Federal Court Offers Cogent Analysis of Warning Causation in Drug Case

A New Jersey federal court granted summary judgment last week to a pharmaceutical defendant in a failure to warn case. See Baker et al. v. APP Pharmaceuticals LLP et al., No. 3:09-cv-05725 (D.N.J.).  The case should be interesting to our readers in part because there really isn't a huge amount of law on warning causation in the busy jurisdiction of New Jersey.

During a hospital stay, plaintiff Baker was administered the commonly prescribed drug heparin. Heparin is an anticoagulant: it prevents blood clots. The opinion noted that the drug is associated  with heparin induced thrombocytopenia (“HIT”), or low blood platelet count. HIT may in a few patients progress to a more serious adverse reaction called heparin induced thrombocytopenia  and thrombosis (“HITT”). Plaintiff received heparin during and after her surgery, and a few days later her  platelet count was down; but according to the opinion it was not known at what point her platelet count reached serious levels because no one measured her platelet level for several days, despite the hospital’s stated protocol to monitor a patient’s platelet count periodically in order to detect possible HIT.

Plaintiff suffered injury to her left foot and leg, and thereafter sued several manufacturers of heparin, asserting they failed to adequately warn of the serious side-effects associated with heparin use. The parties agreed that defendant’s heparin has always contained FDA-approved labeling, including risk disclosures and warnings. In 2001, the heparin label specifically disclosed the risk of HIT and HITT in the “Precautions” section.  In 2005, defendant submitted a supplemental NDA via the “changes being effected” process to include additional HIT and HITT information the “Warnings” section of its heparin labeling. See 21 C.F.R. 314.70. The FDA suggested several alterations, all of which defendant incorporated into the labeling, and the FDA found the updated labeling “acceptable” in June 2007. 

In New Jersey, product liability actions are governed by the New Jersey Products Liability Act (“PLA”). N.J. Stat. Ann. §2A:58C-1, et seq. Under the PLA, in failure to warn cases involving prescription drugs, if the warning or instruction given in connection with a drug has been approved or prescribed by the FDA, there is a rebuttable presumption that the warning is adequate. This is no ordinary rebuttable presumption, remarked the court. Compliance with FDA regulations gives rise to “what can be denominated as a super-presumption.” Kendall v. Hoffman-La Roche, Inc., 36 A.3d 541, 544 (N.J. 2012).  Indeed, the PLA’s presumption that an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary weight than the customary presumption referenced" in the rules of evidence. Bailey v. Wyeth, Inc., 37 A.3d 549, 571 (N.J. Super. Ct. Law Div. 2008), aff’d sub nom. Deboard v. Wyeth, 28 A.3d 1245 (N.J. Super Ct. App. Div. 2011).

In this case, there is no dispute that the heparin labeling was approved by the FDA. Therefore, defendant was entitled to the statutory presumption that its heparin labeling satisfied its duty to warn. Plaintiff tried to rebut the presumption, first, with allegations of deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects by the pharmaceutical company, and second with allegations of an economically-driven manipulation of the post-market regulatory process. See McDarby v. Merck & Co., Inc., 949 A.2d 223, 256 (N.J. Super. Ct. App. Div. 2008).

However, significantly, all of the information plaintiff accused defendant of withholding was publicly available in published scientific and medical literature.  And defendant did in fact disclose much
of what plaintiff claimed was deliberately concealed or withheld. For example, when submitting its proposed updated label to the FDA in 2005, Baxter included several scientific articles and a number of adverse event reports relating to HIT and HITT.  As to the second rebuttal effort, plaintiff offered no real evidence that Baxter rejected the FDA’s proposed changes to heparin labeling, or asked pharmaceutical representatives to avoid discussing HIT and HITT when speaking to physicians, or manipulated the conclusions of heparin clinical trials, or did anything sufficient to "manipulate" the regulatory process.

