The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

prescription pills and caseThe New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law.[1]

Under the Federal Food, Drug, and Cosmetic Act, manufacturers of brand-name drugs must seek approval from the FDA to market the drug and must prove that it is safe and effective and that its proposed label is accurate and adequate. Generic drug manufacturers, however, face a more streamlined process: they can gain FDA approval of a generic drug simply by showing it is identical in active ingredients, safety, and efficacy to a brand-name drug that has already been approved. Similarly, the brand-name manufacturer is responsible for the accuracy and adequacy of a drug’s labeling for new drug applications and updated labeling, while generic manufacturers are responsible for ensuring that the labeling is the same as the labeling approved for the brand-name drug.

When it comes to matching an updated label, generic manufacturers are required to update their labeling at the “very earliest time possible.”[2] Generic manufacturers must therefore routinely monitor the FDA’s website for information on changes in labeling and/or obtain the information in other ways, such as from the FOIA staff at the FDA. Read more ›

About The Author
Posted in FDA

FDA Issues New Draft Guidance Requiring Modifications to Medical Device Tracking Labels

medical equipment with labelThe Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier) Rule”.  The draft guidance is intended to assist both labelers and FDA-accredited issuing agencies to better ensure the UDIs are in compliance with the Rule.  The UDI Rule established a tracking system to adequately identify devices through distribution and use throughout the United States.  Under 21 CFR 801.20, a UDI is required on the label and package of every medical device in commercial distribution in the United States (unless an exception or alternative applies).  Read more ›

About The Author
Posted in FDA

“Auto-Pilot” May Not Be Perfect, But It May Be Better

person in self-driving carVirtually every day there are media reports regarding the introduction of driverless cars to mainstream consumers.  As driverless cars rapidly accelerate from concept to commercialization, it is becoming increasingly apparent that technological refinements remain necessary and are ongoing in response to recent accidents.

For instance, earlier this year in Europe a driver of a Tesla operating in autopilot mode ran into the rear of a van stopped on the highway. Then again, in July of this year, a Tesla operating in autopilot mode crashed on a windy two lane road in Montana. While neither of those drivers were seriously injured, on May 7, 2016, a driver of a Tesla in autopilot mode was killed in Florida when his vehicle failed to stop in the path of a tractor trailer. A spokesperson for Tesla indicated that the car was unable to differentiate between the white side of the tractor trailer against the backdrop of a bright sky.  This is the first reported fatality for any vehicle operating in a self-driving mode.  Although the family of the driver has not sued Tesla, they have reportedly retained counsel who is investigating the crash.  Read more ›

About The Author
Posted in Automotive

New FDA Draft Guidance on Updates to Certain Generic Labeling

generic drug labelingOn July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for reasons other than safety or effectiveness.

The FDA generally requires a generic drug to have the same labeling as the reference drug at the time of approval.  Moreover, all marketing application holders have an ongoing obligation to ensure that their product labeling is accurate, and not false or misleading.  In particular, when new information becomes available that causes the labeling to be inaccurate or misleading, the application holder must update its labeling.

Where the reference drug is still on the market, the reference drug manufacturer frequently proposes changes to the labeling, and generic drug manufacturers are expected to update their labeling accordingly to reflect any approved relevant changes.  While this process is fairly clear cut, the FDA admits there is confusion about what generic drug application holders must do to update labeling when the reference drug is off the market (for reasons other than safety or effectiveness).  This draft guidance seeks to clarify that process. Read more ›

About The Author
Posted in FDA

New Weapon For Manufacturers: Defend Trade Secrets Act of 2016

top secret documentOn May 11, 2016, President Barack Obama signed the Defend Trade Secrets Act of 2016 (the “DTSA”), which provides a federal civil cause of action to manufacturers for the misappropriation of trade secrets under the Economic Espionage Act.  While the DTSA substantially mirrors the protections afforded under the Uniform Trade Secrets Act, currently adopted by 48 states, the DTSA gives manufacturers a choice of whether to file in state or federal court.  Importantly, the DTSA provides manufacturers with a new avenue to address a wide range of trade secret issues.

