Florida Case Provides Insight on Learned Intermediary Doctrine

As we have discussed in prior posts, warnings involving medical devices and/or prescription drugs are issued not to the end user patient, but to the doctor prescribing or using the device.  This does not, however, release the drug or device manufacturer from the duty to adequately warn of the dangers of using the device or product.  In fact, it simply complicates the issue of what an adequate warning looks like. Take the recent case of Horrillo v. Cook Inc., 10-15327, 2012 WL 6553611 (11th Cir. Nov. 7, 2012) [PDF].  This case involved a stent manufactured by the defendant and approved by the FDA for use in bile ducts.  Dr. Michael Rush, however, used it during his angioplasty surgery on Margaret Horillo, not in a bile duct, but in her renal artery.

Within 24 hours of the procedure, Ms. Horillo suffered a serious stroke.

The warnings included by the manufacturer read as follows:

First, it stated that the device was “intended for use in palliation of malignant neoplasms in the biliary tree,” which is to say, treatment for cancer in the bile ducts. Second, under a heading entitled, “WARNINGS,” the instructions for use cautioned that “[t]he safety and effectiveness of this device for use in the vascular system have not been established.”

Deposition testimony in the case, however, revealed that stents such as this one were regularly used “off label” in the vascular system.  In fact, Dr. Rush had used this particular stent in the past in renal arteries.  The off-label use was so widespread, in fact, that the FDA called Cook and several other such manufacturers together about the issue before this surgery was performed.  As a result of that meeting, Cook sent a letter to the hospital where Dr. Rush did the surgery warning of the risk of stroke.

In his deposition, Dr. Rush testified that he was aware of some risk of using the biliary stent in the vascular system.  The degree to which he knew of the risks, however, became the primary issue in litigation.  At the trial level, the magistrate concluded that Dr. Rush was fully aware of the risks, applied the learned intermediary doctrine, and granted Cook’s motion for summary judgment.
The appellate court was not so convinced.  As the court stated, the issue was whether Dr. Cook’s knowledge was equal to that of Rush.  The evidence in the case suggested that it was not, and reversed summary judgment, and remanded the case.  A good reminder that the learned intermediary doctrine comes with its own set of challenges as an affirmative defense.

Judgment in Favor of Zyprexa Manufacturer Upheld in at least Two Matters

On October 4, 2010, Second Circuit Judges, John M. Walker, Jr., Jose A. Cabranes, and Chester J. Straub, upheld the decisions of the Eastern District Court of New York in two lawsuits filed against Eli Lilly & Company, manufacturer of Zyprexa. Belcher v. Eli Lilly & Co., No. 09-5004-CV, 2010 WL 3853003 (2d Cir. Oct. 4, 2010) and Gove v. Eli Lilly & Co., No. 10-216-CV, 2010 WL 3852840 (2d Cir. Oct. 4, 2010). Lawsuits against Eli Lilly & Company (“Eli Lilly”) began to be filed around the country by plaintiffs alleging that its anti-psychotic medication, Zyprexa, caused them to suffer from diabetes. Plaintiffs asserted that if Eli Lilly had properly warned of the drug’s dangers, they would have never been prescribed the drug and not developed diabetes. These similar lawsuits around the country were transferred to the Eastern District of New York pursuant to an order of the Judicial Panel on Multidistrict Litigation. The Belcher and Gove matters discussed here were both decided in favor of Eli Lilly on motions for summary judgment. Thereafter, these appeals were filed.

The Belcher matter was decided in favor of Eli Lilly solely on the ground that her claim was barred by the statute of limitations. Applying California’s discovery rule and its two year statute of limitations for product liability and personal injury actions, the Second Circuit upheld the decision of the Eastern District Court of New York. California was the applicable law since the matter was filed in California and the events giving rise the action occurred there. The Second Circuit found that the statute of limitations began to run in October 2001 when a physician who knew the association between the drug and increased weight gain and blood glucose levels prescribed Zyprexa. Her claim was barred as it was filed in February 2006. The decision of the District Court dismissing the action was upheld.