The more interesting part of the opinion arises from the fact that even if a plaintiff is able to demonstrate that a prescription drug’s warning is inadequate, that plaintiff still must prove that the inadequate warning proximately caused her injury. See Campos v. Firestone Tire & Rubber Co., 485 A.2d 305, 311 (N.J. 1984). “To satisfy this burden, a plaintiff must show that adequate warnings would have altered her doctors’ decision to prescribe.” Strumph v. Schering Corp., 606 A.2d 1140 (N.J. Super. Ct. App. Div. 1992) (Skillman, J., dissenting), rev’d 626 A.2d 1090 (1993) (adopting Judge Skillman’s dissent).

The court noted that “a heeding presumption may be applicable to claims of failure to warn of the dangers of pharmaceuticals.” McDarby, 949 A.2d at 267. A heeding presumption allows one to presume that the plaintiff’s physician would not have prescribed the drug to the plaintiff if there had been an adequate warning; in other words, the plaintiff’s physician would have heeded the adequate warning. The heeding presumption is rebuttable and can be rebutted if the plaintiff’s physician was aware of the risks of the drug that he prescribed, and having conducted a risk-benefit analysis, nonetheless determined its use to be warranted. Also. a manufacturer who allegedly fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all, or if the physician was aware of the risk from other sources and already considered the risk in prescribing the product. In that context, the physician’s conduct is the superseding, intervening cause that breaks the chain of liability between the manufacturer and the patient.

Here, the doctor stood by his decision to administer heparin to Mrs. Baker. She required heparin by standard medical procedure, and well documented clinical knowledge, at several different  points during her operation and for several different reasons, he opined.  Since he was aware of the risks of the drug that he prescribed and, having conducted a risk-benefit analysis, nonetheless determined its use to be warranted, the presumption was rebutted as a matter of law.

Moreover, the prescriber testified in his deposition that he does not read the label of drugs he frequently prescribes, which includes heparin. Therefore, a different warning would not have made a difference in plaintiff's treatment or outcome because there was no evidence he would have reviewed it.

Finally, there was a third causation problem; the opinion notes that it was undisputed that, despite doctors orders, the Hospital failed to follow its own heparin treatment protocol. Had that monitoring occurred, Mrs. Baker’s physicians would have discovered the onset of HIT sooner. Plaintiff's own expert admitted that her injuries “would have been substantially mitigated” with a “good chance of avoiding" them.   Therefore, plaintiff failed to raise a genuine issue of material fact that it was the heparin labeling, as opposed to the conduct of the hospital, that caused her injury.

 Summary judgment on the warning claim.

State Court Upholds Questionable Bystander Liability Claim

The Montana Supreme Court recently upheld the imposition of liability on a bat manufacturer for allegedly failing to warn about the dangers of aluminum bats. Patch v. Hillerich & Bradsby Co., d/b/a Louisville Slugger, No. DA 10-0051 (Mont. 7/21/11).  Bad facts made bad law here. 

Many people consider "The Natural" to be one of the greatest sports movies of all time, and those that think deep thoughts have asserted that the screenplay  (presumably not the 1952 book too?) was based in part on the story of Sir Percival from the Arthurian myths, with the broken bat "Wonderboy" taking the part of the knight's broken sword.  Had Roy Hobbs used an aluminum bat, that aspect of the story would have been lost. Since their introduction in the early 1970's, aluminum bats have become quite popular in youth and amateur adult baseball and softball markets. The new bats are often touted as having a wider sweet spot, more power, better feel, or higher performance. It is pretty much accepted that balls come off metal bats faster than they do from wood bats, but this aspect of performance has fueled an ongoing metal/wood issue in some circles.

While pitching in an American Legion baseball game on July 25, 2003, the eighteen year-old plaintiff was struck in the head by a batted ball that was hit using H&B’s model CB-13 aluminum bat. Tragically, plaintiff died from his injuries. In 2006, Brandon’s parents sued H&B, claiming H&B’s model CB-13 aluminum bat was in a defective condition because of the alleged enhanced risks associated with its use: It increased the velocity speed of a batted ball when it left the bat, thus decreasing infielders’ reaction times, which allegedly resulted in a greater number of high energy batted balls in the infield.

