Hormone therapy has been in use as a purported treatment for women’s menopausal symptoms and the prevention of osteoporosis for almost three decades. Throughout the United States, in both State and federal courts, there are currently about 7,900 claims pending by women who have allegedly been injured by combination hormone therapy. The thrust of these lawsuits, which are being prosecuted against Wyeth and other makers of synthetic hormones, is that combination hormone therapy (horse estrogen plus synthetic progestin) can cause breast cancer, that Wyeth and the other drug makers have known about this risk for decades, and that the drug makers failed to warn physicians or consumers until they were forced to do so in July 2002. Publication of the results of a government-run study entitled the Women’s Health Initiative (WHI) in July 2002 revealed that women taking combination therapy, including Wyeth’s Prempro, are at in increased risk for invasive breast cancer, heart attack, stroke, pulmonary emboli, and deep vein thrombosis. The lawsuits also allege that Wyeth and the other drug makers illegally promoted the drugs for unapproved indications, including the prevention of cardiovascular disease, and that the companies over-promoted the benefits of the drugs while attempting to downplay their risks.
Identity theft is a growing problem in our country, and while there are millions of people victimized by the crime, perhaps more widespread than the number of actual identity thefts is the fear of being victimized by one. As the world becomes increasingly interconnected, and as modes of communication and e-technology become more advanced by the day, the exposure of one’s personal information – whether a Social Security number, an address, or a password – can weigh heavy on the mind.
Many people over the course of the last decade have wisely heeded the advice of consumer advocates, legislators, and law enforcement agencies in taking steps to guard against having personal information stolen in the first place. Obviously, when you suspect that your personal information has been breached, guarding against fraud and protecting or repairing your credit is tantamount. The Federal Trade Commission website provides guidance on those fronts: www.ftc.gov/bcp/edu/microsites/idtheft//. Other websites providing useful advice and resources for victims of personal information exposure or identity theft include www.idtheft.gov, www.idtheftcenter.org, and www.privacyrights.org.
Products liability cases involving modern antidepressants in the class known as Selective Serotonin Reuptake Inhibitors (“SSRIs”) have enjoyed a relatively consistent, if intermittent, place in the media spotlight since the turn of the millennium. The SSRI group includes Prozac, Paxil, Zoloft, Luvox, Celexa, and Lexapro, and there have been a number of events thrusting these drugs into the spotlight, including two of the more prominent cases: that of 12-year-old Christopher Pittman, who killed his grandparents while he was experiencing what was alleged to be a violent reaction to Zoloft and Paxil; and that of 60-year-old Donald Schell, who killed his wife, their daughter, their granddaughter, and then himself after taking only two doses of Paxil. The former resulted in a murder conviction and thirty-year jail sentence in South Carolina, while the latter resulted in a civil verdict of approximately $8 million in Wyoming federal court against the maker of Paxil, SmithKline Beecham.
The deadly effects of SSRIs on children and adolescents has been well-documented: the potential to initiate or exacerbate depression or even cause suicidal thinking or behavior. Several manufacturers began sending out “Dear Dr.” letters warning physicians of these risks in and throughout 2004. By January 2005, manufacturers of SSRIs – and a few other modern antidepressants not technically considered SSRIs (e.g., Effexor, Wellbutrin, Cymbalta) – began warning of the risks in a black box warning contained on the labeling for each of the drugs. In 2006, the black box warning was extended to those beyond their adolescent years, all the way up to age 25.
In the wake of Riegel, if you are a consumer advocate or a products liability lawyer you certainly wait with bated breath for the outcome in Wyeth v. Levine, No. 06-1249, the case currently pending on appeal to the High Court for review of whether or not a prescription drug failure-to-warn case is preempted by federal law. [NOTE: I use the term “federal law” as loosely as Pharma Counsel uses it the prescription drug context. You can pick your meaning – statute, regulation, notice-and-comment rule – because it is equally difficult to find preemptive force in any category you might search.]
The plaintiff, Diana Levine, developed gangrene and lost her arm to amputation following intravenous injection of Wyeth’s drug, Phenergen, which was administered to treat her nausea. She sued Wyeth alleging, inter alia, that the company failed to adequately warn her physician that Phenergen should not be administered intravenously. Following trial, she won a verdict of approximately $6.7 million, and the trial court denied Wyeth’s motions for summary judgment and judgment as a matter of law based upon preemption. The Vermont Supreme Court affirmed, and Wyeth petitioned the United States Supreme Court for certiorari.
With the United States Supreme Court’s recent decision in Riegel v. Medtronic, --- U.S. ---, 128 S. Ct. 999 (2008), the High Court certainly seems to have come one sizable step closer to abiding the Bush Administration’s backdoor tort reform agenda and eliminating consumer lawsuits for harmful products. Post-Riegel, a consumer injured by a product that happens to have been the subject of federal regulatory oversight or approval prior to its having reached the marketplace, will find it difficult to get out from the ever-growing shadow of preemption.
To be sure, the Court’s holding in Riegel is fairly narrow. Indeed, the Court passed on the viability of only a limited class of lawsuits: those involving injuries caused by medical devices that were subject of the FDA’s “pre-market approval” process under the Medical Device Act (“MDA”), which the High Court found to be a “rigorous” one. And, of course, the holding is limited in that it represents an interpretation of the MDA’s express preemption provision, and hence, will not be controlling on questions of preemption arising where there has been no express Congressional intent to preempt. Moreover, only State claims that do not “parallel” the MDA’s requirements are nullified by the federal statute’s express preemption clause.
It continues to amaze me that some physicians still do not warn their patients of the dangers of anti-depressants despite the specific and bold warnings on these drugs to carefully monitor patients for worsening depression and suicidality. Even the drug manufacturers admit that it is absolutely necessary for patients’ families to closely monitor patients for any changes in behavior after beginning or changing a dose with antidepressant drugs.
Recently, the pharmaceutical drug Digitek was recalled because Actavis Group, the manufacturer of Digitek, produced the drug with twice the intended dose of the active ingredient. In other words, a defect in the manufacturing process led to a doubling of the active ingredient contained in each tablet. Therefore, patients prescribed Digitek were receiving twice the intended dosage of the drug, and as expected, suffered severe adverse reactions effects to this unintended overdose - especially if they were previously suffering from renal failure.
Recently, Baxter recalled its heparin products in the United States because of a contaminant found in the drug. Heparin is a drug used to prevent the formation of clots in the blood. The contaminant, a compound that looks like heparin under the microscope, was most likely added to the manufacturing process of the drug while in China.
The Federal Drug and Food Administration issued in June of 2006 (and later with additional FDA Alerts in December 2006 and May 2007), a warning to Health Care Professionals, concerning Gadolinium Based Contrast Agents (GMCAs), used for Magnetic Resonance Imaging (MRI) and the risk of contracting Nephrogenic Systemic Fibrosis (NSF).