Prempro Lawsuit Results in Defense Verdict

A federal jury in Virginia has handed Pfizer a defense verdict in a Prempro breast cancer lawsuit, saying that the plaintiff was properly informed about the potential side effects Prempro, a hormone replacement therapy (HRT). 

The lawsuit was filed by Georgia Torkie-Tork, 65, in federal court in Alexandria, Virginia. Following trial, jurors determined that she did not establish that Wyeth failed to adequately warn about the risk of breast cancer, and returned a verdict in favor of the drug maker.

The decision is the fourth jury victory in a row for Pfizer in a Prempro suit over breast cancer. However, the drug maker has suffered several major losses at trial, which have resulted in tens of millions of dollars in compensatory damages and punitive damages after other juries determined that their Wyeth subsidiary attempted to downplay the risks associated with the medication.

Prempro is a hormone replacement therapy (HRT) that contains a combination of the drugs Provera and Premarin. The drug was originally developed by Wyeth, which was acquired by Pfizer last year.

In 2002 the National Institutes of Health released the results of studies that found women receiving HRT were at higher risk of breast cancer, strokes and heart attacks. The studies, part of the Women’s Health Initiative, sparked most of the Prempro hormone replacement therapy lawsuits currently pending throughout the country.

There are about 9,000 lawsuits over Prempro suits pending against Pfizer’s Wyeth unit. All of the lawsuits claim that the drug caused plaintiffs to develop breast cancer, and that Wyeth failed to warn patients and doctors of the potential side effects of the hormone therapy.

PFIZER EXPANDS RECALL OF LIPITOR, THE BEST SELLING PRESCRIPTION DRUG IN THE WORLD

Pfizer, Inc. has issued the third of a string of recalls for Lipitor. As with the first and second recalls of the common cholesterol reducing drug, the instant recall is due to reports of an unpleasant odor related to the bottles in which the drug is packaged.  The company has identified the chemical 2,4,6-tribromoanisole, commonly used to treat wood pallets used to store and ship bottles, as the cause of the odor.   It is the same chemical which Pfizer’s competitor, Johnson & Johnson, attributed its recalls to earlier this year.

The instant recall affects 38,000 bottles containing 40mg tablets, bringing the total of recalled bottles of Lipitor to an estimated 360,000. 

Although the company claims that the chemical is not likely to cause adverse health consequences, the astounding number of recalls, including those related to household names, Tylenol and Benadryl, should make consumers  more aware of the potential harms of these commonly prescribed and over the counter drugs.  It is unclear if additional recalls will be issued, but in the meantime, be cautious of any foul odors or unusual qualities in any drug you take.

Follow-up study discovers use of hormone replacement drugs leads to more advanced and fatal cancers.

Hormone treatment after menopause was originally studied by the Women’s Health Initiative (WHI) as part of a clinical trial established in 1992 to assess its relationship to coronary heart disease. Those studies were halted in 2002 when the results indicated that women taking a combination of estrogen and progestin had a higher risk of heart disease, stroke, and invasive breast cancer when compared to women taking a placebo. Now, a new study published October 20, 2010 in the Journal of the American Medical Association (JAMA) reports that these breast cancers associated with hormone treatment are more aggressive, more advanced, and have a higher mortality rate. 

The WHI continued to follow the women with breast cancer after the main trial had ended. Some earlier observational studies had suggested that hormone therapy induced breast cancers were less advanced and had a lower risk of death. However, this new WHI finding strongly contradicts those suggestions.   Combined hormone therapy increased the incidence of invasive breast cancer and in many cases the cancer had spread to the lymph nodes making it a more deadly form of cancer. Most significantly, it was found that the use of hormone therapy made the detection of breast cancer more difficult resulting in the cancer being diagnosed at a more advanced stage. 

For many years, menopausal women were treated with a combination of drugs to treat hot flashes and mood swings. Premarin, manufactured by Wyeth, contained estrogen, while Provera, manufactured by Pfizer’s Pharmacia and Upjohn, contained progestin.  In 1995, Wyeth combined the two hormones to form the medication, PremPro. Following the initial findings of the WHI in 2002 that linked estrogen and progestin to increased incidences of breast cancer, sales decreased dramatically. Sales of Premarin and PremPro were approximately $213 million in 2009, down from almost $2 billion prior to 2002. 

 

Lesson: Match Your Class Definition to the Advertising Campaign

On June 17, 2010, the California Supreme Court denied the petition for review and request for depublication in Pfizer, Inc. v. Superior Court, 182 Cal. App. 4th 622 (2d Dist., 2010). Accordingly, this important post-Tobacco II appellate opinion remains good authority.  Pfizer provides a cautionary tale of attempting to certify too broad a class. The lesson here is to tailor your proposed class definition to the scope and manner in which the alleged misrepresentations were made. 

