Sykes Saga Continues · Feb 18, 08:00 PM

Many new developments have recently arisen in the “judicial advocacy” crusade of Rev. Lisa Sykes and Seth Sykes, who for nearly a decade have aggressively promoted the overwhelmingly discredited scientific hypothesis that autism is a consequence of mercury poisoning, and have sought to hold various healthcare providers, pharmaceutical developers and public health professionals legally at fault for supposedly rendering their child autistic.

Rev. Sykes is associate pastor at Welborne United Methodist Church in Richmond Virginia; Mr. Sykes is an assistant dean at Virginia Commonwealth University. Their $20,000,000 lawsuit, Sykes v. Glaxo-SmithKline, was filed in March 2006. The original complaint alleged that their autistic son suffers from neurological and neurodevelopmental injuries caused by the mercury-based antimicrobial thimerosal, contained in vaccines he received during his first three years of life, and which was also contained in Rho(D) immune globulin administered to Rev. Sykes during pregnancy.

The list of defendants included Glaxo-SmithKline, manufacturer of the hepatitis B vaccine Engerix; Wyeth-Lederle, manufacturer of DTP, DTaP, and Hib vaccines; and Bayer Laboratories, manufacturer of HypRho-D. The eight-person legal team representing the couple included Clifford Shoemaker of Vienna, Virginia; Daniel Gallucci, Joseph Roda and Dianne Nast of Lancaster, Pennsylvania; Lawrence Cohan of Philadelphia, Pennsylvania; John Kim of Houston, Texas; and Michael Williams and Thomas Powers of Portland, Oregon. Although the family lives in Virginia, and although most of the child’s treating physicians, and most of the family members and friends named as plaintiffs’ witnesses are also located in Virginia, the lawsuit was originally filed in the U.S. District Court for the Eastern District of Pennsylvania.

Rev. and Mr. Sykes’ original complaint alleged that the vaccines and Rho(D) immune globulin were “unreasonably and dangerously defective” by virtue of their thimerosal content; that the manufacturers of these products failed to adequately warn health care providers of risks associated with their use; that they failed to adequately test their products; and that they intentionally withheld relevant information from the U.S. Food and Drug Administration (FDA) when seeking approval and licensing of their products.

After a year of motions, memoranda, hearings and arguments, on March 28, 2007, Judge Lawrence Stengel issued an Opinion and Order finding that all of the Sykes’ “failure to warn” claims were preempted by FDA regulation of labeling of drugs and biological products (Sykes v. Glaxo-SmithKline, 484 FSupp2d 289, 306–17 (E.D. Pa 2007)). The court further held that the “defective design” and “inadequate warning” claims against the vaccine manufacturers were barred by the National Childhood Vaccine Injury Compensation Act. Since Rho(D) immune globulin is not a vaccine, the corresponding claims against Bayer were allowed to continue to trial. Finally, the court transferred the plaintiffs’ claims against Bayer — the sole remaining defendant — to the U.S. District Court for the Eastern District of Virginia.

The day after the order was issued, Rev. and Mr. Sykes appealed the ruling to the United States Court of Appeals for the Third Circuit. That appeal was dismissed on September 7, 2007. John Kim then withdrew as plaintiffs’ attorney, followed shortly thereafter by attorneys Roda, Nast and Gallucci.

Once the case was transferred to the Eastern District of Virginia, on January 3, 2008, Bayer’s attorneys filed a motion for judgment, arguing that HypRhoD was wholly subject to regulation by the FDA, and that Virginia law did not recognize the claims for strict liability, “failure to adequately test,” or defective design. Two weeks later, plaintiffs’ attorney Clifford Shoemaker responded with a lengthy memorandum discussing the history of thimerosal, and addressing the matter of federal preemption of state law tort claims.

In a rebuttal brief, Bayer’s attorneys called attention to the fact that Mr. Shoemaker had failed to respond to any of their arguments regarding Virginia law. Bayer’s rebuttal also pointed out that the “Legal Argument” section of Mr. Shoemaker’s memorandum replicated word-for-word the text of a brief on the matter of federal preemption he and his colleagues had submitted to the court in August 2006, and the subject of which was extensively addressed in Judge Stengel’s ruling. (The section on thimerosal was largely reproduced from A Review of Thimerosal and Its Ethylmercury Breakdown Product, by Dr. Mark Geier, David Geier, and Rev. Sykes.)

