Some of the largest drug companies in the United States are based in, of have their U.S. headquarters in, New Jersey — e.g., Johnson & Johnson is in New Brunswick, Merck is in Whitehouse Station, Roche is in Nutley, Barr (now owned by Teva) is in Montvale, Sanofi is in Bridgewater — and so New Jersey state courts are home to a huge volume of pharmaceutical injury litigation.

There’s so many Accutane (Roche) and Fosamax (Merck) cases they’re deemed a mass tort, and there’s a good chance that Propecia (Merck) might end up as one, too. Same goes with a large number of the vaginal mesh erosion cases, because Ethicon / Gynecare are made by Johnson & Johnson, and C.R. Bard is in Murray Hill. (But not the two new huge drug cases: Boehringer Ingelheim, maker of Pradaxa, is in Connecticut, while Takeda, maker of Actos, is in Illinois.)

All of which to say is: when the New Jersey Supreme Court releases a new drug or medical device opinion, it’s a big deal. A thousands-of-cases big deal.

There’s thus been a lot of anticipation surrounding the Court’s opinion in Kamie S. Kendall v. Hoffman-LaRoche, Inc., et al., which was decided Monday. The opinion is here. Some reporting has already come out at Pharmalot, and there’s commentary from the mass torts defense firms Ballard Spahr and Dechert (I’ll get that in a moment).

Kendall is an Accutane case, in which the plaintiff developed inflammatory bowel disease (apparently both ulcerative colitis and Crohn’s Disease; her symptoms were so severe she had her colon removed) as the result of Accutane. A jury awarded her $10.5 million back in 2008, then the case then went into a complicated appellate posture. Roche argued (1) that the case should have been barred by the statute of limitations and (2) that its defense was unfairly prejudiced by the trial court’s restriction on the way the parties could present the number of adverse case reports as evidence that Roche acted too slowly in responding to reports that Accutane caused IBD. The New Jersey Appellate Division held the case was filed within the statute of limitations, but nonetheless ordered a new trial on the adverse case reports issue.

The New Jersey Supreme Court then granted an appeal on only the statute of limitations issue. It was a bit of a “head’s you lose, tails I win” situation for the plaintiffs: if they lost in front of the New Jersey Supreme Court, they lost for good, whereas if they won they still had to go through a retrial to fix the adverse events issue. I don’t fault the New Jersey Supreme Court for that — it’s appropriate for Supreme Courts to cherry-pick issues from cases — but I mention it to further dispel tort reform myths that these types of cases are easy money for injured patients and trial lawyers. Kendall’s lawsuit was filed in December 2005, and now, seven years later, neither she nor her lawyers have been paid a dime, and they still have to go through another trial where they could lose.

So let’s move to the big issue in the Kendall case. New Jersey, like every state, has a statute of limitations for negligence and product liability lawsuits, and also has an exception called the “discovery rule” for cases where the plaintiff didn’t learn until later that their injury could have been the result of negligence. The rule is:

Those considerations [of fairness] comprise the so-called “discovery rule,” the goal of which is to avoid [the] harsh results that otherwise would flow from mechanical application of a statute of limitations. Accordingly, the doctrine postpones the accrual of a cause of action so long as a party reasonably is unaware either that he has been injured, or that the injury is due to the fault or neglect of an identifiable individual or entity. Once a person knows or has reason to know of this information, his or her claim has accrued since, at that point, he or she is actually or constructively aware of that state of facts which may equate in law with a cause of action.

Caravaggio v. D’Agostini, 166 N.J. 237, 245 (2001). 

If that was the only issue, then this case would be quite simple, because the trial judge found that plaintiff wasn’t unreasonable in failing to recognize the connection between her Accutane use and IBD until after she saw a commercial for a lawyer that mentioned a link. As the Supreme Court recounted:

At the hearing, Kendall testified, and deposition testimony of Drs. Thomson and Book was read into the record. Kendall’s position was that a reasonable person, in her circumstances, would not have known that Accutane was the cause of her ulcerative colitis by December 2003 because none of the warnings provided to her mentioned ulcerative colitis, IBD, or Crohn’s Disease, by name, and because her doctors did not know of the risk. Individually and in consultation with each other, they continued to prescribe Accutane after her diagnosis.

