Dangerous Drugs & Devices

Nearly half of Americans take at least one prescription drug. Pharmaceutical companies spend nearly $30 billion each year to promote their products to consumers and medical professionals. Across media platforms, the public is bombarded with information about the “benefits” of BigPharma’s medications and treatments. Drug company advertisements tells us that our health problems are holding us back from living better, healthier, and more fulfilling lives. But not to worry: they have the medication for what ails us. “Talk with your doctor,” is the common refrain at the end of a BigPharma ad.

For some patients, prescription medication really does improve the quality of their lives. But for many, these drugs have questionable benefits at best, and serious, unintended side effects at worst.

Taking on drug and device makers requires a law firm that can stand up to some of the world’s largest and most powerful companies. Milberg has the experience, the track record, and the resources to successfully represent large groups of plaintiffs against medical companies. Our defective drug lawyers have held leadership roles in many national drug and device litigations, and recovered billions of dollars in compensation for injured consumers.

Milberg handles defective drug cases in all 50 states and Puerto Rico on a contingency fee basis. We are headquartered in New York and have local offices in California, Georgia, Mississippi, Washington, Tennessee, Florida, North Carolina, South Carolina, and Kentucky. If you suffered an adverse side effect from a drug or device, contact Milberg to schedule a free consultation with an experienced dangerous drug lawyer.

Big Pharma’s Big Marketing

The United States is one of only two countries that allow direct-to-consumer (DTC) drug advertising. On television, in print, on the internet, and elsewhere, Americans see a constant stream of pharmaceutical company ads telling us that a new drug might be just what the doctor ordered.

Over the last couple of decades, pharmaceutical companies have nearly doubled the amount they spend on drug marketing, from roughly $17 billion to around $30 billion. And their investment has paid off. Over the same period, spending on prescription drugs increased from $116 billion to $329 billion.

Not all that marketing is directed towards consumers. About $20 billion, or 68 percent, goes to selling doctors and other medical professionals on prescription drug benefits. Of the approximately $10 billion that goes to DTC advertising about $6 billion is for marketing prescription drugs, reports JAMA. That’s enough money to buy 4.6 million ads, including 663,000 TV commercials. DTC advertising spend also goes to ads in magazines, newspapers, radio, websites, sponsored links, social media, radio, billboards, and mass transit posters and banners.

The Costs of Pharmaceutical Advertising

It seems that wherever you go, and whatever you read or watch, drug companies are trying to sell you their products. DTC drug advertising is regulated by the Food and Drug Administration (FDA). Drug companies are required to follow certain FDA rules when targeting consumers. For example, they must clearly and accurately state the risks associated with their drugs, and the efficacy of those drugs. However, these FDA regulations are not strongly enforced. According to the authors of the JAMA study, “despite the increase in marketing over 20 years, regulatory oversight remains limited.”

Partly, this may be due to the massive amount of promotional materials the FDA must review, and the relatively small number of staff members dedicated to this task. For every FDA employee responsible for reviewing Big Pharma advertisements, there are thousands of promotional materials to review, which means that much of the material is reviewed hastily—if at all. Plus, Big Pharma’s advertising budget is roughly twice the size of the entire FDA budget. While the FDA does issue violation letters for actions such as marketing unapproved uses and inadequate risk information, it can’t possibly be expected to regulate an industry that financially dwarfs it, and provides much of its funding.

Prominent organizations, including the American Medical Association, have called for a ban on DTC drug advertising. Arguments against this type of advertising cite drawbacks that include:

• Misinforming patients
• Overemphasizing drug benefits.
• Promoting new drugs before safety profiles are fully known.
• Manufacturing disease and encouraging drug over-utilization
• Inappropriate prescribing
• Lack of rigorous regulations
• Increasing drug costs

Did you or a loved one suffer a serious prescription drug injury? Contact Milberg for a free case evaluation and learn your legal options.

How Safe Are The Drugs We Take?

The FDA doesn’t just regulate Big Pharma advertising. It also regulates the drug approval process, reviewing new drug applications and allowing or denying them. But at the heart of this process is a major conflict of interest.

The FDA does not perform drug testing. That responsibility mostly falls to the drug companies themselves. The National Institutes of Health (NIH) provides some money for clinical trials, but like the FDA, the NIH has a limited budget. Big Pharma pays for and runs the majority of clinical trials, and the FDA reviews the results to determine the safety and efficacy of a new drug.

