Defective Products

Negligence and Strict Liability in Florida Roll-Over Crash Case

Published on: February 14, 2014 | by Friedman Rodman Frank & Estrada, P.A.

Roll-over cases in Florida involving both negligent driving and product defects can be complex and challenging because different standards apply to different aspects of the case. In a 2012 case, a woman tried to recover damages for injuries she suffered in a car accident. She had been hurt in a roll-over crash while driving her boyfriend’s Ford Explorer.

The woman sued Ford for strict liability, negligence, and associated claims of defects, including negligent design of the suspension system. She alleged that the suspension system was designed so that it would roll over with a sudden lane change, and that its roof and safety systems didn’t offer proper protection.

Ford defended itself by arguing that the plaintiff was negligent in how she drove. It moved for summary judgment on that basis. The evidence attached to the moving and opposing papers were limited. Ford argued that the plaintiff was legally intoxicated at the time of the accident and that was why she was hurt. It also argued she didn’t present expert testimony on the issue of defects.

Supreme Court Assesses Liability of Generic Drug Makers

Published on: March 20, 2013 | by Friedman Rodman Frank & Estrada, P.A.

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.

Fatal Allergic Reactions Leads to Anemia Drug Omontys Recall

Published on: February 28, 2013 | by Friedman Rodman Frank & Estrada, P.A.

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.

Nationally Available Dietary Supplement with DMAA Under Scrutiny Following Military Deaths and FDA Warning

Published on: February 15, 2013 | by Friedman Rodman Frank & Estrada, P.A.

Jack3d, which is sold at health stores in Florida and across the U.S., has been at the forefront of concern as one of several dietary supplements that contain dimethylamylamine, or DMAA. Several companies use the main ingredient DMAA in dietary supplements advertised to maximize your energy, concentration, and metabolism. Dietary supplements are not regulated by the Food and Drug Administration (F.D.A.) in the same manner as food or medications. Dietary supplements are required to only have “dietary ingredients” and must be shown to be safe before they are marketed.

In April 2012, the F.D.A. issued a warning letter to ten manufacturers and distributors stating that they failed to submit a notification that DMAA is being used in their product as a New Dietary Ingredient. 42 adverse event reports had been submitted to the agency with complaints ranging from cardiac to nervous system disorders. DMAA is known to narrow the blood vessel and arteries, raising blood pressure that causes shortness of breath to tightness in the chest to heart attack. Manufacturers of these dietary supplements still insist that their products are safe.

Following the F.D.A warning letters, Drug Testing and Analysis published the results of a study that showed the DMAA found in the dietary supplements was not from a natural source. On the list of ingredients, it is often listed as sourced from geranium, but the researchers found it was indistinguishable from the synthetic version of drug. This finding highlighted the long-running debate for greater regulatory oversight of supplements
The public spotlight has landed on the DMAA product Jack3d after two men in the armed services died after using their product. The Department of Defense went as far as removing all products containing DMAA for sale in stores on military bases. One soldier’s family has filed suit claiming that the companies deceptively marketed the product as safe for use and not warning consumers about the potential health risks.

The basis of the family’s complaint lines up with Florida’s punitive damages requirements, which can be available in wrongful death suits. In a wrongful death suit, the defendant party is held liable as the cause of the death. Those who qualify to sue may recover compensatory damages ranging from loss of wages to medical bills. To recover punitive damages, the defendant party must be found to have acted with gross negligence or intentional misconduct. A party can sue to recover up to two million dollars if they show that the defendant party was motivated by financial gain, and that the managing director, agent, or officer in charge of decision making was aware of the dangerous nature of the conduct.

Two Florida CVS Pharmacies Have Controlled Substance License Revoked

Published on: January 22, 2013 | by Friedman Rodman Frank & Estrada, P.A.

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.

Thousands of Injuries Caused by All-Metal Hip Implants Cause F.D.A. to Tighten Regulations in Florida and Rest of U.S.

Published on: January 18, 2013 | by Friedman Rodman Frank & Estrada, P.A.

The Food and Drug Administration recently announced a proposed set of rules that would make it much more difficult for medical equipment manufacturers to sell all-metal hip implants. Companies took advantage of not having to prove their products safe and effective, and were putting devices on the market that they knew caused injuries and were prone to early failure. Now, the F.D.A. seeks to rectify this, placing the onus on companies to show that their product is safe before they can begin or continue to sell an all-metal hip implant.

The South Florida defective hip implant lawyers at Friedman, Rodman & Frank are ready to use their product liability experience to aggressively seek the compensation you need to treat the injuries caused by an all-metal hip. They are very familiar with the problems caused by the metal-on-metal grinding that releases tiny metal shavings into the body, injuring nearby bone and tissue and elevating levels of cobalt and chromium in the blood to a point of toxicity.

