defective drugs and generics

Understanding Defective Drugs and Generics: Who is At-Fault?

If you follow the news, you might have heard about the recent case involving Endo Pharmaceuticals.

Endo Pharmaceuticals, like many drug manufacturers, keep generic versions of their best-selling drugs on the market and then introduce new formulations to try and avoid lawsuits and complications with their brand label.

About the Endo Pharmaceutical Opana ER Product

Opana ER was released by the company back in 2012 as an opioid agonist to help manage severe pain. The manufacturer advertised their product as one that was safe and effective for long-term treatment with opioids and claimed that their latest pill design prevented opioid abuse with their medication.

The new version that Endo released however had just a handful of new inactive ingredients – mainly the hard coating that made the pills harder to pulverize. Regardless of their “coating,” addicts could cook the painkiller and then inject the cooked liquid.

While the company claims the hard coating deters abuse, the FDA disagreed and urged the company to remove the product from the market.

The FDA urged the company to stop making and selling the drug and stated that the risks outweighed the benefits of the product.

While Endo agreed to stop making the drug and all shipments, they used generics as an end-run around the FDA request.

The Use of Generics in the Endo Pharmaceutical Case

Endo has the patent on the original version of Opana ER, and they fought hard to keep the unique formulation off the market – so that other companies could not capitalize.

While the FDA announcement came in June 2017, Endo agreed in August 2017 to strike a deal with Impax Laboratories to create a generic version of their drug – ensuring Endo still profits from a dangerous opioid.

The Generic Drug Problem in the United States

When you go to the pharmacy to refill a prescription or get a new medication, the pharmacist will ask you if a generic is okay. Your physician might even check the box on the prescription order stating that generics are fine.

Each day, millions of Americans purchase generic drugs. In fact, most drugs sold in the United States are generics, because they are cheaper for insurance companies and consumers – therefore, preferred to the expensive name brand.

If you were to be injured by a generic drug, would you be able to sue the manufacturer of that drug? What about the name brand that sold their formula to the generic manufacturer?

Sadly, this is where many consumers are let down.

How Defective Drug and Pharmaceutical Liability Cases Work

As a consumer, you have the right to hold product manufacturers responsible for the products they sell by filing a product liability claim.

Product liability claims are personal injury cases based on defective or inherently dangerous products. Products include everything from food to prescription medications. Most product liability cases are based on strict liability.

Strict liability means that the manufacturer of the defective drug would be liable for any defect in their medication that caused an injury – whether they were negligent or not. However, these flaws must be outside of the realm of inserts and warning labels, because most medications will have warning labels for side effects and complications.

Some patients might claim that the side effect was not on the label, the off-label use caused an injury, or the warning was not clear enough to the consumer to get around the strict liability defenses.

Strict liability, however, does not work in the case of a generic drug.

The Case of Pliva v. Mensing – the Legal Loophole Generic Drug Manufacturers Enjoy

The Pliva v. Mensing verdict in 2011 is complicated.

However, it states that generic drug manufacturers are not liable for any injuries their medications cause to patients. The reasons behind the decision were that the plaintiff could not win their lawsuit because they would need to sue the manufacturer of the generic drug using state laws – and state laws are stricter than the Food and Drug Administration’s laws approving the drug for consumer use.

If the FDA has already approved the drug for consumption, federal law trumps state law. Therefore, the generic company cannot be responsible. In the case, generic drug manufacturers argued that it was unfair to hold them liable to state standards because it was impossible for a generic drug manufacturer to comply with state and federal laws in every single state they sell their medication.

Sadly, the courts agreed. This agreement led to a group of Americans taking medications that have no legal recourse against the manufacturers of their generic over-the-counter and prescription drugs.

While this sounds concerning, do realize that other cases do give plaintiffs an option for recourse.

Generic Drug Manufacturers Should Owe a Duty to Consumers

While the case of Pliva v. Mensing prevents a person from holding generic manufacturers responsible, it does clear up laws that were otherwise complicated.

Holding Name-Brand Drug Makers Liable for their Generic Manufacturers

Take the case of Endo Pharmaceuticals. They have sold their formulation to a generic, and they are profiting from that formulation. In this case, they could escape any violations of the FDA and profit – but if someone were to sue for defects caused by that generic, could they sue Endo Pharmaceuticals?

One case in Alabama says yes, they can.

The Alabama Supreme Court heard a case regarding whether a name-brand manufacturer could be held liable for a generic made by a competitor.

The Case of Weeks v. Wyeth – a New Door Opened?

The controversial case, Weeks v. Wyeth, changes a few things.

The plaintiff had used a generic version of a prescription medication and suffered an injury from it. Instead of suing the generic manufacturer, the plaintiff sued Wyeth Pharmaceuticals, which was the brand name manufacturer of the medicine.

The plaintiff’s assertion, in this case, was that the manufacturers mislead his physician on metoclopramide regarding facts and issues with the medication.

In this instance, the court decided it was not unfair to hold brand-name manufacturers responsible for generic injuries. If the brand-name manufacturer was the source of the error and generic manufacturers just repeated the mistake, then the brand name company could be held liable.

Does That Mean Relief for Plaintiffs Injured by Generic Medications?

Sadly, this view is considered the minority. In most court rulings, the brand name cannot be held liable for injuries of the generic – even if the brand name is the one that fostered the issue.

Instead, most courts follow the Conte ruling, which happened in California and it is the remaining highest court opinion on these types of cases.

Generic Manufacturers Can be Liable and Brand Names Too

Generic drugs, just like brand-name manufacturers, are regulated by the FDA. While the rules for generics are different, generic drugs must be identical to their brand name counters entirely – that means the exact formulation the brand name uses. They must also consist of the same warning labels and indications as the brand-name, per 21 USC Section 355.

If a generic manufacturer changes labels or the formulation on their own, then they would face lawsuits from the brand-name, but also could be liable for any injuries they cause by deviating from the original formulation sold to them.

While several cases in the past have made generic drugs seem like protected drugs in the product liability sector, they are still vulnerable to lawsuits, and when someone is legitimately injured, they may be able to sue the generic or brand name for those injuries.

Packaging Not Protected

In one case, Trahan v. Sandoz Inc. the patient sued the generic manufacturer for injuries they sustained because of glass shards inside the medication due to faulty packaging. The generic drug manufacturer filed a motion to dismiss citing the numerous cases that protect them from lawsuits. In fact, they argued that they could not change the packaging after the drug went to market; therefore, they were not liable for the glass shards in the product.

While the court did admit that the law prevents them from changing packaging, the drug maker is free to make choices on their packaging before it is sent to consumers. Therefore, the manufacturer must ensure the product is safe, and there are no manufacturing defects before releasing the product. Also, the generic manufacturer has a reasonable duty to protect the public from defects – including glass inside the medication.

Formulations Not Protected

Generic drug liability was further opened by another case known as Guvenoz v. Target Corp, Inc. Sometimes a drug cannot be made safe with formulations or packaging, but that does not absolve the manufacturer from its legal duties to protect the consumer. The court decided that the manufacturer should have removed the inherently dangerous drug from the market rather than cite label and formulation protections.

Were You Injured by a Generic Medication or Brand Name Prescription?

Regardless if you have a generic or brand name prescription, you have rights. Manufacturers owe the public a duty, and they must ensure their products are safe, free from defects, and remove harmful medications from the market.

To explore your options for compensation, you need to speak with an attorney that has experience in these types of cases.

Contact Berkowitz and Hanna, LLC today to schedule a no-obligation case evaluation. Call 866-479-7909 or contact us online to get started.