Big Pharma Liability

New Pharmaceutical Rules Restrict Injured Plaintiff’s Rights

Rules Endorsed by Pharmaceutical Drug Makers

This article, by The Collective Evolution, aptly describes new Congressional Bills that are adverse to those injured by legal drugs, but also might create a windfall for Big Pharma.  Read the story HERE.

If you’re hurt by a pharmaceutical, you can sue the company that made the drug, and be compensated for your losses, right? Most people assume that is the way the justice system works, but the reality is that it’s difficult, and in many cases impossible, for victims of pharmaceutical companies (and other big corporations/industries) to gain compensation or justice.

There are many aspects of the current U.S. legal system that make getting compensation and justice for injuries caused by pharmaceutical drugs difficult, and there are two bills that are currently going through the U.S. House of Representatives (H.R. 985, the 2017 Fairness in Class Action Litigation Act and H.R. 1215, the Protecting Access to Care Act of 2017) that will make justice for victims of pharmaceuticals nearly impossible.

They Can Hurt You as Long as You Were Warned

Currently, people who are hurt by pharmaceuticals are in a legal catch-22 because victims of pharmaceuticals can’t sue drug companies for hurting them, they can only sue for failure to warn. So, if a pharmaceutical drug gives you cancer, you can’t sue the company that made the drug for the fact that it gave you cancer, you can only sue them for failing to warn you IF the warning label doesn’t contain information about the drug causing cancer. If the warning label says that the drug can cause cancer, you can’t sue, because “you were warned.” Even if you were never given the drug warning label, you “were warned” as far as the justice system is concerned — because the learned intermediary doctrine states that pharmaceutical manufacturers aren’t obligated to inform you, the consumer/patient/victim, they’re only obligated to inform the doctor, the “learned intermediary,” about the potential harm that the drug can cause.

If a pharmaceutical drug causes your cancer, but that isn’t noted on the pharmaceutical warning label, you’re not much better off, because proving that a pharmaceutical caused your cancer is near-impossible for a regular person. The only situation in which a person can sue a pharmaceutical drug company for the harm done by their products is when a drug warning label changes. If a pharmaceutical drug warning label changes, there is enough evidence that the drug did the harm, but people who took the drug prior to the warning label change weren’t properly warned, so there is a short window of opportunity for victims to sue and gain recourse/justice for the harm done to them. The inherently dangerous nature of pharmaceutical drugs, the warning labels that accompany them, and the way our justice system is structured, make it so that the vast majority of those who suffer harm from pharmaceutical drugs are unable to sue the maker of the drug(s) that hurt them.

Victims of Generic Pharmaceuticals Can’t Sue

On top of that, victims of generic pharmaceuticals are completely unable to sue the manufacturer of the pharmaceutical drug that hurt them. This is an absurd situation that is an extreme miscarriage of justice. You can read more about the inability of victims to sue makers of generic pharmaceuticals in the New York Times article “In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs” and the posts on, “SCOTUS Decision on Medication Safety: No Product Liability” and “Hurt by a Generic Drug? Victims have no Recourse unless the FDA Changes Rules.” Basically, if you are hurt by a generic drug, you have no recourse because cannot sue a generic drug manufacturer. The FDA has the power to change this situation, but they have failed to do so over the 3+ years that they have been deliberating how they might address it.

The Law Firm wants to help you in medical products liability cases, and other products liability cases.  Call (225) 933-1500 or contact us today.

vertex cystic fibrosis

Vertex Pharmaceuticals Offers Promising Cystic Fibrosis Drug

Promising New Cystic Fibrosis Drug

Reuters New Service has reported that Vertex Pharmaceuticals Inc said on Tuesday its Kalydeco cystic fibrosis treatment, when given with an experimental drug, demonstrated significant improvements in lung function in Cystic Fibrosis patients.  This occurred in two late-stage trials the company plans to use to seek approval of the combination therapy.

Patient discontinuations of the Kalydeco/tezacaftor combination due to adverse side effects, including respiratory-related side effects, were low and similar to placebo. This is important in that bronchial constriction has led up to 30 percent of those prescribed Vertex’s Orkambi combination treatment to stop taking it. Anytime there is a serious adverse reaction to a drug, the user should speak with their physician about discontinuation of the drug.

“If we could get the same efficacy but have a cleaner, safer drug (than Orkambi) that would be a win and the results are actually better than that,” said Dr. Patrick Flume, an investigator on both trials.

“I think they should be very excited about the news,” added Flume, professor of medicine and pediatrics at Medical University of South Carolina, who said he expects the combination to win approval.

Vertex plans to apply for U.S. and European approvals in the third quarter of 2017.   Business Insider

The Law Firm, LLC has handled cases involving medical devices and drugs.  If you feel that you have had an adverse reaction, complication, or potential claim, please contact us at or (225) 933-1500.