Differences Between The 510(k) And PMA Approval Processes And How This Affects Lawsuits

As per U.S. Food and Drug Administration (FDA) rules, anyone planning to manufacture or distribute a medical device within the United States must either obtain premarket approval (PMA) or complete a 510(k) submission for that device. Either way, the specific type of approval required is wholly dependent on the device’s classification, which is directly correlated with its overall risk value. This value is determined by the risk the device in question can pose to a patient or consumer and is separated into three specific classes: Class I, Class II, and Class III. Each class is organized by severity, with I consisting of low risk devices and III consisting of high-risk devices.

Consequently, medical device manufacturers must adhere to three primary steps. First, they must assess the product in order to determine classifications as per FDA guidelines. Once the product is properly classified, the manufacturer will then determine whether the device requires PMA or a 510(k) submission (more on that in a moment). Finally, the manufacturer must submit the appropriate documentation to the FDA for final approval.

Unfortunately, many manufacturers run into snags when it comes to selecting a 510(k) or PMA. This is a crucial decision because it will have a fundamental impact on any lawsuits that may arise. To help demystify any confusion, here is a description of each, as well as an explanation of how each will affect any impending lawsuits.

An Explanation Of Premarket Requirements

Medical devices are divided into three specific classes due to their determined risk factors (sometimes referred to as a “risk profile”) and intended use. The FDA’s website uses the example of a scalpel to establish a definition of “intended use”. According to them, a scalpel’s intended use is to cut organic tissue. If a more specific use is intended, that designation must be appended to the product’s outer label.

Class I devices pose minimal risks to users and are subject to general medical device regulations. As such, they do not require premarket submissions. Class II devices contain some level of risk and cannot be marketed until a 510(k) has been submitted. A 510(k) is essentially a premarket notification. Items that fall into this category are defined as crucial to healthcare but could cause a critical injury upon malfunctioning. Class II devices include sutures, intravenous kits, pregnancy kits, and motorized wheelchairs.

Finally, Class III devices can be defined as those that sustain life or are surgically implanted. Examples include pacemakers and blood vessel stents. The FDA views these devices as substantially risky to patients’ health. Consequently, these devices require PMA submission before being approved for marketing in the United States.

The Differences Between 510(k) And PMA Approval Processes

We have already outlined one clear distinction between 501(k) approval and PMA processes: Class II medical devices require the former, while Class III requires the latter. However, there are a few other distinctions that must be grasped in order to understand how both affect potential lawsuits.

510(k) submissions give the FDA documentation that establishes substantial equivalence. In other words, it proves your device is equivalent to a preceding device that has already been approved for marketing. These types of submissions usually take anywhere from 30 to 90 days. Establishing substantial equivalence requires one to compare their product with something previously released. Typically, this is done in a laboratory setting and human testing is rarely required. Additional information that will help manufacturers successfully submit a 510(k) include documented design controls process, which encapsulates intended use, as well as design inputs and verification.

PMAs, on the other hand, are decidedly more comprehensive than a 510(k). Essentially, they are used to prove that a device is both safe and effective for potential users. This usually necessitates laboratory testing as well as clinical trials involving humans. Needless to say, PMAs have much higher standards than their counterparts. Additionally, the FDA has up to 180 days to accept or reject the application, so the procedure is considerably more stringent.

Lawsuit Considerations

As far as 510(k)’s are concerned, it is up to the plaintiff and defense attorneys to assess relevant evidence as it relates to the case at hand. This assessment can be conducted during any phase of the trial, including prior to filing a complaint, during pretrial, and during discovery. Historically, most defense attorneys prefer to present 510(k) compliance information directly to a jury. The submission of the 510(k) itself shows that their clients adhered to regulations as well as exercised proper safety precautions prior to bringing their medical device to market.