Prior to its recall in 2010, the Johnson and Johnson’s Articular Surface Replacement (A.S.R.) device was a popular pick among doctors as they began using all-metal hip implants for its perceived durability benefits. A hip replacement for a metal-and-plastic implant usually lasts around 15 years. However, it has recently been shown that the manufacturers knew that an estimated 37% of patients using the A.S.R. will need to have it replaced within 5 years.

Hip replacements may be a common procedure, but they are far from easy to perform. Hip replacements, like any other serious medical procedure, can leave the patient exposed and prone to infections and blood clots. 29,210 Florida residents were hospitalized for hip replacements in 2011. Several hospitals had to readmit patients for complications related to the procedure. Complications can stem from the doctor choosing a faulty implant device. Any additional surgeries to replace previous hips are painful and increase a patient’s susceptibility to complications.

Johnson and Johnson’s DePuy Orthopaedics division withheld the results of their internal analysis that determined over 1/3 of the A.S.R.’s will need to be replace. They conducted this investigation while denying the results of a British implant registry that already determined the hip implants would fail at an early rate. Though the implant product had already been recalled during the internal analysis, there were still numerous patients who still had the A.S.R. implanted and were not notified of the potential risks.

This is analogous to the recently released documents regarding the drug Celebrex. The manufacturing company, Pfizer, only released the first six months of a study assessing the pain-killer’s effect on the stomach. Celebrex used the first half of the study in order to claim that their medication was safer than other over-the-counter drugs like ibuprofen, because it protected the stomach from complications often found when using a non-steroidal anti-inflammatory drug (NSAID). The full results showed Celebrex did not have an edge over any other pain reliever. Previously, Celebrex’s effectiveness was questioned because there hadn’t been any studies showing it to be more effective at treating arthritis than other over-the-counter medications.

FDA Sends Warning Letter to St. Jude’s Medical to Fix Faulty Defibrillators Leads, Riata and Durata

Published on: January 11, 2013 | by Friedman Rodman Frank & Estrada, P.A.

The FDA issued a warning letter to the medical device company St. Jude’s Medical to address several violations in the manufacturing of defibrillator leads Riata and Durata. St. Jude’s Medical, following an investigation of its manufacturing plant between September 25, and October 17, attempted to show it had corrected the violations found during the FDA’s investigation. The FDA delineated how its actions and responses were either inadequate or questionable to the point where adequacy could not be determined. The letter ultimately ordered St. Jude to correct the ongoing violations, or else face regulatory action, which could include civil fines and injunctions.

If you have a faulty defibrillator that uses a St. Jude or Boston Scientifc Lead, our South Florida products liability attorneys can help you seek compensation.

Riata and Durata are both essential parts of a defibrillator installed in patients to help monitor and correct their heart rates. The defibrillator senses a life threatening irregularity, and a shock is sent to help correct the heart via the Riata or Durata leads. These leads are surrounded by insulation and are expected to last around 10 years, with the insulation wearing out after several years of wear and tear. The Riata and Riata ST leads were eroding at an alarming, hastened rate and were sending unnecessary, jarring electric shocks throughout the patients’ bodies. St. Jude’s recalled the Riata in 2011, and has been under intense scrutiny every since. The Durata has not been recalled, however the FDA decided to subject that product line to a similar investigation, as it is manufactured similarly and performs the same function as the Riata and Riata ST leads.

More than 200,000 Riata leads have been distributed globally, and it is estimated that approximately 79,000 remain in patients in the United States. Even though the Riata leads have been off the market since 2010, the FDA expected St. Jude to bring its manufacturing process up to statutory code. The FDA is still trying to determine how soon the insulation on the leads fail after the lead is implanted, the timeline of the breakdown (when does the inner insulation fail, when does the outer insulation fail, and when do those failures cause the lead’s shock to migrate), and what risk factors contribute to the accelerated dissolution of the lead insulation.

The FDA has recommended doctors to closely monitor any patient with a Riata lead. Doctors may elect to use imaging tests like a fluoroscopy or X-ray to determine whether or not there is any decay in the insulation that could cause externalized shocks, or they could chose to remove and replace the lead. However, this has its own layer of concern, as the lead is threaded throughout the heart and creates a build-up of scar tissue, which makes each removal laden with risk to the patient.

The FDA requests that all doctors and patients who are either experiencing problems with their Riata or Durata lead, or suspect that the lead insulation is eroding too quickly, to report the problem to their agency so they can better track and correct this medical product defect that affects so many.