Defective Drugs & Medical Devices Lawyer

Defective drug and medical device claims can seem complicated. First, you have to show that the drug or medical device was defective. Then you have to show that you suffered an injury directly related to the defective drug or medical device. Obviously, this can be harder to prove than injuries caused by a defect in a basic type of product – like hand tools or kitchen appliances. Additionally, drugs and medical devices are almost always made by large pharmaceutical companies, which are highly regulated by government agencies. This can make litigation costly, difficult, and extremely time-consuming.

However, many of the issues that make these claims seem so complicated also serve to simplify the claims. For example, pharmaceutical companies generally keep very detailed records of just about everything and have extensive resources to pay settlements or jury awards. Moreover, the government oversight involved leads to comprehensive applications, constant testing, and strict regulations affecting the industry as a whole. These factors are helpful in any single plaintiff litigation, but also makes the claims particularly amenable to consolidation – meaning that numerous plaintiffs can often pool their funds and resources in order to take on large pharmaceutical companies over similar claims.

Below is a 10,000-foot view of how these types of cases generally work. As always, it is best for you to first speak to your doctor if you have concerns about any drugs or medical devices. After that, if you believe you have a potential claim, you should seek the guidance of an experienced law firm. It is also important that you do not delay, considering both the implications to your health, as well as the legal limitation periods that will apply to any claims.

Traditionally, there are three basic types of product liability claims:

1. design defect (the product was not designed to be reasonably safe)
2. manufacturing defect (even though the product was designed to be reasonably safe, the product was not properly manufactured), and
3. failure to warn (even though the product was designed to be reasonably safe and the product was properly manufactured, there was a failure to provide proper instructions or warnings).

These claims are usually codified into different product liability acts, with the vast majority of jurisdictions imposing strict liability and punitive damages under certain circumstances.

Accordingly, many practitioners generally believe that, in the case of a defective drug or medical device, product liability claims against the manufacturer are more tenable than medical malpractice claims against a patient’s physician. Medical malpractice claims are usually more difficult to prove, especially when any injuries were caused by undisclosed defects in a drug or medical device. Simultaneous product liability and medical malpractice claims are also rendered more difficult due to certain defenses, like the learned intermediary doctrine adopted in most jurisdictions (very simply stated, it is a defense for the manufacturer if they can show that, even if the physician knew of the defects being alleged, the physician still would have determined to use the drug or medical device). So, here we are only talking about product liability claims – not medical malpractice claims.

Defective drug and device claims fall into different categories along the product liability spectrum. Some recent examples include drugs that were allegedly adulterated during the manufacturing process, such as Valsartan. Then there are drugs which are alleged to be inherently dangerous, such as Zantac. This same paradigm is followed by medical devices, such as the Exactech hip, knee and ankle replacements and the Paragard IUD. These are all set forth in more detail below.

The United States Food and Drug Administration (FDA) regulates many things, including food, radiation-emitting products, vaccines, blood, transplant materials, cosmetics, tobacco products, veterinary products, over-the-counter (OTC) medications and some nutritional products. Most importantly, the FDA regulates drugs and medical devices, but the government’s treatment of drugs and medical devices differs slightly.

Drugs go through at least three phases of clinical trials over several years, which test the drugs on progressively larger groups of patients for safety and efficacy. A drug must be successful in its clinical trials to receive approval. Following approval, there will be additional trials as the drug is used by the public. Throughout this time doctors and patients are encouraged to report any adverse events to the FDA.

These clinical trials are very expensive and usually unsuccessful. So, pharmaceutical companies are permitted to patent their drugs, which grants a monopoly over manufacturing the drug for several years. Once the patent expires, other companies are permitted to make the drug, which is then considered the generic form of the brand name drug. Because generic drugs are usually less expensive, many healthcare insurers require patients to use generic drugs. Lawsuits against generic drug makers are very difficult, because generic drug makers must essentially use the same label and warnings as the  brand name drug makers. As such, generic drug makers are shielded from liability for failure to warn claims – the most prevalent claims in defective drug product liability lawsuits. Strangely, this could lead to two manufacturers making the same defective drug, but a patient taking the generic drug is left with no claims against the generic manufacturer.

Medical devices face a different approval process. The FDA regulation of medical devices increases with the corresponding risk of illness or injury associated with the product. The class of medical devices posing the highest risk can go through a rigorous process called Premarket Approval (PMA). PMA is a long and costly process involving extensive review of the medical device. A shorter and cheaper process is known as 510(k) clearance (a reference to that section of the Federal Food, Drug, and Cosmetic Act). Like drugs, medical devices are also reviewed after approval and both doctors and patients are encouraged to report any adverse events to the FDA through the Manufacturer and User Facility Device Experience (MAUDE) system.

