmann a professor of obstetrics and gynecology at the Robert Wood Johnson Medical School in New Brunswick, N.J. and appeared in the 2005 Journal of Reproductive Medicine also promoting the use of hormone replace therapy drugs.2

Wyeth's transgressions related to Premarin and Prempro do not stand alone. Other giants in the industry have also been caught red handed. Merck's shenanigans related to the now unavailable Cox2 inhibitor Vioxx, involved deception of, and embarrassment to, the New England Journal of Medicine. After five years of denials and delays, Merck settled the Vioxx litigation for $4.85 billion. Allegations have also been leveled at AstraZeneca and its promotion of the bi-polar medication, Seroquel. However, the prize for the most brazen and cavalier disregard for the truth must go to GlaxoSmithKline, the manufacturer of Paxil and Avandia, both of which are currently the subject of litigation. Between 2000 and 2002 GlaxoSmithKline managed to place articles in prominent psychiatric journals such as the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry touting the use of Paxil, GlaxoSmithKline's antidepressant medication. GlaxoSmithKline's internal ghostwriting program was called - CASSPER.3

Some would argue that this is much ado about nothing and in reality is a victimless 'crime'. In fact, almost everyone comes out ahead in this practice. While the benefit to the pharmaceutical company is the obvious increased profits, other players in the game also reap substantial gain. The lecture circuit can be lucrative for many medical professionals and one's reputation and earning ability as a 'thought-leader' is enhanced greatly by the number of publications on the speaker's resume. Likewise the circulation and profits of the medical journals are increased because they gain access to information on new products, or the latest clinical trial results for existing drugs. This information is provided to them because of their demonstrated willingness to publish everything without examining the raw data on which the articles are based. Almost everyone wins, except for the public who relied on false information and consumed the harmful drugs.

1 http://www.montrealgazette.com/story_print.html?id=1922495
2 http://www.nytimes.com/2009/08/05/health/research/05ghost.html
3 http://blogs.wsj.com/health/2009/08/20/caspper-glaxosmithklines-friendly-ghostwriting-program

The Supreme Court's trend towards stricter pleading standards in civil cases threatens to severely restrict a civil rights plaintiff's constitutional right of access to the legal system. Particularly for members of minority or disadvantaged groups who could be indigent or unrepresented, federal courts provide a forum in which to seek redress for harmful or discriminatory conduct committed in violation of constitutional or federal statutory rights. Fortunately for these litigants, the Federal Rules of Civil Procedure were supportive of such litigation, at least in a general sense. As stated in Conley v. Gibson, 355 U.S. 41, 47 (U.S. 1957), the federal "notice pleading" standard did not require a claimant to set out in detail the facts upon which he based his claim. Rather, Fed. R. Civ. P. 8 only required that a plaintiff provide a short and plain statement of the claim showing an entitlement to relief, in order to give the defendant fair notice of the claim and the grounds upon which it rests. Id. Under Conley, civil rights claimants could effectively bring a claim and conduct discovery without being forced to provide the factual details underlying their claim at the pleading stage.

Perhaps as a result of an abundance of civil rights claims congesting already full dockets, federal courts have become increasingly hostile to such claims. For example, since 1996, federal courts screen all cases before service on defendants in civil actions where a prisoner seeks redress from a governmental entity or employee of a governmental entity. See 28 U.S.C. § 1915A. Additionally, some circuits attempted to impose heightened pleading standards on civil rights plaintiffs. However, the Supreme Court rejected the implementation of higher pleading standards and confirmed that civil rights claims were entitled to the liberal pleading standards articulated in Conley. See e.g. Swierkiewicz v. Sorema N.A., 534 U.S. 506, 510 (U.S. 2002) (rejecting heightened pleading requirements in Title VII and age discrimination cases).

The movement toward stricter pleading standards eventually took hold among a majority of the Supreme Court in 2007, when Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (U.S. 2007) revised the federal pleading standard. In that case, the Court articulated a plausibility standard that required plaintiffs to show a plausible entitlement to relief, citing Swierkiewicz. More recently, the Court raised the plausibility standard to new heights in the 5-4 opinion of Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949 (U.S. 2009). Under Iqbal, "a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face." Id. As articulated by the Court, "[a] claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. Thus, a district court must now disregard allegations that are mere recitals of the elements of a cause of action supported by conclusory statements, because they are not entitled to the assumption of truth. Instead, only well-pleaded factual allegations are entitled to an assumption of veracity and a district court must only determine which well-pleaded factual allegations plausibly give rise to an entitlement to relief. The language of Iqbal makes it clear that these stricter pleading standards apply to all civil cases.

