Several lawsuits have been filed in Ohio in recent years against the manufacturers of drugs that have harmed its users, from opioids like oxycodone to testosterone replacements. At Plevin & Gallucci, we are fighting on behalf of local governments whose residents have been plagued by the opioid epidemic. The U.S. Food and Drug Administration (FDA) has issued safety warnings about these drugs and others that can be harmful, and patients taking them need to be aware of the potential risks.
Ohio’s product liability law allows a person to file a lawsuit against a manufacturer and recover damages if a product was defective or if the manufacturer did not notify consumers about a risk associated with the product. This law covers prescription drugs and medical devices that are prescribed or dispensed by a doctor or pharmacist.
It’s important to note that per Ohio law, a drug is not defective even if some aspect of it is unavoidably unsafe if a manufacturer provides an adequate warning about it. (Ohio Revised Code 2307.75) The manufacturer also is not liable for an inadequate warning if the FDA has not required a warning be given to the user of the drug. (Ohio Revised Code 2307.76) However, a manufacturer can be liable for punitive damages if it fraudulently withheld information from the FDA relevant to the harm a person suffered. (Ohio Revised Code 2307.80)
Below, we’ll go over five dangerous drug cases in Ohio to watch and what to do if you or a loved one has been injured.
Ohio and other states across the U.S. are dealing with an epidemic of opioid addiction and overdose deaths. Ohio Attorney General Mike DeWine has filed a lawsuit against five pharmaceutical companies that marketed the prescription pain medications. The lawsuit alleges the companies misled consumers about the products, created a condition harmful to the health of Ohio residents, and engaged in Medicaid fraud by misleading the state to receive reimbursements.
One of the five companies sued by DeWine — Endo Pharmaceuticals — is the subject of a request by the U.S. Food and Drug Administration to remove one of its products, reformulated Opana ER, from the market. Opana ER is an opioid pain medication, and the FDA believes the benefits of the drug no longer outweigh its risks. It is the first time the FDA has sought to remove an opioid pain medication from the market because of the public health consequences of abuse.
Plevin & Gallucci is serving as local counsel in a lawsuit filed by Cuyahoga County against manufacturers, distributors, and individuals who promoted the sale and distribution of opioids locally. The County has seen a spike in overdose deaths with some of the highest rates in the nation.
2. Testosterone Supplementation
An Ohio man was one of more than 1,000 plaintiffs in consolidated product liability lawsuits filed in 2015 against seven companies who marketed testosterone replacement medication. The man claimed the hormone gel Fortesta caused him to suffer bilateral lung embolisms. Other plaintiffs said they suffered heart attacks, strokes, and blood clots after using the drugs, which include AndroGel.
The lawsuits alleging harm from testosterone drugs claim that the drug manufacturers failed to provide warnings about the increased risk of heart attacks, strokes, pulmonary embolism, deep vein thrombosis, and other cardiovascular injury. They also allege the drug manufacturers engaged in aggressive marketing that encouraged middle-aged men to seek out the drugs to counter age-related effects such as low sex drive, loss of muscle mass, and low energy.
In 2014, the FDA required manufacturers to include a general warning in the drug labeling of testosterone products about the risk of blood clots in the veins, including deep vein thrombosis and pulmonary embolism. Unrelated to the warning requirement, the FDA in 2014 also initiated an evaluation of the possible risk of stroke, heart attack and death in patients taking testosterone products. In 2015, the FDA announced it was requiring manufacturers of testosterone products to change the product labeling to indicate they are approved only for men who have low testosterone levels caused by certain medical conditions. The FDA also required the labels to indicate the possible increased risk of heart attack or stroke associated with the use of testosterone.
Invokana (also known as canagliflozin) is a class of drugs approved by the FDA in 2013 to help lower blood sugar in patients with Type 2 diabetes. Use of the drug has been associated with kidney impairment or failure, dehydration and fluid imbalances, kidney stones, urinary tract infections, and hypersensitivity reactions. The FDA in 2015 issued a warning that the drug can lead to ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. In May 2017, it issued a warning that the drug carries an increased risk of foot and leg amputations for diabetic patients.
Pioglitazone — marketed as Actos, Actoplus Met, Duetact, and Oseni — is prescribed to lower blood sugar in patients with Type 2 diabetes. The FDA has issued several safety warnings, the most recent one in December 2016, indicating use of the drug may be linked to an increased risk of bladder cancer. Japan’s largest drugmaker, Takeda Pharmaceutical Co., agreed in 2015 to pay a $2.4 billion settlement to patients in product liability lawsuits which alleged the company failed to inform them of the cancer risk associated with Actos.
5. Chlorhexidine Gluconate
Chlorhexidine gluconate, a popular antiseptic used on the skin prior to surgery and injections, can cause a rare but serious allergic reaction, according to an FDA safety alert issued in February 2017. The drug is used in over-the-counter skin antiseptics in the form of solutions, washes, sponges, and swabs, as well as in some prescription mouthwashes to treat gingivitis. An allergic reaction can occur within minutes of exposure, and symptoms can include wheezing or difficulty breathing, swelling of the face, hives, severe rash, or shock.
Get Help from an Experienced Ohio Product Liability Attorney
If you have been harmed by using these or any other drugs, you should speak with the attorneys of Plevin & Gallucci who have in-depth knowledge of Ohio’s product liability law. There may be others who also have been harmed, and you may be entitled to compensation for your injuries. The law also limits the amount of time in which you have to file a product liability claim.