DEFECTIVE DRUGS & DEVICES

Medical drugs and devices are extremely lucrative industries. Drug and device companies are constantly striving to develop new products that they can sell to patients who are desperate for treatment for their conditions. These companies therefore have an incentive to skimp on testing, doing the bare minimum to obtain FDA approval, before bringing these products to the market, so they can make the most amount of money with the least amount of effort. Consumers need treatment, and insurance often picks up the tab. It’s a perfect situation for drug and device manufacturers—except for one thing: attorneys like those at Keane Law LLC, who can hold the manufacturers’ feet to the fire when they unleash harmful products on the marketplace.

defibrillatorMedical device litigation is extremely complicated, in part because of the involvement of the FDA. Theoretically, the FDA only approves products that are safe. But as a government agency it has limited resources, depending on taxpayer funds. It tries to balance the limited resources with accomplishing its mission of allowing helpful medical products to be sold to consumers who need them. But it cannot conduct its own scientific studies, so it is dependent on the scientists paid by manufacturers. Unsurprisingly, studies funded by drug companies usually come out in the drug company’s favor.

But despite the limited resources of the FDA, once it puts its stamp of approval on a product, it makes it very difficult for injured consumers to get compensation from negligent manufacturers. This is because of the “preemption doctrine.” This idea is rooted in the U.S. Constitution, which says that federal law trumps state law. Because the FDA is a federal agency, its decisions preempt contrary state law. Normally, product liability and negligence lawsuits are based on state law.

Preemption does not spell the end of medical device cases, though. Clever attorneys can find non-preempted state law claims. For example, you can still sue a medical device manufacturer if it violates the FDA guidelines on how to manufacture a product. Similarly, if it fails to report injuries that occur after FDA approval, or makes misleading statements that were never approved by the FDA, it can still be liable.

medicationsPreemption is just the tip of the iceberg in the complexity of drug and device litigation. The attorneys at Keane Law LLC are well-equipped to navigate this landscape, and have experience and demonstrated results doing just that. We accept cases (including but not limited to) hip implants, intrauterine devices (IUDs), sterilization devices (e.g., Essure), vaginal mesh and blood clot filters. We also represent consumers injured by defective or improperly advertised pharmaceuticals, like Xarelto, Eliquis, Benicar, Risperdal, Invokana, and others.

If you have been injured by a defective drug or medical device, contact us today for a free consultation. We can assess whether you have a case at no charge.