INNsight article by Alan Klein & John Lyons

Observers of American pharmaceutical products liability cases since the 1960’s are today witnessing an evolution away from suits solely against brand manufacturers and are now seeing suits including both the innovator and competing generics as co-defendants. With 7 out of 10 prescriptions written in the U.S. filled with generics, health insurance plans requiring insurers to use generics and offering low co-pays if they do, and generic drugs entering the market at a rapid pace as innovator patents expire, the new paradigm in products liability litigation appears to bring both innovators and their generic counterparts into the courtroom to defend their drugs shoulder to shoulder. This trend is certain to continue into the next decade and beyond. In just a few years, a number of blockbuster innovator drug patents are set to expire, and generics are waiting in the wings to compete. For example, coming off patent in the next year or two are drugs such as Levaquin (levofloxacin), Advair (fluticasone/salmeterol), Plavix (clopidogrel), Crestor (rosuvastatin), Singulair (montelukast), Zometa (zoledronic acid), Viagra (sildenafil), Symbicort (budesonide/formoterol) and Viramune (nevirapine).

Already, brand and generic companies are co-defendants in several significant consolidations of lawsuits, as well as individual cases pending in American courts involving the drugs Accutane (isotretinoin), Reglan (metoclopramide), Prempro (conjugated estrogens and medroxyprogesterone), and the prescription contraceptives Yaz and Yasmin (drospirenone and ethinyl estradiol). Competing against one another in the marketplace, however, does not prevent the innovator and its generic competitors from cooperating in the courtroom. All manufacturers of a drug have shared interests in establishing the drug’s therapeutic benefits, the adequacy of warnings furnished to prescribing physicians, and the state of the medical science on important causation issues.  These shared interests and common goals bring together marketplace rivals, who work cooperatively to defend against a plaintiff’s claim that the drug caused the adverse outcome and that the companies failed to adequately warn physicians.

Common Messages, Common Themes, Common Science
All drug companies – brand and generic – have a positive message to provide to jurors and judges.  They are in the business of curing disease, extending life and promoting and restoring good health. Inevitably, as all drugs contain some risk, whether a manufacturer has properly warned physicians becomes the fulcrum issue in each products liability case for all companies selling the drug. For generics, their warnings under U.S. law must mirror the innovator’s labeling at the time the generic is approved. Expert witnesses for both brand and generic companies will rely on the same body of scientific literature and medical science in evaluating whether the drug generally could cause the injury alleged and whether it actually caused an individual plaintiff’s injury. Because the generic is the bioequivalent of the brand or listed drug with the same pharmacokinetic features, causation issues, not surprisingly, are similar for both.

Likewise, as reporting responsibilities between brand and generics are similar under federal regulations, the database of adverse events reported to all manufacturers, and similar data from the FDA itself, assist both innovator and generic defendants and their expert witnesses in assessing the quality and frequency of such reports, and whether any signals necessitated further inquiry or evaluation.

Some Differences Between Brand and Generic Remain
Certain areas, of course, remain separate as between the brand and generic manufacturers. For instance, plaintiffs’ contentions that a drug was “rushed to market” without proper attention to safety concerns, or the existence of “flawed clinical trials”, cannot be leveled against generics. Under Hatch-Waxman, generics need not perform clinical trials to receive market approvals. Neither do they face the financial or stakeholder pressures brand companies encounter to have drugs “in the pipeline” to replace others coming off patent.

Defense Cost Savings to Generic Manufacturers Through Joint Defense Efforts
Having the innovator in a case can result in cost savings to generic co-defendants.  Working cooperatively under a joint defense agreement, typical in multi-defendant cases, generics can obtain the innovator’s FDA communications, pharmacovigilance records, depositions and trial transcripts from prior cases, and a host of other materials to facilitate and streamline the preparation of the generic’s defense.  Important legal issues can be presented to courts cooperatively, with the brand and generic defense teams allocating responsibilities among themselves to avoid duplication of effort and extra costs.  Similarly, lead counsel responsibilities for gathering information about the plaintiff and other key witnesses, such as the plaintiff’s prescribing and treating physicians, can be shared.

In short, the new paradigm suggested above with innovator and generics cooperatively working together to defend products liability cases in American courts does much to achieve efficiencies and cost savings, and provides innovators and generics with an opportunity to work together to present unified defenses and themes to judges and juries.