Under the more prevalent 510(k) clearance, a manufacturer only has to show that a medical device is substantially similar to an already legally marketed product. Because the PMA medical devices undergo much more scrutiny, it is harder to bring a lawsuit in those cases (most of those claims are preempted based on the close government oversight and resulting approval involved). On the other hand, 510(k) medical devices do not share this type of immunity from suit, since 510(k) clearance requirements are just not as strict as PMA.

All of this overlapping regulatory red tape may start to seem overwhelming, but it is important to keep in mind that the vast majority of these safeguards were put in place to protect patients. These, along with the product liability protections of various jurisdictions, have been successfully implemented by experienced attorneys in countless instances. This has fostered a system whereby lawsuits on behalf of individual patients have been instrumental in making the market much safer for all patients.

FDA drug and medical device recalls come in three different classifications, from most to least serious: Class I – a dangerous or defective product that could cause serious health problems or death; Class II – a product that might cause a temporary health problem, or pose slight threat of a serious nature; and Class III – a products that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws. Recalls can affect an entire product line, or can be limited to certain models and/or lots of a product.

In almost all cases, it is the pharmaceutical company that performs the recall, which is overseen by the FDA. In some instances, the manufacturer is permitted to withdraw the product from the market, without a formal recall. Even in the case of a recall, the drug or device is not always removed from the market, sometimes the manufacturer just has to correct any issues that it has discovered. This means that, depending on the circumstances, patients do not always have to stop using a recalled drug. In the case of recalled medical devices (such as a hip or knee implant), the devices do not necessarily have to be revised or replaced. It is important to note that public notification is not required in all recalls, but this information is generally available from doctors, pharmacists and the FDA website.

Just because there has been a recall, or official warning letter, does not necessarily mean that the drug or medical device is defective for all purposes, and many drugs and devices alleged to be severely defective are sometimes never the subject of an FDA recall. Using the above examples, specific lots of Valsartan made by certain overseas generic manufacturers were recalled because they were allegedly tainted in the manufacturing process by a cancer-causing compound. In the Zantac litigation, an entire product line was pulled from the market because it is alleged that an active ingredient used in Zantac has been shown to cause cancer. Exactech was forced to issue a recall of certain knee and hip replacements, because components of the devices were allegedly improperly exposed to oxygen, causing premature failure of those vital components. Finally, Paragard IUDs have not been recalled and still remain on the market, despite over a thousand lawsuits nationwide claiming that the arms of the device are defectively brittle and prone to break off upon removal.

As you can see, the issues can be nuanced. So, you obviously do not want to just stop taking a drug or try to manipulate a medical device on your own. But there is an easy solution. What you want to do is immediately contact your doctor and have a conversation about your concerns and the best path forward for you and your long-term health.

The first step in figuring out whether you have a potential claim is always to confirm that you are a consumer of the defective drug or medical device. In the case of a defective drug, your medical records (specifically your primary care physician, hospital, prescription, and pharmacy records) will usually show product identification, dates and amounts of use. In the case of a defective medical device, product identification will also come from your medical records (specifically your operative report – when a surgeon implants a medical device, the surgeon will typically attach identifying stickers that come with the device to your operative report). Once you have identified your defective drug or medical device, you can then compare it to pending recall notices/lists, medical literature, complaints, warnings, and pending litigation.

Obtaining your medical records is fairly easy. You can just go to your medical providers and ask for your medical records (you should receive them in a few days), or you can retain an attorney to formally request your medical reports (a formal request will take a few weeks). Note that medical providers are only responsible for keeping records for a certain amount of time. Obtaining older medical records (for example, older than seven years) can be more difficult.

Now that you have identified your defective drug or medical device from your medical records, you have to be able to show you suffered injuries that are the direct result of the claimed defects. As you review any potential claims, it is important to note that just experiencing an injury from a drug is not always actionable. For example, some drugs come with black box warnings that clearly warn of specific, even fatal, adverse reactions if a patient chooses to take the drug. In the same manner, not every injury from a surgically implanted medical device is actionable. For example, every surgical procedure has known risks of complications, such as infection at the surgical site. Unfortunately, every drug and medical device has known side-effects, and every patient has completely unrelated health issues. From time to time, teams of medical experts must review the data in order to determine if there was a defect and if the defect caused an injury. Usually it turns out that the provable defect and the related provable injury are extremely specific. Many times, the science matures and changes as the lawsuits progress.