For manufacturing companies with trade secrets “related to a product or service used in, or intended for use in, interstate or foreign commerce,” the DTSA provides, for example:

  • Federal Civil Action.  The DTSA creates a federal civil cause of action, giving original jurisdiction to United States District Courts.  This will allow companies to file in or move most trade secret litigation to federal court.  The original federal jurisdiction conferred by the DTSA will, in turn, invariably include federal supplemental jurisdiction for claims for breach of contract, related common law claims, and state statutory claims.  Importantly, similar to federal employment laws, the DTSA does not supersede state trade secret laws.
  • Seizure of Property.  Unlike any of the pre-existing state laws, the DTSA includes a provision that permits the Court to issue an order, upon ex parte application in “extraordinary circumstances,” seizing property to protect against improper dissemination of trade secrets.  Interestingly, the DTSA permits such an order only if the moving party has not publicized the requested seizure and includes imbedded confidentiality protections that protect seized information from public disclosure.  If granted, the Court is required to schedule a seizure hearing and the moving party will be required to provide security in an amount to be determined by the Court for the payment of any possible damages suffered as the result of a wrongful or excessive seizure.  This provision of one of the more robust features of the new law, permitting, for example, the seizure of computer hardware and software that has been used for misappropriation without giving notice to the party against whom the order is issued, and thereby decreasing the risk of spoliation of evidence.  This can be an important weapon in dealing with ever-increasing cyber-threats. Read more ›
About The Author
Posted in Manufacturer, Trade Secrets

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

medical device monitoring patient in hospitalThis week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of information on its labeling without adjacent explanatory text (known as “stand-alone symbols”).  The new ruling goes into effect on September 13, 2016.

The ruling brings the labeling regulations in line with the current use of symbols on labels in European and other foreign markets.  Thus, in the view of the FDA, this ruling seeks to “harmonize” the U.S. device labeling requirements for symbols with international regulatory requirements.

In addition to increasing consistency between U.S. device labeling requirements and international requirements, the FDA touts that, by allowing the use of stand-alone symbols, medical device manufacturers will experience a positive net benefit over time in the form of a reduction in costs for the design and redesign of labeling for medical devices currently marketed.

Specifically, the FDA estimated the total benefits annualized over 20 years to be between $7.7 and $25.5 million.  Of course, the switch to stand-alone symbols will require some up front and recurring costs to redesign the labeling and to create an accompanying glossary (more on this below), which the FDA estimates at total annualized amount of $1.1 to $3.2 million over 20 years.  Thus, the total annualized net benefit to medical device manufacturers stands to be in the range of $6.6 to $22.3 million.    Read more ›

About The Author
Posted in FDA

U.S. DOT Moving Closer to Certification of Driverless Cars

cars driving on busy city highwayMotor vehicle design continues to make significant technological leaps incorporating a number of automated features, with many manufacturers pioneering the concept of driverless cars. What was once the stuff of science fiction is making significant headway towards full-scale production and commercialization.  A recent study reveals that existing U.S. laws pose few barriers to adoption of autonomous vehicle technology – that is so long as manufacturers stick with traditional designs permitting human driver control override.

As is often the case with new technology, the pace of advancement has outpaced the U.S. government’s ability to fully regulate driverless technology. In order to sell a motor vehicle in the U.S. market, a vehicle manufacturer must certify that the vehicle meets the performance requirements specified in the Federal Motor Safety Standards, or FMVSS (see 49 U.S.C. 30115).  Unfortunately, the FMVSS was initially drafted in 1966 and was developed with the assumption that vehicles subject to this regulation would be driven by a human driver.  Understanding the need to revise the FMVSS to address the imminent commercialization of driverless cars, the U.S. Department of Transportation commissioned a study by the John A. Volpe National Transportation Systems Center (Volpe Center).