The goal of the defense is to get the jury to agree that the FDA’s approval of the 510(k) meets the societal safety standards in such a way that shows the manufacturer maintained the utmost responsibility and genuine concern for public safety. Plaintiffs, on the other hand, typically do not want 510(k) evidence to go before a jury at all. Their lawyers will usually argue that the substantially equivalent standard of the 510(k) does not correlate with societal safety standards. This stands in stark contrast with PMA standards, as they usually meet these requirements by design. Plaintiffs typically make this argument knowing full well that the jury may decide in the defendant’s favor because the medical device has already passed FDA standards (obviously without knowing that they are far less stringent than what is required for a PMA).

A foundational decision was reached in 1996, when the United States Supreme Court weighed in on Medtronic, Inc. v. Lohr, 518 U.S. 470, which directly concerned the FDA’s approval processes for PMA and 510(k). They found that the FDA averaged approximately 20 hours on each 510(k), while spending an average of 1,200 hours on each PMA. This allowed the court to reach the conclusion that the PMA process is much more thorough and stringent than the 510(k). Today, this decision is integral to current court battles centered around the 510(k).

510(k) Opponents

The 510(k) process is frequently criticized for what is perceived to be a lack of scrutiny, especially when contrasted with the PMA process. More specifically, opponents argue that the substantially equivalent test is not thorough enough to protect consumers in the first place. A frequent weapon used by opponents is statistics addressing the recall rates of 510(k) Class I medical devices. Another popular argument is that the FDA is not privy to all of the information in the manufacturer’s possession or does not have enough employees to exercise proper oversight.

510(k) Proponents

On the other side of things, proponents of the 510(k) argue that the process strikes a perfect balance between safety and availability. In their view, eligible devices receive attention that is equivalent to any potential dangers. Much like the opponents, proponents have their own set of statistical data they love to cite. One study argues that a mere 0.2 percent of all 510(k) approved devices experienced a Class I recall. Further, they argue that the substantially equivalent standard is proof that the FDA has declared the medical device safe for public use.

Staying on top of these dynamically evolving arguments is essential for future prosecution and defense strategies. Additionally, the opposing viewpoints will help define new standards during litigation.



Fisher Price Rock ‘n Play Recall and Litigation


On April 12, 2019, children’s toy company Fischer-Price announced they are in the process of recalling 4.7 million of their Rock ’n Play sleepers. The United States Consumer Product Safety Commission (USCPSC) posted a recall notification on their website that applies to all models. The notification states, “Since the 2009 product introduction, over 30 infant fatalities have occurred in Rock ‘n Play Sleepers, after the infants rolled over while unrestrained, or under other circumstances.” Further, the recall advised that consumers stop using the product entirely “and contact Fisher-Price for a refund or voucher.”

The Initial Warnings: Fischer-Price Issues A Recall Notice, Mattel Steps In

The recall follows in the footsteps of a warning issued one week prior by the company and the USCPSC that instructed consumers to stop using the product “as soon as the infant exhibits rollover capabilities”, which would equate to around three months old. The warning also made mention of 10 infant deaths.

More recently, Consumer Reports worked hand-in-hand with the American Academy of Pediatrics (AAP) to persuade Fischer-Price to remove the product from shelves. An investigation conducted by Consumer Reports turned up 32 dead babies, with some of them even younger than three months. Marta Tellado, president and CEO of Consumer Reports, used this as an opportunity to claim that the report should have been issued much sooner. She said, “The Fisher-Price recall of the Rock n’ Play is long overdue. Fisher-Price and the CPSC knew about deaths linked to this product for years and could have taken steps to avoid this unnecessary tragedy. It took dogged investigation and the voices of doctors, victims’ families, and advocates across the country to make this recall a reality. Congress needs to take a hard look at the CPSC and make sure it is a watchdog that consumers can rely on.”

On Thursday, April 11, Consumer Reports found that four more infant deaths were attributed to two different sleepers produced by the company Kids II: the Bright Starts Playtime to Bedtime Sleeper and the Ingenuity Moonlight Rocking Sleeper.

