Can I File a Medical Malpractice Lawsuit After a Drug Recall?
In short, yes. But it will require more time and effort. Filing a medical malpractice claim requires meticulous planning and solid evidence to prove that negligence occurred between the physician and patient. Factoring in a drug recall into the matter makes it visibly challenging to see who is at fault.
If a patient is prescribed a particular drug or medication for their condition, only to find out later that the drug had to be recalled because the FDA discovered that it was contaminated, is the physician, FDA or the pharmaceutical company to blame? It depends on who was or was not aware of the known risks of the contaminated drug.
Although there are defining key elements that differentiate medical malpractice cases from filing product recall claims, drug recalls can pertain to both types. Seeking legal counsel from the best medical malpractice lawyers like registered nurse and trial lawyer, Eileen Kroll at Cochran, Kroll & Associates, P.C. will clear up any doubts you may have and significantly raise your chances of winning your case. In preparation, it will benefit you to familiarize yourself with the ins and outs of the legal and medical field.
What is Medical Malpractice?
Medical malpractice cases fall under the umbrella of personal injury claims with highly specific components. While personal injury cases encompass a broader scope of accident-related scenarios, product recalls also fall under that category.
For your case to be considered medical malpractice, you need first to establish a doctor-patient relationship, prove that the doctor was negligent or did not follow medical standard of procedures and that the negligence directly harmed the patient.
Most common medical malpractice cases involve medical mistakes, birth injuries, misdiagnosis, delayed or failure of treatment, misuse of medical devices, anesthesia errors, surgical mistakes, misdosages, and failure to warn patients of known risks. Consequently, you’ve suffered from a prescription drug recall that clearly resulted in any medical harm or injury; your case may hold substantial evidence that can be used against pharmaceutical companies and the physicians who prescribed you that drug.
Medical Malpractice Regarding Drug Recall
A physician who prescribes the wrong dose of any drug to a patient is liable for medical malpractice—whether the medicine is subjected to an FDA recall—because the health and safety is the doctor’s responsibility. Improper dosages put the patient at risk and is an example of medical or pharmacy negligence.
In the same way, where it is considered medical malpractice if a physician does not properly warn the patient of known risks, pharmaceutical companies also have an obligation to warn consumers of the potential dangers of taking their drug. Not only are the drug companies improperly marketing and labeling their products, but they are also exposing more risks to the uninformed patients; more victims are being made aware of this and filing “failure to warn” lawsuits.
Though this may seem like a clear case of negligence, it is more challenging to build a case on malpractice based on an FDA-approved drug.
Contaminated Heart and Blood Pressure Medications
The most recently announced drug recalls involves common heart and blood pressure medications: valsartan, losartan and irbesartan. These drugs combined have accounted for more than 77 million prescriptions each year. The recalls initially began in 2018 and have been consistently expanded into the beginning of 2019.
The FDA found that valsartan was contaminated in only specific batches but had to conduct a totally recall because at least ten companies marketed the frequently-prescribed blood pressure drug. Additionally, valsartan was often mixed with other drugs, such as amlodipine and hydrochlorothiazide (HCTZ).
Torrent Pharmaceuticals, Teva Pharmaceuticals and Macleods Pharmaceuticals announced recalls of losartan (sometimes marketed as losartan potassium) which is also used to treat high blood pressure. The third drug irbesartan was recalled by ScieGen Pharmaceuticals and Prinston Pharmaceutical.
The FDA discovered that all these drugs have been exposed to or contaminated with chemicals that are usually used in manufacturing industrial products. The substances are called NDMA or NDEA and have been scientifically shown that these chemicals are carcinogenic and linked to several types of cancer, such as liver, lung and kidney cancer.
If you or someone you know has had blood pressure or are familiar with these drugs, it is recommended you seek out top medical malpractice attorneys or top personal injury lawyers at Cochran, Kroll & Associates, P.C. to receive professional advice.
The fact that these recalled drugs potentially raises the risk of cancer in patients also increases the difficulty of winning lawsuits against the companies who made the drugs. Cancer is slow to develop and hard to pinpoint the root of its emergence. Thus, it may take years for the legal liabilities of the pharmaceutical companies to unfold. But this is even more of a reason to keep track of your current health and be wary of future symptoms.
So, patients ask a more pressing question: Can they sue the pharmaceutical companies that marketed and distributed the dangerous drugs?
Medical law and legal policies vary from state to state, but federal law and court decisions can make winning pharmacy negligence lawsuits harder if the FDA approved the drug. More specifically, most product liability cases are won due to companies “failing to warn” consumers—this also parallels doctor’s negligence of “failing to warn” patients of potential medical risks.
Product liability claims branch off personal injury cases, but if the recalled product is a faulty prescribed medication, then medical negligence plays a factor. But the prescription drugs were approved by the FDA, so who is at fault here?
If the FDA finds new evidence that makes a drug more dangerous or produce different side effects after the product is already on the market, pharmaceutical companies are legally obligated to edit their labels if they learn that new information. In these cases, this rule may overpower cautionary defenses to “failure to warn” lawsuits against the drug companies that marketed the adverse blood pressure medication.
