Lilly Does Not ‘Owe A Duty To The World’
8 CommentsBy Ed Silverman // September 5th, 2008 // 1:37 pm
At about 11 am on Februray 25, 2002, Ellen Crews suffered an adverse reaction to a Lilly diabetes medication while driving her Ford Escort on the Capitol Beltway in Maryland. She began driving erratically and rear-ended a Chevrolet Impala driven by former Prince George’s County Councilman Isaac “Ike” Gourdine, according to The Maryland Daily Record.
Gourdine, 56, lost control of his car and crashed into the back of an illegally parked tractor trailer, and died from a head injury while his legislative aide, Marilynn Bland, suffered minor injuries, according to the paper. Mary Gourdine subsequently filed a lawsuit against the drugmaker, arguing that Lilly failed to warn Crews, a type-1 diabetic taking a combination of drugs manufactured by Lilly, that increased rates of hypoglycemia could occur between 6 am and noon, the paper writes.
The issue at hand, of course, is whether a drugmaker owes a duty to a third party who does not ingest the drugs. The state court of appeals ruled the answer is no. “To impose the requested duty from Lilly to Mr. Gourdine would expand traditional torts concepts beyond manageable bounds…,” Judge Lynne Battaglia wrote for the court. “Essentially, Lilly would owe a duty to the world.”
The court agreed that Lilly did not owe a duty of care to Gourdine based on foreseeability that such an accident could occur. There “may be circumstances where foreseeability alone may give rise to liability to a third party because of policy reasons,” the court wrote, but “this is not the case,” according to the paper.
Dan A.
Perhaps if this true mission statement of thiers was different, things would be better for the corporation- if not the pharmaceutical industry.
Scott
The real question is whether Lilly knowingly failed to disclose information that was discovered in clinical trials, or engaged in selective disclosure of the facts by obfuscating information meant to gain FDA approval of the drug without full disclosure of the facts.
Matthew Holford
I wonder if the Court would hold that Eli DID owe a duty of care to any of the people harmed by the CIA’s administration of the LSD that Lilly supplied to the Agency?
Is it foreseeable that a person unwittingly taking a known hallucinogenic in a completely uncontrolled manner, would suffer an adverse reaction, and kill himself? I think we should be told. Regrettably, the statute of limitations in tort has already passed, on that one.
Matt
Melody
Sounds like Ms. Crews suffered an adverse reaction known as hypoglycemia unawareness. While Lilly contends that they are not at fault, as Scott points out, their failure to disclose, or selective disclosure lies at the heart of the matter. The significance of the term hypoglycemia unawareness lies in the word UNAWARENESS.
I doubt that there is a single treated Type 1 who fails to recognize the dangers associated with insulin usage and possible hypoglycemia. They are educated from day one of this danger. The “UNAWARENESS’ –which was discussed in the NDA when Lilly sought to gain approval from the FDA for this first-ever genetically-engineered drug—either saw patients ‘wash out’ of the study, or the significance was trivialized as marginal. For all intents and purposes, the FDA ignored this significant adverse event. Many T1 diabetics have experienced unexpected hypoglycemic events without having any symptoms. HOW can an individual respond to a low blood sugar if no SYMPTOMS present themselves? Certainly they can “test and test often” but the very nature of rDNA insulin—in some individuals—is that the product provides wide, UNPREDICTABLE swings in bG levels because of its labile nature and the fact it does not cross the blood/brain barrier. If the product itself precludes symptomology, how can a patient be expected to respond to an event he cannot know or expect to be occurring.
While Gourdine may be precluded from having standing, I would hope that Ms. Crews seeks redress from Lilly and/or her doctor for harm done. If she was not adequately informed of the “unawareness” portion of this adverse event . . . and if her doctor and Lilly failed to acknowledge the activity curve was unpredictable and INDIVIDUAL, they SHOULD BE held accountable.
Brent
The case presented by this article may be legally correct, but in terms of humanity, the injustice is magnified several fold, with no accountability. The FDA approved a dangerous drug when they gave Lilly permission to market their product to all diabetics. Consider the possibility that all cars in the U.S. were made without a gas tank. How many people do you think would be left stranded—every day—some in the process of seeking emergency aid, some harming themselves or others as the tank ‘ran dry.’ A diabetic consuming “modern” insulins has no gauge regarding how high or low their blood sugar IS at any time. Lilly KNEW that these modern insulins did not provide adequate warnings—resulting in hypoglycemia unawareness. When this patient has a serious episode of low blood glucose, then the actions which follow are a direct of result of the drugmaker’s faulty product.
All the victims involved should be allowed to sue Lilly because Lilly was instrumental in manufacturing the drug that caused the succeeding events. Of course, the FDA, and Henry Miller (instrumental in pushing approval through) played a part . . . but we all know the FDA does no harm.
Anne
I sued Eli Lilly for killing my son from Zyprexa (profound hyperglycemia) and though my suffering knows no bounds I did not myself take the drug. Should I have not been able to sue?
Melody
Anne–
That is one of the contentious points. Some drugmakers have escaped prosecution because of this ‘lack of standing’ issue. I have lost friends–but have no standing. Those who might be entitled to sue (1) are dealing with profound grief; (2) choose to ‘get on with their lives’; (3) lack incontroverbile ‘proof’ of causality. What a Catch-22!
LILLI
All meidcations react differently to each individual. The courts giving the Pharmaceuticals the benefit is a known factor. Pharmaceutical and the medicalprofession, haealthcare industries and hosptials are influencing and directing our courts and laws. Black Box Label warning are also to protect Pharma—not the patient. There are several factors could prove thst Lilly was to blame. Especially if she was taking the drug for a long time. Medications do cause fatalties that ate npt reported and this incident protects Lily.