The matter was tried in October, 2009, and the design defect and failure to warn claims were submitted to the jury, which concluded that the model CB-13 aluminum bat was not designed defectively, but determined the bat was in a defective condition due to H&B’s failure to warn of the enhanced risks associated with its use. They awarded plaintiffs an $850,000 verdict on their failure to warn claim. Defendant appealed.

The key issue was whether a failure to warn claim can be brought by a bystander -- plaintiff was not the consumer nor the user. H&B asserted that only the individual batting (actual user) and the individual who purchased the bat (actual consumer) could assert a failure to warn claim.  The court disagreed, saying this interpretation of the terms user and consumer is somehow contrary to the definition of the terms as contained in the Restatement (Second) of Torts § 402A. This state court’s products liability jurisprudence had recognized that a failure to warn claim may be brought by some persons who are not actual purchasers or users of a product; previous plaintiffs included those who are passively enjoying the benefit of the product, as in the case of passengers in automobiles or airplanes, as well as those who are utilizing it for the purpose of doing work upon it.  "The realities of the game of baseball" supported, said the court, the decision to submit the failure to warn claim to the jury. The bat was deemed an indispensable part of the game. The risk of harm accompanying the bat’s use extends beyond the user, beyond a player who holds the bat in his or her hands. A warning of the bat’s risks to only the batter standing at the plate inadequately communicates the potential risk of harm posed by the bat’s increased exit speed, concluded the court. In this context, all of the players, including plaintiff, were deemed "users or consumers" placed at risk by the increased exit speed caused by H&B’s bat.

Defendant also argued that plaintiff could not establish causation - reading and heeding the warning. The court held that H&B’s argument erroneously assumed that placing a warning directly on the bat is the only method to provide a warning. While placing a warning directly on a product is certainly one method of warning, other methods of warning exist, including, but not limited to, issuing oral warnings and placing warnings in advertisements, posters, and media releases. Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 131 (9th Cir. 1968) (“[O]ther means of communication such as advertisements, posters, releases to be read and signed . . . or oral warnings . . . could easily have been undertaken . . . .”). Such warnings, if issued by H&B in this case, said the court, could have communicated to all players the potential risk of harm associated with H&B’s bat’s alleged increased exit speed.

What the court here called a "flexible" approach to causation really eviscerates one of the fundamental elements of the claim. The court allowed the jury to infer without any basis in fact that plaintiff would have heeded a warning had one been given-- apparently because he was deceased, and thus real proof of causation was hard to find. There is no basis to allow a jury simply to express sympathy for a tragic accident victim,as here there was not sufficient proof that the plaintiff would have adjusted his behavior after receiving the warning to avoid the injury. The decision puts this court in a tiny minority of states that recognize some kind of bystander failure to warn liability, which most courts agree is unworkable and contrary to the reality of modern commerce.

The concurrence correctly noted that plaintiff did not articulate specifically what a warning should have contained and what message should have been given. Statements to the effect that the bat would hit balls at unusually fast speeds or unusually far distances are the kind of messages accompanying usual product advertising and are not likely to change a player's/plaintiff's behavior. Moreover, they are precisely the qualities in a bat which baseball teams and players seek out. Plaintiff could not articulate specifically how a warning would have changed the result here, in other words, how the failure to warn caused this accident.

H&B also argued that because plaintiff had been hit by batted balls before, he knew he could be hit and, therefore, assumed the risk when he continued playing baseball. The court explained that assumption of the risk defense in this state is inapplicable as a matter of law without evidence the victim actually knew he or she would suffer serious injury or death, and, knowing that, the victim voluntarily exposed himself or herself to the danger. Lutz v. Natl. Crane Corp., 267 Mont. 368, 379-80, 884 P.2d 455, 461-62 (1994). What the victim actually knew is evaluated using a subjective standard in Montana. Here, said the court, there was no evidence that plaintiff actually knew he would be seriously injured or killed when pitching to a batter using one of H&B’s model CB-13 aluminum bats. He knew he could be hit with a screaming line drive, but not that it could injure him seriously?

