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.

Ninth Circuit Decertifies Consumer Fraud Class

The Ninth Circuit last week reversed the certification of a nationwide class raising consumer fraud claims against an auto maker. See Mazza, et al. v. American Honda Motor Co., No. 09-55376 (9th Circuit). 

Honda appealed the district court’s decision to certify a nationwide class of all consumers who purchased or leased Acura RL's equipped with a Collision Mitigation Braking System (“CMBS”). The plaintiffs alleged that certain advertisements misrepresented the characteristics of the CMBS and supposedly omitted material information on its limitations. The complaint stated four claims under California Law, specifically the California Unfair Competition Law (UCL), Cal. Bus. & Prof. Code § 17200 et seq., False Advertising Law (FAL), Cal. Bus. & Prof. Code § 17500 et seq., the Consumer Legal Remedies Act (CLRA), Cal. Civil Code § 1750 et seq., and a claim for unjust enrichment.  Readers know those are the typical claims in a consumer fraud case in the popular forum of California.

The Ninth Circuit held that the district court erred because it erroneously concluded that California law could be applied to the entire nationwide class, and because it erroneously concluded that all consumers who purchased or leased the relevant Acura RL can be presumed to have relied on defendant’s advertisements, which allegedly were misleading and omitted material information.

In 2007, plaintiffs bought Acura RL's from authorized Acura dealerships, and the vehicles were equipped with the CMB System. In December 2007, they filed a class action complaint alleging
that Honda misrepresented and concealed material information in connection with the marketing and sale of Acura RL vehicles equipped with the CMBS. According to Plaintiffs, Honda did not warn consumers (1) that its CMB collision avoidance system’s three separate stages may "overlap,"  (2) that the system may not warn drivers in time to avoid an accident, and (3) that it allegedly shuts off in bad weather.

The district court certified a nationwide class of people in the United States who, between August 17, 2005 and the date of class certification, purchased or leased new or used Acura RL vehicles
equipped with the CMBS. The district court concluded that California law could be applied to all class members because Honda did not show how the differences in the laws of the various states were material, how other states might have an interest in applying their laws in this case, and how these interests were implicated in this litigation. It also held that class members were entitled to an
inference of reliance under California law.

Before certifying a class, the trial court must conduct a rigorous analysis to determine whether the party seeking certification has met the prerequisites of Rule 23.  The party seeking class certification has the burden of affirmatively demonstrating that the class meets the requirements
of Federal Rule of Civil Procedure 23. And, under Rule 23(b)(3), a plaintiff must demonstrate the
superiority of maintaining a class action and show that the questions of law or fact common to class members predominate over any questions affecting only individual members.  Here, Honda contended that common issues of law did not predominate because California’s consumer protection statutes may not be applied to a nationwide class with members in 44 jurisdictions.
It further contended that common issues of fact did not predominate because the court  impermissibly relied on presumptions that all class members were exposed to the allegedly
misleading advertising, that they relied on misleading information in making their purchasing decision, and that they were damaged as a result.

First, choice of law. Under California’s choice of law rules, the class action proponent bears the initial burden to show that California has significant contact to the claims of each class member. Also, California law may only be used on a class-wide basis if the interests of other states are not found to outweigh California’s interest in having its law applied.  Honda argued that the district court misapplied the three-step governmental interest test.  The Ninth Circuit agreed. The district court abused its discretion in certifying a class under California law that contained class members
who purchased or leased their car in different jurisdictions with materially different consumer protection laws.  For example, some state consumer fraud laws have no scienter requirement, whereas many other states’ consumer protection statutes do require scienter. See, e.g., Colo.
Rev. Stat. 6-1-105(1)(e), (g), (u) (knowingly); N.J. Stat. Ann. § 56:8-2 (knowledge and intent for omissions); Debbs v. Chrysler Corp., 810 A.2d 137, 155 (Pa. Super. 2002) (knowledge
or reckless disregard).  Some states require named class plaintiffs to demonstrate reliance, while some other states’ consumer protection statutes do not.  These differences are "not trivial or wholly immaterial."  

The court of appeals reminds us that consumer protection laws are a creature of the state in which they are fashioned. They may impose or not impose liability depending on policy choices made by state legislatures. Each state has an interest in setting the appropriate level of liability for companies conducting business within its territory.  Maximizing consumer and business welfare, and achieving the correct balance for society, does not inexorably favor greater consumer protection; instead, setting a baseline of corporate liability for consumer harm requires balancing these competing interests.  Getting the optimal balance between protecting consumers and attracting foreign businesses, with resulting increase in commerce and jobs, is not so much a policy decision committed to a federal appellate court, or to particular district courts where a plaintiff may sue, as it is a decision properly to be made by the legislatures and courts of each state. More expansive consumer protection measures may mean more or greater commercial liability, which in turn may result in higher prices for consumers or a decrease in product availability.  Here, the district court did not adequately recognize that each foreign state has an interest in applying its law to transactions within its borders and that, if California law were applied to the entire class, foreign states would be impaired in their ability to calibrate liability to foster commerce.

The court of appeals also found that the district court abused its discretion in finding that common issues of fact predominated, because the scale of the advertising campaign here did not support a presumption of reliance, even if one were legally available.  It was likely that many class members were never exposed to the allegedly misleading advertisements, insofar as advertising of the challenged system was very limited. And it was not dispositive that Honda’s advertisements were allegedly misleading because of the information they omitted, rather than the information they claimed.  For everyone in the class to have been exposed to the omissions, it was necessary for everyone in the class to have viewed the allegedly misleading advertising. Here the limited scope of that advertising makes it unreasonable to assume that all class members viewed it.
Honda’s product brochures and TV commercials fell short of the extensive and long-term fraudulent advertising campaign that might support a presumption in the eyes of some courts.  Even if Honda allegedly might have been more elaborate and diligent in disclosing the limitations of the CMB system, its advertising materials did not deny that limitations exist. A presumption of reliance does not arise when class members were exposed to quite disparate information from various representatives of the defendant.  California courts have not allowed a consumer who was never exposed to an alleged false or misleading advertising campaign to recover damages under California’s UCL.