The Gove matter was also decided in favor of Eli Lilly on the ground that her claim was barred the by the statute of limitations as well as on the ground that Gove had failed to establish that Eli Lilly’s failure to warn was the proximate cause of her injuries. The Second Circuit upheld the District Court’s decision merely on the ground that Gove failed to establish proximate cause. The applicable law in this matter was Arizona’s substantive law because this matter was filed in Arizona and the events giving rise the action occurred there. The Second Circuit found that Arizona recognized the learned intermediary doctrine but applied the “heeding presumption” by shifting the burden of production to the manufacturer. If the manufacturer meets this burden, the burden shifts to plaintiff to show proximate cause. Applying these principles, the Second Circuit found Eli Lilly’s presumption satisfied by evidence that Gove’s nurse practitioner that prescribed the drug testified that an alternative warning would not have affected her prescribing habits. Further, because Gove’s practitioners were aware of the risks and would not have changed their treatment decisions, the Second Circuit found that Gove failed to establish proximate cause. The Court upheld the decision of the District Court.

Georgia vs. Texas

No, this post is not about college football. (Spring practices have just gotten under way at most colleges around the country and unfortunately for this blogger, August can’t get here soon enough!) Today’s post is a reflection upon the recent Georgia and Texas cases dealing with the learned intermediary defense (previous discussed individually on this site here and here). Specifically, I wanted to highlight a key distinction in how each court analyzed the doctrine.

In Dietz v. Smithkline Beecham Corp., No. 09-10167, 2010 WL 744273 (11th Cir. March 5, 2010) the court was interpreting Georgia law and correctly focused on the proximate cause between the decedent’s death and the adequacy of the warning provided to the physician. Dietz at *2-3. The court’s analysis was that the court, when applying the doctrine, must first look to the adequacy of the warning that was given. Id. at *2. The court cited to well-established Georgia case law that states that if the warning is adequate, the analysis ends and the plaintiff is barred from recovery. Id. In Dietz, the evidence was that the decedent’s physician testified that regardless of whether he knew about the increased risk of suicide with the use of Paxil, he still would have prescribed the drug to the decedent. Id. As such, the court reasoned that the Plaintiff could not establish proximate cause since the alleged failure to warn did not have an effect on the decision to prescribe the drug.

In seemingly direct contrast, the court in Centocor, Inc. v. Hamilton, No. 13-07-00301-CV, 2010 WL 744212 (Tex. App. – Corpus Christi March 4, 2010, no pet h.), in its creation of an exception to the learned intermediary doctrine, did not end its analysis with a determination of the adequacy of the warning. In Centocor, the evidence was that the Plaintiff’s physician that originally prescribed the drug at issue, Remicade, testified that he warned her of the potential risk of developing a lupus-like syndrome. Centocor at *6. As such, it would appear that the physician warned the Plaintiff of the exact risk that was the basis for her lawsuit–she developed a lupus-like syndrome after taking the drug. Instead of ending the analysis with the initial physician’s testimony, the court then went into a long discussion about advertising techniques of drug companies and the theoretical underpinnings of the doctrine.

In this blogger’s opinion, the Centocor court should have ended its analysis when it found that the Plaintiff’s physician provided her with a warning about the risk of developing a lupus-like syndrome. Based on the doctor’s testimony, any potential proximate cause link between use of the drug and any warning would have been severed. I, along with others, am left to wonder how a physician’s direct warning of a potential risk can not, as a matter of law, be an adequate warning and thus invoke the doctrine?

Texas-sized change in the learned intermediary doctrine?

In Texas, they say everything is big. Big cars, big steaks, big football stadiums. Sounds like my kinda place. In a recent decision by the Thirteenth Court of Appeals in Corpus Christi, the jurisprudence was similarly Texas-sized, with a 35 page opinion in which the court carved out an exception to the learned intermediary defense. Centocor, Inc. v. Hamilton, No. 13-07-00301-CV, 2010 WL 744212 (Tex. App. – Corpus Christi March 4, 2010, no pet h.). Authored by Justice Linda Reyna Yanez, and joined by Justices Nelda V. Rodriguez and Rose Vela, the opinion creates an unfortunate Texas-sized exception to the learned intermediary doctrine.