So, in the recent examples used above, currently a potentially viable Valsartan claim would entail you using one of the recalled lots of drugs, for an extended period of time and contracting a specific type of cancer. The same would be true of Zantac – use of brand name Zantac for an extended period of time and contracting a specific type of cancer. Similarly, a potentially viable Paragard IUD claim would specifically involve the breakage of an arm of the device upon removal, causing internal injury. A potentially viable Exactech hip, knee or ankle case would be based upon a failure of the liner of the devices, leading to specific injury and required revision surgery. Thus, a successful claim involves a specific provable defect that led to a specific provable injury. In these examples, if your claims do not fall within these parameters, chances are that you will likely not have a scientifically and legally provable claim. You can click on any of the foregoing links to get a better understanding of the product and the related injuries, as well as other likely case criteria.

You did some research on your drug or medical device, you consulted with your doctor – now you will want to get some legal advice. Two things to keep in mind:

1. make sure to talk to a law firm that specializes in defective drug and medical device cases across the nation, and
2. do not wait, because there are different deadlines and statutes of limitations that apply to your claims.

Do your homework and research the firm you will be working with – there is a good chance it will not be the same lawyer that handled your last speeding ticket, or one of the 1-800 numbers that flash across your television screen late at night. Make sure you are dealing with a law firm of experienced trial attorneys that will be handling your case, not just some marketing firm. It is important to put this on the top of your pile of things to do, as only bad things can happen if you wait too long to pursue a claim. Finally, note that law firms will invariably take your case on a contingency basis, meaning you do not pay anything if your case is not successful – this should be spelled out in your retainer agreement.

Defective drugs and medical devices frequently lead to single plaintiff lawsuits. However, the injuries in those cases usually have to be catastrophic, and the liability fairly straightforward, in order to support the costs of suing a large pharmaceutical company. These cases proceed in much the same way as any civil case, though usually slower than a garden variety product liability case. As anyone who has been involved in a lawsuit before knows, the only certainty in litigation is that there will be delays, more delays than anyone can imagine.

Many defective drug and medical device claims are amenable to consolidation into what is known as a mass tort. Mass torts are frequently consolidated at the federal level into multidistrict litigations (MDLs). In an MDL, cases filed in federal district courts throughout the nation are consolidated in one federal district court. Many MDLs consist of tens of thousands of individual claims from across the nation. Similarly, mass torts can also be litigated on the state level, as most states have their own versions of MDLs. These proceedings all usually share the use of uniform pleadings, discovery, motion practice and trials. The structure allows the plaintiffs’ attorneys to pool and maximize their resources, while, unlike class actions, each individual case retains its separate identity. Notwithstanding, MDLs have proven very successful in reaching global settlements of large numbers of claims.

Again, mass tort procedure varies slightly from the standard lawsuit, so it is helpful to know what to expect. Once you have retained an attorney, they will go about researching your claims and obtaining/compiling your records. Your lawsuit will eventually be filed and you will have to respond to written discovery questions. Throughout this period, there will be quite a bit of hurry up and wait. All the while, teams of attorneys will be collecting boat loads of records from the defendants, conducting depositions and conferring with experts. These experts will be pouring over the documents, data and studies in order to be able to prove general liability, causation and damages. Throughout the litigation there will be various motions filed by each side.

Eventually, a very few representative cases will be selected to be prepared for what are known as bellwether trials. Those cases will go through bellwether discovery, trials, more motions, and maybe appeals. The hope is that the bellwether trials will act as test cases in order to help the parties assess the value of the claims and come to acceptable settlements. At every step of the process, there is always the possibility that some or all of the claims are unsuccessful. If there is no settlement at the end of the bellwether trials, the MDL court can remand cases to other courts in order to prepare more cases for trial. If there is a global settlement and your claim qualifies, you will be given the option to opt into the settlement. At that point, the administrative claims process and resolution of medical liens would begin, eventually resulting in the payment of awards.

It is important to remember that, as this process unfolds over the course of several years, it can seem like your lawsuit is languishing. Despite outward appearances, the day-to-day litigation and administration of these enormous, complex cases can be something like a well-choreographed legal ballet (or, at times, a chaotic rugby scrum). The proceedings are also very transparent, as they are usually followed closely in the media and most MDL courts post their filings on readily accessible websites. Lastly, you should never hesitate to reach out to your attorney – your attorney may not always be sitting next to their phone or keyboard, but getting back to you in a reasonable amount of time with a status update is never too much to ask.