On January 22, Mr. Shoemaker filed a motion requesting permission to amend the complaint originally submitted to the court almost two years before. The proposed amended complaint eliminated all references to vaccines, and, in addition to Bayer Corporation, named Bayer Biological Products (the division of Bayer that produces immune globulin products), Eli Lilly & Company and other, unidentified thimerosal manufacturers as defendants. As previously, the proposed amended complaint charged the defendants with negligence and inadequate design and formulation of their products, which were alleged to be unfit for their intended purposes, and also charged the defendants with negligent infliction of emotional distress. The plaintiffs also sought to renew the “failure to warn” claim against Bayer, which had been previously dismissed with prejudice by Judge Stengel.

Also included on the expanded list of defendants was Dominion Resources, operator of a coal-burning power plant in Richmond, Virginia that generates power for Virginia Electric and Power Company. The plaintiffs sought to charge Dominion with negligence due to emission of mercury from its coal-burning power plants; they claimed that their child’s “exposure to airborne mercury in the environment through inhalation, the food chain, and other sources contributed to the cumulative mercury toxicity and was a substantial factor causing [his] neurological damage.”

In response to the court’s directive, the plaintiffs subsequently filed a brief setting forth facts, arguments, and legal authorities to support their motion to amend the complaint. In that brief, they promised that their sojourn through the Virginia courts would be a long one, regardless of whatever judicial decision might ensue.

“Plaintiffs would urge that, in the interests of justice, the Court allow the joinder of these additional parties at this time so that the cumulative effect of their negligence in exposing W[…] to mercury from a variety of sources can be litigated together. Counsel for plaintiffs would like to make it clear, however, that adding these defendants will make this litigation even more protracted, requiring more discovery and more time before Plaintiffs will be prepared to move this case to trial. If Plaintiffs are not going to be allowed adequate time to conduct such discovery that is necessary, then Plaintiffs would prefer that their motion to add defendants not be granted, and they will pursue these defendants in other litigation.”

Bayer’s attorneys opposed the request, asserting that Rev. and Mr. Sykes should not be allowed to reintroduce previously dismissed claims “by employing slight variations in legal theory or by engaging in artful pleading.” They argued that the reassertion of both the previously dismissed claims and new claims against Bayer would be futile. They protested the Sykes’ efforts to name new defendants, especially Dominion Resources, whose activities are unrelated to their own; although both companies were being accused of causing harm by exposing Rev. Sykes and her son to mercury, “the alleged occurrences involve different manners of exposure occurring at different periods of time.” They asserted that addition of Dominion to the list of defendants would, “as Plaintiffs expressly admit, unduly and unnecessarily complicate this case.” Given the fact that Bayer had already spent two years defending itself against the plaintiffs’ charges, and had no desire to “be put to the needless expense of litigating over air pollution when Plaintiffs have already signaled their willingness to file a separate case to pursue such claims,” the company invited the court “to accept Plaintiffs’ suggestion to bring the claims against the other proposed defendants in a separate proceeding.”

On Tuesday, February 12, Judge James R. Spencer issued a Memorandum Opinion granting Bayer’s request that the pending claims against the company be dismissed. The court held that under Virginia law, only activities, not substances, can be “abnormally dangerous”; that the Sykes based their design defect claim upon a false premise, that is, that Bayer could have avoided using a preservative by packaging HypRho-D differently; and that “failure to test” was not a claim recognized under Virginia law.

Turning to the Sykes’ request to amend their complaint and add new defendants, Judge Spencer held that while federal policy encouraged the granting of such requests “if justice so requires,” it would be futile to allow them to reassert most of their claims against Bayer. The “failure to warn” claim had already been dismissed by Judge Stengel, and the Sykes had offered no compelling reasons why that decision might be erroneous. Since Judge Spencer had just determined that the “failure to test” claim was legally insufficient, he denied their request to reassert that claim in a new complaint. Although the Sykes had sought to add claims for negligent misrepresentation, intentional misrepresentation, fraud, gross negligence, and negligent infliction of emotional distress, they had failed to set forth any facts to support their allegations. The court therefore ruled that such claims could not be included in a new complaint.

Rev. and Mr. Sykes’ efforts to seek punitive damages were similarly rebuffed, since they had set forth no facts that might support their allegations that Bayer’s conduct was fraudulent, reckless, malicious, willful or wanton.