In Pfizer, a consumer sued a mouthwash manufacturer pursuant to the unfair competition law (UCL) (Bus. & Prof. Code, § 17200 et seq.) and the false advertising law (Bus. & Prof. Code, § 17500 et seq.). The consumer alleged the manufacturer marketed its mouthwash in a misleading manner by representing the use of mouthwash could replace the use of dental floss in reducing plaque and gingivitis.

The trial court certified a class of "all persons who purchased Listerine, in California, from June 2004 through January 7, 2005." The Court of Appeal granted Pfizer's petition for writ of mandate, concluding the trial court's class definition was overbroad. The Supreme Court granted review. On August 19, 2009, the Supreme Court transferred the matter back to the Court of Appeal with directions to vacate the decision and reconsider the matter in light of In re Tobacco II Cases (2009) 46 Cal.4th 298 [93 Cal.Rptr.3d 559, 207 P.3d 20] (Tobacco II). Having done so, The Court of Appeal again concluded the class definition is overbroad and granted Pfizer's petition.  

In reaching its decision, the Court of Appeal noted that with respect to the remedy of restitutionary disgorgement, Tobacco II holds:

"[T]he language of section 17203 with respect to those entitled to restitution--'to restore to any person in interest any money or property, real or personal, which may have been acquired' (italics added) by means of the unfair practice--is patently less stringent than the standing requirement for the class representative--'a person who has suffered injury in fact and has lost money or property as a result of the unfair competition.' (§ 17204, italics added.) This language, construed in light of the 'concern that wrongdoers not retain the benefits of their misconduct' [citation] has led courts repeatedly and consistently to hold that relief under the UCL is available without individualized proof of deception, reliance and injury. [***16] [Citations.]" (Tobacco II, supra, 46 Cal.4th at p. 320.)”

Nevertheless, the Court of Appeal found the class definition too broad because it included persons who were not entitled to restitution because they were never exposed to the “effective as floss’ representation. The appellate court wrote:

“Be that as it may, one who was not exposed to the alleged misrepresentations and therefore could not possibly have lost money or property as a result of the unfair competition is not entitled to restitution. Here, the class certified by the trial court, i.e., all purchasers of Listerine in California during a six-month period, is grossly overbroad because many class members, if not most, clearly are not entitled to restitutionary disgorgement. The record reflects that of 34 different Listerine mouthwash bottles, 19 never included any label that made any statement [*632] comparing Listerine mouthwash to floss. Further, even as to those flavors and sizes of Listerine mouthwash bottles to which Pfizer did affix the labels which are at issue herein, not every bottle shipped between June 2004 and January 2005 bore such a label. Also, although Pfizer ran four different television commercials with the "as effective as floss" campaign, the commercials did not run continuously and there is no evidence that a majority of Listerine consumers viewed any of those commercials. Thus, perhaps the majority of class members who purchased Listerine during [***17] the pertinent six-month period did so not because of any exposure to Pfizer's allegedly deceptive conduct, but rather, because they were brand-loyal customers or for other reasons.”

The Court contrasted the limited six-month Listerine marketing scheme with the extensive and lengthy campaign used by the tobacco industry to sell cigarettes.

“The circumstances herein stand in stark contrast to those in Tobacco II, where the tobacco industry defendants allegedly violated the UCL "by conducting a decades-long campaign of deceptive advertising and misleading statements about the addictive nature of nicotine and the relationship between tobacco use and disease." (Tobacco II, supra, 46 Cal.4th at p. 306.) Tobacco II allows a class representative who actually relied on the defendants' misleading advertising campaign to represent other class members who may have lost money by means of the unfair practice. Tobacco II does not stand for the proposition that a consumer who was never exposed to an alleged false or misleading advertising or promotional campaign is entitled to restitution.”

“As Pfizer argues, it is one thing to say that restitution can be awarded to purchasers of cigarettes where the cigarettes were marketed as part of a massive, sustained, decades-long fraudulent advertising campaign on the grounds the tobacco industry defendants "may have ... acquired" [***18] (§ 17203) the purchase price as a [**804] result of such a pervasive fraudulent campaign. It is entirely another to say that restitution can be awarded to all purchasers of Listerine in California over a six-month period where the undisputed evidence shows many, if not most, class members were not exposed to the "as effective as floss" campaign and therefore did not purchase Listerine because of it.”

In other words, large numbers of persons in the class defined by the trial court were never exposed to the “effective as floss” representations and, accordingly, there is zero likelihood they were deceived by the claimed misrepresentation or that Pfizer obtained money from them by the alleged UCL violation. Had the class definition been limited to persons exposed to the “effective as floss” representation (as opposed to all purchasers) the definition might have withstood appellate scrutiny

Recent Verdicts Against Wyeth Underscore Momentum in Favor of Plaintiffs Who Claim to Have Developed Breast Cancer as the Result of Hormone Therapy

KPA Moves Forward in Complex Litigation on Behalf of Women with Breast Cancer Linked to Premarin and Prempro

Two multi-million dollar verdicts in Philadelphia last week against pharmaceutical company Wyeth, a division of Pfizer, reinforce that juries are consistently finding the company responsible for breast cancer in women who took its Premarin and Prempro hormone replacement therapy (HRT) drugs.

