73 The Alabama Lawyer 58 (2012). Adverse Reaction Without a Remedy.

• Author: By Steven F. Casey and David A. Lester

Alabama Bar Journal

2012.

73 The Alabama Lawyer 58 (2012).

Adverse Reaction Without a Remedy

Adverse Reaction Without a Remedy By Steven F. Casey and David A. Lester Most consumers decide whether to buy

a brand-name or generic drug based on one of two considerations-price or myths regarding quahty. Few, if any, give thought as to whether their choice will affect their ability to pursue a claim against the manufacturer in the event they suffer an adverse reaction to the drug. However, after recent decisions by the United States Supreme Court, consumers who purchase generic drugs may have no avenue to pursue claims against generic drug manufacturers for failing to warn about potential adverse effects of drugs. To comprehend how a consumer could possibly suffer an adverse drug reaction and be left without a legal remedy, it is helpful to review a bit of the history of drug regulations in the United States.

History

The Food, Drugs, and Cosmetics Act ("FDCA") can trace its roots back to the Pure Foods and Drugs Act of 1906.(fn1) From 1906 to 1962, drugs were reviewed and approved only for safety.(fn2) During this time, a generic version of a brand name drug could be approved based upon the submission of a "paper" new drug application, which contained published scientific and medical Hterature demonstrating that the drug was safe.(fn3) The FDCA was amended in 1962 to require drug companies to show that their drugs were effective through clinical trials.(fn4) The amended FDCA contained no provision by which companies could gain approval of a generic version of a brand-name drug in an abbreviated process.(fn5) The generic drug companies were hesitant to invest the time and expense required for clinical trials and, as a result, by 1984, there were 150 drugs whose patents had expired but for which there was no generic drug equivalent.(fn6) In fact, only 35 percent of the top-selling drugs with expired patents had generic equivalents.(fn7)

By the early 1980s, as the availability of generic drugs declined, the average price for prescription drugs increased.(fn8) The Food and Drug Administration ("FDA") began considering the possibility of implementing new regulations that would allow abbreviated new drug applications for generic drugs.(fn9) Instead, Congress intervened and passed the Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman amendments to the FDCA.(fn10) The amendments sought to balance two competing objectives:

* Encourage competition from generic drugs and * Continue to provide incentives for brand-name drug companies to develop new drugs.(fn11)

The Hatch-Waxman amendments preserved the incentive for brand-name companies to invest in research to develop new drugs by increasing the patent exclusivity period for new drugs.(fn12) The amendments also allowed brand-name drug companies to obtain patent extensions for a period of time equal to the time the drug spent in clinical trials, so that the brand-name drug company could reap the financial benefits from its new drug for the entire patent term.(fn13)

The amendments streamlined the process for approving generic drugs by requiring only that manufacturers demonstrate bioequivalence to an already-approved drug through the submission of an abbreviated new drug application.(fn14) Bioequivalence means that the active ingredient in the generic drug is absorbed at the same rate and to the same extent as the active ingredient in the brand-name drug.(fn15) The tests required to prove bioequivalence are much less costly than those required to prove safety and efficacy.(fn16) The amendments also require that generic drug companies label their drugs with the same label that is approved for their brand-name equivalent.(fn17) The amendments further allowed generic drug companies to submit abbreviated drug applications before the expiration of the brand-name drug's patent.(fn18) This change alone shortened the average time between the expiration of a brand-name drug's patent and the entry of generic versions into the market from three years to three months.(fn19)

There is no doubt that the Hatch-Waxman amendments achieved the goal of increasing competition from generic drug manufacturers. In 1983, generic drugs accounted for 13 percent of the prescription drug market.(fn20) In 2010, generic drugs accounted for 78 percent of all drugs sold in the United States.(fn21) Today, on average, more than 80 percent of a brand's prescription volume is replaced by generics within six months of patent expiration.(fn22)

Pharmaceutical Litigation After Hatch-Waxman

As long as there have been prescription drugs on the market, there have been patients who suffered adverse reactions from taking those drugs. Accordingly, litigation has been a part of the pharmaceutical industry for as long as it has been around. Some adverse reactions are foreseeable and drug companies warn of those potential reactions in their labels and warnings. Sometimes, there are reactions that were not discovered in clinical trials. Over the years, plaintiffs have asserted claims against pharmaceutical companies based upon countless theories of liability, but most claims have included some variation of a common law failure to warn claim.

Both brand name and generic pharmaceutical companies have also experimented with many...