The Dangers of the FDA 510(k) Process: How Drugs and Devices Skip Clinical Tests

Did you know that 32 million Americans have at least one medical device implant?

As the main regulatory agency charged with ensuring the safety and efficacy of drugs and medical devices, the Food and Drug Administration (FDA) is entrusted with the safety and well-being of countless Americans every day. Their mission statement describes the agency as being “responsible for protecting the public health by ensuring the safety” of products, such as medical devices and pharmaceutical drugs.

However, the reality is that many people are hurt by medical devices that have slipped through loopholes in the FDA’s regulatory framework. This includes the 510(k) Fast Track program.

What is the 510(k) Fast Track Program?

Americans want solutions, and they want them fast. In an effort to reduce the time it takes for a medical device to become available to the public, many manufacturers often use a fast-track premarket approval process known as the 510(k) Fast Track program when submitting their devices to the FDA for marketing approval.

Through this process, the manufacturer must demonstrate the device is safe and effective enough to be marketed without further testing. Thus, the length of the approval period is significantly shortened.

How Products Are Approved Under the 510(k) Program

For a device to be approved under 510(k), manufacturers must first file a Premarket Notification (PMN). The FDA will review the PMN within 90 days to determine which class the device falls into.

Devices are put into one of three categories:

  • Class I: This class is considered “low risk” and involves devices not intended to treat potentially fatal conditions, or that won’t cause life-threatening harm if misused. Class I devices are available over-the-counter and not governed by the FDA.
  • Class II: This class is for “medium risk” devices that are not typically intended to treat potentially fatal conditions but can cause harm if misused. Class II devices are eligible for 510(k).
  • Class III: This class is for “high risk” devices that are intended to support or sustain life and present high risk of injury or death if misused. Class III devices are not eligible for 510(k).

In addition to this three-tiered system, the FDA allows what is known as substantial equivalency through the 510(k) program. This means that a new device can be approved if the manufacturer can demonstrate that it is as safe and effective as a similar, previously approved medical device, known as the primary predicate.

To prove substantial equivalency, the device must have:

  • The same intended use as the predicate; and
  • The same technological characteristics as the predicate;

Or

  • The same intended use as the predicate; and
  • Different technological characteristics, yet does not raise different questions of safety and effectiveness; and
  • The information submitted to FDA demonstrates that the device is at least as safe and effective as a similar, the legally marketed previously approved device.

Proving a device is similar enough to another device already on the market bypasses specific testing. Because of this, almost two out of three 510(k) applications are cleared within six months.

Why the 510(k) Program is Faulty

The FDA’s 510(k) fast-track program often causes more problems than it solves.

Thousands of unsuspecting consumers might imagine that our medical device industry only delivers quality, life-saving products to Americans in need. However, the reality is that our medical device industry actually willingly bypasses important testing by expediting the approval process, skipping vital steps that could save lives.

510 (k)

Fast-tracking puts devices on the market with little to no specific testing. Because many products do not undergo important clinical trials, consumers end up being the true test subjects for manufacturers. New side effects and dangers are only discovered over the life of the device – and without clinical trials – unsuspecting patients can be injured.

To complicate matters, it is difficult to remove a device from the market once it has been approved, even if it has injured multiple consumers. If a device’s primary predicate is recalled, there is a significant chance that the substantially equivalent 510(k) device is also dangerous. However, the two products are treated separately, meaning the 510(k) device may remain on the market even if its predecessor was later proven dangerous.

Popular Medical Devices Recalled After 510(k) Program Approval

Many products fast-tracked through the 510(k) Fast Track Program have caused untold damage to countless Americans. Notorious devices include metal-on-metal implants and transvaginal mesh.

Certain hip replacements released to the public were made of titanium parts, which corroded when the joints rubbed together. This released metallic debris into the bloodstream, leading to a dangerous condition known as metallosis, or blood poisoning. These metal-on-metal implants received 510(k) clearance without additional clinical testing after proving substantial equivalence to earlier devices.

