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Articles Tagged with medical devices

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By Jessica Surber, Partner

English, Lucas, Priest & Owsley, LLP

Women seeking relief from a variety of issues, including incontinence and other problems after child birth, sometimes receive a mesh implant made by a variety of companies including Boston Scientific. The mesh often ends up causing more problems than it solves.

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By Jessica Surber, attorney
English, Lucas, Priest and Owsley, LLP

medic-hospital-laboratory-medical-40559Kentucky Attorney General Andy Beshear announced today that he is suing Johnson & Johnson for false marketing of transvaginal mesh, a medical product that the company sold to doctors and surgeons. The mesh is an implant used to treat pelvic organ prolapse and relieve stress urinary incontinence.

Beshear said in a press conference that the mesh has been implanted in 15,000 Kentucky women without Johnson & Johnson or Ethicon, the medical device subsidiary, providing proper information to women about the product.

The lawsuit doesn’t seek compensation for women harmed by the transvaginal mesh. Instead, it seeks civil penalties against Johnson and Johnson.

This type of lawsuit by an attorney general is unusual, and while it seeks to punish the manufacturer of transvaginal mesh, it doesn’t help women who are suffering because of this product. Anyone who has been injured is strongly urged to seek help from a qualified attorney, who can help them advocate for their rights.

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Bair Hugger

By Jessica Surber
Attorney, English, Lucas, Priest and Owsley, LLP

In the late 1980s, Dr. Scott Augustine, an anesthesiologist, invented what he thought would be a very helpful device for patients and doctors: a forced air warming blanket. The blanket is a single-use device that covers patients during and after surgery. It is hollow and filled with warm, forced air. The technology has become widely used throughout hospitals all over the country, and at least initially, was hailed as a way to help patients heal faster and bleed less during and after surgery.

Since he invented this technology, Dr. Augustine stepped away from Arizant, the company that manufactures the device. The Bair Hugger forced air warming blanket is manufactured and marketed by 3M and its subsidiary, Arizant. 3M purchased Arizant in 2010.

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In Putnam v. Medtronic, Inc., an Indiana woman filed a medical product injury lawsuit asserting 15 state-law causes of action in Jefferson County Circuit Court against her Kentucky doctor, the manufacturer of a medical product, and the Kentucky hospital where she underwent spinal fusion surgery. According to the woman’s complaint, the physician used the medical product to treat her in an off-label manner that was not approved by the Food and Drug Administration. In addition, she accused the manufacturer of the product of intentionally and illegally promoting it for off-label use. The woman claimed she suffered harm as a result of this unapproved use and asked the Circuit Court to award her both compensatory and punitive damages.

The manufacturer of the medical product immediately removed the woman’s case to the Western District of Kentucky in Louisville based on diversity of citizenship. The manufacturer also asserted that removal was appropriate because the case involved questions of federal law. In response, the woman filed a motion to remand the lawsuit back to state court.

In considering the woman’s motion, the U.S. District Court examined the two sources of federal jurisdiction alleged in the case. Diversity jurisdiction is proper when the amount in controversy exceeds $75,000 and the parties hail from different states. Federal question jurisdiction exists only when a lawsuit arises from the United States Constitution, federal statutes, or a treaty the nation is a party to. The U.S. District Court continued by stating the burden of establishing federal jurisdiction is on the party that seeks removal, and the case must be remanded if jurisdiction is not proper.

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In Waltenburg v. St. Jude Medical, Inc., a man received an implantable cardioverter defibrillator (“ICD”) that was manufactured by St. Jude Medical, Inc. The electrical ICD device was inserted into the man’s body through a vein and then attached to his heart in an effort to correct irregular heart rhythms. Not long after the device was implanted into the man’s chest, he apparently began experiencing unexpected and unnecessary electrical shocks. Several years later, the man’s physicians reportedly told him that the ICD device implanted into his body was faulty, but it was too risky to remove it. The man filed a products liability lawsuit seeking damages for physical injury and emotional distress from the manufacturer of the ICD in the Western District of Kentucky.

In his complaint, the man claimed the medical device manufacturer was strictly liable for the allegedly defective ICD. He also claimed the company manufactured the product in a negligent fashion, negligently failed to warn him about the product defect, and alternately should be held accountable through the doctrine of negligence per se. A negligence per se cause of action normally arises when someone is injured after another party violates a law that was designed to protect the public or a specific class of individuals from the type of harm that the injured person sustained. In general, negligence per se is easier to prove than other types of negligence because the reasonableness of an at-fault actor’s conduct is not at issue.

The medical device manufacturer countered by alleging the man’s claims were preempted by the Medical Device Amendments (“MDA”) to the federal Food, Drug, and Cosmetic Act and argued the lawsuit should be dismissed because the man failed to state a claim on which relief may be granted. Preemption occurs when a state law conflicts with a federal law in such a way that the purpose of the federal law is thwarted. According to the Supremacy Clause of the United States Constitution, federal law controls in such cases.

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medical device labWhen a doctor or surgeon recommends a particular medical device, such as a hip replacement, you probably assume that the device has been tested thoroughly, that it is safe and proven to be an effective treatment for your ailment. But recent studies have shown that this really isn’t the case, and that patients should be prepared to do their own research into medical devices prior to accepting a doctor or surgeon’s recommendation.

News stories and medical studies since 2011 have indicated there are problems with the process the Federal Drug Administration (FDA) uses to review and approve medical devices. The most recent news stories indicate that the data the FDA says it requires is often missing.

The latest story is a report from international news agency Reuters by reporter Andrew Seaman. The story was published on September 29, 2014. That article says that two new studies both indicate that medical devices are not tested thoroughly enough before being approved for implantation in the human body. The two most recent studies were published in JAMA Internal Medicine. You can read one of the studies here.

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