South Florida Injury Lawyer Blog

Our Miami-Dade Drug litigation lawyers have been following the developments with regard to Pradaxa. Pradaxa was released in October 2010 with great fanfare. It is an anti-coagulant drug, or “blood thinner.” Pradaxa is typically prescribed by your doctor for the treatment of a heart condition known as atrial fibrillation, or “afib,” that is not caused by a heart valve problem.

Atrial fibrillation, or “afib,” is an irregular heartbeat. It is one of the most common irregularities involving the atria of the heart. With “afib,” blood does not flow properly from the atria to the ventricle of the heart. Since the blood does not flow properly, there is an increased risk for the development of blood clots, and consequently stroke.

To treat “afib,” your doctor may have prescribed Pradaxa for you. Pradaxa was, and is, touted as being a major advancement over other anti-coagulants, such as Coumadin, as it requires less monitoring of blood levels. Unfortunately, however, it appears to have come with a different set of problems.

Pradaxa has been linked to an increased risk of life-threatening bleeding. During the first (3) months it was on the market, the FDA received more complaints about it than 98.7% of other drugs. Further, during the first year it was on the market it has been linked to more than 360 deaths due to internal bleeding. As a result, on December 7, 2011 the FDA announced it was launching a safety review of Pradaxa, only (14) months after it came on the market!

One of the little known facts about Pradaxa is that, unlike with other anti-coagulants such as Coumadin, there is no way to reverse its affect. In other words, there is no known drug or agent that can be administered to reverse the anti-coagulant effects of Pradaxa should bleeding occur, such as can be done with Coumadin.

Despite the FDA’s investigation of Pradaxa, there are several hurdles to proceeding with a suit against its manufacturer. Among them, Florida has adopted the “learned intermediary doctrine.” This means that the manufacturer’s duty to warn of risks associated with a drug is directed to the doctor, not the patient. Nevertheless, the courts do recognize a cause of action brought by a patient on the basis that the manufacturer misrepresented information to the doctor, and the doctor relied upon the misrepresentation in prescribing the drug, such as Pradaxa, to the patient. See the court’s decision in Mardegan, 2011 U.S. Dist. LEXIS 89787.
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Our South Florida medical device litigation attorneys have been following the DePuy hip case implant developments closely. In August of 2010, DePuy Orthopaedics, Inc., a division of Johnson & Johnson, recalled its ASR XL Acetabular metal-on-metal hip implants. However, as early as 2009, the Food and Drug Administration notified DePuy that it was denying the company’s application to sell the implants domestically. Consequently, according to the New York Times article, “Hip Device Phaseout Followed F.D.A. Data Request,” it appears Johnson & Johnson executives initiated a product phaseout of DePuy ASR hip implants as early as 2009, in lieu of a complete recall, only weeks after the Food and Drug Administration requested supplemental safety data from the company.

In 2009, reports from countries outside the United States, illustrated the device was performing less productively and safely than data submitted by DePuy itself. On average, hip implants should last fifteen (15) or more years. Recently, research has surfaced indicating that DePuy’s hip implant failed up to 49% of time in the United Kingdom, and globally failed in patients within a few years of hip replacement. However, citing slow product sales, rather than factors related to safety, DePuy planned to phase out the hip implant globally by 2010.

Several design defects in the ASR hip implant can cause product failures, resulting in DePuy hip implants recall cases. Patients may suffer from “metallosis”, or metal poisoning. Metallosis is a condition associated with metal-on-metal implants. When metal-on-metal hip implants are used the two sides of the implant can rub together, and, in doing so, shed tiny metal particles shown to cause inflammation, soft tissue damage, and/or necrosis. Specifically, the ASR hip implant has cobalt and chromium elements which the Food and Drug Administration not only considers hazardous, but potentially carcinogenic. Other known problems include loose-fitting implants, friction transfer to the acetabulum, and hip implant dislocations. Moreover, design defects like the cobalt/chromium metal construction, shall cup depth, and exceptionally low angle tolerances can cause malfunctions leading to costly supplemental surgeries, known as “revision surgeries”, and/or additional hip replacements.

Presently, it is not known how many patients received ASR XL Acetabular metal-on-metal hip implant. However, according to the aforementioned New York Time’s article, in an eight year period, roughly 93,000 patients received the defective implant, one-third domestically. In Florida, cases are currently being filed that share factual issues surrounding whether DePuy is strictly liable for defectively designing and/or manufacturing the ASR XL Acetabular Hip System, and whether DePuy failed to provide adequate warnings concerning the device to consumers. See Barnes v. Bayside Orthopaedics, Inc., 2012 WL 162368 (M.D.Fla.). Ultimately, patients may suffer irreversible damage, and the longer patients wait to have the ASR revised, the more permanent and damaging the effects can become.

Strict liability in Florida extends to those in the distributive chain including manufacturers and other entities responsible for the sale of a prosthetic device. See Porter v. Rosenberg, 650 So.2d 79, 81 (Fla. 1995). Consequently, it is imperative to note that retailers, like manufacturers, can be held liable for injuries resulting from defective products. However, physicians are generally not subject to strict liability. Courts tend to treat healthcare providers akin to users as opposed to distributors. Moreover, in many product liability cases, including DePuy hip implants, choice of law rules may be a factor that needs to be considered. Under Florida law, a true conflict exists when two or more states have legitimate interests in a particular set of facts in litigation and laws of those states differ or would produce different outcomes. See Chapman v. DePuy Orthopedics, Inc., 760 Supp.2d 1310 (M.D.Fla. 2011). Choice of laws rules carry great significance, nor more than determining which state’s statute of limitations to apply. In Florida, the state has a four-year statute of limitations for product liability claims.
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