510 (k)

Another example, transvaginal mesh, received nationwide attention after the FDA received more than 3,000 reports of adverse reactions in just two years. Two such products – ProteGen bladder sling and Mentor ObTape – have been removed from the market. However, Avaulta’s vaginal mesh sling remains on the market, despite numerous side effects and lawsuits filed by recipients.

The FDA has since concluded that transvaginal mesh, originally labeled as having “moderate risk,” was linked with serious complications such as organ perforation, chronic infections, mesh erosions and other permanent damage.

Contact the Defective Drug Attorneys at Searcy Denney

Unfortunately, the FDA’s 510(k) program has caused many Americans to be unwillingly used as guinea pigs for uncovering dangerous side effects of medical devices that should have been properly tested beforehand. If you were harmed by a dangerous medical device, you are not alone. Thousands of injured individuals have taken legal action to stand up against Big Pharma.

Our team of experts understands the pain and heartache caused by dangerous medical devices. With our experience, we can help answer any of your questions so that you feel confident in your choice to seek legal remedy.

At Searcy Denney, we stand upon 40 years of experience helping our clients return to their normal lives after they are injured from the negligent and careless acts of others. We can help you, too. Find out how in a free, private consultation today by calling (800) 388-3905.

Popular Fluticasone Nasal Spray Recalled by Manufacturer

Small particles of glass are to blame for the recall of a widely used fluticasone nasal spray that treats symptoms of hay fever in children.

The nasal spray, known by its brand name Fluticasone Propionate Nasal Spray USP and manufactured by Apotex Corp., of Weston, Fla., was pulled voluntarily from the market by the company, which said the glass particles could clog the bottle and cause it to malfunction and, more importantly, abrade the inside of the nose. The U.S. Food & Drug Administration (FDA) said the issue was detected via a complaint.

Glass Particles Found in Spray Bottle

“The glass particles could block the actuator and impact the functionality of the pump,” the FDA said in a safety alert titled “Fluticasone Propionate Nasal Spray by Apotex Corp: Recall – Due to Potential for Small Glass Particles.” “There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product.”

With the exception of the complaint, Apotex Corp. has not been made aware of any other adverse events as a result of the recall.

“Patients, wholesalers, retailers, hospitals or institutions with Lot# NJ4501 and an expiration date of July 2020, should stop use and distribution of the remaining units and quarantine immediately,” according to the safety alert. “Healthcare Professionals in your organization should be informed of this recall.”

Fluticasone Widely Used for Allergies

Fluticasone By Ramon FVelasquez [CC BY-SA 3.0 (https://creativecommons.org/licenses/by-sa/3.0)], from Wikimedia Commons

Fluticasone inhalers

Fluticasone Propionate Nasal Spray USP is for patients between the ages of 4 and 17 who suffer from seasonal allergies, sinus pain, sneezing and a stuffy nose. The drug also helps with itchy, watery eyes. It is a corticosteroid. WebMD explains its uses:

“The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or use this drug more often or for longer than directed. Your condition will not improve any faster, and your risk of side effects will increase. You may be directed to start with a higher dose of this drug for the first several days until you have begun to feel better, then decrease your dose. Children may need to use this drug for a shorter amount of time to lower the risk of side effects. If a child is using the over-the-counter product, read the package information to see how long he / she should use it and when you should check with the doctor.”

WebMD notes that the drug does not relieve symptoms immediately.

“You may feel an effect as soon as 12 hours after starting treatment, but it may take several days before you get the full benefit. If your condition does not improve after 1 week, or if it worsens, stop using this medication and consult your doctor or pharmacist. If you think you may have a serious medical problem, get medical help right away.

Precautions Necessary for Fluticasone Use

WebMD describes some of the precautions, as well.

“Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness / injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may slow down a child’s growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child’s height can be checked. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.”

Anyone who has experienced problems with Fluticasone Propionate Nasal Spray USP should contact his or her physician immediately. The affected product’s label reads “50 mcg per spray 120 Metered Sprays.” It was distributed to wholesalers, including Sam’s Club and Walmart, nationwide.