The focus of this study was to highlight standards in the current FMVSS that may create certification challenges for automated vehicle concepts.  The Volpe team conducted two separate reviews of the FMVSS: one identified instances in the FMVSS where a “driver” was referenced, and the second review looked to identify current language in the FMVSS that could pose direct challenges to a range of automated vehicle concepts.  Read more ›

About The Authors
Posted in Automotive

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure

shutterstock_104336624Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad.  This situation presents an important cautionary tale and one that is not strictly limited to medical device manufacturers.

A duodenoscope is a reusable medical device and is used in more than 500,000 procedures a year in the United States.  It is a flexible, lighted tube that can be threaded through the mouth, throat and stomach to the top of the small intestine.  Duodenoscopes are used in a specific procedure called an endoscopic retrograde cholangiopancretography or ERCP.  The use of duodenoscopes provides an alternative to traditional surgery and can be used to drain fluids from pancreatic and biliary ducts which may be blocked by tumors, gallstones or other conditions.

The duodenoscope, unlike other gastric scopes, contains a hollow chamber which allows for the injection of contrast dye or the insertion of other instruments to obtain tissue samples.  It also contains a moveable elevator part at the tip.  This elevator changes the angle of the accessory existing in the accessory channel and allows it to access ducts to address problems with fluid drainage.

Keeping in mind that hindsight is 20/20, Olympus’ issues began in 2010 when Olympus modified the scope by redesigning them to seal a narrow internal channel in the hopes of keeping out blood and infectious materials.  The challenge in cleaning and disinfecting the duodenoscope stems from the fact that some parts are very hard to clean.  For example, the elevator portion of the device contains microscopic crevices that cannot be reached with a brush thereby permitting residual body fluids and debris to remain after cleaning and disinfection.  And, as it would be later alleged, this closed channel design actually allowed bacteria to remain inside the device.

Read more ›

About The Authors
Posted in FDA, Manufacturer, Recalls

Federal Preemption Narrowed For Aviation Suppliers In Sikkelee v. Precision Airmotive Corp.

shutterstock_129919190On April 19, 2016, the Third Circuit Court of Appeals issued its opinion on the issue of federal preemption in Sikkelee v. Precision Airmotive Corp.  The sixty-one page opinion effectively narrowed the scope of federal preemption and held that aviation product liability claims are to be controlled by state tort law standards of care as opposed to federal standards of care.  This opinion could expose aviation product manufacturers to potential liability, as well as the unpredictability of non-uniform standards across the states.

Sikkelee involved an airplane crash in July 2005, where the pilot David Sikkelee crashed his Cessna 172N aircraft shortly after taking off from the Transylvania County Airport in Brevard, North Carolina.  Tragically, Mr. Sikkelee died as a result of serious injuries and burns suffered in the crash. Plaintiff Jill Sikkelee, the wife of David Sikkelee, alleged that the aircraft lost power and crashed as a result of a malfunction in the engine’s carburetor, which is designed to regulate the proper mixture of fuel and air that enters the engine’s cylinders.

As a result, Ms. Sikkelee filed suit in the Middle District of Pennsylvania in 2007 against seventeen defendants, asserting state law claims of strict liability, breach of warranty, negligence, misrepresentation, and concert of action.  In 2010 the District Court granted the defendants’ motion for summary judgment holding that plaintiff’s state law claims, based on state law standards of care were preempted by federal standards of care.  Plaintiff subsequently filed an amended complaint, continuing to assert state law claims, but also alleging numerous violations of FAA regulations. Read more ›

About The Author
Posted in Uncategorized

Bellwether Trials: What Manufacturers Can Learn from the GM Ignition Claim MDL

shutterstock_215438209As product liability multidistrict litigation becomes more prevalent, it is important for manufacturers to understand how the bellwether trial process works and how to use it to their advantage.  The ongoing bellwether trials in the GM faulty ignition switch MDL have generated a significant amount of media attention and serve to highlight the factors that manufacturers should consider when navigating the bellwether process.

