Global Insight Perspective | |
Significance | This trial of two Vioxx patients, which is being heard in New Jersey under Judge Carol Higbee, has been unique in being divided into two phases: one relating to the general issue of the company’s alleged failure to warn over the drug’s dangers, and the other relating more specifically to the cases of the two plaintiffs. |
Implications | The case was considered important for Merck, as the company ran a risk of facing “collateral estoppel” of arguing that it sufficiently warned patients if they were defeated in the first phase here. However, the jury has ruled that the company did not fail to warn after it changed Vioxx’s label in April 2002, which has significant repercussions for future litigation. |
Outlook | Merck had an uphill task in the first phase of the trial, and the mixed verdict is a moderate positive surprise, as it could return to haunt plaintiff lawyers’ claims on the issue of collateral estoppel—effectively, if this is true, it dismisses the failure to warn case for all Vioxx patients who had heart attacks after April 2002. |
A New Twist
The two-year old litigation proceedings over Merck & Co.’s (U.S.) withdrawn arthritis drug Vioxx (rofecoxib) took yet another twist on Friday (2 March), with a mixed verdict from the ongoing coordinated trial in the Superior Court of Atlantic County (New Jersey). In addition to the inclusion of two plaintiffs in the trial, Judge Carol Higbee had controversially split it into two phases: one dealing with the general issue of failure to warn, and the other considering whether Vioxx played a role in the specific circumstances of the two plaintiffs’ heart attack. Vioxx was withdrawn in September 2004 for its link to cardiac side-effects.
Merck generally faces an uphill battle with coordinated cases, as they potentially obscure the specific facts over a patient’s potential risk factors, but its protests have been met by a brick wall in the face of Judge Higbee, who is overseeing the largest number of Vioxx litigation and is favouring a coordinated strategy. Coupled with the two-phase nature of the trial, which again generalised the cases and forbade Merck from arguing the specific circumstances of the role that the plaintiff doctors may have had in addressing the safety warnings over Vioxx, this was a dangerous case.
The result of the first phase is interesting, in that it has put the April 2002 change on Vioxx’s label, which highlighted the drug’s cardiac side-effects as seen in the VIGOR trial (originally published in March 2000), at the centre. The label change splits the two plaintiffs, as it occurred before the fatal heart attack of Brian Hermans in September 2002, but after the heart attack of Frederick “Mike” Humeston in September 2001. Merck was originally cleared of wrongdoing in the case of Mr. Humeston in November 2005, but Judge Higbee threw out the case after New England Journal of Medicine’s (NEJM) dubious "expression of concern" after the trial. Merck has now been found to have failed to warn him over the side-effects, but not Mr. Hermans.
The jury did find that Merck had committed consumer fraud by misrepresenting the drug’s clinical profile. The trial now proceeds to the second phase, but Kathleen Hermans Messerschmidt, who filed litigation proceedings on behalf of her brother, is unlikely to be able to seek compensatory or punitive damages. Plaintiff lawyer Mark Lanier, who has been one of the very few to successfully trial a Vioxx case in the past, has appealed this decision and argued that the second phase must proceed with the inclusion of the Hermans case. Mr. Hermans took Vioxx for roughly a year before the label change in April 2002. Judge Higbee will rule on this request later today.
Outlook and Implications
The trial today proceeds to the second phase, which will focus specifically on whether Vioxx contributed to Mr. Humeston’s heart attack unless Judge Higbee orders that the Hermans case is also included in the hearings. Mr. Humeston had previously been shown to have had numerous cardiac risk factors, including high cholesterol. The Hermans estate have the opportunity to appeal, but their case has effectively been defeated, though Merck may face some minor out-of-pocket legal and medical costs due to the consumer fraud verdict.
However, for Merck the implications of the outcome do not so much relate to the specific case itself, but rather to the signal that it sends out to other cases. Firstly, Mr. Lanier’s confident assertion earlier in the trial proceedings that Merck could face collateral estoppel from arguing on the failure to warn issue in future has been shown to be moot. The trial has placed the April 2002 label change at the centre of proceedings, where Merck’s increasingly fragile 18-month defence previously stood. The jury in New Jersey has effectively said that Merck was not responsible to warn any further after this label change. Interestingly, the FDA only acted on this two years after the publication of the original VIGOR data, when the cardiac signals were widely disseminated and known.
Secondly, the trial again shows that Merck’s chances in the Vioxx litigation are very much down to the composition of the juries, as the same arguments are being presented, but different outcomes are emerging. In New Jersey, the jury was able to differentiate the myriad of factors, particularly relating to timelines, from two different patients. It sends another signal that Judge Higbee’s strategy of consolidating cases is not working—she is doing this because she considers the cases to be similar and should have similar outcomes. However, both the consolidated trials so far have resulted in mixed verdicts. She continues to be an abrasive thorn in the side of Merck, and most analysts had not expected any favourable outcome from this case.
Merck is currently also defending a case in Madison Country (Illinois), while a new coordinated trial will occur in Los Angeles Country (California) on 10 April. Two days later, an FDA advisory panel will issue its recommendation on Arcoxia (etoricoxib), Merck’s follow-up COX-2 inhibitor. Merck also faces two trials in May, followed by a summer break, before three trials are heard in September.