Several new claims against Bayer were, however, allowed. Although the original design-defect claim was dismissed since it was based on false factual allegations, Judge Spencer determined that a different design-defect claim with a different factual basis would not necessarily be futile, and was therefore permissible. For the same reason, he also allowed the presentation of new claims for breach of warranty of merchantability — that is, claims for harm caused by a seller’s failed guarantee that a product is fit for its intended purpose.

Finally, the court approved the addition of Bayer Biological Products as a defendant, since the Sykes’ claims against both Bayer and its Biological Products division involve common questions of law and fact. However, their request to add Lilly, other thimerosal manufacturers, and Dominion Resources was denied, since their claims against these entitities were not reasonably related to their claims against Bayer, and since adding these new defendants would delay the resolution of the suit.

A new complaint, answers and rebuttals, discovery and depositions are yet to come. Given Rev. and Mr. Sykes’ promise to the court, a small scourge of new lawsuits against their newly identified demons will doubtless ensue.

And thus the Sykes’ legal odyssey continues ad infinitum — a hydra-headed quest for revenge, for compensation, and for judicial validation of autism causation theories roundly rejected by the greater scientific community, by numerous courts, and by a great number of individuals and families whose interests they purport to represent.

Docket reports:
Sykes et al v. Glaxo-SmithKline et al, Phase One
(Case 2:06-cv-01111-LS, U.S. District Court for the Eastern District of Pennsylvania)
Sykes et al v. Glaxo-SmithKline et al, Phase Two
(Case 3:07-cv-00660-JRS, U.S. District Court for the Eastern District of Virginia)

Comments


  1. They’re a tenacious bunch. I can only imagine that they believe they have god on their side, and having turned it into a religious battle, will fight to the bitter end. Here’s hoping our tax payers money will see the bitter end very soon.

    — Bartholomew Cubbins    Feb 18, 09:26 PM    #

  2. Has Mrs. Sykes considered suing God for the contribution of volcanoes and other geothermal sources to environmental mercury levels?

    Or would she and her legal team just mentally subtract “God’s” mercury from that of the power plants and the pharmaceutical companies, as far as her son’s total level of mercury (which I expect is, and always was, normal)?

    — Ms. Clark    Feb 18, 10:49 PM    #

  3. How many times do these people have to be told NO?

    Someday the Sykes’ son will grow up and wonder why his parents spent his childhood arguing that he was a walking tort.

    — isles    Feb 18, 11:38 PM    #

  4. Boy, can these folks perseverate or what?!

    — andrea    Feb 19, 01:06 AM    #

  5. Jeebus,

    These peeps are costing most families with autistic children. Think about the funding that could be available to families and kids who need it.

    — anonymous    Feb 19, 01:38 AM    #

  6. I don't think that this suit per se is diverting any funds that might otherwise be allocated for autism research or support services (although the publicity circus that's been collectively staged by thimerosal plaintiffs and their provocateurs is certainly a significant distraction from reasonable consideration of the kind of research and support services that will actually help autistic people and their families). The plaintiffs’ lawyers aren’t publicly funded like they are in the VICP. And the Sykes, like all other citizens, are entitled to their day in court.

    The question is, how many days will they be entitled to? And by the time that this lawsuit and all of its clones have played out, how many judges and law clerks will have spent how much time examining how many briefs that recycle the same old cut-and-paste arguments presented by the same little cadre of autism-as-tort-chasers over and over again?

    — Kathleen Seidel    Feb 19, 07:56 AM    #

  7. What the Sykes, and others of their ilk do, is divert attention away from the day-to-day needs of the families with special children. They also stigmatize Autism as something so bad, that one parent killed her child to rid her of evil.

    These parents need mental health treatment before they damage any others.

    — TheProbe    Feb 19, 10:48 AM    #

  8. As a treater/expert, it will be interesting to see to what extent Geier will testify re his Lupron protocol and its effects on the Sykes’ child. He’s going to open himself up to cross-exam (assuming it even makes it that far). And if I’m Geier, sitting on the stand, testifying in support of my oft administered protocol, I have to be wondering how many med/ethics boards are paying attention.

    — bones    Feb 19, 01:09 PM    #

  9. I’ll say. The Sykes’ child is “Child X” on the Lupron Protocol patent applications. That’s where the Geiers describe administering massive doses of Lupron to him, supplemented by Androcur — which isn’t even FDA approved for sale in the United States. Wouldn’t it be fun if someone asked Geier on the stand where that Androcur came from and how he knew what was inside those pills.

