Menges v. Depuy Motech, Inc.
| Decision Date | 11 June 1999 |
| Docket Number | No. 3:96 CV 0026 AS.,3:96 CV 0026 AS. |
| Citation | 61 F.Supp.2d 817 |
| Parties | William MENGES, Plaintiff, v. DEPUY MOTECH, INC., et al., Defendants. |
| Court | U.S. District Court — Northern District of Indiana |
Mark D. Boveri, Barnes and Thornburg, South Bend, IN, for Depuy Motech Inc.
Michael R. Fruehwald, Barnes and Thornburg, Indianapolis, IN, for Depuy Motech Inc., Depuy Inc.
This case is one of more than two thousand separate products liability actions filed in this country by more than five thousand plaintiffs claiming that defective "pedicle screw fixation devices" which were surgically attached to the pedicles of their spines during spine fusion surgery have caused them to suffer physical injuries. Pursuant to 28 U.S.C. § 1407, the Judicial Panel on Multi district Litigation (MDL) transferred these cases to the United States District Court for the Eastern District of Pennsylvania for consolidated pretrial proceedings. The MDL court, through Judge Louis C. Bechtle, managed the litigation through extensive procedural matters, including dismissal of the original complaints, the filing of amended omni complaints, discovery, and the resolution of numerous motions. In April 1997, Judge Bechtle issued a thorough opinion in In re Orthopedic Bone Screw Products Liability Litigation, No. MDL 1014, 1997 WL 186325 (E.D.Pa. April 16, 1997), detailing the plaintiffs' allegations in the consolidated omni actions, describing the pertinent regulatory framework of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., and its Medical Device Amendments, 21 U.S.C. § 360(a) et seq. The pre-trial proceedings have now been completed as respects pleading, discovery, and motions that the transferee court determined could and should be considered in the transferee court. The motions that remain to be considered, when filed in the transferor courts are those that are both case and fact specific as opposed to motions that would affect issues that apply to either substantial numbers of cases or all cases in MDL No. 1014. Accordingly, the MDL court has remanded cases to their respective District Courts. See In re Orthopedic Bone Screw Products Liability Litigation, 1998 WL 411380 (E.D.Pa. June 30 1998). Defendant filed its motion to dismiss on January 20, 1999. The parties have fully briefed the issues and this Court heard oral argument on May 7, 1999. Defendant's motion is now ripe.
Jurisdiction is proper pursuant to 28 U.S.C. § 1332 due to diversity of the parties and a proper amount in controversy. Plaintiff and all treating physicians are residents of Wisconsin. Defendant is an Indiana corporation with its principal place of business in Warsaw, Indiana.
On September 15, 1993, Plaintiff, William Menges (Menges), injured his lower back when he fell while at work. He experienced severe back and hip pain after the fall and was examined by Dr. Richard Karr, an orthopedic surgeon who diagnosed Menges as having a slippage (spondylolisthesis) of his L5 vertebra and a narrowing of his L4-L5 disk space.1 Dr. Karr noted that in his opinion the fall aggravated a pre-existing lumbar spinal stenosis and accelerated the problem. Fusion of the L5-S1 and L4-L5 vertebrae was recommended.
In 1994 due to continuing severe back and left leg pain, Menges consulted with Dr. Stephen Robbins, an orthopedic surgeon. Dr. Robbins confirmed the earlier diagnosis and recommended anterior and posterior fusion surgery using MOSS instrumentation on the posterior site. Defendant manufactures the MOSS instrumentation.
On February 10, 1994, Dr. Robbins performed the surgery. There were no recorded complications. After the initial surgery Menges initially had improvement in his back and leg pain. On May 3, 1994 an X-ray revealed a fractured screw in Menges spine. Dr. Robbins noted that there was no change in the position of the instrumentation and the alignment of the lumbar vertebrae was within normal limits. He continued to follow Menges post-operative progress.
