Articles Posted in Defective Drugs

Oral contraceptives and other types of hormonal and non-hormonal birth control devices are necessary and life-changing for many women who want to take charge of their fertility, address premenstrual syndrome conditions, and control some forms of acne. However, despite rigorous testing, many hormonal birth controls have side effects that may result in serious injuries and illnesses to their users. After taking an oral contraceptive or the insertion of an intrauterine device, individuals who suffer injuries may file a Florida dangerous drug lawsuit to recover for their injuries.

Many of these pills and devices contain a synthetic form of progestin. Although most women adjust to the pills, or do not suffer serious side effects, others experience significant medical side effects. Some side effects include deep vein thrombosis, venous thromboembolism (blood clots), heart attack, stroke, organ damage, or even death. Although the Food and Drug Administration (FDA) requires pharmaceutical companies to improve their warning labels, women continue to suffer complications from these medications. In some cases, the warning labels are inadequate and do not clearly include the list of side effects. In other situations, doctors fail to assess their patients appropriately before prescribing the medication.

For instance, a circuit court of appeals recently issued an opinion in an unsafe oral contraceptive lawsuit relevant to Florida product liability plaintiffs. In that case, a woman suffered a debilitating stroke after taking an oral contraceptive, known to increase the risk of blood clots. The woman and her husband filed a lawsuit against the drug manufacturer for failure to provide an adequate warning of stroke risk. In response, the company moved to dismiss the claim, alleging that the learned intermediary doctrine limits their liability.

Pharmaceutical companies and retailers have strong financial motivations to get their products on shelves as quickly as possible. However, in some instances, these drugs can have potentially dangerous side effects for consumers. When someone suffers injuries because of a defective drug in Florida, they may be able to recover financial compensation for the harm that they suffered.

Most defective drug lawsuits are a type of Florida product liability claim and brought under strict liability theories. In some cases, other approaches may be appropriate, depending on the type of drug that the patient took, the harm that they experienced, and the warning that the company provided. There are three main defective drug claims that a Florida patient may pursue against a pharmaceutical company or retailer:  a defective manufacturing claim, an improperly marketed drug claim, or a dangerous side effect claim.

Defective manufacturing claims occur when a product is contaminated or otherwise tainted during production. Sometimes products will become contaminated during production at the facility; in other cases, a product may become compromised at some point between manufacture and when the patient receives the drug. Improper marketing claims arise when the pharmaceutical company uses inappropriate or inadequate warnings, instructions, or recommendations regarding the use of the product. These types of claims may incorporate various theories of liability. Finally, a dangerous side effects claim generally transpires after a patient suffers injuries because the company failed to reveal hazardous side effects appropriately. In some cases, the product’s dangerous propensity is not discovered until sometime after the product has been on the market; however, patients may allege that the company knew of the side effects but failed to warn the public. In some cases, companies will not issue a formal recall but will provide an enhanced warning. This does not always suffice, and the company may still be liable.

All Florida personal injury cases must be brought within a certain amount of time. Florida Statutes section 95.11 provides the statutes of limitations for each cause of action. For example, most personal injury lawsuits alleging negligence must be brought within four years; however, Florida medical malpractice lawsuits must be brought within two years.

It is essential that a plaintiff is aware of the applicable statute of limitations in their case, so they know how long they have to bring their case. However, determining when a statute of limitations begins to run can be tricky. For example, the statute of limitations in a Florida medical malpractice lawsuit begins when the “incident was discovered, or should have been discovered with the exercise of due diligence.”

Recently, a federal appellate court issued an opinion interpreting a similar statute of limitations regarding a lawsuit brought against a prescription drug manufacturer.

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In Teva Pharmaceutical Industries v. Ruiz, a Florida man who apparently suffered serious personal injuries after using a contaminated pharmaceutical product filed a negligence and strict liability lawsuit against an Israeli drug manufacturer in Florida. In response, the drug manufacturer filed a motion to dismiss the case for lack of personal jurisdiction.

A state court always has personal jurisdiction over residents of the state. For a court to have personal jurisdiction over a non-citizen, however, a defendant must have sufficient minimum contacts with the forum, such as conducting business within the state in which the lawsuit was filed. This requirement was established in order to protect a defendant from being required to litigate a case in a distant forum.

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Florida’s Fifth Circuit Court of Appeal has refused to grant a hospital’s petition for a writ of certiorari. In Holmes Regional Medical Center, Inc. v. Dumigan, a man was apparently injured by a drug that was used on him during a surgical procedure even though it was previously recalled. As a result of the hospital’s alleged failure to dispose of the recalled drug, the man and his wife filed a negligence and products liability action against the medical facility where his surgery was performed. After a trial court refused to grant the hospital’s motion to dismiss the case, the hospital asked Florida’s Fifth District Court of Appeal to review the lower court’s order.