    The Sykes’ child is also “Patient 1” or otherwise numbered in most of the Geiers’ human-subjects studies (which mama helps review from her perch on the IRB). And, according to their 2005 and 2006 Autism One presentations, he’s the child whose diagnosis quietly morphed from “precocious puberty” the first year — handy for getting insurance to pick up the research tab — to “hyperandrogenicity” the next — more of a hard sell, you might have to dazzle some claims processor over the phone to get them to fork over, but there’s not much more you can do once those “precocious puberty” diagnoses you’ve been handing out like candy don’t hold up to scrutiny any longer.

    Oh to be a fly on the wall at the deposition.

    — Kathleen Seidel    Feb 20, 01:58 PM    #

  10. So good of you to allow for someone’s day in court, even though you plainly regard your position to be the morally correct one and clearly you should be judge and jury. Interesting how motivated you are to slam these parents, who are doing what they believe is best for their child (a right and a responsibility of every parent), and you mock their religious convictions as well. What have they done to you? My question is, how stupid does anyone have to be to purposefully put MERCURY, a neurotoxin, into a child? Why not advocate a little lead to chew on too, it is less toxic, you know? What possible defense is there for such reckless disregard for the children? The logic on this site boggles the mind.

    — Damomma    Feb 22, 06:03 PM    #

  11. Damomma said “My question is, how stupid does anyone have to be to purposefully put MERCURY, a neurotoxin, into a child? “

    So, tell us, in your expert opinion is the thimerosal that used to be in the DTaP (but no longer) a worse neurotoxin than tetanospasmin?

    — HCN    Feb 23, 04:38 PM    #

  12. Damomma, do you have a point?

    — bones    Feb 24, 04:35 PM    #

  13. Damomma, thanks very much for visiting, even if you are appalled by what you read here. Would you please point out the instances where I have supposedly mocked Rev. and Mr. Sykes’ religious convictions? It’s the sort of thing I try to avoid, and I was not aware that I had crossed over that line. I have publicly criticized Rev. Sykes’ exploitation of her position as a minister to promote her views on scientific subjects, and to further her interests in litigation. As far as I’m concerned, that’s fair; ecclesiastical robes don’t and shouldn’t confer immunity to criticism.

    I have no doubt that the Sykes are doing what they believe is best for their child. However, I am convinced that they have been grossly misled, and are misleading others, not only with respect to the cause of autism, but also with respect to the medical treatment of autistic children. I welcome you to read my series of articles and letters about the Lupron Protocol for more detail.

    — Kathleen Seidel    Feb 25, 06:46 AM    #

  14. Have you read this article:

    http://www.medicalnewstoday.com/articles/38784.php

    “An article in the March 10, 2006 issue of the Journal of American Physicians and Surgeons shows that since mercury was removed from childhood vaccines, the alarming increase in reported rates of autism and other neurological disorders (NDs) in children not only stopped, but actually dropped sharply – by as much as 35%.”

    How do you explain this?

    If you guys want to prostitute the truth, somebody will want to find out who is paying the bills. That is probably why you were subpoenaed.

    — William Wallace    Apr 4, 12:07 PM    #

  15. Yes, I have read it. Here's what I had to say about it shortly after it was released. For more commentary, see Interverbal: A Review of “Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines, and Respectful Insolence: The Geiers go dumpster-diving yet again.

    — Kathleen Seidel    Apr 4, 12:44 PM    #

  16. I just read your first link, and jumped to the end, where you write:

    “One must conclude that the Geiers determined the results of their study prior to conducting their analysis of data upon which it was based.”

    I think you’re overstating your case on this point. Perhaps it should have been reworded to something like

    “One can conclude that the Geiers recognized early on the likely results of their study prior to conducting their final analysis of data.”

    I saw this because today, on a lark, and after learning about your situation, I thought, hey, Thimerosal has been out of most childhood vaccines for a period of time now, what a great opportunity. I did a search, and found the Autism Rates Drop After Mercury Removed From Childhood Vaccines article about the Geier paper at number 3 of the google results.

    I’ll reread all your links when I find time, but do you know if anybody has had a rebuttal to the Geier & Geier paper published in a peer reviewed journal?

    — William Wallace    Apr 4, 02:37 PM    #

  17. Okay, I found this:

    http://www.jpands.org/vol11no2/correspondence.pdf

    Processing. Thanks for the pointers.

    — William Wallace    Apr 4, 02:44 PM    #

  18. They have the right to file just as you have your right to whine.

    — Keith    Apr 5, 03:57 PM    #