“When inhaling nasal spray, glass probably tops the list of things you hope aren’t accidently in the bottle,” Healthcare Packaging states in an article on its Web site titled “Nasal Spray Recalled After Packaging Found to Contain Glass Particles.” “According to a recent FDA news release, Apotex Corp. has voluntarily recalled one lot of Fluticasone Propionate Nasal Spray for just that reason.”

Consumers who have questions about the recall are encouraged to reach out to Apotex Corp. at (800) 706-5575 or at uscustomerservice@apotex.com. Healthcare professionals are encouraged report adverse events to the FDA MedWatch program at fda.gov/medwatch A form also can be obtained by calling (800) 332-1088.

Data Breaches Prove Costly for Major Businesses

In an age where data is widely available and almost everything is stored online, data breaches are becoming more common, and the outcomes of cases involving data breaches are unpredictable. Data involved in a breach can range from financial data, such as credit card numbers, to health data, such as treatments and medical history. Based on previous settlements reached, stolen health data typically has the most extensive damages due to the incredibly personal nature of the data, while stolen credit card data has the least damages. It is a lot easier to cancel and replace a credit card than it is to replace identifying information such as a Social Security number. When there is a breach of identifying information, continued alertness is necessary to prevent identity theft, adding to the costs.

The Type of Data in a Data Breach Matters

There are two cases that illustrate the disparity between settlements involving different types of data. An infamous hacker who goes by the name “Cumbajohnny” was responsible for hacking both T.J Maxx and Heartland Payment Systems. Data for approximately 130 million credit and debit cards was stolen from Heartland, and more than 45 million credit card5s were affected from the T.J Maxx breach. However, the Heartland settlement was $500,000, despite involving the breach of three times the amount of data. The T.J Maxx settlement was valued at $6.1 million. The court’s value was based on the type of data breached; Cumbajohnny and his cohort stole identification information from at least 450,000 customers of T.J Maxx, including Social Security and driver’s license numbers. Although the nominal value of credit card information was larger for Heartland, considering the threat of identity theft, the real value of the 455,000 people affected from T.J Maxx was much greater. In fact, eighty-six percent of the T.J Maxx settlement was from the much smaller number of identifying information stolen, and the other fourteen percent is attributed to the 45 million stolen card records.

Although identifying information is valuable in settlements, medical records often add the most value to a data breach settlement because they contain deeply personal information. For example, the breach of Advocate Health Care included unencrypted medical records, affecting 4.03 million patients. The case settled for $5.55 million, remaining the largest HIPAA settlement to date. This case exemplifies the need to keep up with the swiftly-evolving digital landscape to protect clients’ information. It may also demonstrate legislative attention to particularly personal and sensitive data. Due to the variation and uniqueness of each data breach case, it is important to evaluate the types of compromised data.

Identify Theft Also Important Factor

Generally, cases with elements identity theft will be stronger because it is difficult to prove standing without it. Some jurisdictions require the plaintiff to have suffered from identity theft to have standing. It can be difficult to prove that the hacker had malicious intention and/or sold the data they stole, and until they do sell it, some jurisdictions will not give the class standing. For large data breach cases, such as the T.J Maxx settlement, the plaintiff’s attorneys must be prepared to litigate the case under the standing rules of the federal court in any district because many cases filed all over the country can be consolidated into one federal district court for multidistrict litigation.

The value of data breach cases does not only include the monetary value of the breach. Protection against future losses, such as improved digital security and credit monitoring, are important to preventing identity theft and ensuring the affected company isn’t breached again. It can be beneficial to the plaintiff if the company at fault had a previous breach and did not take proper measures to increase their security.

What Happened After the Breach?

Before initiating a case, it is valuable to research what a company has already done after experiencing a breach. Oftentimes, the company will offer one-year free credit-monitoring for customers who experience ongoing credit risk. While credit-monitoring is helpful for preventing a breach, some companies may only monitor one of the three credit bureaus (Equifax, Experian, and TransUnion) to keep costs low, leaving customers vulnerable to fraudulent activity that shows up on other bureau’s credit reports.