According to the hospital’s petition for a writ of certiorari, the plaintiffs’ lawsuit was inappropriately characterized as a products liability and negligence action. The medical facility claimed that the statutory presuit notice requirements enumerated in the Florida Medical Malpractice Act (“FMMA”) instead applied to the case. Since the plaintiffs failed to comply with the FMMA’s notice requirements, the hospital argued that the trial court should have dismissed the case.

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The Middle District of Florida in Tampa has remanded a products liability case back to state court. In Wier v. DePuy Orthopaedics, Inc., a man was allegedly hurt by a medical device that was surgically implanted in his hip. As a result, he filed a lawsuit against the manufacturer of the device and the distributor in the Twelfth Judicial Circuit in Sarasota County. In the man’s case, he asserted the two companies were negligent, failed to warn him, committed breach of an implied warranty, and should be held strictly liable for his harm. He also claimed that the medical device manufacturer was guilty of breach of express warranty.

Although the device manufacturer hailed from a different state, the defendant distributor was a Florida citizen for purposes of diversity jurisdiction. Under 28 U.S.C. § 1332(a), a lawsuit that was filed in state court may be removed to federal court if the parties are citizens of different states, and the amount in controversy exceeds $75,000. In general, any doubts regarding whether federal jurisdiction is proper should be decided in favor of a lawsuit proceeding in state court. Despite this, the manufacturer successfully removed the case to the Middle District of Florida based on diversity of citizenship.

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In Plascencia v. GlaxoSmithKline, LLC, a Florida woman filed a products liability action against a drug manufacturer on behalf of her minor child and herself in 2012. According to the woman’s complaint, she ingested an anti-depressant medication that was manufactured by the drug company during the first six weeks of her pregnancy. As a result, the woman alleged her child was born in 1996 with numerous heart defects.

In December 1997, the woman’s primary care physician noted in her medical record that the child’s heart condition was “apparently due to” his mother’s use of the pharmaceutical medication. In 2005, the drug manufacturer notified the woman’s doctor and other physicians across the country that a recent study found the drug was associated with an increased likelihood for congenital conditions, including heart defects. A second letter sent by the drug company said another study found that women who ingested the medication during the first trimester of pregnancy increased their risk of delivering a child with a cardiovascular malformation.

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The U.S. Supreme Court recently heard arguments regarding whether or not federal law regulating generic drugs preempts New Hampshire’s design-defect law. The case may determine whether or not the injured plaintiff is able to recover from the generic manufacturer. The trial court and lower appellate court found that federal law did not preempt New Hampshire’s strict product liability law. However, other recent Supreme Court decisions barring recovery may guide the result of this case, depending on whether there’s enough of a distinction between a state law requiring a duty to warn and a state law allowing recovery under strict liability.

Florida also allows recovery under the theory of strict liability for defective products, where negligence and intent to cause harm does not have to be shown in order for an injured plaintiff to recover. The design has to be defective, and injury or other damage shown to be caused as a result of the defect. Florida’s law includes both consumers and bystanders and does not require that the product be shown to be “unreasonably dangerous”.

The injured plaintiff in the current Supreme Court case took a prescribed, generic anti-inflammatory medicine for shoulder pain. As a result, she suffered from two painful syndromes, Stevens-Johnsons Syndrome and toxic epidermal necrolysis which caused her skin to slough off, esophageal burns, near-blindness, and lung injuries. She sued the manufacturer of the generic drug, claiming the medication was “unreasonably dangerous”, and that the risks outweighed the potential benefits.

The Food and Drug Administration had previously deemed the brand-named version of the drug as “safe and effective”. That not only allowed the brand-named drug to sell its product on the market, but the generic versions to sell with that designation as well, including the drug that harmed the plaintiff in this case before the Court. The F.D.A. says that a generic drug, by law, must contain the same active ingredients in identical amounts as the brand named product. It should also be the same in dosage, safety, strength, how it is taken, quality, performance, and intended use. These are supposed to be seen as the “therapeutic equivalent” to brand-named drugs. They are also required to have the same warning labels as their brand-named counterpart.

