The pharmaceutical industry and its associated companies have been repeatedly accused of misleading consumers in their marketing of drugs and medical devices, including promoting non-FDA-approved uses for drugs (so-called “off-label” uses) and promoting the use of drugs in non-FDA-approved patient populations.
The law generally requires pharmaceutical companies to warn patients and the medical community about potential injurious side effects and contra-indications associated with their products. Such warnings allow consumers and their doctors to make informed choices concerning their medical care and treatments. The law also demands that pharmaceutical companies market their products honestly, for the appropriate uses and patients.
We believe consumers have a right to accurate, truthful information in the pharmaceutical and medical device marketplace. We fight to protect consumers when pharmaceutical and medical device companies fail to adhere to good manufacturing standards; when they fail to warn consumers about potential dangerous side effects associated with the use of their products; and when they market their products for particular uses or to patient populations which the FDA has not approved. We seek redress for alleged negligence by drug and medical device makers because consumers have a reasonable right to safety when using pharmaceuticals and medical devices as directed.
Gibbs Law Group’s Medical Product Liability Attorneys have extensive experience representing patients who have been injured by drugs and medical devices. Our attorneys have pursued claims in the following cases:
- In re: Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (S.D Ill.)
Plaintiffs alleged that Defendant Bayer Healthcare Pharmaceuticals, Inc. knew and failed to warn consumers of the increased risk of thrombotic events associated with the use of drospirenone, the third-generation progestin in its Yasmin and Yaz birth control pills. Claims were also brought regarding Ocella and Beyaz birth control pills, the generic forms of Yasmin and Yaz that are manufactured by other pharmaceutical companies. Some plaintiffs also alleged that the use of Yasmin and Yaz negatively impacted gallbladder function, causing the development of gallstones and sometimes requiring choleocystectomy, or removal of the gallbladder. Bayer has entered into settlement agreements with both groups of plaintiffs and has paid out $1.7 billion thus far to women injured by their products and its derivatives.
- In re: Pelvic Repair System Products Liability Litigation (S.D.W.V.)
Ethicon, Bard, American Medical Systems, Boston Scientific, and Coloplast Corp. were all named as defendants in separate consolidated proceedings concerning allegedly defective pelvic repair system products, or transvaginal mesh products. Some of these companies have engaged in settlement discussions with attorneys for women who suffered serious and sometimes-life-threatening complications after insertion of the mesh, such as mesh erosion, recurrent pelvic organ prolapse, infection, vaginal bleeding, urinary problems, and pain.
- In re: Actos (Poiglitazone) Products Liability Litigation (W.D. La)
Consolidated cases are currently in the trial phase of litigation, with claims alleging that the use of pioglitazone-containing products – such as Actos – increases patients’ risk of acquiring bladder cancer. Under the “bellwether” trial approach being used in this litigation, a few individual cases have been selected for trial to provide a sample of how juries rules on the claims. The first federal bellwether trial resulted in a $37 million punitive damages award. A second federal bellwether trial is expected to begin in 2015.
- In re: Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation (MA & D. Mass.)
In consolidated proceedings in both federal court and Massachusetts state court, plaintiffs allege that the use of Fresenius Medical Care’s Granuflo and NaturaLyte dialysate products during hemodialysis can cause cardiac arrest and death. The litigation is currently in the discovery phase, during which the parties develop evidence to support their claims and defenses. Approximately 30 cases have been selected for bellwether trials scheduled to begin in late 2015 and early 2016.