Researching if the company bulked up its security after a breach is also useful. It can be difficult to find exactly what the company did in the aftermath because the discovery may not be accessible. Cybersecurity blogs can come in handy to get technical details of how the hacker was able to get into the company’s system in the first place and learn what, if anything, the company did to improve security. If there is a lot of room for security or credit-monitoring improvement, the value of the settlement may be greater, however the court can enforce this by either raising the dollar value of the settlement or mandating the company increases security. For example, after the Target data breach, which affected 41 million customers, the settlement required Target to employ a chief officer who manages security, to actively monitor its systems for security events, provide security training to its employees for five years, and perform routine security assessments. The case settled for $18.5 million, but the injunctive relief was much greater.

Third Party Vendors Can Play Role

Determining if the company or a third-party vendor is at fault for the breach can be challenging. The company experiencing the data breach often claims they have the most up-to-date security systems, however discovery usually reveals gaps that the hackers used to get in and out with the data. If a third-party could be responsible, it would be best to establish the relationship between the company and the vendor as soon as possible and determine if the vendor is primarily responsible for the breach.

An example where the vendor was unmistakably at fault is the case of the Stanford Hospital data breach. The hospital’s business associate (BA), Multi-Specialty Collection Services, LLC, posted 20,000 patients’ emergency room records, including hospital account numbers, billing charges, and emergency room admission and discharge dates, to a student homework website asking how to graph the patients’ data. Stanford Hospital properly encrypted the records before sending them to the vendor, but they were still responsible for paying the administration costs of the $4 million settlement. The hospital also agreed to train its vendors on how to most effectively protect patient data. Since vendors are typically smaller entities, they likely have fewer resources, and this could affect the settlement amount.

Toxic Chemicals Still Found in Many Common Cosmetics

The U.S. Food and Drug Administration’s (FDA) slow and retroactive response to toxic chemicals found in cosmetics is being called into question. In the past year, there have been more protests urging the FDA to ban lead acetate, a compound found in hair dyes. It was banned in Canada and Europe nearly a decade ago for causing toxic levels of lead to build up in the blood, so what is taking the U.S. so long? Part of the reason why harmful chemicals aren’t banned from cosmetic products faster is that the FDA can only regulate products if it receives “reliable information,” as stated in the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Public protests, such as the petitions against lead acetate, are the beginning of the process that incites the FDA to begin research of the chemical, but this research can take years to complete. It is the responsibility of the FDA to find evidence that a certain product is harmful when used as intended because the manufacturer of the product is not required to submit their data. The research necessary to find such evidence takes time to complete. In the meantime, these dangerous chemicals will already have continued to harm many people.

Cosmetic Industry Also at Fault

The FDA’s response to toxic chemicals in cosmetics is not the only issue; there is no regulation of chemicals before the cosmetic products go to market. A company does not have to perform particular tests on products containing new chemicals, nor is it mandatory for the companies to publicize safety data they collect. Lack of accountability has allowed cosmetic manufacturers to use chemicals in everyday items, such as shampoo and toothpaste. Some cosmetics can contain formaldehyde, a byproduct of some preservatives put into cosmetics. The chemical is commonly used as a preservative for dead animal parts, such as the frog you may have dissected in science class. Formaldehyde was declared a human carcinogen by the National Toxicology Program at the Department of Human Health and Services in 2011 because it can cause cancers of the nasal cavity, myeloid leukemia, and rare cancers. About one fifth of cosmetics contain formaldehyde, a scarily high percentage.

Preventative Measures Are Ready For Congressional Passage

toxic chemicals cosmetics

Henri de Toulouse-Lautrec’s “Woman at her toilette”

Consumers should not have to worry about using cosmetics which may have toxic effects on their bodies. One preventive measure the U.S. could enact is to ban chemicals based on preliminary toxicity data rather than the exhaustive data and research that is required. The Personal Care Products Safety Act is a piece of legislation recently introduced in Congress by Senator Dianne Feinstein which may help solve the problem. If passed, the bill will give the FDA the authority to take products off of store shelves immediately after receiving any reports of customers experiencing bad reactions. This will help close the gap between initial complaints and the years it takes the FDA to gather information before banning the chemical. Furthermore, the bill includes the mandate that manufacturers register their facilities and pay a fee to the FDA. The money will be used to determine the safety of at least five cosmetic ingredients a year. This preventative measure will help eliminate the inefficient process of removing harmful products from store shelves after they have gone to market.

