Most people have never heard of the Mensing Decision that was passed down by the US Supreme Court just this past June. That is unless they have filed or are about to file a defective drug lawsuit. All of a sudden victims of a defective drug are fully aware of Mensing and its consequences, particularly if they are trying to hold a generic drug manufacturer accountable for their actions. However, there has been some good news.
What is a Defective Drug?
This is a drug whose devastating side effects outweigh the drug’s approved benefits. These side effects could result in the serious medical injury or wrongful death of the patient. In some cases victims have found that the drug is not only harmful, but the manufacturer may have been found to have known about the side effect and not properly informed the public of the effects.
This is the point that the victim or their loved ones seek justice through compensation. The Mensing Decision seriously effected the victim’s ability to even bring their case to court against generic drug manufacturers.
What is a generic drug?
To understand a generic drug and the Mensing Decision, one must first have an idea of what it takes to produce a pharmaceutical and take it to market. You see, the global pharmaceutical industry is a multi-billion dollar industry that rivals or eclipses some of the largest industries in the world such as oil, weapons, food, and illegal drugs.
Bringing a pharmaceutical to market:
- Research and development discovers a drug benefit – This is the very early stages of discovery and has not been fully tested.
- A drug patent is applied for and received – This is a 20 year patent intended to protect research and guarantees exclusive rights to a single company. The race taking the drug to market begins.
- Animal testing begins – This process is needed to test whether the drug will be deadly to humans.
- Human clinical trials begin – This process allows researchers to log results and find out side effects.
- Results are vetted – In case after case, drug manufacturers have been found to pick and choose results from clinical trials and only present the most favorable for approval to the Food and Drug Administration (FDA).
- Results are submitted to FDA for approval – The FDA reviews all research and approves drugs for sale in the US market. It’s approvals are also the catalyst for other countries to approve the drugs for sale in their markets. Around 80% of the FDA’s funding comes from drug manufacturers. This leaves them horridly underfunded and over extended, thus unable to determine biased research.
- Labels and warnings are established – The FDA assigns directions for use, limitations, and warnings based on the research provided to them by the manufacturer.
- The drug is taken to market – This involves aggressive marketing campaigns and pushing the drug on doctors to prescribe to their patients using the same biased research used for approval.
A Generic Drug is a drug that is produced after that 20 year patent expires and the drug is able to be produced by any company willing to produce it under FDA regulations and standards. They are required to use the same labeling and warnings as the previous patent holder.
What happens when a drug goes generic?
Often it takes years for a group of people fall victim to a defective drug while it is still under patent. At that point a study must be conducted to establish causal evidence to determine the legitimacy of their claims. The FDA might also conduct an independent review. Often, this whole process lasts so long that the drug becomes eligible to be manufactured in a generic version.
When patent expires and the drug becomes generic, generally the original patent holder will:
- Produce the generic version of the drug through a subsidiary
- Make slight changes and patent the drug under a different brand
- Make slight changes and patent the drug as “extra strength”
- Sell the brand to be produced by a generic manufacturer, retain the rights
When a drug goes generic the price immediately plummets because, beyond what major drug companies will tell the public, drugs are incredibly cheap and easy to produce, generally costing pennies. It becomes even cheaper when they are produced in foreign labor markets.
The benefit is that it allows millions to have access to the drug, however, this also creates a massive sample group that reveals the full devastating effects of a defective drug. However, even though the generic manufacturers are enjoying the profit of these millions of new customers, the Mensing Decision released them of liability.
What is the Mensing Decision?
In PLIVIA Inc. v. Mensing, the Supreme Court ruled 5-4 that generic drug makers couldn’t be sued for allegedly inadequate warnings on their labels because they’re required by law to use the same warning label language that’s used for the equivalent brand name drug.
Of course, as would be expected, generic drug manufacturers and their legal teams took this to the extreme claiming that the decision exonerates them of any and all liability for any injury or death resulting of the taking of the drug. Generic manufacturers such as Teva Pharmaceuticals USA Inc. and Sandoz Inc. in October, took it as far as to say that, under Mensing, all generic suits should be dismissed. This move proved to be the decision’s undoing.
Philadelphia Common Pleas Court Judge Sandra Mazer Moss sided with plaintiffs who argued that Mensing only preempted claims targeting the warning labels on the drugs. Judge Moss’s ruling marks a significant set-back for the generics, which have sought to use their Supreme Court win to escape mass torts actions plaguing them in other state courts. The generics have filed similar motions to dismiss in New Jersey and California state courts.
Defective Drug Attorneys
This certainly isn’t over by a long shot. The profit is far to high for drug companies to give up and settle at this point. However, it seems that the victims are now being empowered and able to once again seek justice.
Can I File A Defective Drug Lawsuit Against A Generic Drug Manufacturer? Yes you can, and the experienced legal team at Phillips Law Firm will fight hard for you to get you the justice and compensation you deserve.
Phillips Law Firm is a team of experienced defective drug attorneys with a proven track record of successful defective drug litigation. If you or a loved one have experienced serious injuries or death due to the side effects of a generic drug call us today for a free consultation and to find out your legal rights.