Shortly after, Mattel, Fisher-Price’s parent company, posted a recall notice on their website letting customers know how to initiate the refund process. It also explained that if they had owned a Rock ’n Play Sleeper within the last 6 months, they would receive a full cash refund. Further, the notice stated that customers who still had their receipts would be “reimbursed for the receipt amount including sales taxes paid.” Those without receipts were told to write the month and year the purchase was made on one of the items they are returning. While it is certainly acceptable that the company is accepting returns, some are wondering whether that is enough.

Claims Of Dubious Marketing

A quick glance at Fisher-Price’s social media content yields hundreds, if not thousands, of images of babies snugly positioned inside the Rock ’n Play. Some are crying foul because the marketing campaign seems designed to assuage sleep deprived parents into thinking the product will ensure they get a peaceful night’s rest. Images aside, examining the copy a little more closely makes it clear that customers still did not understand the potential harm that could result from using the product.

Several lawsuits are now echoing claims previously raised by doctors and consumer safety advocates that accuse Fisher-Price of failing to do all that was necessary to fix the problem. During the most recent recall, the company deflected blame for the 30 sleeper-linked child deaths. In their view, they claimed that the customers were not using the device properly. Specifically, they claimed that customers had failed to properly strap their children in or had put additional items in the sleeper along with the infant. Never mind that Fisher-Price’s previous marketing campaign included phrases such as “baby can sleep at a comfy incline all night long”, which directly contradicts pediatricians’ suggestion that children should sleep on their backs and without restraints.

Claims Of Hesitation

Consumer rights advocates also hit Fisher-Price with accusations of waiting too long to initiate a recall. They pointed out how the first sleeper-related suffocations occurred years before the recall. Rather than doing anything, the groups claimed, the company sat back and relied on government-issued warnings. Meanwhile, their marketing campaigns continued unabated.

Responding to these accusations, Fisher-Price claimed that their products consistently met all necessary regulations within the United States. Further, the company claimed that each sleeper included “very specific and conspicuous product usage instructions and warnings that we urged parents and caregivers to read and follow carefully.”

Class Action Lawsuits

Combined, the infant deaths, Fischer-Price’s marketing campaign, and the company’s alleged inaction resulted in a slew of class-action lawsuits. One suit in particular involves Samantha Drover-Mundy and Zachary Mundy, whose 12-week-old child died after spending a short amount of time in a Rock ’n Play. The pair sued Fisher-Price, their parent company Mattel, and Amazon for promoting marketing copy that touted “dangerous features as selling points.” Additionally, the Mundy’s claim Fisher-Price lobbied the government to sidestep various regulations that would have otherwise resulted in the sleeper’s removal from the market.

Reports Of Sleeper-Related Injuries Have Been Pouring In Since 2005

Sleepers function by propping infants up in a specific position. The manufacturer, along with many parents, claims that this helps with babies’ tempers and general discontent. However, despite claims to the contrary, Consumer Reports says they received more than 675 reports from 2005 and on describing sleeper-related injuries in children. Prior to 2018, the sleepers saw approximately 8 recalls, which amplified concerns about children being critically injured.

Nearly 7 years later, in 2012, the United States Food and Drug Administration (FDA) issued a warning that instructed consumers to refrain from placing their babies in sleepers. However, at that point in time there had been around 13 sleeper-related deaths. According to the AAP, each year just under 4,000 infants die in the United States as a result of sleeper-related injuries. However, a slew of awareness campaigns throughout the 1990s resulted in much lower mortality rates.

Specifically, the AAP mentioned the dangers of products that keep the infant restrained, stuck in an inclined position, or both. As mentioned earlier, they have instructed consumers to let infants sleep on their backs on a flat surface without the soft bedding that usually lines the interior of sleepers. However, it is plain to see that the Rock ’n Play, released in 2009, never adhered to these guidelines in the first place.

Boasting a $40 price tag, the Rock ’n Play was an obvious choice for many sleep deprived parents looking for a thorough night’s rest. For some, the problem was so severe that they were chronically missing work just to catch some extra sleep.