Plaintiff's apparent theory, as articulated in closing argument, was that H&B should have
advertised that its bat “could kill.” And the inference which plaintiff asked the jury to draw in order to establish causation was that, following the publishing of a warning “that this bat could kill,” the parents would have prohibited Brandon from playing baseball.  That tells you how unworkable the theory is. This was a terrible accident on a baseball field, the kind of accident that has also occurred with wood bats. The bat was not defective. It was made in accordance with the rules approved for play by baseball's organizing and governing bodies. Bad facts again make bad law.
 


 

5th Circuit Clarifies Heeding Presumption in Learned Intermediary Case

In a previous post, MassTortDefense began analysis of the 5th Circuit's decision in Ackermann v. Wyeth Pharmaceuticals, 2008 WL 1821379 (5th Cir, April 24, 2008), in which the Fifth Circuit addressed a couple of very important issues affecting the learned intermediary doctrine. The Court emphasized that the prescriber testified that he reviewed the plaintiff’s proposed “fuller” warning, concluding that if the proposed warning had been communicated to him effectively and in a prominent manner before he prescribed Effexor to plaintiff, he would have considered it, but it would not have changed his prescription decision. What about the heeding presumption?

Heeding Presumption 

Appellant also contended that, regardless of Dr. Sonn’s testimony, Texas law created a presumption supporting a causal link between Wyeth’s inadequate warning and her husband’s death. The Court rejected that broad argument: Texas law creates no such presumption. In general, when a manufacturer fails to give adequate warnings or instructions, a rebuttable presumption arises that the product user would have read and heeded such warnings or instructions (the “read and heed” presumption). This presumption’s effect is to shift the burden of producing evidence to the party against whom it operates. But, significantly, the Court found that neither Texas nor federal courts applying Texas law have applied the read-and-heed presumption to pharmaceutical cases involving learned intermediaries. In fact, Texas has explicitly rejected the Restatement (Second) of Torts  § 402A, Comment j’s “read-and-heed” presumption for policy reasons, and because it has been superseded by the Third Restatement  § 2. See Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 336–37 (Tex. 1998). 2008 WL 1821379 *6. [Indeed the comment 1 to Section 2 calls the prior language “unfortunate.”]

Further, the Fifth Circuit doubted that the Texas Supreme Court would apply such a presumption here, when it would not serve its intended purposes. The read-and heed presumption has been justified because it excuses plaintiff from the necessity of making self-serving assertions that he would have followed adequate instructions, simply to put the issue of causation in sufficient dispute to avoid summary judgment or directed verdict, and it assists plaintiffs in cases where the person injured has died and evidence of what he would have done is unavailable for that reason. In the learned-intermediary context, however, it is the prescribing physician, not plaintiff, who has to testify about his or her decision to prescribe. 2008 WL 1821379 *7.

Moreover, MassTortDefense would point out that applying the read and heed presumption to prescription product contexts confuses two very different warnings: unavoidable risk warnings, and preventable risk warnings. The latter describe risks that can be avoided by the consumer by using a product in certain manner. The former, however, associated with prescription products, can only be avoided if the consumer chooses not to use the product at all. Thus, the question becomes whether the potential benefit of the prescription product outweighs a potential risk. The choice is not between a safe, or less safe use, or unsafe use, of the product, but whether to use the product at all. With prescription products, the FDA has determined that for indicated populations, the risks do not outweigh the benefits. A good albeit older discussion of why the heeding presumption doesn't make sense in this context is found in Thomas v. Hoffman-LaRoche, 949 F.2d 806, 812-14 (5th Cir. 1992).

Further, even if the presumption applied, it arguably would not have changed the result here. It is a rebuttable presumption, and Dr. Sonn remained firm in stating that even if Ackermann’s proposed “black box” warning had been given to him, he would have considered it -- but it would not have changed his decision to prescribe Effexor. For all these reasons, the Fifth Circuit concluded that the district court properly granted summary judgment to Wyeth on appellant’s failure-to-warn and strict-liability claims because she failed to show that an inadequate warning was a producing cause of her husband’s death.

