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Injured by a Defective Drug or Medical Device? We can help.

Due to our extensive practice in medical negligence litigation, we are often contacted by potential clients with complaints about a prescription drug or a medical device.

Some of these cases involve problems that are not inherent to the drug or device, but instead have to do with errors made by pharmacists fulfilling prescriptions or health care providers incorrectly using the medical devices. We investigate and prosecute these cases in the same basic manner as any other medical negligence case, focusing on the negligence of the individual health care professional. We have handled many of these types of cases and we welcome inquiries.

Cases involving alleged defects in drugs and medical devices, as opposed to a doctor’s or pharmacist’s negligence, typically take a different path. When there are many cases lodged around the country against a particular drug or medical device manufacturer, the cases are now routinely transferred to a single federal judicial district so that global discovery proceedings can be conducted on issues that are common to all cases. This sort of a proceeding is called a Multidistrict Litigation, or “MDL.” MDLs can now be found in federal judicial districts around the country. Because of the enormous costs associated with litigating products liability claims against these manufacturers, the use of MDLs is for most plaintiffs the only cost-effective of way of conducting discovery because it enables all the plaintiff attorneys in the MDL to pool resources during the discovery phases of their cases. It also gives the plaintiffs a forum in which to conduct global settlement negotiations. If a global settlement is not reached and an individual case is not otherwise resolved during the MDL period, the case is simply returned to its home district for trial.

Given the inherent advantages of MDLs, we usually focus our investigations on drugs and medical devices for which an MDL has been formed or will likely be formed soon. Although the statute of limitations period for filing product liability cases is typically longer than for medical negligence cases, it Is still important not to delay in discussing a potential claim with an attorney. A listing of the drugs and devices we are currently reviewing is provided below.

Prescription Drugs

  • Belviq (lorcaserin HCI) – Belviq and Belviq XR are weight loss drugs incorporating a drug called lorcaserin. The drugs are manufactured and marketed by Eisai Inc., a healthcare company with its U.S. headquarters in New Jersey. When the FDA initially approved lorcaserin for U.S. marketing in 2012, it required Eisai Inc. to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of heart-related problems. In this trial, which was conducted in approximately 12,000 participants over 5 years, more patients taking lorcaserin were diagnosed with cancer compared to patients taking a placebo. On January 14, 2020,the FDA alerted the public to the results, and indicated that while it could not conclude that lorcaserin contributes to the cancer risk, it wanted to make the public aware of this potential risk. On February 13, 2020, the FDA requested that the company voluntarily withdraw Belviq and Belviq XR from the U.S. market, and the company complied. On April 12, 2021, plaintiffs with individual cases around the country involving Belviq joined together to ask that an MDL be created in the Eastern District of Louisiana to conduct collective discovery proceedings for Belviq cases nationwide. You should consult with an attorney if you previously were prescribed Belviq and have subsequently been diagnosed with breast cancer, lung cancer, colon cancer, colorectal cancer or pancreatic cancer.
  • Blood pressure medications Valsartan, Losartan and Irbesartan – These blood pressure medications, which are all angiotensin II receptor blockers (ARBs), have been the subject of ongoing concerns about contamination by carcinogenic nitrosamines. Beginning in June 2018, the FDA learned that some generic versions of the prescription drug valsartan contained unexpected impurities that posed a safety concern. The impurities in ARB medications, N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) are probable human carcinogens (cancer-causing), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) is a potential human carcinogen. Not all valsartan, losartan, and irbesartan-containing medications were considered affected and subject to recall. In 2019, an MDL was initiated in New Jersey. To date, the litigation has focused on valsartan containing drugs (“VCDs”) Claims involving the losartan containing drugs (“LCDs”) and irbesartan containing drugs (“ICDs”), which were filed and coordinated later, have been paced to allow the valsartan claims to proceed first. You should consult with an attorney if you previously were prescribed an ARB and have subsequently been diagnosed with cancer.