While passage of this bill would be an excellent start to solving the problem, the FDA must enforce more thorough regulation of cosmetic products all around. Unfortunately, the laws on regulation of cosmetics do not require FDA approval before being put on the market, apart from color additives. The administration advises the manufacturers to consult available toxicological test data and perform any additional tests necessary to ensure the safety of the product. However the FDA has no legal jurisdiction to ban a product unless a law has been broken, such as the misbranding of a product. Implementing stricter regulations on companies will bring more peace of mind to consumers who should not have to worry about the toxicity of their cosmetics in the first place.

Plaintiff Awarded $27.8 Million in First Xarelto Pennsylvania State Trial

On Tuesday, a jury entered a verdict of $27.8 million against Johnson & Johnson’s Janssen Pharmaceuticals, Inc. and Bayer AG’s Bayer Pharmaceuticals Inc. in the first state court trial out of the Philadelphia County Court of Common Pleas’ mass tort program consolidating Xarelto-related injury lawsuits. Plaintiff, Indiana resident Lynn Hartman, sought damages after she was hospitalized in 2014 with a gastrointestinal bleed. She stated she required four blood transfusions to counter the injury. Ms. Hartman testified she took Xarelto for more than a year – to treat her atrial fibrillation – before her hospitalization. She blamed her Xarelto use for the hospitalization, noting that she subsequently used another blood thinner without incident. The jury agreed with her and awarded $1.8 million in compensatory damages and $26 million in punitive damages.

The plaintiff’s claims were based, in part, on allegation that Janssen and Bayer manipulated the clinical trials for Xarelto and failed to adequately warn patients of the bleeding risks involved with Xarelto use. Former FDA Chief David Kessler testified at trial that, in his opinion, the drug’s warning label did not sufficiently inform doctors or patients of the severity of the potential bleeding risks.

Janssen and Bayer responded to these allegations by arguing the warning label statement that Xarelto “can cause serious and fatal bleeding” was more than sufficient warning of the drug’s bleeding risks. Additionally, the defendants relied upon testimony of Ms. Hartman’s treating physician that she would still have prescribed Xarelto to the plaintiff even with the heightened warning, even though she felt additional information should have been included on the label.

Trial_by_Jury_UsherWitness Tampering Allegations

This trial was not without its share of drama. At the beginning of trial, the plaintiff’s attorneys alleged witness-tampering by a Janssen sales representative. The representative had visited one of Ms. Hartman’s treating physicians, Dr. Aldridge, prior to the physician’s deposition. During the deposition, Dr. Aldridge testified that he did not believe the plaintiff’s gastrointestinal bleed had been cause by Xarelto; his testimony seemed to contradict his notes made during Ms. Hartman’s 2014 hospitalization.

Judge Michael Erdos, who presided over the trial, granted the plaintiff’s request to take Dr. Aldridge’s deposition during the trial. Granting a mid-trial deposition is an unusual event, to be sure. However, following the deposition, Judge Erdos denied Ms. Hartman’s request to use the doctor’s testimony during trial. The judge’s denial was grounded in what he determined to be a lack of evidence showing an attempt to influence Dr. Aldridge’s testimony.

Where Does Xarelto Litigation Go from Here

Lynn Hartman’s case was one of approximately 1,500 cases pending in the Philadelphia County Court of Common Pleas. The federal multidistrict litigation currently has around 20,000 cases. Three bellwether trials have concluded from the MDL. All three trials resulted in verdicts in favor of Janssen Pharmaceuticals and Bayer Pharmaceuticals. The next Philadelphia trial is scheduled to begin in January.

Johnson & Johnson and Bayer officials have stated they will appeal the December 5, 2017 Philadelphia verdict.