Liability Associated with Drug Side Effects
A common question when someone or a loved one suffers harm from a dangerous drug is who is responsible? Who is at fault? Who can be sued?
The drug company, meaning the manufacturer of the drug is liable for the side effects of prescription drugs. What that means in practical terms is that if you have a bad reaction to a drug even when you used the drug as it was prescribed, the drug company is likely at fault. The law holds the manufacturer of the drug responsible for any injuries its products cause, even if the drug company did not know that the drug was dangerous. The law only cares whether the company should have known it was dangerous. The manufacturer knows enough about its product as they have done studies to prove the drug is safe or effective. This is required prior to FDA approval. That said, the FDA does not require studies to prove the safety of drugs beyond the appropriate use. In other words, they require that it work for the purpose it is intended but not that it will not cause side effects.
A typical manufacturer defense is that the prescribing doctor is the one who should be liable. This is not generally true . Attorneys call this the learned intermediary doctrine. The defense holds that the doctor should be the one advising the patient about the risks involved in the drugs he or she is prescribing. The learned intermediary doctrine doctrine states that the manufacturer is not liable for the side effects of its drug due to the fact that it gave adequate warnings to the prescribing physician about the side effects and the physician failed to provide that information to the person whom he or she prescribed the drug.
In other words, the drug company’s liability exists only (or at least it is diminished) when the prescribing physician is informed and fully aware of the drug’s hazards and warns the patient. If the prescribing doctor reasonably failed to do this, then the drug company may still be liable for having a dangerous drug on the market.
Remember, the drug company has the burden to prove that the prescribing doctor had knowledge of the drug’s dangers. On top of that, there are some exceptions to the learned intermediary doctrine. For example, this does not apply to marketing pharmaceuticals, so if something is marketed to the general public, the drug company is liable.
Common Types of Drug Side Effects and Legal Issues
The side effects of drugs can be as common as mood swings, headaches, rashes and fatigue. They also range in severity from inconvenient to tolerable to life-threatening. But they come under every cover, from the common cough to the rarest debilitating disease. Not will all side effects manifest in every person, even if the drug is the ultimate cause, but by random chance they may appear in anyone. And a reaction can stem from any substance ingested, inhaled, injected or applied to the human body.
Drugs that have well documented side effects include anti-depressants (increased suicidal ideation), blood thinners (internal bleeding), cholesterol medications (muscle damage), pain relievers (gastrointestinal bleeding), and a number of others. These reactions are a natural defect or result in the design and manufacturing of the drug. Some patients may be particularly sensitive to a specific drug, or they may have a specific genetic inheritance that intensifies a side effect.
A pharmaceutical company is responsible for the safety of their product. If you experience a side effect from the drug which you were not informed of through the label or advertising, you might have cause to file a case against that company. You might also have a case if the labeling or advertising of the medication is confusing or vague. A third possible ground for a claim is if the drug is inadequately manufactured. There are many factors which might also contribute to this poorly manufactured drug including contamination, or incorrect testing.
Establishing a Case Against a Pharmaceutical Manufacturer
Evidence of the claim for the lawsuit against a drug company will include medical history forms, physician notes and recommendations, medical records with tests performed, surgeries performed, medical billing documents, and other treatises and documents that support the claim. A detailed report by the user’s physician regarding any operations performed to the specific area of the body that was defective as well as long term effects and prognosis are extremely important.
The next step after the medical history is to hire a pharmaceutical expert witness. A medical expert is retained to offer their testimony based upon their education and experience with the drug and the sick or injured patient. An expert witness can testify as to issues related to the product itself and whether or not the drug was defectively made or designed in a manner that did not protect the patient from its harmful side effects. An expert witness could also testify about how the drug company failed to warn the consumer or physician of the potential harm from the use of the drug.
As with all personal injury matters, causation is a significant issue for the plaintiff or injured person. The first step in causation is to determine if the drug was the proximate cause of the injury or if the injury would have occurred regardless of whether the drug was ingested. For example, if a patient died due to an existing condition, it must be determined if the drug accelerated or caused the fatal outcome. If not, the plaintiff cannot prevail in a case against the drug company. There is no need to establish "but for" causation, meaning that the injury would have occurred "but for" the ingestion of the drug. The plaintiff must only prove that the faulty drug "contributed to" or " aggravated" the injury.
Causation is different in a defective design and a defective manufacturing defect. With a defective design, the plaintiff must show that the pharmaceutical product would have hurt the user or user’s heirs even if the product had been made correctly. A defective manufacturing defect alleges a flaw in the manufacturing process that caused the contamination or defect.
What to Do If You Are Affected By Drug Side Effects
The first step is to get medical attention immediately. Doctors can administer treatment if they are aware of the problem and the extent of it. If you have suffered serious injury or death as a result of side effects, a report should be made to police authorities.
By keeping an accurate journal or diary of the drug side effects you have felt over time, you will have better evidence to present in court. Details of exact dates and times, places where they occurred, specific symptoms, and severity will all help your case. Collecting any medical records associated with the treatment of the side effects will also present more evidence for the jury . Keep in mind that medical doctors and other medical professionals may be called to testify in court to explain their findings and observations of the drug side effects. Providing an accurate history will help them with their testimony.
