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 ,

Forum Non Conveniens: Be Careful What You Ask For

By on February 27, 2012

In defending a United States defendant in an action involving a foreign accident and foreign claimants, it is almost a knee jerk reaction to file a motion to dismiss on forum non conveniens grounds. In a thought provoking article, “Be Careful What You Ask For – the Forum Non Conveniens Dilemma,” Cozen O’Connor lawyersRichard Dunn and Raquel Fernandez bring this practice into question. Mr. Dunn and Ms. Fernandez urge a different standard for analyzing whether to file the motion. The question that should be asked is whether it is beneficial for the U.S. defendant company to be subject to the laws and procedures in the foreign jurisdiction.

Thus, it is critical to understand the foreign jurisdiction’s law before your client is stuck there in litigation. A few of the considerations to think about include:

(1) Can your client get out of the case on summary judgment? Many foreign jurisdictions do not provide for summary judgment. Therefore, all matters before a court must be tried to conclusion, which may potentially lengthen and increase the cost of proceedings;

(2) How much time will your client have to prepare its case? Some foreign jurisdictions allow a short time for defendant to mount its defense, which may be an important consideration in a complex product liability case where it is necessary to hire and prepare appropriate experts. Moreover, the documentary evidence that supports your client’s case has to be translated into the foreign jurisdiction’s official language; 

(3) Will discovery be allowed? In some foreign jurisdictions, there is nothing akin to the discovery procedures that benefit parties in the United States;

(4) Will expert testimony be allowed? Often, the foreign court will place great emphasis on the government accident investigation report rather than on the expert evidence. In some jurisdictions, your client’s liability may be determined by the government authorities charged with investigating the accident, although they may not be competent;

(5) What is the role of the judge? Is the court the sole trier of fact?;

(6) Are there multiple claimants? You should determine whether all of the claimants involved in the incident can be consolidated before the same tribunal. If each claimant is able to file suit in his or her own locale, the client may need to defend numerous actions before numerous judges in different locations; and

(7) What are the attitudes towards the United States and American businesses in the foreign jurisdiction?

Anti-American bias and corruption figured prominently in Chevron’s environmental litigation in Ecuador. In the early 1990’s, Ecuadorian claimants filed suit in the United States alleging that Texaco’s operations polluted the rain forests and rivers in Ecuador, resulting in environmental and personal injury damages. The lawsuit was dismissed in 2002 on forum non conveniens grounds and the case was refiled in Ecuador the following year. In February 2011, an Ecuadorian court entered an $18,000,000,000 judgment against Chevron (which had earlier acquired Texaco).

Scott A. Edelman, a partner at Gibson Dunn in Los Angeles, made a compelling presentation at a recent IADC meeting concerning serious irregularities and a lack of impartiality in the conduct of that case. Chevron alleges that the plaintiffs’ lawyers are guilty of fraud and misconduct and have filed a civil lawsuit under RICO in New York federal court against the trial lawyers and consultants involved. Chevron’s suit alleges that these attorneys and consultants used the Ecuador lawsuit to threaten Chevron, mislead U.S. government officials, and harass and intimidate Chevron employees, to extort a financial settlement from the Company. Chevron further alleges that plaintiffs built their case through fabricated evidence and a campaign to incite public outrage.

It is likely that the pervasive fraud that permeated the Ecuador litigation would not have occurred in a U.S. federal court. As a result of Chevron’s experience, a U.S. defendant would have to think twice about filing a forum non conveniens motion if there was any likelihood that the case would end up in Ecuador or somewhere similar.

 

Filed under Chevron, Connor', Cozen O, Ecuador, Environmental, Federal Court Litigation, Forum Non Conveniens, Gibson Dunn, IADC, International Association of Defense Counsel, rain forest, Scott Edelman, Texaco Tagged with

Lone Pine Orders–Shutting The Door On Frivilous Toxic Tort Suits

By on November 10, 2009

A Lone Pine Order is a case management tool that requires toxic tort plaintiffs to produce credible evidence to support a key legal component of their claim prior to the commencement of pre-trial discovery.  As Niall A. Paul and Timothy D. Houston of Spilman Thomas & Battle write in a recent IADC Newsletter article titled, "Checking Meritless Mass Tort Claims at the Door–Lone Pine Case Management Orders Reinforce the Obligation of Plaintiffs’ Counsel to Have a Case Before Filing Suit," a Lone Pine Order should be designed to weed out frivolous claims "before a defendant is forced to undergo the financial rigors of protracted discovery and invest hundreds of thousands of dollars and irrecoverable time only to face the stark reality that plaintiffs are devoid of credible evidence–to establish exposure, injury or causation."   In light of the the enormous defense costs consumed in document production and pretrial and the increasing emphasis by in-house counsel on cost control in toxic tort litigation, it is surprising that Lone Pine Orders are not sought by defense counsel more frequently than they are.  A Lone Pine Order can require the plaintiffs to produce credible evidence on the issues of (1) exposure; (2) causation; and (3) damages.  However, that may impose a greater burden on plaintiffs’ counsel than some courts, particularly state courts, may be willing to require early in a litigation. However, I have had success in identifying a single issue–my client’s best issue–and seeking a Lone Pine Order on that sole issue rather than on multiple issues.  For example, in the Happyland Social Club Fire Litigation, which case arose from the deaths of some 87 people at an illegal social club in New York City on March 23, 1990 (see photo above), defendants obtained a  Lone Pine Order on the sole issue of product identification.  Plaintiffs’ theory of the case was that the defendants’ products were fire initiators, fire promoters or, alternatively, emitted toxic fumes when burned.  The contents of the social club were stored by Plaintiffs Steering Committee in a huge warehouse in lower Manhattan.  The Catch-22 for plaintiffs was that if a  product was in the warehouse more or less intact, it could not  have burned and contributed to the deaths of the plaintiffs.  On the other hand, if the product was consumed in the fire, there was no way of identifying the product or its manufacturer.  As a result, plaintiffs were not able make a proper product identification in many instances, pursuant to the Lone Pine Order and, consequently, many defendants were dismissed from this Bronx state court case. It is unlikely that a state court judge in the Bronx would have entered a more onerous order.  In every instance were they are employed, Lone Pine Orders foster judicial economy and substantially reduce the litigationn costs for all parties. In In re Vioxx, 557 F.Supp. 2d 741 (E.D.La. 2008), the federal district court in Louisiana observed that Lone Pine Orders also reduced the litigation expenses incurred by plaintiffs’ counsel in prosecuting mass tort actions. 

Filed under case management tool, Happyland Social Club Fire Litigation, IADC, In re Vioxx, International Association of Defense Counsel, Lone Pine, Lone Pine Order, Spilman Thomas & Battle Tagged with