In beginning its commentary on the doctrine, the Texas court looked outside of its own state and turned to, of all things, a decade old opinion from the New Jersey Supreme Court.

Our medical-legal jurisprudence is based on images of health care that no longer exist. At an earlier time, medical advice was received in the doctor’s office from a physician who most likely made house calls if needed. The patient usually paid a small sum of money to the doctor. Neighborhood pharmacists compounded prescribed medicines. Without being pejorative, it is safe to say that the prevailing attitude of law and medicine was that the “doctor knows best.”

Pharmaceutical manufacturers never advertised their products to patients, but rather directed all sales efforts at physicians. In this comforting setting, the law created an exception to the traditional duty of manufacturers to warn consumers directly of risks associated with the product as long as they warned health-care providers of those risks.

For good or ill, that has all changed. Medical services are in large measure provided by managed care organizations. Medicines are purchased in the pharmacy department of supermarkets and often paid for by third-party providers. Drug manufacturers now directly advertise products to consumers on the radio, television, the Internet, billboards on public transportation, and in magazines.

Perez v. Wyeth Labs., 734 A.2d 1245, 1246-1247 (N.J. 1999) (citation omitted).

The Centocor, Inc. court then framed the issue as being “…whether a drug manufacturer can rely on its adequate warnings to physicians to satisfy its duty to warn the ultimate consumer, the patient, when it directly advertises to the patient in a misleading fashion.” Centocor Inc. at *1. The facts of the case were that the Plaintiff was prescribed Remicade by her gastroenterologist for treatment of her Crohn’s disease. Id. at *6. The prescribing physician testified that he discussed the risks of using Remicade with the Plaintiff, including the risk of developing a lupus-like syndrome. Id. The Plaintiff and her husband denied that her gastroenterologist (Dr. Hauptman) discussed this particular risk with her. Id. Dr. Hauptman referred the Plaintiff to an infusion clinic for the administration of a trial of Remicade (three intravenous infusions over a set period of time). Id. At the infusion clinic, the Plaintiff was shown a video produced by Centocor, Inc. while she was receiving her infusion. Id. at *6-10. It was undisputed that the video did not list lupus-like syndrome as a possible side effect. Id. at *9.

The Plaintiff ultimately began to exhibit lupus-like syndrome symptoms. Interestingly, even after filing the lawsuit, she continued to receive Remicade treatments. The jury awarded a verdict in the Plaintiff’s favor and found that Centocor, Inc. was liable for fraud, negligent misbranding, negligent marketing to the Plaintiff’s doctors, misrepresentation to the Plaintiff’s doctors and negligent undertaking. Id. at *19. The court performed an exhaustive analysis of the origins of the learned intermediary defense. The court also identified four “theoretical underpinnings” of the doctrine. These underpinnings include: (1) “…courts have held that the choice of which drugs to prescribe properly belongs to the doctor because prescription drugs are manufactured for administration only by a physician…” (2) “Texas courts have held that ‘only a physician would understand the propensities and dangers involved.'” (3) “…courts around the country have been reluctant to interfere with the physician-patient relationship by requiring a direct warning from the manufacturer to the patient because warnings that contradict the advice given by a physician may undermine the patient’s confidence in the physician.” and (4) “…it has been assumed that doctors are in a better position to warn their patients than the drug manufacturers…” Id. at *22-23.

The court then took a curious turn in the opinion. The court provided a discourse on “changes in pharmaceutical advertising.” Essentially, the court stated that in the 1980’s drug companies began utilizing direct marketing techniques (read “TV commercials”) that were intended to target the ultimate consumer of their products. Interestingly, the court also commented that in modern times, doctors spend less time with their patients and that “informed consent” now requires a “patient based decision rather than the paternalistic approach of the 1970’s.” Id. at*26-27. At this point in the opinion, the court stated that when drug manufacturers directly market consumers the theoretical underpinnings of the learned intermediary doctrine do not apply. Id. at *28.