Even her doctors didn’t know and didn’t tell her that there was a link between Accutane and IBD, so how could she be expected to know? How could a court ever hold that a “reasonable” patient should know more than their doctors?

But, because New Jersey has a lot of pharmaceutical companies, it also has special laws that favor pharmaceutical companies, like the Product Liability Act, which states in pertinent part:

In any product liability action the manufacturer or seller shall not be liable for harm caused by a failure to warn if the product contains an adequate warning or instruction or, in the case of dangers a manufacturer or seller discovers or reasonably should discover after the product leaves its control, if the manufacturer or seller provides an adequate warning or instruction.

An adequate product warning or instruction is one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product, taking into account the characteristics of, and the ordinary knowledge common to, the persons by whom the product is intended to be used, or in the case of prescription drugs, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician.

If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration …,  a rebuttable presumption shall arise that the warning or instruction is adequate. 

Frankly, I don’t see what the Product Liability Act has to do with the statute of limitations at all. The Act doesn’t mention anything about the statute of limitations or the discovery rule. It creates a “rebuttable presumption” that FDA-approved warnings are adequate, but that’s a different issue entirely from the statute of limitations.

Unsurprisingly, my fellow plaintiffs’ lawyers at the New Jersey Association for Justice filed an amicus brief arguing that the Product Liability Act was irrelevant and that the cornerstone of the discovery rule is the question of whether or not the plaintiff’s actions were reasonable.  On the flipside, the New Jersey State Chamber of Commerce and a couple other business interests argued that the Product Liability Act had silently eliminated the discovery rule entirely from lawsuits against drug companies — an argument that was little more than another variation on the prescription drug industry line that FDA approval should render drug companies entirely unaccountable to consumers.  Finally, the Medical Society of New Jersey filed an amicus brief arguing that New Jersey should do away with juries and trial judges entirely and have appellate judges make credibility assessments about witnesses they’ve never met based on nothing more than the briefs filed by the parties. (I’m only slightly exaggerating about that one — they argued that Kendall’s claim should be barred under the discovery rule, regardless of the Product Liability Act.)

In the end, the New Jersey Supreme Court adopted a “middle of the road” approach, in which the Product Liability Act’s rebuttal presumption that an FDA-approved warning is good enough plays a role in the proceedings, but the main issue is still whether or not the plaintiff’s conduct was reasonable:

We are accordingly satisfied, as was the Appellate Division, that a middle-of-the-road approach is justified. That approach permits the judge at a Lopez [statute of limitations] hearing to consider the presumption of adequacy. However, we see no warrant for viewing the presumption, in the Lopez setting, as a “virtually dispositive” super-presumption. Rather, it should be treated, as would any presumption in the ordinary course, as capable of being overcome by evidence which tends to’ disprove the presumed fact, thereby raising a debatable question regarding the existence of the presumed fact. If, in the face of the evidence, reasonable people would differ regarding the presumed fact, the presumption will be overcome. Ultimately, the burden remains on the plaintiff seeking application of the discovery rule to show that a reasonable person in her circumstances would not have been aware, within the prescribed statutory period, that she had been injured by defendants’ product.

(Citations and quotations omitted.) That’s not the rule that I would have imposed if I were a New Jersey Supreme Court Justice, but I certainly don’t think the case is going to join my list of the worst prescription drug court opinions for patients.  My concern is more one of how the test will work in practice.