Even though the FDA approved the drugs valsartan, losartan and irbesartan to treat high blood pressure, they were unaware those medications were contaminated by dangerous external chemicals. Keeping this in mind, victims should not use the FDA as a basis for their medical malpractice case.
Frankly, the negligence most likely came from pharmaceutical companies.
The purchase of the contaminated blood pressure drugs was traced back to a Chinese manufacturer, Zhejiang Huahai Pharmaceuticals. It appeared that the emergence of the contamination began in 2012 when the Chinese company changed components in their manufacturing process.
There were only a handful of pharmaceutical companies who handed out the specific drugs. Knowing this, they went ahead and purchased the drugs from Zhejiang Huahai anyway and either failed to detect the contamination or knew about the dangers and proceeded to market and distribute the defective despite the issue. Both cases are forms of negligence.
If your medical provider was unaware of the potential risks of a prescribed drug, your claim would not be based on “failure to warn.” It would be a different matter if the doctor did know and still gave you the medication, they forgot to warn you, or if they knew of the risks and intentionally refrained the information. Overall, this depends on their knowledge and intent.
Understand the various constituents between filing a medical malpractice claim and product liability claim while taking into account the similarities and differences of both types of personal injury cases.
Here is a detailed list of recalled blood pressure medication from the FDA.
How to File a Medical Malpractice Lawsuit
1. Familiarize yourself with the statute of limitations. This is necessary because it determines the deadline for your claim, and also varies from state to state. For example, the statute of limitations is two years after the negligent incident in Michigan. If you fail to file a medical malpractice claim within that deadline, the statute of limitations may give you more time to file a lawsuit from the date you were made aware of your injury.
2. However, there are some exceptions to the statute of limitations in rare cases. Did your healthcare provider harm your reproductive system? If you think you suffered medical negligence, did your doctor try to cover it up? Were you or someone you know a minor during the time of the injury? If any of these scenarios are applicable, you may be qualified for exceptions. Consult with a medical malpractice attorney at our law firm for clarification.
3. You have to fill out a Notice of Intent to File Suit before you start your claim in Michigan. Filing the form is a necessary prerequisite that acts as a cautionary notification to officially notify the state of your intent.
4. You must also fill out an affidavit of merit. The affidavit summarizes your allegations to ensure that your medical malpractice claim is valid. After you properly turn in the affidavit, the form will go to the medical board who reviews malpractice claims to see if your case meets the qualifications.
5. Be wary of your state’s damage caps. These determine how much the victim can financially gain in a medical malpractice case. In Michigan, the applicable damage caps are $445,500 for noneconomic damages and $795,500 for certain injuries, including brain and spinal cord injuries.
6. Seek out, professional legal counsel. Although medical malpractice cases only cover a fraction of all personal injury cases, it amongst the top three leading causes of death–only a step behind heart disease and cancer. Distinguishing the elements of your specific case can be laborious. Do you have a medical malpractice case on your hands, or is it just a personal injury case? Are you fully aware of the rules that cover pertain to the former and not the latter?
Why it’s Important to Act Now
The complexities of recalled prescription drugs are much heavier to sift through than a regular product liability claim or medical malpractice case. This matter is particularly pressing because of its massive recalls in current times. Even if flawed drugs were recalled a year or more ago, its long-term effects might not emerge until much later in your life.
If you know someone who had cancer or high blood pressure and was familiar with the medication valsartan, losartan or irbesartran contact a medical attorney. You may feel perfectly healthy now and not even feel as if those drugs worked, but you need to educate yourself and pay heed to your future health. The FDA found solid evidence that the recalled drugs were contaminated by carcinogenic chemicals that could cause cancer. Cancer can be a slow-growing disease, but it also has the potential of rapidly spreading and causing premature death.
The biggest barrier to tackle to win malpractice lawsuits regarding recalled drugs is the need to show real proof that the specific defected medication caused a patient’s cancerous condition.
Who to Contact
Have you or a family member been prescribed any of the aforementioned blood pressure medication or taken any contaminated drugs? If you can’t recall or are unsure, you can contact Cochran, Kroll & Associates in Michigan to speak to a medical attorney, such as Eileen Kroll. As a former registered nurse in the surgical care unit, Kroll can bring her wealth of medical knowledge and expertise into her legal field. Kroll has not only won hundreds of cases in medical malpractice and personal injury claims, but she is devoted to plaintiff litigation and also personally prioritizes her client’s goals over anything else.
Even if you don’t live in Michigan, you can get connected to top medical malpractice attorneys and top personal injury lawyers who can practice law outside their jurisdiction. Medical malpractice cases that involve recalled prescription drugs may take months, or even years, before they come into fruition, so it is highly recommended to take action now rather than wait until your situation worsens. You can call (866)-642-4529 to speak to a legal professional at our law firm for a free consultation and case evaluation. At Cochran, Kroll & Associates, P.C. we never charge a fee unless a recovery is made.