A North Carolina woman has filed a product liability lawsuit in Commonwealth of Massachusetts, Middlesex County Superior Court against medical device manufacturer Stryker^®, claiming she sustained serious and disabling injuries caused by the illegal off-label promotion and use of OP-1 Putty, a Stryker medical device during a spine surgery. The docket number is 1581-CV-06475.

Plaintiff Isabel M. Lucas claims that defendants Stryker^® Biotech, LLC of Cambridge, Massachusetts, a subsidiary of Stryker^® Corporation, and Stryker^® Corporation of Michigan are liable for the injuries she suffered after undergoing an unapproved spine surgery. Her complaint includes five counts plus claims for punitive damages:

•    Fraud

•    Negligence

•    Breach of Express Warranty

•    Breach of Implied Warranty

•    Violation of the North Carolina Unfair and Deceptive Trade Practices Act

Stryker Biotech, LLC, and a number of its employees and managers, including its former President, were criminally indicted in Massachusetts for their nationwide illegal off-label promotion of Calstrux and OP-1, and Stryker Biotech, LLC subsequently pled guilty and paid a $15 million criminal fine in connection with its illegal off-label promotion of OP-1 and Calstrux.

In March of 2009, Isabel M. Lucas consulted with Charles S. Haworth, M.D. at Duke Neurological Associates in North Carolina to address pain arising from lumbar stenosis and severe degenerative disc disease, as well as previous spinal fusion surgeries. In July 2009 at Southeastern Regional Medical Center, Dr. Haworth performed posterior lumbar interbody fusion spine surgery from L4-L5 and L5-S1, placing an unapproved mixture of OP-1 Putty and a synthetic bone void filler.

OP-1 Putty is a bone morphogenetic protein (BMP) whose effectiveness was never scientifically established. According to the lawsuit, Dr. Haworth used OP-1 Putty in what is considered an "off-label" procedure, as OP-1 had never been approved by the FDA for use with other products (such as synthetic bone void fillers).

Following her July 2009 spine surgery, Ms. Lucas began to experience worsening back pain in her lower back accompanied by severe discomfort and immobility. Nearly a year following her surgery, she could hardly walk due to the pain shooting down her left leg. She engaged the services of Dr. Haworth, as well as other physicians, for multiple post-surgical follow-ups, including a subsequent remedial surgery as well the recent implantation of a spinal cord stimulator to attempt to alleviate her ongoing and debilitating pain.

In her lawsuit, Ms. Lucas claims that Stryker^® knew that mixing OP-1 Putty with synthetic bone void fillers was ineffective and would result in formation of bone in undesirable areas, including formation of bone over nerves which could cause pain, nerve damage and serious injury. She claims that she sustained hypertrophic and unwanted bone growth in her lumbar spine, which she alleges was caused by the unapproved implantation of OP-1 and a synthetic bone void filler and is responsible for her ongoing debilitating pain.

The lawsuit further alleges that Stryker^® sales representatives directly and indirectly promoted, trained and encouraged surgeons, including her surgeon, and hospital surgical staff to engage in the off-label procedure of mixing OP-1 with other products such as synthetic bone void fillers.

Ms. Lucas claims that as a result of her 2009 spine surgery, she now endures significant mental and physical pain and discomfort, and has suffered disfigurement and ongoing disability, which has greatly affected her personal life.

About Baum, Hedlund, Aristei & Goldman

Baum Hedlund Aristei & Goldman is representing Ms. Lucas in her Stryker lawsuit.

The firm has successfully argued against preemption (drug/device manufacturer immunity) in several OP-1 Putty cases involving Stryker as well as one against Medtronic regarding InFUSE.

• Cabana v. Stryker Biotech, LLC et al., Case No. BC465313, 2012 WL 3729227 (Cal.Super. Ct., August 20, 2012) (holding that injured patient's state law claims arising out of medical device manufacturer's off-label promotion of its bone morphogenetic protein [Infuse] were not expressly nor impliedly preempted by federal law)

• McCormick v. Medtronic, Inc., 219 Md. App. 485, 101 A.3d 467 (2014) (unanimously reversing the trial court's preemption/dismissal ruling and holding that injured patient's claims arising out of medical device manufacturer's off-label promotion of its medical device were not preempted by federal law and thus allowing plaintiff to proceed with his meritorious claims)

• Boutte v. Stryker Biotech, LLC, 67 F. Supp. 3d 732, 734 (M.D. La. 2014) (denying defendant's motion to dismiss and permitting plaintiff to proceed with his products liability claims against medical device manufacturer)

• Hricik v. Stryker Biotech, LLC, 89 F. Supp. 3d 694 (E.D. Pa. 2015) (granting plaintiff's motion to remand the case back to state court)

The firm has successfully* represented more than 4,000 clients in pharmaceutical injury and defective medical device cases, including illegal and off-label use of drugs and medical devices. The firm is listed in publications such as The Best Lawyers in America^® (2014-2016), the Martindale Hubbell^® Bar Register of Preeminent Lawyers (1992-2015), and Top Ranked Law Firms™ based on AV^® Preeminent™ Martindale Hubbell^® Lawyer Ratings.

*Prior case results do not guarantee future legal outcome.