Regarding Kendall’s specific case, the Court reasoned that the warning, even if “presumed” adequate, still didn’t give Kendall enough notice of the link between Accutane and IBD:

Kendall, who the trial judge found to be credible, said her doctors never advised her not to take Accutane or of the risks of IBD and that she would not have taken or continued the drug had they done so. The 2003 warning, which was focused on pregnancy and suicide, indicated that a patient should “stop taking Accutane” (emphasis added) if certain symptoms occurred, but did not mention IBD or colitis. Nor did the consent form Kendall signed. Indeed, she never received a warning which specifically mentioned IBD or ulcerative colitis.

Although we can conceive of circumstances in which the 2003 warning might have been sufficient to alert a plaintiff of the connection between Accutane and her disease, it was certainly not sufficient, in these circumstances, to cause Kendall to doubt her physicians or to disregard the advice and information that had been imparted to her by them for the prior six years. That is particularly so in light of the lack of a discernable link between Kendall’s symptoms and the ingestion of the drug.

The New Jersey Supreme Court thus held in Kendall’s favor on the statute of limitations, which means she goes to the trial court for another trial that will correct the adverse events issue.

Coming back around to the commentary on the opinion, Dechert, which makes millions of dollars every year defending pharmaceutical companies, argues in its newsletter that the decision is both irrelevant to other cases and a victory for the defense:

Although one could disagree with the majority’s ultimate ruling on the merits in this narrow, fact-specific opinion, it is difficult to disagree with its broad and ringing reaffirmation of Perez, with its designation of the appellation, “super-presumption”, to the presumption of adequacy for FDA-approved warning labels in the liability phase, and with its reminder that “only in the ‘rare case[ ]’ will damages be assessed against a manufacturer issuing FDA-approved warnings.”

That’s stretching it: at best, the “super-presumption” and “rare case” language is dicta, because this opinion was solely about the statute of limitations and didn’t even reach the merits of the claim.

Ballard Spahr, which also makes lots of money defending pharmaceutical companies, had a far more reasonable analysis that raises an interesting question as to whether the “middle of the road” test is any different from the normal discovery rule:

Although it answers and attempts to clarify an important legal question, it is not clear that the Kendall opinion will have much practical impact on Lopez hearings in drug and medical device cases. While the court did hold that the PLA’s presumption of adequacy applies to plaintiffs asserting the discovery rule, it specifically held that it did not apply with the virtually dispositive, super-presumption force articulated in Perez.

Indeed, as a practical matter, the standard that the court set for overcoming the presumption is identical to the existing standard for satisfying the discovery rule, i.e., whether a reasonable person in the plaintiff’s circumstances would have been aware of the claim within the statutory period. Nonetheless, defendants should be sure to include a robust discussion of the PLA’s presumption of adequacy and its underlying rationale as part of their limitations arguments in New Jersey.

I think that’s largely correct, but I do worry about some courts taking the “presumption” too far and using it to wrongly draw inferences in favor of the defendants. I can see instances in which a drug company changes a warning label but the label isn’t brought to the patient’s attention, either because the patient doesn’t realize the label is updated (and so doesn’t read it) or because the doctor doesn’t mention it to the patient. I see that in Actos cases all the time: the FDA updated its label back in August 2011 to warn patients that they should contact their doctor if they see “experience any sign of blood in the urine … or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer,” but most of our clients — and their doctors! — are unaware of that connection until they hear it from some source other than the product information, like a news article on the lawsuits.

All of which brings me back to how absurd and unfair it is to impose a short statute of limitations like two years in mass torts drug cases. What benefit is there to society by punishing people who are unaware they have a claim? Millions of patients have no clue that a drug they took for years has now been tied to their very illness until they see an advertisement specific to their circumstances — even their doctors tend not to know until the patients see those advertisements and ask the doctors about it.

We have statutes of limitations to protect defendants from stale claims where evidence has been lost and memories have faded, but neither of those concerns are even remotely present in your typical pharmaceutical mass tort case. The vast majority of the patients’ medical records are stored for decades, and the presence of the mass tort litigation imposes a duty on the drug company to maintain its own records. If Kendall had filed her claim today there would still be no prejudice to Roche, and yet for some reason we would give them a free pass.