However, many pediatricians noticed that infants who spent prolonged amounts of time in sleepers were experiencing a condition called torticollis, where the head twists to one side or the other as a result of excessive strain. On the other hand, some pediatricians claimed it was responsible for flat spots in babies’ skulls. Still, others were claiming that the sleepers were developing a dangerous mold that could cause respiratory problems. This latter claim prompted the recall of nearly 800,000 sleepers in 2013.

As some have likely inferred, all of this occurred in the midst of the Consumer Reports study that associated 32 infant deaths with the Rock ’n Play. One complaint in particular mentioned a child who fell from one of the sleepers despite being properly restrained, while another addressed a child who had died as a result of rolling over in theirs. Despite warnings, which prompted officials in Australia and Canada to ban the product from being sold, the United States allowed the product to remain on the market, where it continued to sell very well.

Still, some have continued to swear by the product. Actor and blogger Stuart Brazell sings its praises, touting its exceptional quality along with the fact that she has used it to harness her son for over a year. Brazell had signed up to be a part of Fisher-Price’s influencer campaign, specifically designed to advertise the Rock ’n Play to consumers via social media channels such as Instagram and Facebook. She claims she was given very specific instructions that had to be adhered to, including ensuring her child was properly harnessed and that the product was placed on a flat surface. Fisher-Price also insisted on approving the image prior to its being made public.

However, it is important to note that Brazell has recently changed her tune. She stopped using the product when her child, now 9 months old, began to roll over. Now, she claims that if she had a second child she would be completely unsure of what to do.

If you and your family have been affected by issues associated with the Rock ’n Play, Cowper Law is ready to help. We understand that dealing with this can seem impossible and overwhelming, which is why we are here to help in any way we can. We will provide the representation you need and strive for the best outcome possible. Give us a call at 877.LAW.3707 or visit our website to schedule a consultation.



Xarelto MDL: Settlement

An In Depth Look At The Xarelto Case

Johnson & Johnson and Bayer, who were recently sued as part of several mass tort litigations on both state and federal levels, have agreed to pay $775 million to settle approximately 25,000 lawsuits involving the blood thinner Xarelto, which is jointly sold by both companies. They decided to split the settlement evenly between them.

Warafin, Xarelto, And Andexxa

Intended as a replacement for Warafin, which had been on the market for about 60 years, Xarelto thins the blood in order to prevent arterial fibrillation, a rhythmic heart disorder, and to prevent the types of blood clots that cause pulmonary embolisms, strokes, and heart attacks. It was approved by the U.S. Food and Drug Administration (FDA) in 2011.

The lawsuits allege that the medication triggered substantial bleeding that led to death and grave injury. The episodes were resistant to standard treatments, and patients had to endure years without an antidote. Last year, however, the FDA approved Andexxa, which successfully stops bleeding induced by Xarelto. The medication is sold by Pfizer and Bristol-Myers Squibb.

Interestingly, patients taking Warafin, the original drug, had to be closely monitored, including undergoing frequent blood tests, to confirm that the drug was working at all. Too little of the drug could result in a stroke, too much could result in the kind of stomach bleeding exhibited in the Xarelto cases.

Statements And AccusationsBoth state and federal cases blame the companies for failing to warn about potentially fatal bleeding that can occur when the drug is ingested. Interestingly, neither company admitted liability, with each noting in separate statements that they had won in six previous lawsuits that actually went to trial.

Hartman Etal vs. Janssen Pharmaceuticals, Inc Etal

Plymouth, Indiana resident Lynn Hartman, 75, was prescribed Xarelto by her doctor and took the drug from March 2013 to June 2014. Throughout that time Hartman claims she experienced gastrointestinal bleeding, at which point she stopped taking the drug. Hartman drew from the Xarelto amended master complaint to bring the following claims: design defect, manufacturing defect, negligent misrepresentation, breach of express warranty, failure to warn, breach of implied warranty, and both fraud and violation of consumer protection laws in Indiana and Pennsylvania.

A Flawed Clinical Trial?