The outcome of this case will guide whether or not an injured plaintiff will be able to sue in state court for injuries caused by generic drugs. The manufacturers of the drug argue that the strict liability imposed by the state adds duties to the drug manufacturers that are not congruent with federal laws requiring “sameness” between generic and brand-named drugs. Other recent Supreme Court decisions have held that federal law preempted a state failure-to-warn action. The injured plaintiff’s attorney, however, is arguing that there is a distinction between her action, centered around strict liability, and the ruling of the prior Supreme Court decision.

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The Food and Drug Administration (F.D.A.) has posted a notice that Affymax and Takeda Pharmaceuticals have recalled their drug, Omontys, or peginesatide, designed to treat anemia. It has received 19 reports of a severe allergic reaction, where three patients died and others required medical intervention. The pharmaceutical companies have explained that hypersensitivity to the drug has been shown for 2 of every 1000 patients, and that the reactions have occurred upon the first dose. Those patients who have had more than one dose have not had an allergic reaction.

Prescription pharmaceuticals must undergo a development and approval process by the F.D.A. Before a drug goes on the market for sale, the company must test the product and provide the results of the test to F.D.A.’s Center for Drug Evaluation and Research. The drug must be shown to be safe and effective for its intended use. Benefits must outweigh the possible risks. The F.D.A. does not test the drug itself, it only looks at the data provided by the company. However, as discussed recently on this blog, some companies, like Celebrex, have withheld information from the public and the F.D.A regarding the effectiveness of their drug.

A patient who was harmed by a medical device or drug can find legal relief in Florida for the injuries suffered from a defective product. Knowledge of the testing practices and the science behind the creation of the drugs is essential in a successful civil action. Witnesses providing testimony in such a specialized field must have a background that shows they can competently testify about the subject matter. An experienced litigation attorney is needed to deftly challenge a drug company witness’s ability to testify about the testing method and what is considered safe in the industry.

Proving what compensation is needed can also be tricky and require specialized medical knowledge. Often, a defective medical product exacerbates an already present medical problem and someone who can pinpoint how an adverse reaction, like anaphylaxis, occurred and why it occurred is crucial. This type of testimony can influence how much compensation is awarded for past and future medical bills, past and future lost wages from missing work or the inability to return to work, loss of enjoyment of life, and past and future pain and suffering.

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The U.S. Drug Enforcement Agency spent 2012 cracking down on entities they felt enhanced prescription drug abuse, including two CVS pharmacies near Orlando. Narcotic drug abuse often leads to serious injuries or death. Pharmacies have a responsibility to handle the drugs they prescribe with professional care. This can range from ensuring individual attention to a patient filling multiple prescriptions for narcotics in a short period of time, or avoiding an alarming number of pain-killer prescriptions that contribute to illegal sale and use.

Pharmacists are the gate keepers to safe, responsible controlled substance use. If they fail in their duties, then life-long injuries or death can occur, regardless of whether it was a narcotic or other medication. If you’ve been affected by a prescription drug error, Miami attorneys Friedman, Rodman & Frank can help you find the legal relief you need.

Two other Florida whole-sale distributors were also blocked from shipping out certain drugs to other pharmacies. This is an extension of the D.E.A.’s attempt to crack down on the “pill mill” of prescription drugs funneled from companies or doctors’ offices that present themselves as legitimate. The D.E.A. picked the distributors and pharmacies based on the high volume of suspicious sales. Pharmacists and pharmacies are now moving forward with caution, balancing regulations with patient care.

Following statutory regulations while providing patient care is not a new task to those handling medications. The Florida Court of Appeals previously held that a pharmacist has the duty to warn “customers of the risks inherent in filling repeated and unreasonable prescriptions with potentially fatal consequences”. In Powers v. Thobani,et al., No. 4D04-2061 (Fl. Ct. App. June 1, 2005), the pharmacist filled several prescription of pain killers before previous prescriptions were scheduled to run-out. The court pointed out that pharmacists were already under a duty to interpret and assess the prescription order for potential adverse reactions, interactions, and dosage regimen he or she felt appropriate, prior to the transfer of the drug.

Florida courts have long viewed that the state legislature never intended to create a private cause of action when it enacted a statute requiring pharmacists to check for harmful reactions and interactions and to counsel customers. (See Johnson v. Walgreen Co., 675 So.2d 1036 (Fla. Dist. Ct. App. 1996) However, injured patients can always look toward any acts of negligence to support a civil suit claim against the pharmacist or pharmacy. (See Pysz v. Henry’s Drug Store, 457 So.2d 561 (Fla. Dist. Ct. App. 1984). If the pharmacist confused medications while filling a prescription because he or she was overworked or tired, then that pharmacist failed to meet the established set of professional standards set by various regulatory bodies.

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