hand holding moneyWhen it comes to medical device and pharmaceutical lawsuits, the class action lawsuit is very common. In a class action lawsuit, one plaintiff or a group of plaintiffs files a lawsuit on behalf of a class of people who have similar legal and factual allegations. In general, there are four requirements that the plaintiffs must satisfy before a court will certify the matter as a class action. First, the class must be so numerous that it is not practical to join all of the prospective plaintiffs in one lawsuit. Next, there must be common questions of fact and law among the class members. Third, the claims or defenses that the representative plaintiffs intend to assert must be typical of the class members. And finally, the representative plaintiffs must advance the class interests fairly and with adequate protection.

There have been many laws and court opinions that define the basic rules and requirements for class action lawsuits. One of them is the federal Class Action Fairness Act (CAFA), which expanded subject matter jurisdiction for federal class action cases. A federal court may assert jurisdiction over a class action lawsuit when the amount in controversy exceeds $5,000,000 and when the class consists of at least 100 members, among other requirements.

In 2015, the Ninth Circuit Court of Appeals decided an important case that had broad implications for class action lawsuits. In that case, the plaintiff was an employee who brought a lawsuit in state court, asserting a number of workplace violations and wage requirement violations. Overall, the plaintiff asserted 10 causes of action, but only nine of them included class claims.

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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.bee

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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nut butter jarFood safety is one of the most popular topics in the headlines these days. Whether it is major foodborne illness outbreaks at popular national chain restaurants or contaminated food products on store shelves, consumers face serious risks when food providers and manufacturers fail to take reasonable precautions and to use due care.

Recently, a couple in California filed a lawsuit against the maker of SoyNut Butter, IM Healthy, alleging that one of the spouses suffered serious injuries as a result of consuming SoyNut Butter that was contaminated with E. coli O157:H7. The complaint alleges that as a result of the contamination the wife required hospitalization and extensive medical treatment. The complaint also states that she purchased the product at a popular retail store in California.

The outbreak associated with the soy nut butter spread was first identified by the Maryland Department of Health and Mental Hygiene after a resident of that state who became ill stated that they had consumed SoyNut Butter shortly beforehand. The Centers for Disease Control and the U.S. Food and Drug Administration, in addition to a number of local health departments, have launched investigations into the outbreak. Recently, IM Healthy initiated a recall for the product and stated that the voluntary recall applied to its Original Creamy SoyNut Butter product that bears a Best By date of August 30, 2018 or August 31, 2018. The company also stated in the recall announcement that the recall was due in part to the FDA’s notice that it was investigating a potential link between the product and cases of E. coli-related illness.

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hand holding implantBreast 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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steaks on grillThere are many benefits that our modern food system has to offer, including the ability to ship produce around the globe so that we can enjoy some of our favorite fare throughout the year. This same benefit, however, also exposes consumers to hidden dangers. It’s not always a guarantee that imported food products were produced according to the same food safety standards adopted in the United States.

Recently, China and the European Union ceased imports of meat from Brazil, the world’s largest beef exporter, after police officials alleged that some of the inspectors may be accepting bribes to approve salmonella-contaminated or rotten meats for export. The announcement came as part of an anti-corruption probe in Brazil. Inspectors play a key role in ensuring the safety of meat products, preventing contaminated or diseased meat from entering the food supply and helping to enforce food safety regulations at processing plants.

The police force orchestrated 200 raids involving 1,100 officers in an operation dubbed “carne fraca” in an attempt to obtain additional evidence to corroborate the bribery claims. Following the raids, the police stated that they verified 40 cases of suspected bribery or other wrongdoing, including adding chemicals to expired meat to improve the smell or adding flour or cardboard to sausages to increase volume.

The government responded to the accusation by saying it is false and that it is based on only a few isolated cases. In the meantime, the Brazilian Agriculture Minister suspended exports from 21 meat processing facilities in the country. There are over 4,800 meat processing facilities in Brazil, and the country exports meat products to 150 countries. China’s suspension of meat imports has serious implications for Brazil because China imports roughly one-third of Brazil’s meat exports, accounting for nearly $14 billion.

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blue dialysis machinesMedical 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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Serious Faced WomanA 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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woman stretching shoulderThe 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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A senator from Virginia has introduced a proposed piece of legislation that would have dramatic implications for class action litigation if passed. The senator proposed the legislation with the intent of making class action lawsuits more fair and more efficient for all parties involved, including the court system. The bill would increase the recoveries for victims deemed deserving and filter out claims considered unmeritorious. These meritless claims are viewed as an unnecessary burden on judicial resources, according to proponents of the bill.

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There are a number of ways that the legislation would change class action litigation in federal courts throughout the United States. Here are some examples. First, the legislation would require the plaintiff to demonstrate to an affirmative degree that there is “a reliable and administratively feasible mechanism” that the court can use to determine which potential class members are encompassed within the class. That mechanism would also need to provide a feasible and reliable way to distribute funds to those class members.

Next, attorneys would be prohibited from receiving class counsel fees until an accounting of the overall amount of fees that the defendant had dispersed is conducted. One of the things that the accounting would need to identify is the overall amount of compensation given to the class, the estimated or actual number of members in the class, the average compensation amount disbursed, and the highest sum provided to any single class member. It would also have to list any amounts paid to other individuals, including plaintiff’s counsel, and the reason for the payment.

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Neti Pot WomanWhen you are suffering from a bad cold or illness, finding a cure to alleviate your symptoms becomes a priority. There are a wide variety of over-the-counter methods available, but one of the most popular products on the market today is a Neti Pot. The Neti Pot is a device that flushes out congested nasal passages and helps people breathe more easily. The device is usually filled with water and a saline solution. The end of the device with a nozzle is inserted into the nostril, and the user then applies pressure to the device to force the water into the nostril and through the nasal passage.

According to a recent report from the U.S. Food and Drug Administration, however, Neti Pots may actually increase users’ risks of contracting an infection. In a statement warning consumers about Neti Pots, the FDA said that some tap water used in conjunction with the device can contain harmful bacteria and protozoa, including amoebas. If these bacteria are swallowed, the stomach is capable of killing them. If the organisms enter the nasal passage, however, they can survive and cause a potentially life-threatening infection. The FDA is advising consumers to use sterile or distilled water in Neti Pots in lieu of tap water. They also suggest boiling tap water and allowing it to cool before using it in the Neti Pot. Filtered water or bottled water may also be a viable option. It is also advisable to sanitize the device between uses to prevent cross-contamination or recontamination.

If you experience an infection linked to a Neti Pot, you can report the incident to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Although Neti Pot is one of the most popular brands of nasal rinsing products, there are many similar devices sold under other brand names that pose an identical threat of nasal passage infection.

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