Articles Posted in Medical Devices

The U.S. Food and Drug Administration recently published a warning letter that it sent to St. Jude Medical, stating that the company likely downplayed the risks associated with its defibrillator batteries last fall. A defibrillator is a device that provides an electric shock to the heart in the event it begins to beat irregularly or cease beating entirely. The device is implanted in the patient’s chest and is battery powered.

The letter also indicates that St. Jude may have failed to notify management officials within the company, in addition to its medical advisory board, that these battery-related issues resulted in the death of a patient.

The letter also indicates that the agency has determined that St. Jude Medical has not taken sufficient or adequate measures to resolve the issue with the batteries. The company has 15 days to provide the FDA with a revised reporting plan.

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There are countless allergy sufferers in the United States. For many of these people, having an allergy to certain foods or insects is a relatively minor health aspect. But for others, being exposed to an allergen can result in death. Some common examples of severe allergies include bee stings, seafood, and peanuts. Recently, the manufacturer of the anti-allergy medicinal medication EpiPen initiated a recall after learning that some of the units may not work as intended, placing patients and other individuals who rely on the device in serious jeopardy. The device contains epinephrine, a chemical that counteracts the effects of a severe allergic reaction in the body.

Meridian Medical Technologies, the manufacturer of EpiPen and EpiPen Jr, recently expanded this recall to include South America, Europe, and Asia. The recall covers 13 lots of the devices, which are auto-injector pens that are used to help treat severe allergic reactions in emergency situations. The recall notice states that the covered lots may suffer from a defect that prevents the pen from activating.

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Breast implants are very common and have been used as a cosmetic modification for several decades. According to some reports, breast implants are the second-most common cosmetic operation that women seek out. The most common procedure is liposuction. In 2015 alone, more than 300,000 breast augmentation procedures were performed. There are many different types of breast implants that are approved in the U.S., including saline-filled or silicone gel-filled implants.

Recently, the United States Food and Drug Administration reported that breast implants may be linked to a rare type of cancer. In the same report, the FDA stated that at least nine incidences of this cancer have been linked to breast implants.

The cancer at issue is referred to as anaplastic large cell lymphoma, or ALCL. It is a type of non-Hodgkin’s lymphoma that the FDA first began investigating in 2011. The FDA is now examining 359 reports that purport to identify a link with both saline and silicone solutions in breast implants. So far, studies indicate that the cancer typically develops 10 years after the implants were inserted and usually develops close to the area where the implant was inserted. There are some reported instances in which the cancer spread, however. Some of the most common initial symptoms reported associated with the cancer include pain and swelling at the site.

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Medical devices are intended to improve our ailments and make our lives easier. Although this is achieved in many cases, there are some instances where medical devices do more harm than good due to design defects or a manufacturer’s failure to provide adequate warnings about the potential side effects.

Recently, Fresnius Medical Care won the first trial in the pending multi-district litigation (MDL) involving its GranuFlo and NaturaLyte dialysis drugs. These products were intended to reduce the level of acid in dialysis patients’ blood during treatments. According to the plaintiffs’ allegations, these drugs contain a high concentration of acetone, which created unusually high levels of bicarbonate in the patients’ blood during and after treatments. The products contain more bicarbonate than other comparable dialysis treatment aids on the market. The high levels of bicarbonate can lead to a variety of health problems including fatal heart conditions and strokes. In many of the MDL lawsuits, the plaintiffs are estates or surviving heirs bringing claims on behalf of a decedent, alleging that the decedent died soon after receiving a dialysis treatment involving GranuFlo or NaturaLyte.

In the most recent trial, a Massachusetts jury concluded that the plaintiff failed to prove its case. The trial was the first of its kind to go forward in the MDL. The plaintiffs rejected a proposed $250 million settlement roughly one year ago.

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A federal judge in California recently entered an order approving a $12.3 million settlement involving Caldera Medical’s transvaginal mesh product and associated insurance claims. According to the terms of the settlement, Caldera’s insurance company will provide $10.6 million in payments to nearly 3,000 members of the class, in addition to over $600,000 in payment for attorney’s fees and costs associated with the lawsuit.

The judge issued the order despite 36 objectors who wanted the court to order an independent audit. The objectors argued that there was not enough evidence regarding whether the payment would be larger if the company, based in Agoura Hills, CA, went through a liquidation.

Regarding the mesh product, Caldera’s Vertessa Lite mesh was made of polypropylene mesh and used repair pelvic organ prolapse. Some reports estimate that as many as 40 percent of women experience some type of prolapse and that as many as 250,000 surgical procedures are performed to address this condition each year. When marketing the product, Caldera claimed that it was 31 percent stronger than other comparable mesh products on the market, lighter, and that it featured stronger suture pull-out strength.

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The U.S. Food and Drug Administration (FDA) recently announced a Class I recall for the Zimmer Biomet Comprehensive Reverse Shoulder System, Model 115340 (“CRS”). A Class I recall is the highest level of recall according to the FDA’s regulations. This class of recall is used in situations in which there is a reasonable probability that using the subject product or exposure to the subject product will cause adverse health consequences or even death. Zimmer Biomet initiated the recall after reports indicated that the CRS device fractures at a higher rate than indicated on the label.

