INFUSE Bone Graft Lawsuits

The INFUSE Bone Graft, which was once believed to be a game changer in bone surgery, has come under fire, as has the product’s manufacturer, Medtronic. Originally approved by the Food and Drug Administration (FDA) in 2002 for use in certain spinal procedures, was used for promoting bone growth. Following the approval for use during single-level anterior lumbar fusion surgery, it was approved in 2004 for tibia repairs and in 2007 for dental procedures.

It was developed as an alternative to traditional bone graft procedures, which involve either the use of bone harvested from the hip or another part of the body, or bone extracted from dead bodies. Complications from these traditional procedures involved the risk of the cadaver bone being rejected by the body. In essence, the graft is used to fill in spaces where bone is needed.

Recently, a number of lawsuits have been filed against Medtronic concerning INFUSE Bone Graft. Plaintiffs accuse the manufacturer of intentionally concealing dangerous side effects and encouraging off-label uses of the bone graft. The product has been promoted for off-label uses in certain spinal surgeries. These actions drew two whistle-blower lawsuits and a $40 million settlement with the Department of Justice in 2006.

In a recent securities filing by Medtronic, they state there are approximately 700 pending lawsuits over INFUSE. Although many cases have been filed across the country, most have been moved to Arizona, the home of Medtronic. To date, the Judicial Panel on Multidistrict Litigation has not centralized these cases in multidistrict litigation or “MDL”. Of course, with more and more lawsuits being filed, the JPML may consolidate these actions in the future.

The off-label uses in other spinal surgeries include cervical fusion, thoracic fusion, posterior lumbar fusion, as well as multi-level fusions. It is estimated that 1 Million people were implanted with INFUSE Bone Graft, with 85% of those uses off-label.

When used during these unapproved procedures, Medtronic Infuse side effects may cause bone growth in areas where it is not wanted, which may cause severe inflammatory reaction, airway compression or breathing problems, nerve impingement resulting in severe back or neck pain, hospitalization with treatment in ICU, need for a feeding tube or tracheotomy, additional surgery to remove excessive bone from the spinal canal, or death. There are even claims that INFUSE use can lead to cancer.

In May of this year, Medtronic announced that they will settle about 950 lawsuits for $22 million, and an additional $120-140 million will be set aside to resolve over 3,000 additional claims.

Pittman, Dutton & Hellums, P.C. is currently investigating INFUSE Bone Graft injury claims. If you or a loved one were injured as a result of Medtronic’s INFUSE Bone Graft, please contact Booth Samuels at 1-866-515-8880 or by email at booths@pittmandutton.com.

Major Victory for Plaintiffs Against Generics Out of Alabama Supreme Court

               On January 11, 2013, the Alabama Supreme Court issued an opinion in Weeks v. Wyeth, a matter pending in the Middle District of Alabama.  Wyeth filed an application for rehearing.  On August 15, 2014, the Supreme Court overruled the rehearing application but substituted a new opinion.  In other words, the January 11, 2013 “outcome” remained unchanged.

            The Middle District posed the following certified question:  “Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?”.  In an opinion written by Justice Bolin, the Supreme Court answered in the affirmative.  This “outcome” is contrary to similar rulings in other jurisdictions.

            Weeks’s treating physician wrote a prescription for Reglan but did not specify that the pharmacist must fill the prescription with “brand-name” Reglan.  As permitted by a state statute and encouraged by medical insurers, Weeks’s pharmacist provided him with a generic version of Reglan, which Weeks ingested.

            Chief Justice Moore, who was not on the Court on January 11, 2013, wrote a dissent in which he advocated that the Court should not have accepted the invitation to answer the posed certify question because there was an insignificantly developed factual record.

            Wyeth’s position appeared to be that Weeks was seeking to prosecute AEMLD claims in a situation where he was injured after taking a drug which was not manufactured by Wyeth.  Justice Bolin wrote that, as to Wyeth, Weeks was not prosecuting any AEMLD claim, predicated on the prescribed drug being defectively.  Instead, Weeks’s theory was that Wyeth’s fraudulent conduct lead to Reglan being prescribed in the manner that it was.

            Justice Bolin noted (a) that, like many states, the Alabama Legislature enacted a law which allowed pharmacists to substitute a generic version of a prescribed “brand name” drug unless the physician mandates that the prescription be filled with the “brand name” manufacturer’s drug and (b) that health insurers and others prefer filling prescriptions with generics and there are economic reasons why a patient may be willing to accept a generic over a brand name.  Justice Bolin also outlined the FDA rules and regulations which prevent generic manufacturers from providing information and warnings different from those approved for dissemination by the brand-name manufacturer.  In other words, the brand-name maker, and not the generic company, controls the information upon which physicians rely in choosing to prescribe the subject drug. 

            The opinion expressly stated that the Court was not ruling on the ultimate merits of the case.  The Court merely found that Weeks could pursue this theory despite having not ingested Wyeth’s product.  [This may explain Chief Justice Moore’s dissent because there were no facts developed as to whether the prescribing physician relied on Wyeth-supplied information in deciding to prescribe Reglan in the manner in which he did.]

            This opinion appears to promote the notion that brand-name drug manufacturers should be held legally accountable if they made misrepresentations or omissions which resulted in physicians “mis-prescribing” a drug.  Brand-name manufacturers know that, when a physician prescribes a drug by its brand name, the prescription may be filled with a generic version and that physicians may rely on the information which can only come from the brand-name manufacturer because the generic manufacturer typically cannot provide any differing information.

Judge Rules For O'Bannon

Last Friday, Judge Wilken ruled in favor of the O'Bannon plaintiffs against the NCAA. Judge Wilken presided over a non-jury trial in June that lasted approximately three weeks. 

In the landmark case, Judge Wilken ruled that football and men's basketball players could be compensated for the use of their names, images, and likenesses for television and other media broadcasts and video games. She ruled that the current NCAA bylaws that prohibit such compensation violates well-established anti-trust law.

The ruling, which will surely be appealed by the NCAA, is the first major victory for college athletes against the NCAA. Several other cases are currently pending against the institution, including the Keller case set for trial early next year.

To read Judge Wilken's ruling, click here.

Georgia Debt-Collection Firm Accused of Filing 350,000 Lawsuits

A story broke recently about a Georgia law firm which filed over 350,000 lawsuits over the last four years. The lawsuits were collection efforts against consumers, many of whom may not actually owe debts or owe less than the amounts claimed. The government has filed a complaint against the firm alleging, “…in Georgia alone, the Firm sued about 78,000 consumers in 2009; about 84,000 in 2010; about 71,000 in 2011; about 57,000 in 2012; and about 60,000 in 2013. In sum, the Firm filed more than 350,000 collection suits from 2009 through 2013.” The firm denies the allegations.

It was reported that roughly 40,000 of the 350,000 suits were dismissed when challenged in court. It was also noted that consumers who retained attorneys were almost four times more likely to get their cases dismissed.

The amount of collection lawsuits filed has increased dramatically over the last number of years. A recent survey estimated that 1 in 3 adults with a credit history -- or 77 million people -- are so far behind on some of their debt payments that their account has been put "in collections." Click the link below to read more on that study:

http://money.cnn.com/2014/07/29/pf/debt-collections/index.html?iid=HP_LN&hpt=hp_t2

Identity theft has also been on the rise. We have all heard in the news the major data breaches at Target and Mapco recently. One of the best methods you can take to make sure your identity has not been stolen is to monitor your credit reports monthly through a variety of services offered.

Booth Samuels handles identity theft cases. If you have been the victim of identity theft, call 1-866-515-8880 or email him directly at booths@pittmandutton.com.