In the opinion of this blogger, it appears that the Texas court made a Texas-sized mistake in interpreting the application of the doctrine. The court simply discounted the fact that the Plaintiff’s physician admitted that he discussed the specific risk of developing a lupus-like syndrome. In addition, the court seemed to overlook the fact that when the Plaintiff viewed the “direct marketing” video, she had already been prescribed the drug and was in fact undergoing an infusion of the drug at the time she viewed it. Finally, the video itself contained disclaimers that stated that the video should not be used a substitute for consulting with a physician. Id. at *9. These facts indicate that at the crucial time in which the Plaintiff obtained the prescription, she was warned about the potential risks of using the drug by a learned intermediary. In addition, at that crucial time it appears that all four of the “theoretical underpinnings” were in place and had not been compromised by any direct marketing of the drug. That is, when the Plaintiff first accepted her prescription and advice of her doctor, she hadn’t even seen the video yet. Perhaps the Texas Supreme Court will get to address this very issue in the near future.

Paxil and The Learned Intermediary Defense

The learned intermediary defense appears to be alive and well in the State of Georgia. For years it seems that drug companies have been able to rely on the venerable learned intermediary defense to avoid liability in personal injury cases brought by plaintiffs that have obtained their products through a physician prescription. The defense has recently come under scrutiny in light of the marketing attempts by drug companies that intended to inform the public about their products. The trial lawyers’ bar seems to be asserting that the advertisements by the drug companies are attempts to provide warnings to the public.

Last week the U.S. Court of Appeals for the Eleventh Circuit considered the defense. In Dietz v. Smithkline Beecham Corp., No. 09-10167, 2010 WL 744273 (11th Cir. March 5, 2010), the court upheld the trial court’s grant of summary judgment in favor of the defendant. In Dietz, the plaintiff brought a wrongful death claim in which the surviving spouse claimed that her husband’s suicide was proximately caused by his use of Paxil. Id.at *1. The plaintiff actually brought the claim under three theories: strict liability, negligence and breach of warranty. Id. The defendant raised the learned intermediary defense, an affirmative defense under Georgia law. Id.

The facts in Dietz were that the plaintiff’s husband had visited his family physician with “anxiety, depression, insomnia, and stress, but expressed that he had no suicidal ideation.” Id. His physician prescribed him to take Paxil as well as a sleep aid, Ambien. Id. Eight days after obtaining his prescription and after he began to take the drug, he committed suicide. Id.

The decedent’s family physician testified during a deposition that the decision to treat the decedent with Paxil was an appropriate decision and that even after reviewing the results of an updated prescription information sheet, there was nothing that about the new information that would have made him decide to not prescribe Paxil to the decedent. Id. *2. The Dietz court reviewed the long-standing doctrine of the learned intermediary defense:

[T]he manufacturer of a prescription drug … does not have a duty
to warn the patient of the dangers involved with the product, but instead has a
duty to warn the patient’s doctor, who acts as a learned intermediary between the
patient and the manufacturer. The rationale for the doctrine is that the
treating physician is in a better position to warn the patient than the
manufacturer, in that the decision to employ prescription medication …
involves professional assessment of medical risks in light of the physician’s
knowledge of a patient’s particular need and susceptibilities.

Id. at *1 (internal citations omitted). The court then went on to hold that the plaintiff could not establish that the defendant’s alleged failure to warn the physician about the increased risk of suicide associated with Paxil proximately caused the decedent’s death. Id. at *3. The court’s decision hinged upon the doctor’s testimony that even after reviewing the new prescription drug information sheet and the warnings mandated by the U.S. Food and Drug Administration, he still would have prescribed the drug. As such, the learned intermediary (decedent’s physician) had an adequate warning and the potential chain of causation proffered by plaintiff was severed.