Legal landscape note: This article was originally published in 2015 and describes the law as it stood at that time. New Jersey law changes frequently.
You took Prempro or Premarin for menopause symptoms, were later diagnosed with breast cancer, and want to know what became of the New Jersey lawsuits over those drugs. The short answer, as of early 2015: the state's hormone replacement therapy mass tort ended quietly, without a single case tried to verdict here and with no publicly known recoveries because any settlements were confidential. That silence is striking when, in other states, juries returned large awards -- awards that trial and appellate courts then slashed -- and Pfizer, which acquired Wyeth in 2009, reported roughly $1.7 billion in litigation costs nationwide.
Source: "How a Billion-Dollar Mass Tort Fizzled in NJ" -- Mary Pat Gallagher, January 30, 2015.
Litigation that resulted in multimillion-dollar verdicts around the country is poised to shut down in New Jersey without a single case tried to verdict and no known recoveries by the hundreds of women who claimed the hormones they took to alleviate symptoms of menopause instead caused cancer and other problems.
The New Jersey court system is preparing to close the book on the centralized litigation over hormone replacement therapy (HRT).
The lawsuits were once numerous enough to be designated a mass tort and sent to a single county, but now, as similar litigation elsewhere has largely ended, the New Jersey cases have all been resolved.
A Jan. 14 notice to the bar said “all active litigation has been concluded” and invited comment or objection on the proposed termination of the centralized status by Feb. 13. As of Jan. 29, no one had spoken up, according to the judiciary.
Any settlements would have been confidential, so it is not known what, if anything, drug makers paid out to New Jersey plaintiffs.
But it would have been far less than might have been expected given that Wyeth Pharmaceuticals, maker of two of the biggest-selling HRT drugs -- Premarin and Prempro -- was headquartered in Madison, N.J., and the state has a reputation as a plaintiff-friendly forum.
One indication of the large sums recovered elsewhere is that Pfizer, which acquired Wyeth in 2009, said in its most recent 10-K filing with the Securities and Exchange Commission, covering 2013, that the litigation has cost it a total of $1.7 billion.
Pfizer also indicated that out of the more than 10,000 HRT lawsuits filed against it in various jurisdictions, more than 99 percent had been resolved or were in the process of settling and that it had set aside another $25 million to deal with all but a few pending class actions and purported class actions.
Hormone replacement therapy, in use since the 1940s, involves the use of real or synthetic estrogen, progesterone or some combination of the two to counter the bone loss, hot flashes and dryness that often accompany menopause. It was also thought to protect against heart disease.
The flood of litigation began after researchers in a National Institutes of Health study, the Women’s Health Initiative, revealed in July 2002 that the estrogen-progestin combination increased the risk of heart attacks, strokes, blood clots and breast cancer, with consequences so adverse that the study was terminated prematurely.
In early 2003, the U.S. Food and Drug Administration responded by adding a black box warning, the most serious type, to Premarin and Prempro.
The New Jersey Supreme Court designated HRT litigation a mass tort in September 2004, centralizing the suits in Atlantic County, where they were assigned to Judge Carol Higbee.
The court acted at the request of attorney Esther Berezofsky, who wrote to the Administrative Office of the Courts on June 21, 2004, saying her firm, Philadelphia-based Williams Cuker Berezofsky, had already filed 13 cases in Atlantic County and planned to file another 25 in the coming week.
Berezofsky argued mass-tort status was warranted because the number of anticipated cases was substantial and they had common issues and facts, with most of them involving the same defendant, Wyeth.
By the time HRT got the designation, three months later, more than 80 actions were pending and the defendants included Barr Pharmaceuticals, Novartis Pharmaceuticals and Bristol-Myers Squibb. Berezofsky was named plaintiffs’ liaison counsel.
The cases were later moved to Middlesex County, where, in 2008, the first of two decisions that ultimately proved devastating to the plaintiffs’ claims were made in what were to be the first cases to go to trial in New Jersey: Bailey v. Wyeth and DeBoard v. Wyeth.
The plaintiffs, Dora Bailey and Loretta DeBoard, alleged they developed breast cancer as a result of taking Premarin and Prempro, along with Provera, made by Pfizer subsidiary Pharmacia & Upjohn Co., according to court documents. They claimed that Wyeth and Pharmacia violated New Jersey’s Products Liability Act by failing to provide adequate warning of the breast cancer risk.
The act creates a rebuttable presumption that warnings or instructions approved or prescribed by the FDA are adequate and courts have construed it to require some sort of intentional misconduct to overcome the presumption.
“The ultimate decision of the FDA to provide or not provide certain information in a prescription drug label cannot be criticized unless a plaintiff has provided evidence of the pharmaceutical company’s deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects or if the pharmaceutical company was found to have manipulated the post-market regulatory process,” Judge Jamie Happas ruled.
Finding that the plaintiffs failed to present such evidence, Happas granted summary judgment dismissing their failure-to-warn claims.
Happas also threw out claims for violation of the New Jersey Consumer Fraud Act and common-law claims of fraudulent and negligent misrepresentation, finding they were subsumed by the Products Liability Act claims.
Bailey and DeBoard appealed, a stay was granted and activity in the almost 170 remaining suits at the time essentially came to a halt.
The appeals process came to an end June 28, 2012, when the state Supreme Court denied certification.
For those residing elsewhere, she set a May 1 deadline to file choice of law motions.
At that point, only 38 cases remained, brought by plaintiffs from 12 different states, including 12 plaintiffs from New Jersey.
The mass-tort status of the litigation was a major factor in showing New Jersey had a more significant interest in applying its law than that of other states and the parties had benefited from having a single judge oversee the litigation, Mayer said.
Mayer also found plaintiffs were estopped from seeking application of any other law because they had convinced the judge to issue a stay pending appeal in Bailey / DeBoard Though court records still list 24 HRT cases as of Jan. 1, judiciary spokeswoman Tammy Kendig said they are only open because “they are awaiting the filing of some paperwork” and substantive issues have been resolved.
“Litigation in New Jersey is completed,” Berezofsky said, adding that most cases nationally are completed, too.
Pfizer attorney Sheila Birnbaum, of Quinn Emanuel Urquhart & Sullivan in New York, who argued the Bailey/DeBoard appeal, referred a request for comment to the company, which released a statement saying, “We are pleased to have closed the docket on these cases in New Jersey, where the court found the warnings on Wyeth’s HRT medicines were adequate as a matter of law.” While HRT litigation never gained traction in New Jersey, it played out far differently elsewhere.
At one point, thousands of cases were consolidated in the U.S. District Court for the Eastern District of Arkansas, and some cases that went to trial yielded substantial verdicts.
For example, in Pennsylvania, which drew a lot of litigation because Wyeth had a location in Collegeville, Pa., there were multiple plaintiffs verdicts, including one as high as $78.7 million, in Barton v. Wyeth in 2009.
Composed of $3.7 million in compensatory damages and $75 million in punitive damages, the verdict was eventually reduced to $11.2 million when the punitives were slashed to $7.49 million. That sum stood when the Pennsylvania Supreme Court denied an appeal in 2013.
Three women who sued Wyeth in Nevada were awarded $134 million in damages -- $35 million compensatory and $99 million punitive. It was cut to $57 million -- $22 million and $35 million, respectively -- which that state’s Supreme Court affirmed in 2010.
Additional trials took place in federal courts in Arkansas, Connecticut, Nebraska, Puerto Rico, Utah, Virginia and West Virginia, according to information provided by Pfizer.
All in all, there were 14 final judgments for Wyeth and nine for plaintiffs, one of which is not final, the company said.