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Articles Posted in Pharmaceutical Injury

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By Jessica Surber, Attorney

English, Lucas, Priest & Owsley, LLP

dangerous products
Our firm routinely handles nursing home abuse, neglect and wrongful death cases. We see families every day who have trusted their loved ones to assisted living facilities or nursing homes but have found that the care was not up to basic standards.

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Risperdal drug injuryEarlier this month, a jury in Pennsylvania delivered the largest verdict yet against the maker of Risperdal, an antipsychotic medication. A jury awarded a family $70 million as compensation for devastating drug side effects suffered by their son. According to media reports, this is the fifth such lawsuit in Philadelphia, but by far the largest verdict, against Janssen, the manufacturer of Risperdal.

The plaintiff in the lawsuit, a boy who lived in Tennessee, grew large breasts as a result of taking the drug. The condition he suffered from is called gynecomastia, which is a known possible side effect of Risperdal. In marketing the drug and in Janssen’s defense in court, the manufacturer downplayed this side effect – but as this family can tell you, it is an incredibly difficult ordeal for those who develop it.

Risperdal is used in some patients to treat psychiatric disorders. In 2002, the U.S. Food and Drug Administration approved it for use for those who suffered from schizophrenia. In 2003, the FDA approved Risperdal for treatment of manic episodes of bipolar disorder. Since those are limited uses confined to small populations, the company began seeking more ways to market the drug.

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Pinnacle hip replacementA two-month trial in Dallas brought back a huge verdict against Johnson & Johnson, the manufacturer the Pinnacle hip replacement, which is a metal-on-metal hip replacement system. The jury verdict came back today after only one day of deliberations. The jury verdict awarded $497.6 million in damages to five plaintiffs whose cases were combined as part of a multidistrict litigation. The figure included $360 million in punitive damages against DePuy.

The case is considered to be a bellwether case, meaning the outcome of the case indicates how the courts and juries may see future hip replacement cases. The result of the case was posted on law news site Law360 today.

The device targeted in this lawsuit is the Pinnacle Acetabular Cup System, which is made by DePuy, a division of Johnson & Johnson. One of the key components of the Pinnacle hip replacement is a cobalt and chromium liner in the cup part – which was also a key part of the problem with the device.

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dangerous products

According to the Centers for Disease Control and Prevention, about half of all Americans take at least one prescription medication. Many also take over-the-counter medications – such as pain relievers, vitamins, and antihistamines – on a regular basis. It is, therefore, very important that pharmaceutical products be carefully monitored.

Patients who are harmed by unreasonably dangerous or defective medications may be able to obtain compensation for their injuries via a product liability lawsuit. Such suits often allege multiple theories of liability, including negligence, strict liability, failure to warn, and breach of warranty.

The United States Food and Drug Administration (FDA) is the federal agency charged with protecting and promoting the health of Americans through the regulation and supervision of prescription drugs, over-the-counter medications, dietary supplements, and related products.

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When a consumer is injured because of a dangerous product, the consumer has a right to pursue financial compensation for his or her injuries via a product liability lawsuit. There are several types of theories that may be used in product liability cases, depending upon the circumstances.

These types of theories include strict product liability, design defect, manufacturing defect, failure to warn, and breach of warranty. Design defects typically affect an entire line of products that were manufactured according to an inherently dangerous design. Manufacturing defects, on the other hand, may involve only a few products that were the subjects of a flaw in the construction or production process.

Damages available in a product liability case may include past and future medical expenses, pain and suffering, and lost wages. In some cases, there is also the possibility of punitive damages in cases of particularly egregious conduct by the manufacturer.

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Depakote kickback

According to a press release issued by the United States Department of Justice, the second-largest nursing home pharmacy in the nation – Louisville-based PharMerica Corporation – has agreed to pay some $9.25 million in a settlement of various claims arising from its alleged participation in a Depakote kickback scheme.

According to the company’s website, the “voluntary civil settlement” related to its possible violations of the False Claims Act and/or the Anti-Kickback Statute from 2001 to 2008. The company, which primarily serves institutional health care providers like nursing homes, stated that it was “pleased to resolve this matter” and “remains focused on operating with integrity.”

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medical device injury

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

Product liability lawsuits proceed under the theory that manufacturers and sellers should be held accountable for injuries resulting from defects that make a product unreasonably unsafe. As with other lawsuits, a trial court must have jurisdiction (both personal and subject matter) over a defendant before it can proceed to adjudicate the issues between the parties.

Sometimes, a defendant may argue that, although the court technically has jurisdiction over the case, the court should decline to exercise that jurisdiction because justice would be better served in another forum.

In the recent case of Pantuso v. Wright Medical Technology, Inc., a Utah man filed a lawsuit in the Circuit Court of Shelby County, Tennessee, seeking to recover damages resulting from an allegedly defective hip replacement device. Although the defendant manufacturer admitted that its principal place of business was Tennessee, it filed a motion to dismiss the man’s complaint on the doctrine of forum non conveniens.

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RisperdalThe Huffington Post is in the midst of publishing a 15-part series that details Johnson & Johnson’s push of the anti-psychotic drug Risperdal. The drug was approved for sale in 1994 for patients with psychosis, but was not approved for use in adolescent or elderly patients. Skirting the Food & Drug Administration and the law became the crux of Johnson & Johnson’s aggressive marketing plan, which was designed to make Risperdal the best-selling anti-psychotic drug on the market.

The series is a bombshell. Three chapters of the 15-chapter series have been published by The Huffington Post so far. Every day brings a new chapter – and more tales of how one of the world’s largest pharmaceutical companies pursued sales at all costs. Selling the drug to approved patient groups for FDA-approved uses wasn’t enough for Johnson & Johnson. Drug sales representatives pushed the drug onto doctors who dealt with psychiatric illnesses in children and elderly, and pushed them to prescribed the drug for symptoms such as agitation in the elderly, which is not an approved use.

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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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Pregnant woman

Recently, the U.S. Food and Drug Administration sent a not-so-friendly letter to to a drug manufacturer concerning a certain reality star’s social media post about a medication she is allegedly taking to help her deal with morning sickness during her pregnancy.

While it may seem like just another nugget of celebrity gossip, the FDA’s letter is important because it brings to light the influence that so-called “celebrity endorsers” can have on their massive fan base.  The FDA calls the celebrity endorsers and the drugs’ manufacturers to task for not mentioning drug side effects as required by federal law.

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