5th Circuit Clarifies Learned Intermediary Doctrine and Heeding Presumption

In Ackermann v. Wyeth Pharmaceuticals, 2008 WL 1821379 (5th Cir, April 24, 2008), the Fifth Circuit addressed a couple of very important issues affecting the learned intermediary doctrine. Readers of MassTortDefense recognize that the LI doctrine is an important exception to the rule that a manufacturer must warn the end user or consumer of its product. In the case of prescription drugs and medical devices, which a patient may receive through the advice and with the permission of a prescribing physician, the duty to warn extends to this learned intermediary, who in turn uses his or her expertise, judgment, and knowledge of the specific patient, to decide not only which product the patient should receive, but which aspects of the long and detailed warning information should be emphasized with the patient.

Background of Decision

In Ackermman, plaintiff’s decedent alleged that defendant Wyeth failed adequately to warn about the drug-induced risk of suicide from its drug Effexor, and this deficiency led to her husband’s suicide. Effexor is a member of the class of drugs referred to as “selective serotonin and norepinephrine reuptake inhibitors” (“SNRI”). SNRIs are used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, and social anxiety disorder. The FDA generally groups Effexor with the selective serotonin reuptake inhibitor (“SSRI”) class of antidepressants, which includes Celexa, Prozac, Paxil, and Zoloft.

Plaintiff apparently suffered from clinical depression brought on by severe business and family problems. Martin sought treatment from psychiatrist Dr. Thomas Sonn on January 4, 2002. Martin saw Dr. Sonn four times in the following eight days. During that time, Dr. Sonn changed Martin’s medication to Effexor. On January 12, Martin complained to Dr. Sonn of various side effects he attributed to Effexor, including anxiety. Martin announced he would no longer take the medication. Dr. Sonn changed Martin’s medication from Effexor to Celexa because of the apparent side effects. Plaintiff terminated his relationship with Dr. Sonn. Nevertheless, Martin continued to take Celexa for five days until January 17, 2002, when he apparently committed suicide with a revolver. At the time of his death, Martin had detectable levels of Celexa, but not Effexor, in his bloodstream. 2008 WL 1821379 *1.

Dr. Sonn testified at deposition that he believed the package insert for Effexor as it existed in January 2002 adequately warned him of the risks of suicide and that he would continue to prescribe the drug to depressed patients. Wyeth filed for summary judgment, which was granted by the district court on the basis of the learned intermediary doctrine.

The Learned Intermdiary Doctrine

The Fifth Circuit noted that under the doctrine, a patient-purchaser’s doctor stands between the patient and the manufacturer, professionally evaluating the patient’s needs, assessing the risks and benefits of available drugs, prescribing one, and supervising its use. If the doctor is properly warned of the possibility of a side effect and is advised of the symptoms normally accompanying the side effect, it is anticipated that injury to the patient will be avoided. Accordingly, the doctrine excuses a drug manufacturer “from warning each patient who receives the product when the manufacturer properly warns the prescribing physician of the product’s dangers.” Porterfield v. Ethicon, Inc., 183 F.3d 464, 467–68 (5th Cir. 1999). Under Texas law, the learned-intermediary doctrine is not an affirmative defense, but it delineates to whom a defendant owes the duty to warn. 2008 WL 1821379 *2-3.

To recover for failure to warn under this doctrine, a plaintiff typically must show that (1) the warning was defective, and (2) the failure to warn was a producing cause of the injury. In other words, under Texas law, a plaintiff who complains that a prescription drug warning is inadequate must also show that the alleged inadequacy caused her doctor to prescribe the drug for her. If the physician was aware of the possible risks involved in the use of the product but decided to use it anyway, the adequacy of the warning is not a producing cause of the injury and the plaintiff’s recovery must be denied. And even if the physician is not aware of a risk, the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e., that but for the inadequate warning, the treating physician would have not used or prescribed the product. 2008 WL 1821379 *3.

Application To The Facts

Applying that review to the facts here, the Fifth Circuit noted that the January 2002 package insert warning mentions the risk for suicide twice, cautions that close supervision of high-risk patients should accompany initial drug therapy, and identifies the frequencies of suicidal behavior observed in patients taking Effexor. Even if not as explicit as plaintiff demanded post hoc, taken all together, the insert’s discussions of suicide establish that at least some risk of suicide exists when a patient takes Effexor.

