Companies that make products that injure Americans are usually liable for any harm that comes to them. That is the legal theory behind the hundreds of Pradaxa internal bleeding class action lawsuits, Risperdal gynecomastia class action lawsuits, and more. So how is it that certain drugs are seemingly invulnerable regardless of the harm they may cause? Some people are waiting for the U.S. Supreme Court and the U.S. Food and Drug Administration (FDA) to figure that out.

The rub is the process by which generic drugs makers can put their medications on the market. After the original patent holder’s paperwork expires, other companies can bring similar products onto the market. Currently, however, the FDA requires that the patient information packets and side effects warnings must be exactly the same as the medication on which it is based.

Current jurisprudence also takes a dim view of class action lawsuit attorneys who try to pin the blame on the original company. While officials could update warnings based on studies or adverse reaction reports to the FDA, there seems to be a substantial disconnect between drug makers and their creations once they go generic. In Mutual Pharmaceutical Co. v. Bartlett, an appeals court judge noted that this “makes it difficult if not impossible to hold the generic manufacturer liable.”

Instead, the U.S. District Court judge noted that the plaintiff has “not brought suit against [GlaxoSmithKline] for tortious conduct committed strictly as a manufacturer of products. And, though GSK implicitly urges to the contrary, I see no reason why all suits brought against GSK must be brought against GSK [as a] manufacturer.”

It should be noted that the jurisprudence comes in an order dismissing a motion for summary judgment. As class action lawsuit attorneys often inform their clients, the facts must be read by a judge in the light most favorable to the plaintiff. However, reading between the lines in the order indicates the possibility of separating out negligence because the resultant products are affected due to FDA regulations.

Why is this so important? As an example, Risperdal class action lawsuits over Risperdal side effects have been filed by plaintiffs who took the generic drugs, or a therapeutic equivalent. Along with that atypical antipsychotic, several other generic versions of popular drugs with major side effects are also the subjects of class action lawsuits. Among them:

• The birth control family linked to Yaz stroke side effects.
• A popular statin drug that studies show increases Lipitor type-2 diabetes risks.
• Older antibiotics and epilepsy drugs like Dilantin and Lamictal that carry a black box warning for Stevens-Johnson Syndrome side effects.
• The popular antibiotic azithromycin, which the FDA has required Pfizer to advise patients of Z-Pak heart arrhythmia reports.

While patients who suffer side effects from generic drugs can find challenges in pursuing their lawsuits, may be an alternate pathway to seeking justice. While the Hatch-Waxman Act that was supposed to improve drug affordability put same-label requirements in place for generic drug makers, the FDA has significant leeway in putting forth other regulations.

And the agency has decided to open up discussions allowing those companies to add more warnings for problems like Z-Pak heart arrhythmia side effects. In either case, it would be a significant victory for plaintiffs who have been harmed by drugs linked to Yaz stroke reports, Lipitor type-2 diabetes, and other conditions caused by drugs not made by the original patent holder.