Beware of Generic Drugs

Beware of Generic Drugs

Think twice the next time you accept a generic version of a brand-name drug. Americans are not protected by tort liability law if they become injured after taking a generic version of any drug. Though 84  percent of prescriptions written in the country are filled by a generic, the U.S. Supreme Court, in two hotly contested 5-4 votes, ruled to give international drug makers a free pass from liability whenever their generic drugs harm people. (See Pliva, Inc. v. Mensing  and Mutual Pharmaceutical Co. v. Bartlett).

The makers of brand-name drugs, by contrast, can still be held accountable when the drugs they make harm people, that is, if those peoples’ attorneys can prove the drug maker failed to adequately warn of the potential harm, or else exaggerated the benefits, or perhaps simply committed negligence or fraud in getting the drug placed on the market in the first place.

Considering the millions of Americans this miscarriage of justice concerns daily, there has been almost a media blackout regarding the issue. Recent developments, however, show this may be changing. NBC’s Today Show on November 8 aired the story of Viola Purcell, a woman suffering from a permanent nerve disorder called tardive dyskinesia, which was caused by a generic version of Reglan that she took for five years. Ms. Purcell is not alone. Thousands of others were also hurt by generic versions of Reglan, and thousands more have been hurt by generic versions of other drugs. Many of these cases sit in legal limbo in state courts across the country, while lawyers attempt to navigate around the Supreme Court blockade against people hurt by generic drugs.

While plaintiffs lawyers from Matthews & Associates in Houston and a few other law firms continue trying to get around the blockade by bringing various state court actions to hold generic drug makers accountable, the FDA also seems to finally be ready to take action to give generic drug makers the incentive to report adverse events and to change their drug labels as needed.

It’s too little too late for Ms. Purcell and the thousands of other injured people the highest court hung out to dry; but it may someday help restore the discerning drug taker’s confidence in generic drugs and the FDA’s ability to work for the tax payers they’re entrusted to protect.

Pradaxa Fraud

Pradaxa Fraud

Warfarin has been an effective blood-thinning product for nearly 60 years. Like any blood thinner, it can work too well and cause uncontrolled bleeding; but there is an anecdote to stop the bleeding from Warfarin. Such is not the case with Pradaxa.

Touted by Boehringer Ingelheim Pharmaceuticals  as a new generation of Warfarin, Pradaxa is a disaster. Unlike Warfarin, there is no anecdote to stop the bleeding of someone taking Pradaxa; a patient can consequently bleed to death. Pradaxa’s creator rushed it to market without properly studying it for safety. The research behind Pradaxa shows little to no substantive proof that it works as well or any better than Warfarin, or any definitive proof that it is even safe, whether its benefits can be said to outweigh its serious risks. Pradaxa is a fraud perpetrated on the public.

Boehringer Ingelheim Pharmaceuticals sells Pradaxa (dabigatran etexilate mesylate) to reduce the likelihood of stroke in atrial fibrillation patients, or those with  irregular heart rhythm.

An anticoagulant, Pradaxa works by blocking an enzyme in the blood necessary for clotting. Blood clots can lead to strokes.

Lawsuits filed against Boehringer Ingehleim Pharmaceuticals charge that the company misrepresented Pradaxa as safe and effective, though they were aware, and several studies later proved, that no antidote exists to undo the drug’s penchant for causing uncontrolled bleeding.

Lawsuits also charge that Pradaxa’s maker negligently failed to use due care in developing Pradaxa, failed to provide Pradaxa users with adequate warnings,  failed to give actual rates of irreversible bleeds associated with Pradaxa, failed to conduct adequate trials, released misleading information regarding Pradaxa.

Suits also claim that Pradaxa’s makers concealed knowledge that Pradaxa can cause life-threatening, irreversible bleeds, hence failing to warn plaintiffs, their decedents, the general public and the medical community of Pradaxa’s real dangers.

Some facts and observations regarding Pradaxa:

a. There is no research for the safety of Pradaxa and no good-faith attempt to instruct users in how to stop the uncontrolled bleeding which can occur from its use.

b. The study on which Pradaxa was approved is based on lies.

c. the maker of Pradaxa was told not to use direct-to-consumer marketing, but did so anyway.

d. the makers of Pradaxa have been sanctioned by the court four times for discovery violations.

e. Pradaxa makers have claimed their product is 35 percent better than Warfarin, but there may be a fraction of one percent difference in effectiveness.

f. In May 2013 the FDA told Pradaxa’s makers that they could no longer use the bogus 35% for their claims of greater effectiveness.