And just last month, a ruling from the 8th Circuit Court of Appeals confirmed that Wyeth did wrong, and that juries should be permitted to hear this evidence and determine whether the company should be punished.

In the verdicts announced last week, juries awarded Donna Kendall of Decatur, Illinois $6.3 million in compensatory and $28 million in punitive damages, and Connie Barton of Peoria, Illinois $3.7 million in compensatory and $75 million in punitive damages.

Through an ongoing federal multi-district litigation mass tort action, Wyeth still faces lawsuits from more than 10,000 women nationwide who claim that the company’s drugs caused their breast cancer. Of the 12 verdicts announced to date, plaintiffs have been awarded money in 10 of the cases. Every jury that has been permitted to deliberate on punitive damages has returned substantial awards.

To date, winning plaintiffs have been awarded a total of more than $42 million in compensatory and $165 million in punitive damages. In addition, 13 women have settled their HRT claims with Wyeth or Pfizer outside of court.

Shawn Khorrami, founding partner of KPA, is a member of the Plaintiffs’ Steering Committee for the MDL litigation team, and his firm represents around 150 individuals pursuing cases against Wyeth.

A press release on the firm’s involvement with the litigation was released today. For more information on the Barton and Kendall verdicts watch the video below.
 

 

David and Goliath

The world’s largest drugmaker, Pfizer, indicated it would challenge the latest verdict and an earlier verdict that went against Wyeth. A Philidelphia court recently ordered Pfizer to pay $28 million in punitive damages to a woman who is a breast cancer survivor. She was a consumer of Pfizer’s hormone replacement drugs for 11 years.

The drug giant inherited numerous personal injury lawsuits involving the drugs Premarin and Prempro. These drugs are prescribed by doctors to alleviate the effects of menopause. Pfizer recently acquired Wyeth. Provera is also sold by Pharmacia & Upjohn, the latter acquired by Pfizer in 2003.

There was a $4 million compensatory damages award and $75 million in punitive damages. This came after $6.3 million award that Pfizer was ordered to pay in compensatory damages when the jury concluded that the drugmaker failed to warn the consumer about the risks of the durgs Premarin, Prempro and Provera, which contributed to the plaintiff’s cancer.

A jury concluded that Pfizer’s actions warranted punitive damages because its actions constituted a reckless disregard for plaintiff’s safety, health and welfare. Pfizer, of course, intends to appeal, if post trial motions are unsuccessful. The company believes that neither liability nor punitive damages were supported by the evidence presented at trial. Both Wyeth and Pharmacia & Upjohn argued at trial that the drugs were approved by the U.S. Food and Drug Administration and known risks were included on the labels.
 

CAUGHT! Pharmaceutical Giant Pfizer, Pays Record Fine for Defrauding YOU

In the largest settlement in United States Justice Department history, Pfizer agreed to pay $2.3 billion to settle claims of misbranding and off-label marketing of a number of its pharmaceutical products.  While the settlement covered 13 different drugs manufactured by Pfizer and its various subsidiaries including Pharmacia & Upjohn, the primary focus was on the conduct related to the anti-inflammatory drug Bextra, which was withdrawn from the market in 2005 amid reports of increased risk of heart attacks, strokes, toxic epidermal necrolysis, and Stevens Johnson Syndrome, a potentially fatal skin disease.  

The investigation of Pfizer and its questionable marketing practices was initiated as the result of whistleblowers inside the company. Sales representatives drew the line at attempts to increase profits when those sales meant risking the lives of the drug consumers. One would hope that a settlement of this magnitude would cause a major philosophical change in the way the drug companies do business in the future, but that prospect is unlikely because of the sheer profits to be made in this industry. Pfizer reported revenues of $48.3 billion in its latest annual review and had reserved funds to cover this settlement in 2008. 

An ‘agreement’ to plead guilty to a felony charge and pay $2.3 billion ($1.3 billion in fines, and an additional $1 billion to state and federal authorities to resolve civil allegations of fraud) might present a public relations nightmare, but Pfizer did not blink. Citing their dedication to healing and better health, a Pfizer spokesperson stated they were proud of the actions they have taken to strengthen their internal controls to comply with state and federal laws regulating their practices.   Pfizer also stated that corporate integrity is a top priority for the company and the conclusion of this matter allows Pfizer to focus on what they do best. 

What they do best according to Mike Loucks, acting U.S. Attorney for the District of Massachusetts, is blatantly disregard the law. While negotiating yet another agreement to resolve criminal conduct of Warner-Lambert, its newly acquired subsidiary, Pfizer was itself violating the same laws. Attributing unproven beneficial aspects to certain products while concealing potentially fatal risks, and bribing doctors are criminal activities, yet no one went to jail. There is no personal accountability here, which is why we will see this type of behavior repeated by other pharmaceutical companies.