Are Prescription Drug Manufacturers Safer In Indiana Than Children?

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Indiana is the main forum for multiple federal court decisions, derailing consideration of whether certain judges improperly aligned with a multi-billion dollar, prescription drug manufacturer to supposedly conceal an alleged link between one of its products and the adverse prescription drug reaction of a child and possibly other children. Pending before the United States Court of Appeals for the Seventh Circuit is Crenshaw v. Antokol et al. which chronicles that litigation and what Zena Crenshaw considers her related efforts to expose potential risks of a synthetic, antibacterial combination for children suffering initial, uncomplicated episodes of urinary tract infection.

Sylvia would not have received this synthetic combination of Trimethoprim and Sulfamethoxazole (TMP-SMZ) under a brand name or as a generic if LaRoche adequately persuaded doctors to prescribe a less potent antibiotic for children suffering their first, uncomplicated urinary tract infection

Ironically, the State featuring license plates proclaiming "Kids First" and that once was the home of America’s current Chief Justice, says appellant Zena Crenshaw, "is also the main forum for multiple federal court decisions, derailing consideration of whether certain judges improperly aligned with a multi-billion dollar prescription drug manufacturer, to conceal an alleged link between one of its products and the adverse prescription drug reaction of a child and possibly other children". The state is Indiana; the story began nearly two decades ago; and is chronicled by the full record of Crenshaw v. Antokol et al. 3:04-CV-00182, now pending as appeal number 06-2046 before the United States Court of Appeals for the Seventh Circuit.

According to Crenshaw, the full record of her appeal reflects that "a young lady named Sylvia was seven and recovering from a near fatal prescription drug reaction occasioned by the treatment of her urinary tract infection in 1992". The matter was reportedly referred to Crenshaw who describes herself as an African American woman, then emerging in East Chicago, Indiana as an attorney and litigator. Crenshaw explains that she "filed suit against the doctor claimed to have prescribed Bactrim Suspension (Bactrim) for her client, the pharmacist and pharmacy that allegedly overfilled his prescription, as well as the emergency room physician reported to have misdiagnosed Sylvia’s adverse reaction". Ms. Crenshaw reports also suing Hoffman-LaRoche, Inc. (LaRoche), a party to her current appeal.

LaRoche "manufactured and marketed the drug Sylvia was prescribed, though the pharmacy dispensed a generic version of the medication" according to Zena Crenshaw and court records. Zena reasons and claimed in lower courts that "Sylvia would not have received this synthetic combination of Trimethoprim and Sulfamethoxazole (TMP-SMZ) under a brand name or as a generic if LaRoche adequately persuaded doctors to prescribe a less potent antibiotic for children suffering their first, uncomplicated urinary tract infection". Crenshaw adds that "despite my years of academic distinctions and gradual recognition as a skilled lawyer in the small region of my hometown, I never imagined that with Sylvia and her mother, I was launching a 'David versus Goliath' story-gone-bad."

According to Crenshaw, "a local pediatrician advised me I would need a pharmacologist to prove the doctor’s negligence in the use of TMP-SMZ to treat Sylvia". Zena says, "I researched and verified the limited circumstances in which a pharmacologist has been able to establish the requisite standard of care for physicians" and reportedly retained an accomplished pharmacologist to do the job for Sylvia and her mom. Crenshaw adds that "the expert witness was then a pharmacologist and toxicologist, heading the ‘Department of Pharmacology and Toxicology’ for the ‘School of Pharmacy and Pharmacol Sciences’ at Purdue University’s West Lafayette main campus." He also lectured for three decades on pharmacology to second year classes of the Indiana University School of Medicine according to Zena.

Crenshaw reports that among other things, her expert detailed by affidavit his recommended course for using one or more antibacterial agents. Quoting the affidavit she remarks, while the procedure "may not have stopped Sylvia from experiencing a serious drug reaction...", it would have "...reduced the likelihood" of such an occurrence and "better assured (Sylvia) of prompt medical care." Zena says that although to her, "the affidavit made Sylvia’s primary doctor seem the most egregious of all the defendants involved, my research and analysis confirmed for me that each exposed Sylvia and her mom to unnecessary risks for which they were appropriately sued".

Zena shares that "I arranged for a modest settlement with the pharmacist and pharmacy and ultimately determined to dismiss the emergency room physician with no exchange of funds as it would be difficult to impossible to quantify how much they exacerbated my clients’ harm". She maintains, " the trial court resisted my novel claims against LaRoche, but I didn’t fret as these theories exposed name brand manufacturers to liability for the ingestion of generic drugs by patients under foreseeable circumstances". The implications were serious and to the extent they suggested new law had to be forged in Indiana, Zena claims she "understood that a trial judge may want to leave such a task to higher courts."

"It was not until the Indiana Supreme Court declined to review the case and thereby allowed my clients’ prescribing doctor and LaRoche to escape liability, and the trial judge ordered me, Sylvia, and her mom to reimburse LaRoche for more than $14,000.00 in legal fees did the scales of justice seem to me inexplicably unbalanced", says Zena. "I suspected the outcome perpetrated an arguable trend in the response of local courts to relatively complex, potentially lucrative personal injury claims prosecuted by minority attorneys, and some of the area’s most seasoned African American litigators reportedly shared my suspicion". "The local bar association of African American attorneys, individual lawyers, some civil rights and religious leaders, as well as some private citizens formed a loose local coalition called 'Struggle for Justice' and rallied to denounce the situation", Zena recalls. "For strategic reasons, I focused on the judgment for fees against me and my indigent clients and publicly requested various state authorities to investigate the sanction as alleged, unlawful bias" she says.

Writing for the Roger Williams Law Review in 2004, Professor Carl T. Bogus described "a culture of quiescence" in which criticism by lawyers of American government and particularly courts is considered "...professional treason... punished by both courts and colleagues". Zena considers it interesting that "challenging an Indiana court allowed me and my clients to avoid paying thousands of dollars to the wealthy LaRoche." Her federal complaint notes that the sanction was reversed on appeal with the Indiana Appellate Court noting a "...variety of novel theories accepted in some jurisdictions which would have imposed liability on Hoffman (LaRoche) regardless of whether (Sylvia) used or consumed a product Hoffman actually sold or manufactured". "As evidenced by my pending appeal in federal court", Zena says, "I believed such novelty was unavailing for Sylvia and her mother because of alleged institutional bias against African American and/or female lawyers in Indiana". She goes on to say that as a result of her requests for investigation, "I was the only person extensively investigated and prosecuted".

The appeal of Crenshaw v. Antokol et al. should be totally briefed by the parties as of mid-July 2006. The full record of that appeal, Zena states, "chronicles my efforts to vindicate all those allegedly caught in the backlash of my trying to expose alleged risks of TMP-SMZ in relation to children suffering initial, uncomplicated episodes of urinary tract infection". "Not a single jury has heard any portion of the convoluted saga which has been dismissed by one judge after another". She further reports, "plausible health risks for children remain unexplored due to court orders derived without thorough discovery, expert testimony, and/or indisputable logic."

"Focus on Indiana" is a national campaign to encourage various government agencies and officials to explore the prospect of serious, avoidable health risks for children being concealed through serial, judicial acquiescence or misconduct. It is spearheaded by Zena Crenshaw, Executive Director of the National Judicial Conduct and Disability Law Project, Inc. (NJCDLP). More information about "Focus on Indiana" is available at http://www.focus-on-indiana.org.

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