  • Elmiron (Pentosan Polysulfate Sodium) – This drug, manufactured and marketed by Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, is used to treat bladder pain and discomfort associated with interstitial cystitis (IC). In June 2020, Janssen added a warning for “retinal pigmentary changes”to the drug’s label. Visual symptoms in the reported cases include difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. An MDL was initiated in the Southern District of New York in 2020 to conduct collective discovery proceedings for Elmiron cases nationwide. You should consult with an attorney if you previously were prescribed Elmiron and have subsequently developed vision problems.
  • Kombiglyze XR (saxagliptin and metformin) and Onglyza (saxagliptin) – These are drugs known as DPP-4 inhibitors that are intended to treat Type 2 diabetes. Lawsuits have been filed alleging that the drugs caused serious cardiac complications. The manufacturers who have been sued, Bristol-Myers Squibb and AstraZeneca, began selling the drugs before completing a cardiac risk study recommended by the U.S. Food and Drug Administration. An MDL was initiated in 2018 in the U.S. District Court for the Eastern District of Kentucky to coordinate discovery in cases across the country.
  • Singulair (moneteukast sodium) – Singulair, manufactured by Merck & Co., is the brand name for an asthma medication, moneteukast sodium, which has also been used for allergic rhinitis. The FDA updated the product labeling in 2008 to include information about neuropsychiatric events reported with use of montelukast. On March 4, 2020, the FDA announced that that it was requiring a boxed warning – the agency’s most prominent warning – for montelukast to strengthen the existing warning about the risk of neuropsychiatric events associated with the drug,The warning followed the FDA’s review of available data regarding continued reports of neuropsychiatric events with montelukast, such as agitation, depression, sleeping problems, and suicidal thoughts and actions. The FDA determined the risks of montelukast may outweigh the benefits in some patients, particularly when the symptoms of the disease are mild and can be adequately treated with alternative therapies. For allergic rhinitis in particular, the FDA has determined that montelukast should be reserved for patients who have not responded adequately to other therapies — or who cannot tolerate these therapies. Although there is no current MDA pending regarding Singulair or its generic equivalents, Merk & Co. is now facing lawsuits from Singulair users. If you suffered the sort of problems discussed above while taking Singular, you should consult with an attorney.
  • Xeljanz (tofacitinib) - Xeljanz (tofacitinib) and Xeljanz XR are auto-immune drugs manufactured by Pfizer that are used in the treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. On September 1, 2021, the FDA issued a Drug Safety Communication based on a review of the findings of the randomized trial, concluding that there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib). The randomized safety clinical trial compared Xeljanz with another type of medicine used to treat arthritis called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz. A prior FDA Drug Safety Communication based upon earlier results from this trial reported an increased risk of blood clots and death only seen at the higher dose. The FDA is requiring new and updated warnings for two other arthritis medicines in the same drug class as Xeljanz, called Janus kinase (JAK) inhibitors, Olumiant (baricitinib) and Rinvoq (upadacitinib). The FDA reports that Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated. However, since they share mechanisms of action with Xeljanz, the FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial. Although there is no current MDL pending regarding Xeljanj, these cases are being investigated on an individual basis. If you suffered the sort of problems discussed above while taking Xeljanz, you should consult with an attorney.
  • Zantac (ranitidine) – Zantac is the brand name of a prescription drug, ranitidine, which is also sold in generic forms. On April 1, 2020, the FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications. NDMA is a probable human carcinogen (a substance that could cause cancer). The FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. There is a pending MDL for Zantac cases in the Southern District of Florida. If you have received a cancer diagnosis after taking Zantac, you should consult with an attorney.