The effect of these judicially mandated heightened pleading requirements is profound, as the civil rights plaintiffs' constitutional right of access to the legal system has been severely restricted, as has their opportunity to seek redress for the violation of federal or constitutional rights by agents of the government. District Court judges now have the power to cut off the plaintiff at the pre-discovery stage and discourage litigation in cases where the evidence is largely in the hands of the defendants.

In the spirit of justice and equality, and in order for pro se or indigent plaintiffs to at least conduct discovery, civil rights claims deserve to benefit from the liberal "notice pleading" standard articulated by the Court in Conley. Fortunately, this cause has caught the attention of Congress. The Notice Pleading Restoration Act of 2009 (S. 1504), introduced by Senator Arlen Specter (D. PA), provided that "federal courts shall not dismiss complaints under rule 12(b)(6) or (e) of the Federal Rules of Civil Procedure, except under the standards set forth by the Supreme Court of the United States in Conley v. Gibson, 355 U.S. 41 (1957)." This bill has been referred to Committee, which is essentially the first step in the legislative process. Thus, it remains to be seen whether Congress will revive the federal "notice pleading" standard of Conley. In the meantime, attorneys and civil rights litigants should be mindful of these new pleading requirements and be sure to conduct sufficient factual investigation before filing in federal court.

Concerns over vaccine damage have arisen at a time when parents have unprecedented access to information and platforms to share their views. While the medical professionals have questioned the link between the vaccinations and the claimed injuries, parents who believe their children were damaged by vaccines have refused to take no for an answer.

Due to the vast number of claims made against physicians and vaccine manufacturers that threatened to endanger the availability of vaccines, a federal program was initiated to address the growing concern. The National Vaccine Injury Compensation Program is a federal program aimed to resolve the ongoing issue of vaccine tort liability. Prior to the program, the vast number of claims made against physicians and vaccine manufacturers endangered the availability of vaccines and thus called for governmental action.

Background
The National Vaccine Injury Compensation Program ("VICP") was created in 1988 under the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660). The program was created, not only to protect physicians and manufacturers from tort liability, but also to provide a no fault system that reduced the burden of proof for those claiming vaccine related injuries. The Act mandates that those claiming vaccine related injuries first file a petition under the VICP and exhaust the statutory remedy before they can file a civil action against the manufacturers or physicians.

The VICP compensates claimants for vaccine related injuries through the Vaccine Injury Compensation Trust Fund. The Trust is funded by a $.075 excise tax that is imposed on each dose of vaccine purchased and depends on how many diseases the dose can prevent. If a vaccine can prevent more than one disease, then the number of diseases prevented in that dose is multiplied by $0.75 to calculate the total tax due. Currently, there is almost three billion dollars in the Trust Fund to compensate any qualifying claims.

The Process
To initiate the proceeding, a claimant must file a petition which either alleges a Table Injury or a "causation-in fact" claim. The Table lists and explains the injuries or conditions that are recognized to be caused by vaccines. It also lists time periods in which a claimant must suffer the first symptom of these injuries after receiving the vaccine. For a Table Injury, the claimant must show that he or she received a vaccination listed on the Vaccine Injury Table. If there is a table injury and the claimant has suffered the injury within the prescribed timeline, it is presumed that the vaccine was the cause of the injury, unless there is evidence to suggest otherwise. In these cases, a claimant need not prove an actual causal connection.

However, it becomes more complicated when a claimant is alleging a non-Table injury, as a more difficult burden of proof is applied. Here, the claimant must prove a "causation-in-fact" which must satisfy the "preponderance of the evidence" standard.

Autism Related Injuries
Beginning in 2001, there was a dramatic shift in all claims being filed - including upward increases in the filing of both Table and non-Table conditions. This increase was attributed in large part to petitions alleging that certain vaccines were related to a disorder known as "autism spectrum disorder (ASD)," or autism for short.

Autism is normally recognized during a child's first few years of life, sometimes during the first year, but sometimes not until later years. Autism can vary widely in severity. For many children the condition can become extremely harsh and devastating, leaving the autistic individual utterly unable to care for themselves.