A consultation with a legal expert is needed to further pursue action against the drug company. An initial meeting with an attorney allows them to determine if they are the best fit for the case. They will determine if a pharmaceutical drug company has caused you or a loved one harm, and if a lawsuit is appropriate. They will discuss payment of attorney’s fees and how to move forward with the case.
Difficulties in Pharmaceutical Drug Lawsuits
One of the most difficult challenges that must be overcome when suing a pharmaceutical company is the impenetrable defenses that they erect. Big Pharma has virtually unlimited resources, and they can afford to settle with a minority of plaintiffs in order to maintain a favorable precedent in the majority of cases. Even if the plaintiff is right, they have to go through this same grueling process as all of the other plaintiffs. This is not to say that it’s impossible to collect damages, but it is a daunting and expensive process to under.
The producer of a defective drug has an undeniable legal advantage. Not only can they afford to hire high-priced legal firms and expert witnesses, but their long history gives them an understanding of how to manage these cases that goes beyond their understanding of the law. They can afford to settle with people who have genuinely been harmed while still maintaining a favorable position in the majority of cases.
A major pharmaceutical company just went through a period of $26 billion of litigation costs for all their cases. This is the cost for cases about medications that were later discovered to be perfect competitors of existing drugs, without patent infringement. It represents over a month of lawsuits at that rate. On that same front, generic drugs made by other companies are more than willing to file suit against any pharmaceutical company; the laws against perfect imitation are quite lax. However, the generic drugs are far more affordable because the litigation cost is lower.
When these pharmaceutical companies decide to fight, they often go for the jugular. A 2013 case involving Vioxx (a pain reliever) resulted in the jury recommending treble damages, which would triple whatever compensation the jury decided was adequate. The plaintiff in this particular case was suffering from a heart attack after reporting using this medication for only the first two weeks when a heart attack occurred.
In many cases, the drug companies will openly attack the character of the afflicted. They will do this by bringing up any preexisting conditions that might conceivably make the drug in question stand out even more. For instance, Vioxx has a known history of exacerbating existing heart conditions.
Sometimes, drug companies will try to coerce patients into dropping their case by phoning them on a monthly basis to remind them of their due date for payment and to personally speak with them about how much difficulty they’ve caused them in the weeks. It is also possible that the drug companies will send a third party medical collections agency to place them in a round-the-clock watch, which effectively means that someone will trail them everywhere they go throughout the day.
The rules of the court will also be against the average plaintiff. They can require a bench trial or a jury with alternating personalities, or they can do anything else to ensure that the odds are entirely with the defendant. A bench trial, for example, will place the judgment completely in the hands of the judge, who almost always works for the defendants.
The difficulties presented by the law have a longer shelf life than the difficulty presented by the defendant. Once the drug company releases the defendant from their watch, the drug company has no further string to hold over them. If they want to keep the lawsuit out of court, the defendant will be far more likely to sign away their rights for something less than they deserve, so there is considerable incentive to do so.
In conclusion, while it is certainly possible to get compensation from a pharmaceutical company, an inexperienced attorney will likely be woefully outmatched by their opponent, and hired help can also easily become the defendant rather than the plaintiff.
Winning Cases: Precedents and Examples
While no two cases are identical, examining past successful lawsuits can offer insight into the potential strategies to employ in your particular situation. Several notable cases have preceded your situation and their outcomes can help you understand both the way Law firms function when fighting against drug companies for compensation and the likely route your case will take.
The 2012 DePuy Orthopedics Inc. Liability Thousands of hip implant lawsuits were consolidated in a MDL series of cases known as In Re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation. This case ended with a $4.02 billion settlement. DePuy Orthopedics, Inc., a subsidiary of Johnson & Johnson, designed, manufactured and sold hip replacement systems that were defective. The design flaw in the all-metal implants caused early failure in the form of hip dislocations or bone fractures. The defective implants also led to medical complications such as metallosis and tissue damage. These consequences left plaintiffs to deal with numerous revision surgeries, pain and suffering, and other negative medical conditions.
The Wright Medical Technology Inc. Settlement In June 2016 , the company agreed to a settlement for $240 million for the recall of its metal implant product. Approximately 5,000 plaintiffs accepted the settlement and the payment was distributed evenly so that each plaintiff would receive a minimum payout of $80,000. The payout was far less than those in the top levels of settlement categories, which were $575,000 for death or total disability to $250,000 for periprosthetic fractures and infections. Judges also approved settlements for 901 cases from June to December of 2015 in the Wright Medical Technology products liability litigation, representing $22.5 million from its liability insurance coverage.
In re: Xarelto (Rivaroxaban) Products Liability Litigation An estimated 40,000 Xarelto cases have been filed since 2014. These cases allege that the drug causes patients to experience uncontrollable bleeding for which there is no known antidote. Multidistrict litigations were consolidated in the Eastern District of Louisiana.
There are thousands of examples of successful drug company lawsuits that have been recovered from drugs that caused severe side effects—these should give you more than enough reason to seek legal counsel if you have suffered such symptoms.