We can be reached online or by phone at (386) 258-1622.

Medical Devices and Health Care Products

  • Allergan Biocell Textured Breast Implant - On July 24, 2019, the FDA requested that manufacturer Allergan recall its BIOCELL textured breast implants and tissue expanders. The request was based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)related deaths associated with these devices. The recalled products all have the same BIOCELL textured surface (shell), which is a unique surface used only by Allergan. The FDA indicated that its analysis demonstrated that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and that continued distribution of Allergan's BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.On December 18, 2019, an MDL was created centralizing lawsuits regarding this matter in the District of New Jersey. The transfer order lists the common factual questions in the MDL as (1) whether BIOCELL textured breast implants and tissue expanders can cause BIA-ALCL; (2) whether defendants knew or should have known of the risk of BIA-ALCL; (3) whether they provided adequate warnings as to the risks; and (4) the adequacy of defendants’ product design, testing and manufacturing. If you have been diagnosed with BIA-ALCL after receiving an implant of this product, you should consult with an attorney.
  • Ethicon Physiomesh Flexible Composite Hernia Mesh Products – In May 2016, Ethicon, a subsidiary of Johnson & Johnson, recalled its Physiomesh flexible composite hernia mesh after studies showed a relatively high rate of revision surgeries after its use in hernia repair. In 2017, an MDL was started in the Northern District of Georgia to oversee Physiomesh lawsuits. If you have experienced complications after the implantation of Physiomesh, you should consult with an attorney.
  • IVC Filters – Inferior Vena Cava (IVC) filters are medical devices that are implanted in the inferior vena cava (a major blood vessel) to prevent blood clots originating in the legs from traveling to the lungs and causing pulmonary embolisms. The filters are made by several different manufacturers. There have been claims that patients who were implanted with certain brands of IVS filters were injured because the filter broke inside their bodies and damaged body organs. The FDA has been monitoring this situation for over a decade and in 2013 developed a quantitative decision analysis using publicly available data from the medical literature to assess whether there is a time period during which the risk of having an IVC filter is expected to outweigh the benefits. The mathematical model suggested that if the patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation. Although there have been no mandatory recalls of these devices, IVC manufacturers have made voluntary recalls of specific models on several occasions. Three different MDLs have been established to deal with IVC filter lawsuits, in the Southern District of Indiana for Cook Medical, Inc., devices, in the District of Arizona for C.R. Bard devices, and in the Superior Court of California, County of Alameda, for Cordis devices. If you have experienced complications after the implantation of an IVC filter, you should consult with an attorney.
  • Johnson & Johnson Baby Powder - Johnson &Johnson baby power is a talc-based powder that has been in widespread use around the world for decades. However, internal Johnson & Johnson documents reportedly reveal that since as far back as the late 1950’s, the company has been aware that the powder has sometimes tested positive for contaminants which were either determined to be asbestos or were described in terms typically applied to asbestos. While most people exposed to asbestos never develop cancer, even small amounts of asbestos can reportedly be enough to cause cancer to develop years later. In 2019, Johnson & Johnson instituted a voluntary recall of a single lot of its Johnson’s Baby Powder (33,000 bottles) in response to an FDA test indicating the presence of sub-trace levels of chrysotile asbestos contamination in samples from a single bottle purchased from an online retailer. There are currently thousands of pending lawsuits against Johnson & Johnson by plaintiffs claiming that they have been injured by the product. These cases have been assigned to an MDL in the District of New Jersey, which has had jurisdiction over the matter since 2016. If you believe that you may have contracted cancer as a result of exposure to Johnson &Johnson baby powder, you should consult with an attorney.
  • Paragard IUD – The Paraguard IUD (intrauterine device) is a long-term intrauterine birth control device, consisting of a T-shaped plastic frame wrapped with copper wire that that is intended to produce an inflammatory response that is toxic to sperm and eggs. In December 2020, lawsuits from around the country were consolidated in an MDL in the Northern District of Georgia. The lawsuits accuse defendants Teva Pharmaceuticals USA, Inc., Teva Women’s Health, Inc., The Cooper Companies, Inc., and Cooper Surgical Inc. of failing to warn users of the alleged risks posed by the device, more specifically, that the device can essentially break apart and cause pieces to become imbedded in the uterus. If you have been a user of the Paraguard IUD and have had a failure of the device as discussed above, you should consult an attorney.
  • Proton Pump Inhibitor heartburn drugs (e.g., Nexium, Prevacid and Prilosec) – Drug makers, including AstraZenica and Pfizer, have been accused of failing to adequately warn that Proton Pump Inhibitor (“PPI”) heartburn drugs, such as Nexium,Prevacid and Prilosec, can cause kidney damage. In 2017, an MDL was initiated in the District of New Jersey. If you were prescribed a PPI heartburn drug and have subsequently suffered kidney damage, you should consult an attorney.
  • Smith & Nephew Birmingham Hip Resurfacing Hip Implant Products – Smith & Nephew, Inc., is a medical technology company based in the United Kingdom which markets a hip resurfacing system known as the Birmingham Hip Resurfacing (BHR) system. Plaintiffs have alleged that the metal-on-metal design of the system causes cobalt and chromium ions from the implants to migrate into surrounding tissues, resulting in adverse symptoms like pain, metallosis, and bone and tissue necrosis. In April 2017, the lawsuits were consolidated in an MDL in the District of Maryland. Recently, the Judicial Panel on Multidistrict Litigation added a Total Hip Arthroplasty (THA) track to the MDL. THA devices are comprised of BHR and non-BHR components and allegedly lead to many of the same injuries caused by BHR devices. If you have received a hip implant using Smith & Nephew BHR components and have subsequently developed these sorts of symptoms, you should consult an attorney.
  • Stryker LFIT V40 Femoral Head Products - These cases concern alleged defects in Stryker-branded LFIT Anatomic CoCR V40 femoral heads, a prosthetic hip replacement device which was recalled by the manufacturer in 2016.The LFIT V40 femoral head is made of cobalt and chromium and has allegedly caused the sort of metal-on-metal adverse issues associated with other metallic implants. An MDL was commenced in the District of Massachusetts in 2017. If you have received a hip implant using a Stryker-branded LFIT Anatomic CoCR V40 femoral head and have subsequently developed problems such as metal poisoning, joint instability, adverse tissue reaction and excessive wear, you should consult an attorney.
  • Zimmer M/L Taper Hip Prosthesis – The Zimmer M/L Taper Hip Prosthesis is a component of a prosthetic hip replacement system which originally received FDA clearance in 2003. Plaintiffs have alleged that the Zimmer M/L Taper or M/L Taper with Kinectiv Technology when paired with a VerSys femoral head can cause metallosis, pseudotumors and adverse local tissue reaction necessitating revision surgery. An MDL was commenced in the Southern District of New York in 2018. If you have received a hip implant using a Zimmer M/L Taper or M/L Taper with Kinectiv Technology and have subsequently developed problems like those discussed above, you should consult an attorney.

Contact our firm at (386) 258-1622 to discuss your case with one of our Daytona Beach defective drug and products liability lawyers. We serve clients throughout Volusia County.

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