To address the vast number of these filings the Office of the Special Master established a procedure for the Omnibus Autism Proceeding (OAP). As of February 1, 2009, of the 12,850 cases that have been filed, over 5,500 claims represent autism related injuries.

The Plaintiff's Steering Committee (PSC) in the OAP engaged in discovery on the general causation issue for about four years between 2002 and 2006. They proposed that the general causation evidence be divided among three separate theories: (1) the combination of the MMR vaccine and thimerosal-containing vaccines can cause autism; (2) thimerosal containing vaccines alone can cause autism; and (3) the MMR vaccine alone can cause autism.

Between 2006 and 2007, three test cases, Cedillo v. Secretary of Health & Human Services, Snyder v. Secretary of Health & Human Services, and Hazlehurst v. Secretary of Health & Human Services, were picked to be tried under the first theory. After thousands of pages of discovery and post-hearing briefings the records were closed on July 31, 2008.

On February 12, 2009, all three cases were rejected under the applied theory. Petitioners each sought review of their respective decisions within the prescribed time but their claims were once again denied because the Office of the Special Master found that the petitioners were unable to demonstrate the causal link between the vaccines and autism in these specific cases based on the theories presented.

Although a general causation hearing for the third theory was initially scheduled to be heard in September of 2008, the PSC has decided that they will not introduce any new evidence and that they would rely on everything that has already been submitted in support of the first theory proceedings.

The only remaining theory to be decided is the second theory that thimerosal containing vaccines alone can cause autism. The hearing for three test cases picked for this theory, King v. Secretary of Health & Human Services, Mead v. Secretary of Health & Human Services, and Dwyer v. Secretary of Health & Human Services, were conducted in July of 2008, and are now in the post-hearing briefing stage.

With the pending decision regarding the second theory comes an uncertainty for the fate of the remaining autism related vaccine injury claims. Currently, there are over 5,000 unresolved claims that are attempting to demonstrate that these vaccines can cause autism. Notwithstanding rulings concluding that there is no clear scientific evidence that autism is caused by vaccines or any preservative or additive used in vaccines, families continue to place the blame on the vaccines for their children's autism.

The effect of media attention
Recent attention from the media has made the vaccine issue a household topic. Jenny McCarthy was one of the first celebrities to put a spotlight on the connection of the vaccines and autism related injuries. She's made guest appearances on shows such as "The Early Show," "Oprah Winfrey," and "Larry King Live." In 2007, she published a book titled Louder than Words: A Mother's Journey in Healing Autism. She continues to serve as an advocate for Talking About Curing Autism (TACA) and participates in fundraisers, online chats, and other activities for the non-profit organization.

Her public claims on national and cable television have led to a higher rate of parental concerns about the link between vaccines and autism.

Television shows such as Law and Order SVU, Doctors and Eli Stone have also dedicated episodes to confronting the conflicts that parents are faced with in deciding whether or not to vaccinate their children. Credible talk shows like Oprah Winfrey, Diane Sawyer, Larry King, and Meet The Press have provided a forum for discussion between parents, scientist and physicians.

In May of 2008, the Los Angeles Times published an article about the rise of measles in the United States. According to this article, the US was on track to report the highest incidence of measles since 2001. In California alone, 1.11% of kindergartners had received personal-belief exemptions from vaccines in 2002 while that number rose to 1.41% four years later.

In 2008, a survey done by the Florida Institute of Technology (First National Public Opinion Survey: Americans' Knowledge and Understanding of Autism, 2008) reported that one in four (about 24%) of those surveyed said that because vaccines may cause autism it was safer not to have children vaccinated at all. Another 19 percent were not sure.

According to the Center for Disease Control, between January and July of 2008, there were a total of 131 cases of measles reported. This is a drastic rise from the average of 63 cases per year between 2000 and 2007.

It is indisputable that the rising attention that the mass media and pop culture are giving to the vaccine cases has in part contributed to increased concerns and even a boycott of the vaccines all together.

Regardless of what scientists claim, what the media portrays, or what physicians recommend, parents still have no real answers as to whether or not a routine vaccine can put their child's health at risk. This uncertainty notwithstanding, however, most parents recognize that immunizing children against life-threatening diseases is something worth doing despite their beliefs about the dangers of vaccination. The real goal and focus should be on making vaccines safer and eliminating potentially damaging ingredients.