By way of brief background, two years ago GM admitted that it failed to disclose for a decade its faulty ignition switch installed in millions of small cars.  Following the admission, GM settled a criminal investigation by the Justice Department by agreeing to pay $900 million and has agreed to fines by the Transportation Department.  Although GM has already settled more than 1,000 death and injury claims and settled a class-action suit by shareholders, the MDL representing about 235 wrongful-death and injury cases remains pending in state and federal court in the United States District Court for the Southern District of New York.  Three of the six planned bellwether trials have been tried or settled, providing insight into how the manufacturer is using the bellwether process to its advantage.

The use of bellwethers has developed mainly in the MDL setting, where it can “flourish.”[1]  Merriam Webster defines “bellwether” as “someone or something that leads others or shows what will happen in the future.”  The term comes from the Middle English “bellewether” and refers to placing a bell around the neck of a castrated ram (called a wether) who would lead the flock of sheep.  The idea being that the movements of the flock could be heard via the bell before the flock was seen.  Initially, bellwethers were used in an attempt to bind related claimants.  In other words, one related plaintiff could be bound by the decision in separate, but related, case.  This is no longer the case and the outcome in one bellwether has no binding effect on another case.

What is the purpose of bellwether trials if they aren’t binding all claimants like a class action?  The primary advantage is to enhance and accelerate the MDL process.  Significantly, bellwether trials provide incredibly valuable information about the strengths and weaknesses of representative cases that can assist and hasten the global settlement process.  Naturally, the maturation of bellwether trials from discovery to verdict provides a more predictable expected value to each individual claim.  This knowledge serves as a catalyst toward ultimate resolution.

Another benefit is to allow attorneys to test the waters by putting a number of cases before juries and seeing how juries react to various cases, theories, and defenses.  For example, the defense can use the bellwether trial as an opportunity to try an argument that has the potential to knock out a particular element of the litigation, such as causation or damages.  The ability to test different strategies and defenses in front of a real jury supplies more useful and realistic knowledge about the strength of the case than do the alternatives like mock juries.  Finally, as noted by the GM MDL court, bellwether trials also provide the parties the chance to develop a litigation framework, or trial package, that can be used by local counsel in cases remanded back to the original jurisdictions, at lower cost.

However, defendants must be careful in their choices if the bellwether process is to provide maximum benefit.  The Manual for Complex Litigation notes that if bellwether trials “are to produce reliable information about other mass tort cases, the specific plaintiffs and their claims should be representative of the range of cases.”  MANUAL FOR COMPLEX LITIGATION (Fourth) § 22.315 (Federal Judicial Center 2004); Rothstein, et al., MANAGING MULTIDISTRICT LITIGATION IN PRODUCTS LIABILITY CASES: A POCKET GUIDE FOR TRANSFEREE JUDGES at 44 (Federal Judicial Center 2011).  Obviously, the more typical the bellwether case is of the universe of claims in the MDL, the more valuable its outcomes.

Bellwethers can be chosen at random from a pool of cases or the parties can have a say in choosing the cases.  When the parties choose cases, you often see a mix of some cases stronger for the plaintiff and some for the defendant.  Looking at the outcomes individually and collectively can then help to inform the decision of how the large pool of cases should be handled and resolved.  Defense attorneys must resist choosing only their best cases because the purpose of the bellwether is to represent a prototype for the rest of the litigation.  Atypically favorable cases for one side or the other fail to meet this purpose.  To identify the appropriate bellwether cases, it is useful to first catalog the entire universe of cases and then choose a few variables within the cases to consider (e.g., type of injury or date of injury).  Out of this catalog, the parties or judge can choose the pool of cases that will proceed to case specific discovery.