The Court allowed the possibility that some issue of fact could be made out about whether the defendant’s characterization of the infrequent risks, was within a requisite degree of accuracy or was misleading. 2008 WL 1821379 *4.

However, the appeal could be resolved on the second prong of the analysis, namely, whether any defect in the Effexor warning was a substantial cause of Martin’s death. There must be a genuine issue of material fact whether the physician, here Dr. Sonn, would have prescribed Effexor even had the warning been “adequate” in plaintiff's terms. Here the court had to look at Dr. Sonn’s testimony about the certainty of his decision to prescribe Effexor, and alternatively, at the so-called “read-and-heed” presumption presuming that when an adequate warning is given by the manufacturer, it is heeded by the learned intermediary. 

Prescriber Testimony Key

Dr. Sonn testified that he reviewed the plaintiff’s proposed “fuller” warning, concluding that if the [proposed] warning had been communicated to him effectively and in a prominent manner before he prescribed Effexor to plaintiff, he would have considered it “but it would not have changed my decision to prescribe Effexor XR to Martin Ackermann to treat his depression, beginning with low-dose pills. It also would have not changed my decision to monitor and observe Martin Ackermann closely for suicide-related risks as I did… and as I did with Martin Ackermann, I would address the suicide-related risks reflected in that warning by close monitoring and observation, rather than through discussions with the patient expressly mentioning the risk of suicide or drug-triggered suicide.” 2008 WL 1821379 *5.

The Court rejected plaintiff’s argument that this was somehow contradictory testimony; his testimony was unequivocal. That he said he would have read it and heeded it did not mean anything other than he would have considered it, would have included it in his decision-making calculus. In his deposition and in his later declaration, Dr. Sonn affirmed that he would have prescribed Effexor to Martin and adhered to the treatment regimen he used regardless whether he had received the proposed stronger warning. In December 2005, he testified that he would not have warned Martin about the possibility of an increased risk of suicide primarily based on his belief that the suggestion would either plant seeds in the patient’s mind that suicide was an option or would discourage the patient from pursuing pharmacological treatment. And that, MassTortDefense readers, is a crucial notion. Any argument from the plaintiff that the prescriber was or would be legally required to pore over all the details of the warnings with a sick patient [and thus scare plaintiff into not taking the drug] is fundamentally inconsistent with the ethical duties of the physician.

Dr. Sonn was also asked to review the warning label accompanying Effexor that was in effect at the time of his deposition in December 2005, which included a “black box” warning for potential increased suicide in children and adolescents. When asked a follow-up question about a proposed similar warning for adults, Dr. Sonn reiterated his prior testimony and confirmed that it would not have changed his decision to prescribe Effexor XR to Martin Ackermann to treat his depression.

Because she construed this as a “no warnings” case, plaintiff's decedent argued that Wyeth completely sabotaged the intermediary, who, in turn, failed to warn of the risk of suicide. For this reason, she viewed Dr. Sonn’s testimony that he would have given a required warning to mean, “if Wyeth had given me a better warning, I would have warned.” This interpretation, however, is incompatible with Dr. Sonn’s testimony that his treatment protocol would not have changed and he still would have prescribed Effexor regardless of the warning given by the manufacturer.

This part of the decision is consistent with some other useful cases out there, including Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004)(Zoloft); Porter v. Eli Lilly & Co., 2008 WL 544739 (N.D. Ga. Feb. 25, 2008)(Prozac); Longs ex rel. Estate of Buchanan v. Wyeth, 536 F.Supp.2d 843 (N.D. Ohio 2008)(Redux); Allgood v. Glaxosmithkline Plc, 2008 WL 483574 (E.D. La. Feb.20, 2008)(Paxil); Vanderwerf v. SmithKlineBeecham Corp., 529 F. Supp.2d 1294 (D. Kans. 2008)(Paxil).


In our next post, MassTortDefense will switch focus to the 5th Circuit's handling of the heeding presumption.