Conflicts of Interest at the FDA

Critics say this amounts to a situation where the fox is guarding the henhouse. Drug companies, which have a financial interest in getting their products approved, could falsify study results, hide dangerous side effects, or focus on the benefits of a drug while downplaying the risks. As if this isn’t concerning enough, it gets worse.

Big Pharma funds three quarters of the FDA’s budget used for the drug review process, according to Pro Publica.

In an article entitled “FDA Repays Industry by Rushing Risky Drugs to Market” Pro Publica writes that:

“The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. Faster reviews mean that the FDA often approves drugs despite limited information. As patients (or their insurers) shell out tens or hundreds of thousands of dollars for unproven drugs, manufacturers reap a windfall.”

Post-Marketing Research Issues

With the FDA approving drugs faster and with less clinical testing, a greater emphasis is placed on so-called “postmarket studies” and “postmarket surveillance.” This type of research, performed after a drug is already on the market, has major drawbacks. Post-marketing studies can take a decade or longer to complete, and most drug makers report incomplete side effects to the FDA. The bigger issue, though, is that drugs with questionable safety and benefit profiles are allowed to be sold to consumers, who effectively act as real world clinical trial subjects. Not surprisingly, many of the medications approved by the FDA are later found to have serious, even life-threatening, side effects.

Medical Devices

Medical devices cover a broad range of products, from surgical gloves and tongue depressors to artificial joints and pacemakers. Like pharmaceutical products, medical device are regulated by the Food and Drug Administration. And also like prescription drugs, there are serious questions about the safety of many medical devices sold to Americans.

Many Devices Undergo No Clinical Testing

Medical devices are divided into three categories: Class I (low risk to patients), Class II (moderate risk), and Class III (high risk). Many Class I devices, such as bandages and gloves, do not require any FDA review prior to marketing, although they must be registered in a central database. Class II devices, which include wheelchairs, contact lenses, and blood transfusion kits, often avoid clinical testing for safety and efficacy though the “510(k)” process. This process requires device makers to show that a new device is “substantially equivalent” to a device already on the market. Clinical testing is not required under 510(k) clearance.

Class III devices—products like heart valves, implanted prosthetics, and defibrillators—must be submitted for premarket approval (PMA). PMA typically requires clinical testing. However, testing requirements are lax compared to prescription drugs. In addition, device makers are frequently able to exploit regulatory loopholes that allow them to obtain fast-track approval.

Of the tens of thousands of different medical devices on the market, very few have demonstrated that they are safe and effective. Some devices later prove to be unsafe, ineffective, or both. According to STAT, over a recent 10-year period, there were more than 80,000 deaths and 1.7 million injuries caused by medical devices. Most of these devices were approved with little clinical testing.

Did a medical device injure you? Schedule a free case review with an experience device and drug lawyer at Milberg.

Defective and Dangerous Drug Injuries

Drugs and devices do not need to be proven completely safe in order to be marketed. Most patients are willing to weigh the potential benefits of a drug or device against its potential risks when making a healthcare decision. But if there are flaws in the product, including in the way it is marketed, and these flaws are not publically disclosed, it is impossible for patients and their doctors to make informed decisions.

When defective and dangerous drugs and devices slip through regulatory cracks and harm people, their only recourse may be to file a personal injury lawsuit against the product manufacturer(s). Plaintiffs may be eligible to recover injury compensation from manufacturers that includes money for:

• Past, ongoing, and future medical expenses
• Lost wages
• Pain and suffering
• Diminished quality of life
• Funeral expenses and other wrongful death-related losses

Pharmaceutical companies and medical device manufacturers have paid millions, and even billions, of dollars in settlements and verdicts to compensate injury victims in the past. But filing a personal injury lawsuit against these large corporations is not an easy task. It requires experienced defective drug lawyers with significant financial resources and a proven track record of success.

Milberg’s Nationally-Recognized Defective Drug Attorneys

Very few law firms have what it takes to successfully prosecute the makers of defective drugs and medical devices. Milberg’s defective drug attorneys are national leaders in mass torts and class actions. Our history of handling these types of claims has allowed us to take leadership roles in many national defective drug and device litigations, including cases against industry giants such as Merck, Zimmer, Bayer, Johnson & Johnson, GlaxoSmithKline, Pfizer, and Janssen.

Since Milberg’s founding in 1965, the firm has repeatedly taken the lead in landmark cases that have set groundbreaking legal precedents, prompted changes in corporate governance, and recovered over $50 billion for our clients. To speak with a defective drug lawyer from our award-winning team, schedule your free case evaluation.