Genetic Transformation Injury As A Basis For Emotional Distress Damages

By on October 14, 2013

The traditional rule in tort law is that the threat of future harm, not yet realized, is not sufficient to state a claim. However, over the past twenty-five years, plaintiffs in toxic tort litigation have sought to assert new non-injury damage claims, such as medical monitoring and fear of cancer. Providing compensation for an event that has not yet occurred and, indeed, may never occur, is a long way from traditional tort, which only permits recovery when a victim has suffered a harm.

In November 2012, KBR, the largest U.S. military contractor, lost a federal court jury verdict in Portland, Oregon, in the case, Bixby et al v. KBR, Inc, et al,  and ordered to pay twelve U.S. soldiers $85,000,000 in non-economic and punitive damages for alleged toxic  hexavalent chromium dust exposure at a company work site in Iraq in 2003. The trial was a test case over injuries allegedly suffered by Oregon National Guardsmen who were tasked with protecting KBR workers at Qarmat Ali, a water treatment facility the company was hired to rehabilitate after the overthrow of Saddam Hussein in 2003.

The Veterans Administration has developed a medical surveillance program for veterans who may have been exposed to hexavalent chromium at the Qarmat Ali Treatment Facility in Iraq. The program is provided free of any charge.  While VA does not expect to find many serious Qarmat Ali-related illnesses, the VA believed it prudent to monitor the health of those who may have been exposed.

The jury awarded each plaintiff $850,000 in non-economic damages (later reduced to $500,000 under the Oregon statutory damages cap) and $6,250,000 in punitive damages. The only “injury” plaintiffs had in common was an untested, fleeting, and imperceptible “genetic transformation injury” on which their emotional distress damages for fear of cancer were based.

On its pending appeal before the Ninth Circuit, KBR argues that it was error for the trial court to permit such recovery on the ground that Oregon law does not permit recovery of emotional distress damages where, as here, there is no present physical harm associated with the purported future risk of harm or, indeed, there is no physical injury at all.

An Amici Curiae brief filed by the International Association of Defense Counsel (“IADC”) and American Chemistry Council (“ACC”) argues persuasively that a majority of U.S. courts do not permit a plaintiff to satisfy the physical injury requirement through allegations of sub-cellular harm where the plaintiff is asymptomatic with no observable physical symptoms. For this important assignment, IADC and ACC turned to veteran appellate lawyers, Mary-Christine Sungaila and Patrick Kelly of Snell & Wilmer LLP,  Thieir brief provides an excellent overview of the law on this issue.

Courts are properly concerned about flooding the judicial system with false emotional distress claims. To allay this concern, some courts have imposed “floors” for recovery (e.g., a requirement that emotional distress be “serious”) and “hurdles” to recovery (e.g., the presence of physical harm requirement for emotional distress claims).

 In the KBR litigation, the plaintiffs’ expert, Dr. Carson, was unable to say whether any individual plaintiff experienced a “genetic transformation injury” at Qarmat Ali, much less whether such an injury persisted in any particular individual. Moreover, he acknowledged that “genetic transformation injury” is asymptomatic with no observable physical symptoms and may be spontaneously repaired by the body.

As the Ninth Circuit held in Dumontier v. Schlumberger Technology Corp., 543 F.3d 567 (9th Cir. 2008), “not every alteration of the body is an injury” and sagely observed that “all life is change, but all change is not injurious.” Thus, even if radiation always changes DNA, that does not mean that there will always be corresponding compensable physical pain, injury or disease.

On the basis of their well-crafted arguments, Sungaila and Kelly argue that if the court were to accept plaintiffs’ claim, it would throw open the possibility of litigation by any person experiencing even the most benign sub-cellular damage. Sungaila and Kelly distinguish KBR from other cases where, for example, a plaintiff who demonstrated actual mutations that would trigger cancer upon arriving at the age of puberty or sexual maturity.

We look to the Ninth Circuit to reverse the trial court decision and to reject plaintiffs’ argument that sub-cellular or genetic transformation is sufficient, in and of itself, to permit recovery for emotional distress damages.
 

Filed under American Chemistry Council, Amicus Curiae, Association, bixby v. kbr, Counsel', defense", Dumontier v. Schlumberger Technology Corp, emotional distress, genetic transformation injury, KBR, Mary-Christine Sungaila, Negligent Infliction Of Emotional Distress, non-economic damages, Qarmat Ali, sub-cellular harm, war in Iraq Tagged with

Texas Adopts Learned Intermediary Doctrine

By on June 29, 2012

The Texas Supreme Court rendered judgment in favor of Centocor, Inc., the pharmaceutical manufacturer subsidiary of Johnson & Johnson, in a landmark decision involving the learned intermediary doctrine, Centocor, Inc. v. Patricia Hamilton, Thomas Hamilton and Michael G. Bullen, M.D. (No. 10-0223). The International Association of Defense Counsel (IADC), which often weighs in on signficant jurisprudential issues before appeals courts, filed an amicus brief requesting that the Court reject the direct-to-consumer advertising exception to the learned intermediary doctrine that had been recognized by the intermediate appellate court.  Porter Hedges LLP  filed the brief on IADC’s behalf.

The decision is significant because it the first time that the Texas Supreme Court has expressly recognized the learned intermediary doctrine. Texas now joins the vast majority of states that have adopted the learned intermediary rule. In a press release issued yesterday, IADC reported that the Court declined to create a direct-to-consumer advertising exception to the learned intermediary rule, despite the fact that two other states had done so. The Court also recognized that a plaintiff cannot plead around the learned intermediary rule by asserting causes of action such as fraud in what is, at its core, a failure to warn case. Significantly, the Court also recognized that the learned intermediary rule is not an affirmative defense, but a legal doctrine that is part and parcel of the plaintiff’s burden of proof. Further, the Court determined that where a prescribing physician is aware of a drug’s risks, "any inadequacy of the product’s warning, as a matter of law, is not the producing cause of the patient’s injuries."

In the opinion, the Court indicated that "Under the learned intermediary doctrine, the manufacturer of a pharmaceutical product satisfies its duty to warn the end user of its product’s potential risks by providing an adequate warning to a ‘learned intermediary,’ who then assumes the duty to pass on the necessary warnings to the end user." The Court held that "the doctrine generally applies within the context of a physician-patient relationship and allows a prescription drug manufacturer to fulfill its duty to warn end users of its product’s potential risks by providing an adequate warning to the prescribing physician."

Notably, the Texas Supreme Court was critical of the lower court’s opinion, which had attempted to carve out an exception to the learned intermediary doctrine for direct-to-consumer advertising. Although plaintiff Hamilton alleged various common law causes of action, all of her claims pivoted on the issue of whether the Centocor had provided an adequate warning to her physician in its prescribing information.  Therefore, the Court ruled,  the learned intermediary doctrine applied to all of Hamilton’s claims. It was incumbent upon plaintiff to demonstrate that an inadequate warning to her prescribing physician was responsible for her injury.  Because plaintiff failed to present any evidence that the purportedly  inadequate warning was at the root of the physician’s  decision to prescribe the medication, her claims failed as a matter of law."
 

Filed under Centocor, Inc, defense", durect-to-consumer advertising, IADC, intermediary, International Association of Defense Counsel, learned, learned intermediary doctrine, Pharmaceutical & Medical Device, Porter Hedges LLP, Remicade, Texas Supreme Court Tagged with ,