Lawyers for the plaintiffs in previous lawsuits questioned whether the initial clinical trial that resulted in the drug’s approval was inherently flawed due to a defective blood-testing monitor that was used throughout the study. Essentially, the lawyers claimed the machine skewed the results. However, the FDA eventually stepped in and concluded that the defects had no bearing on the trial’s outcome.

The device in question is the INRatio, which is sold by Alere. The INRatio was originally used to test whether patients were administered correct doses of Warafin. During the trial, the plaintiff’s attorneys compared the overall number of bleeding occurrences experienced by patients taking Xarelto to those who used to take Warafin. One of the key questions regulators are examining is whether the defective INRatio may have given doctors inaccurate information, which caused them to prescribe too much Warafin.

The Defendants Settle Despite Winning Streak In State And Federal Courts

Johnson & Johnson and Bayer’s decision to settle seems all the more perplexing in light of a specific 2018 case that saw the plaintiff, Lynn Hartman, awarded $28 million, only to have the ruling subsequently reversed by Judge Michael Erdos. This decision was quickly followed by another victory for the defendants.

Lawyers for the plaintiffs in the second case accused Johnson & Johnson and Bayer of spreading “inaccurate or misleading statements regarding the present status of the Xarelto litigation in an attempt to undermine the soundness of plaintiffs’ failure-to-warn claims”.

The defendants responded to this accusation by detailing the specific accusations against them they deemed to be false. First, they were accused of improper testing prior to release, as well as lacking a black box warning about potential bleeding risks. Second, they said they were accused of failing to inform doctors about certain testing. The latter theory was eventually rejected in three multi district litigation (MDL) trials.

Michael M. Weinkowitz, a member of the plaintiff’s legal counsel, claimed the reversal had more to do with the doctor who wrote Hartman’s prescription: “The dismissal was based on a very narrow issue related to Mrs. Hartman’s prescribing physician. However, the court also ruled that the jury’s punitive damages verdict was appropriate and that sufficient evidence existed for the jury to find that the defendants acted with reckless disregard for human life.”

Weinkowitz went a step further in suggesting that the jury’s $26 million in punitive damages “has far broader implications for the Xarelto litigation as a whole”, thus implying that this ruling could be the turning of the tide.

The Defendant’s Decision Bears Similarities To An Older Case

In 2014, German pharmaceutical manufacturer Boehringer Ingelheim paid $650 million to settle approximately 4,000 lawsuits over their drug Pradaxa, which was facing similar accusations of injuries and bleeding deaths. Their response was strikingly similar to Johnson & Johnson and Bayer’s: “Time and again, the benefits and safety of Pradaxa have been confirmed.”



Surgical Staplers

FDA Moves On Surgical Stapler Malfunctions

Surgical staplers and implantable staples are used in a variety of surgical procedures, including gynecological surgery, gastrointestinal surgery, appendectomies, lung surgery, heart surgery, and thoracic surgery. Compared to manual suturing, surgical staplers and staples drastically reduce the overall time it takes to complete a procedure. The staples can be placed relatively quickly, cause negligible tissue reaction, and carry a low risk of infection. However, this does not imply they are not without serious problems.

A recent U.S. Food and Drug Administration (FDA) internal analysis reveals that between January 1, 2011 to March 31, 2018, the agency received more than 41,000 MDRs regarding surgical staplers and staples. Incidents listed in the reports consisted of over 32,000 malfunctions, 9,000 serious injuries, and 366 deaths. Unfortunately, this information was not made available to the public until very recently.

According to FDA data, common problems included opened staple lines, malformed staples, and misfiring staplers. Another recurring issue was misapplied staples, which can occur in two ways: when a staple is applied to the wrong area, or when a staple of the wrong size is used. Complications from surgical stapler and internal staple malfunctions can be severe and can result in an extended surgical procedure, additional surgeries, and further complications such as bleeding, tearing of the organs and surrounding tissue, and death.