The CRS device is a shoulder replacement mechanism that is implanted into eligible patients, and it is designed with the intention of restoring arm movement. Some of the most common patients who have received the CRS device in a surgical procedure are patients who experience a tear in their rotator cuff and who experience severe arthritis in their shoulder as a result. This level of arthritis is commonly referred to as arthropathy. The patients have also typically experienced a failed shoulder joint replacement procedure prior to receiving the CRS implant.

According to the recall announcement, physicians who have used the CRS device in shoulder replacement procedures are affected. The announcement encourages them to review the safety notice and other associated information regarding the CRS device, identify any remaining devices that have not yet been used in surgical procedures, and contact any patients who received the CRS device in a surgical procedure. Patients who received or believe they have received the CRS device should consult their physician immediately. Devices subject to the recall were manufactured between August 25, 2008 and September 27, 2011.

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Intuitive Surgical, the company who developed and markets the da Vinci surgical robot, is facing another lawsuit challenging the sufficiency of the warnings that the manufacturer provided with the device. Recently, the Washington Supreme Court ruled that a plaintiff could proceed with a product liability lawsuit on behalf of her deceased husband against Intuitive Surgical. In his complaint, the plaintiff alleged that he suffered serious physical injuries during a prostatectomy using the da Vinci surgical device. According to the plaintiff’s allegations, the physician who performed the surgery noticed during the procedure that the plaintiff’s rectal wall had suffered lacerations. As a result of this complication, the physician had to perform immediate open surgery to repair the lacerations.

Following the surgery, the husband reported experiencing a serious reduction in his quality of life. During ventilation, the husband experienced respiratory failure requiring ventilation, renal failure, and an infection. The husband’s complaint also alleged that he was required to wear a colostomy bag and that he also experienced incontinence. The complaint also alleged neuromuscular damage and that the husband was unable to work correctly without assistance. Roughly four years after the procedure, the husband died. According to a physician who testified on behalf of the plaintiff, the da Vinci robot’s malfunction was a contributing factor in the husband’s death.

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Johnson & Johnson was named as a defendant in a recently filed product liability lawsuit involving its silicone breast implant product. The action, which was filed in state court in California, alleges that the plaintiff suffered severe injuries as a result of receiving the company’s silicone breast implants. The plaintiff’s alleged injuries include severe muscle pain, nausea, and more.

In 1992, the U.S. Food and Drug Administration banned the use of silicone in breast implants. The agency prohibited their use based on research suggesting that they cause health problems like rheumatoid arthritis. The primary manufacturer of silicone implants faced so many lawsuits at the time that it eventually filed for Chapter 11 bankruptcy. The FDA ultimately required the company to pay a total of $3.2 billion in damages to implant recipients. In 2006, the agency lifted this ban, and Johnson & Johnson became the first company to offer a silicone-based implant product in the years that followed.

The lawsuit is seeking damages based on Johnson & Johnson’s alleged failure to provide sufficient warnings to the plaintiff about the potential side effects and safety of the implants. The plaintiff contended that the silicone implants are prone to leaking, which can cause a host of physical injuries and ailments.

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Johnson & Johnson, the manufacturer of the DePuy Pinnacle hip implant device, has asked a federal judge to issue an order granting new trials after juries returned a total of $1 billion in judgments to six total plaintiffs. Each of these plaintiffs sued the medical device maker, alleging that the Pinnacle hip implant device failed to include proper warnings about its potential side effects and that it was designed in an unreasonably defective manner. These plaintiffs alleged specifically that the metal-on-metal aspect of the device resulted in dangerous side effects, including metallosis, a condition in which metal particles escape into the bloodstream.

In December 2016, a jury in Dallas concluded that the metal-on-metal hip implant devices were designed in a defective manner and failed to include warnings about their dangers. The Dallas jury awarded the six plaintiffs $32 million in compensatory damages and over $1 billion in punitive damages. Compensatory damages are a type of damages designed to compensate a plaintiff for expenses associated with his or her injuries that stem from the accident. Common examples include medical expenses and lost wages.

Punitive damages, on the other hand, are a separate category of damages that are designed to punish a defendant for engaging in particularly egregious, wanton, and willful conduct while also serving to deter other similarly situated individuals from engaging in similarly reprehensible behavior.

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In the final days of 2016, a federal appellate court revived a lawsuit brought by a group of shareholders accusing Medtronic, a major medical device and technology company, of concealing information about the negative impacts of its bone growth protein product, Infuse, for over 10 years.

According to the United States Court of Appeals for the Eighth Circuit, a lower court judge incorrectly concluded that the plaintiffs filed their action outside the statute of limitations. According to the lower court record, the plaintiffs did not file their complaint until two years after they learned about Medtronic’s alleged fraudulent activity. The lawsuit also states that executives at the company were not truthful with investors regarding the commercial viability and safety aspects of the Infuse bone growth protein. They also allege that company analysts were not truthful about the prospects of a possible follow-on product, Amplify.

The complaint states that the shareholders purchased shares of Medtronic stock in reliance on these misrepresentations and suffered serious financial harm when the stock price crashed after numerous reports questioning the safety of Medtronic’s Infuse product surfaced. These reports and numerous lawsuits filed against Medtronic allege that the Infuse bone growth paste was used in countless off-label procedures.

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