Closing Loophole Would Help Generic Reglan Tardive Dyskinesia Patients

New York, NYMonths after the Supreme Court ruled that generic drug companies do not share the same level of responsibility as their brand-name counterparts when it comes to updates of their product labeling, a noted New York publication continued to push for the generic labeling loophole in the law to be closed. Such a response would benefit patients suffering from Reglan tardive dyskinesia, regardless of whether or not the adverse reaction was triggered by a generic, or name brand Reglan.

Tardive dyskinesia is a particularly nasty reaction, in that it presents as an adverse event people can actually see. All drugs have side effects, most of which are fairly invisible. The patient suffers in silence, but at least can take solace in knowing their pain or discomfort—or frustration—is not readily apparent to others.

Tardive dyskinesia, in contrast, is painfully visible and can affect a wide demographic in patients. The condition is characterized by involuntary movements of the eyes, mouth, lips and tongue, jaw, and even limbs. It can impact an individual's life and livelihood, and many a Reglan lawsuit has been filed due to the emergence of such debilitating symptoms simply by taking a drug prescribed for such everyday maladies as Gastroesophageal Reflux Disease (GERD), acid reflux disease and heartburn.

The Reglan neurological side effects are permanent.

The problem is when patients suffer from Reglan side effects through the use of a generic. When a drug manufacturer's exclusive patent expires, competing manufacturers are allowed to make less-expensive equivalents of the same drug. Given the troubled health care system in the US, it's little wonder that 80 percent of prescriptions in the US are filled using less-expensive generic brands. Congress actually mandates the use of a generic drug, over the more expensive original, if available.

It's the same formulation, as well as the same label. In fact, generic drug manufacturers are not allowed to alter the labels of their products, given the product is a mirror copy of the original. Thus, the label needs to be a mirror copy as well.

To wit, a generic manufacturer, according to a close Supreme Court decision in June of last year, is not liable for deficiencies in its product labeling as it is encumbered to use the same label as that used by the original drug—in this case, Reglan (metoclopramide).

In this way, a generic-using plaintiff can't sue the manufacturer of Reglan, as Reglan was not actually used. Nor can the plaintiff sue the generic manufacturer for failure to warn from an inadequate label, as the label is beyond the control of the generic manufacturer. A classic case of Catch-22.

In April, Newsday (4/23/12) opined the loophole needs to be changed. The opinion referenced plaintiffs Gladys Mensing and Julie Demahy, who launched lawsuits after they began to suffer Reglan tardive dyskinesia following the ingestion of generic metoclopramide. However, even though the generic metoclopramide is a copy of Reglan, the relationship between Reglan and tardive dyskinesia for these two plaintiffs is suspect in the eyes of the law given they used the Reglan knock-off—which pharmacies are mandated to provide unless actual Reglan, at far greater expense, is specified.

Newsday noted the plaintiff's lawsuits claiming failure to warn against tardive dyskinesia failed at the behest of the US Supreme Court "because the Food and Drug Administration requires them to use the same labeling as the equivalent brand-name drug and bars any changes. Had the women used the brand-name drug, Reglan, their lawsuits wouldn't have been tossed."

The venerable New York publication noted in April that until Congress was prepared to address the issue, consumers have two choices: ingest drugs without legal protections, or specify more expensive brand name drugs. And be prepared to pay for them.

Along with tardive dyskinesia, Reglan adverse reactions are feared to include a suspected risk for Reglan side effects in infants through breast milk, given Reglan's capacity to stimulate the production of breast milk. Reglan began carrying a boxed warning for tardive dyskinesia as of February 2009. Prior to that time, critics advocate, the risk for tardive dyskinesia was not adequately spelled out.

Reglan drug side effects also include the potential for Neuroleptic Malignant Syndrome, or NMS.