This Previous Ruling Could Be Indicative Of Future Trends

In 2015, a California jury awarded approximately $80 million in damages ($10 million in compensatory and $70 million in punitive) against Ethicon, a Johnson & Johnson subsidiary. The plaintiff, a former police officer, was injured when doctors accidentally stapled her anus shut during a hemorrhoid operation. The accident resulted in scars and a deformed bowel, which necessitated the use of a colostomy bag.

The plaintiff’s complaint alleged that the surgeon could not fire the stapler properly due to a severe defect, and that this defect could be detected in almost one third of Ethicon’s hemorrhoid staplers. The jury agreed, concluding that the device lacked essential lubrication as the result of a manufacturing defect. However, the jury did not assign blame to the surgeon, who the plaintiff also listed as a defendant. The doctor could not have been responsible, they concluded, because they received no warning of the device’s defectiveness. The jury assigned the blame to Ethicon, who they alleged was aware of the device’s issues but instead opted to blame the doctors rather than work to improve the manufacturing processes.

During the trial, evidence was presented that showed Ethicon may have been aware of the hemorrhoid stapler’s problems for over a decade but failed to take action until a Class 1 recall in 2011. Class 1 recalls are reserved for devices or drugs that can cause severe health problems, up to and including death.

Reporting-Exemptions and Litigation Complaint Summary Reporting

Dr. Douglass Kwazneski was assisting a Pittsburgh surgeon with the removal of an appendix when the surgical stapler they were using locked up. After the event, Kwazneski scoured the Manufacturer and User Facility Device Experience (MAUDE) database, the FDA’s public database for tracking medical device failures, and could not find anything related to his inquiry. Shocked, Kwazneski consulted several prominent surgeons and discovered that approximately two-thirds had either experienced similar problems or were aware of someone who did.

Following Kwazneski’s inquiry, Kaiser Health News (KHN) launched an investigation that subsequently discovered that the FDA had granted an exemption to makers of surgical staplers that allowed them to sidestep MAUDE and file reports pertaining to device malfunctions in a secret repository. According to an article in the Miami Herald, since 2016 over 1.1 million incidents were diverted from the publicly available MAUDE and stored in this repository.

The FDA eventually confirmed the existence of a reporting-exemption program, as well as acknowledged thousands of instances of injury or device malfunctions that had never been made public. In 2018, the exemption program was nearly eliminated (they still remain in place for implantable defibrillators and pacemaker electrodes), resulting in an alarming slew of surgical stapler-related reports. For example, Medtronic analyzed reports of Covidien’s surgical staples and found 1,000 malfunctions in 2015 compared to 11,000 in 2018.

Another tool the FDA has handed device manufacturers is litigation complaint summary reporting, which allows manufacturers to file a single “summary” report with up to 1,175 individual patient injury reports attached. If one were counting the number of injuries related to a particular product, that summary report would emerge as a single injury. To put this in perspective, FDA records provided to KHN show that the program kept over 480,000 injuries or malfunctions from public view.

The FDA’s Solution: Reclassification

Hours after KHN’s investigative findings were published, the FDA sent a letter to healthcare providers that signaled their awareness of the rising number of medical device reports (MDRs) involving surgical staplers and surgical staples. The letter also outlined two safety precautions the agency is planning in the coming months: a public advisory hearing and a draft guidance with labeling instructions for manufacturers. According to the agency, the goal of each of these steps is to improve the safety of surgical staplers and implantable staples.

As of this writing, surgical staplers are regulated as Class I medical devices, meaning premarket submission to the FDA is not mandatory. Conversely, implantable surgical staples are Class II and require premarket review. The FDA is essentially considering reclassifying surgical staplers to Class II, which would enable the use of several key tools, such as strict performance testing, usability demonstrations, and labeling comprehension.

Looking to the Future

The Global Surgical Staplers market is expected to exceed $4 billion by 2024. This is largely due to the growing number of surgical procedures performed per diem, the rising popularity of medical tourism, various technological advancements, and the development of minimally invasive procedures. Given the severity of potential injuries, the lack of publicly available information, and current litigation trends, it is very likely that we will witness a slew of device-related mass-tort trials in the near future.