The GM MDL followed these guidelines.  The court began by identifying eighteen personal injury and wrongful death cases that would be identified for fact specific discovery.  The Court referred to these cases as “Initial Discovery Pool.”  The court then stated that a subset of those cases would be selected for additional pretrial discovery and proceedings in preparation for trial.  In order to even be included in the Initial Discovery Pool, a claim had to satisfy certain criteria.  For example, the claim had to involve an accident occurring after the “new GM” acquired substantially all of the “Old GM’s” assets on July 10, 2009 and the claimant could not have accepted an offer through the GM Ignition Compensation Claims Resolution Facility which was set up to settle claims of individuals having accident involving the ignition switch defect.  Ultimately, each side selected half of the bellwether trials from this pool.

There are a total of six GM ignition bellwethers.  The first trial was a success for GM after the plaintiff’s case imploded and was dismissed in January 2016 following accusations that the plaintiff had given misleading testimony about his health and financial condition.  Specifically, the plaintiff claimed to suffer neck and back injuries after an accident in which he alleged the defective switch disabled his air bag.  GM found evidence undercutting these claims, including the extent of plaintiff’s injuries and the details of the plaintiff’s house eviction after the accident.  GM found evidence that the family was evicted because they doctored a federal government check stub to provide proof of funds necessary for the move.  Although this case did not proceed to trial, it provides the important lesson for defendants and manufacturers to search for evidence that could undermine plaintiff’s claims of injury or damages.

GM emerged victorious in the second bellwether case as well.  The trial was selected by GM as a favorable case, and as predicted, the case was tried to a jury verdict in March.  Significantly, the jury found that while the plaintiff’s GM vehicle was unreasonably dangerous as a result of the defect, and that GM failed to use reasonable care to warn consumers of the danger, the defect did not cause the accident at issue, and therefore, there were no damages.  Notably, the judge dismissed the plaintiff’s fraud claim at the end of witness testimony and rejected a demand for punitive damages.

The third GM bellwether was thought to be a much stronger case for plaintiff in that it involved a fatal accident.  That case recently settled.  It is likely that GM decided to settle the case to avoid trying a case involving a fatal accident in front of a jury.  The fourth bellwether is scheduled for trial on July 18, 2016 and the fifth and sixth follow thereafter.

The GM cases highlight the benefit of the bellwether process.  Given the criminal and other government investigations into GM’s faulty ignition, the issue has received massive media attention.  Where GM has been taken to task, especially given the criminal and other government investigations, it would appear that the defectiveness of the ignition switch is a forgone conclusion and GM was squarely at fault.  However, the defectiveness of the ignition switch, as it relates to causation of accidents, remained an issue in the second bellwether.  It showed that a jury was able to tease out the differences between a defective product and causation of plaintiff’s damages.  Further, both the first and second bellwether cases tested damages.  Even where the case is inherently favorable to GM, that remains a powerful affirmation heading into the next bellwether trials and will likely play a role in the global settlement process.

The takeaway lesson from all of this is that the bellwether process is one which plays a critical role in complex litigation and which must be carefully used and managed in order to get the best results possible.

[1] Eldon E. Fallon, Jeremy T. Grabill, & Robert Pitard Wynne, Bellwether Trials in Multidistrict Litigation, 82 Tulane L. Rev. 2323 (2008).

About The Authors
Posted in Automotive
Subscribe to New Posts


Products Liability Prevention & Defense
Our attorneys represent foreign and domestic designers, manufacturers, and distributors of a diverse array of products, from food and drugs to industrial equipment and building materials. We help clients respond to major personal injury and property damage claims in the form of single-product cases, class actions, mass torts, and multidistrict litigation, as well as all types of congressional, regulatory, or criminal investigations. Our team works closely with corporate counsel to minimize a company’s overall liability and establish efficient protocols for fielding claims and advise on labeling, marketing, manuals and instructions, supply and distribution contracts, and insurance and indemnification issues.
Recent Comments
Cozen O’Connor Blogs