The FDA and other regulatory bodies strictly control pharmaceutical production, advertising, and testing. It can be difficult for companies to comply with all of the rules and regulations that state and federal governments require. Even if a company follows every requirement to a T, it may still face legal claims when accidents happen or when further research is brought to light.
Is your business ready to handle a lawsuit from a government agency, disgruntled citizen, or a class action claim? Individuals with grievances are aware that pharmaceutical companies and drug manufacturers often have significant insurance coverage and deep pockets. Pharmaceutical claims will likely lead to numerous or class-action lawsuits. Is your company prepared? The attorneys at Orndorff Mowen are here for you. We are ready to litigate the case through trial or appeals on your behalf.
Why Are Pharmaceutical Cases Often Product Liability Cases?
Product liability claims assert that a product was defective in some way. The alleged defects could be due to a manufacturing error or a design flaw. Product liability applies in the pharmaceutical industry because medicines are considered “products” even though they are ingested or consumed.
Most product liability cases that affect pharmaceutical companies involve allegations that the medication did not work properly for an individual. However, a “defective drug” claim could occur for several reasons, but the most common one is user error. For example, perhaps the individual mixed the drug with another pharmaceutical drug or did not take it as instructed.
Although user error is extremely common in allegations against drug companies, individuals may claim the defects were due to manufacturing errors or poor labeling. In rare cases, the plaintiff alleges that the pharmaceutical company deliberately hid information or misled users. In reality, these allegations are rarely true, but companies must still invest time, effort, and money to defend against such claims.
Defend Against Claims of Negligence or Faulty Drugs
Product liability cases involving pharmaceuticals are extremely complicated. They require a thorough understanding of the drug at issue in the case, and they require experience and knowledge relating to specific defenses that might be available. Unfortunately, inexperienced attorneys often miss these critical defenses, forcing clients to pay thousands, if not millions, in class-action damages. When our experienced West Virginia drug lawyers work for you, it can mean the difference between a huge award for damages and a defense verdict.
The injury must be related to the product for a claim to be compensable. When the plaintiff only presents unrelated factors and cannot prove a direct connection between the injury and the product, the pharmaceutical company may not be liable. The plaintiff has the burden to prove the product caused the injury in product liability cases, and this usually requires expert testimony.
The State of West Virginia is a modified comparative fault state. That means plaintiffs can recover damages if they are 50% at fault or less. Plaintiffs are barred from recovery if they are 51% at fault. Negligence is rarely used as an argument of damage recovery in product liability cases in West Virginia, but in lawsuits where comparative fault may apply, your legal team may use this defense to allocate some fault back to the plaintiff.
Assumption of the Risk
Assumption of the risk is a defense option in many product liability claims; it functions much like comparative fault. Essentially, it means the plaintiff knew or understood the risk and voluntarily took a specific action anyway. The plaintiff does not need to show they had information about a precise risk for this defense to apply. If a person has general knowledge of a risk, it is enough to use assumption of the risk as a defense.
The product must have been significantly altered after it left the manufacturing facility to assert the altered product defense. For example, if a drug was mixed with another medication and then consumed, that alteration would likely warrant using this type of defense in pharmaceutical cases.
The person or entity that altered the product could be the end user, distributor, pharmacist (in the case of prescription drugs), or anyone else who touched it before the consumer used or consumed it. A West Virginia attorney with experience in pharma cases can review the facts to determine if this type of defense is available.
In some cases, a liability waiver may provide a defense to a pharmaceutical product liability claim. These situations are rare, but they relate to warnings, instructions, and disclaimers. Essentially, if an end user is properly informed of the potential side effects, that information might negate allegations of product liability. Review your case with our experienced pharmaceutical defense lawyers to determine if this type of defense is right for your situation.
Learned Intermediary Doctrine
The learned intermediary doctrine is directly related to pharmaceutical litigation. It essentially provides a defense against pharmaceutical lawsuits for prescription medication. The learned intermediary doctrine recognizes that there is a prescribing physician that is between the manufacturer and the end consumer. As long as a pharmaceutical manufacturer provides complete information about known risks to the prescribing physician, it has fulfilled its duty to warn related to the end user.
The West Virginia Supreme Court rejected the common law version of the learned intermediary doctrine in 2007. However, since that time, the West Virginia legislature passed a codified version of the learned intermediary doctrine. Specifically, the code sets out that manufacturers or sellers of prescription drugs can only be liable for inadequate warnings if they acted unreasonably in failing to provide instructions or warnings regarding foreseeable risks to prescribing doctors or other healthcare providers.
In some situations, federal and state laws will conflict, especially in areas the federal government regulates heavily. The pharmaceutical industry must comply with state and federal laws, but that can be difficult when those laws are at odds with one another. The preemption doctrine generally holds that federal law will “preempt” or trump state law when there is a conflict between state and federal law. The foundation of the preemption doctrine is the Supremacy Clause in the United States Constitution.
The preemption doctrine often comes up in situations where the FDA has approved a drug or medical treatment, but the state government has banned or limited a particular medication or device. It might also be used as a defense in warning cases where the FDA has approved a specific warning, but the warning may not be as detailed or comprehensive as required under state law. Essentially, the defense states that if the warnings comply with federal law, it may not matter that they do not quite meet some stricter requirements under state law. A corporate pharmaceutical attorney in West Virginia will be able to help companies determine whether this type of defense might be available for their situation.
What Is the Statute of Limitations for a Plaintiff to File a Claim?
In West Virginia, the statute of limitations for a plaintiff to file a lawsuit against your company for a personal injury or product liability case is two years. This two-year limitation also applies to wrongful death claims.
The statute of limitations clock starts ticking when one of the following occurs:
· The plaintiff experiences the negative side effects of the drug.
· The plaintiff discovers a link between the negative side effects and consuming the drug.
The “discovery rule” allows plaintiffs time to make the connection between their alleged damages and using the drug. However, the two-year time period is limited. It is usually based on a reasonable person standard or whether the plaintiff “should have known” the connection between their damages and the drug.
The statute of limitations can be a viable defense in many pharmaceutical cases. Whether this defense is available to you will require an in-depth factual review of the circumstances surrounding the claim.
West Virginia Pharmaceutical Attorneys with Decades of Experience
Claims against pharmaceutical companies can be extremely complex. They require a level of knowledge and experience that few defense attorneys possess. Companies need to know they are trusting their defense to a legal team that understands the complexities of product liability law in West Virginia.
The attorneys at Orndorff Mowen have decades of litigation experience defending companies against high-risk legal claims in multiple practice areas, including allegedly dangerous drugs, medical malpractice, defective medical devices, toxic torts, and opioid claims. These claims can be extremely damaging to pharmaceutical companies, both in high financial costs and in hits to their reputation and brand name. Orndorff Mowen understands what is at risk and advocates for you against dangerous drug claims.
Have You Provided Safe and Reliable Products?
Even if a company has followed all the laws and regulations, dangerous drug claims may still arise. Hire a legal defense team you can count on to understand the stakes and the defenses available to you. We provide actionable legal advice and can assist in both state and federal court. Call the West Virginia pharmaceutical attorneys at the law firm of Orndorff Mowen at 866-481-2765, or fill out our online contact form for more information.