By August 16, 1994, Menges was complaining of headaches. Dr. Robbins noted that these were usually related to exertion. Menges also continued to complain of back pain. X-rays showed both S1 screws had fractured. Dr. Robbins indicated that further tests needed to be done to rule out a meningocele. He suggested that if a meningocele was found it would need to be surgically repaired and recommended that at that time Menges hardware could be changed to a larger device.
A myelogram and CT scan performed on August 30, 1994, revealed a pseudomeningocele (leakage of spinal fluid) in the L5-S1 area. The fluid had collected outside the dural sac from L3 to S1. As a result of the fluid leak, Dr. Robbins indicated additional surgery was needed to close the site. Additionally, Dr. Robbins informed Menges that he would remove the MOSS instrumentation and replace it with a larger (MOSS Miami) device. The surgery was performed on September 1, 1994. During this surgery Dr. Robbins found evidence of pseudarthrosis (failure to fuse). His post operative notes indicate that he found a slight tear along the proximal lateral aspect of the nerve root sheath and that the CSF fluid was leaking from there. The tear was successfully repaired. Dr. Robbins later testified that in his opinion the dural leak interfered with the posterior fusion by decreasing the blood flow to the area where fusion was being attempted (Robbins Dep. 38, 61-62) He further testified that the leak most probably occurred during the original surgery and was unrelated to the MOSS device. (Robbins Dep. 36-37, 75-76).
Dr. Robbins continued to see Menges for follow-up until November 29, 1994. During this time Menges continued to complain of back and leg pain. X-rays showed good positioning of the Moss Miami device and ongoing consolidation of the fusion. (Robbins Dep. 44). Dr. Robbins noted that Menges' symptoms were most likely secondary to normal scar tissue formed after the surgeries or irritation from the dural tear, or both, but were unrelated to the instrumentation. (Robbins Dep. 44-45, 77-78 see also Robbins medical notes of 11/29/94).
In January 1995, Menges changed doctors and began seeing Dr. Lawrence Frazin, a neurosurgeon. Dr. Frazin noted that "the patient's course was complicated by the development of a pseudomeningocele which required another surgery." (Frazin Notes 1/25/95). After several visits, diagnostic tests and x-rays Dr Frazin concluded that as of September 1995 the fusion attempted in September 1994 was solid throughout. The pedicle screw position appeared appropriate and the bone graft was appropriately positioned. (Id.) He also noted that Menges had a narrowing in a new area of his spine at the L3-L4 and L2-L3 levels and had generalized disk bulging. (Id.) In February 1995, Dr. Frazin referred Menges for treatment for failed back syndrome. Menges did not wean himself from narcotic medication and nor did he continuously participate in physical therapy as his doctor had prescribed. He claimed he was in too much pain. Dr. Frazin's September 26, 1995 note states that X-rays show the hardware is in good position with no evidence of fracture and the posteriolateral fusion appears good. He referred Menges to a pain specialist.
Menges filed this lawsuit on January 10, 1996. On February 16, 1996, Dr. Karr opined that Menges had reached an end of healing relative to the 9/93 workplace injury and released him to return to work with four permanent work restrictions pertaining to lifting and bending. He suggested physical exercise, weight loss and weaning Menges off pain-killers.
Spinal fusion surgery is a method of placing bone graft material between two mobile segments of the spine to knit them together as one bony unit and eliminate motion between the segments. Fusion surgery can be performed with or without the use of spinal instrumentation for internal fixation. With or without the aid of internal fixation instruments, there is a risk that the fusion will not occur. Internal fixation instruments are used to provide stability to decrease motion between segments of the spine to allow the bone fusion to knit together. They act as an internal splint. If a solid fusion is obtained, the device is no longer providing structural support and can be removed. If a solid fusion is not obtained at some point in time the internal fixation device will fail. Internal fixation devices may be attached with hooks, wires or bone screws. When bone screws are employed they are screwed into the pedicles of a vertebra and connected to rods or plates to stabilize movement between the vertebrae to which they are connected. Smith v. Sofamor, S.N.C., 21 F.Supp.2d 918, 919 (W.D.Wis. 1998).
Under the Medical Device Amendments ("MDA") to the Federal Food, Drug and Cosmetic Act ("FDCA"), medical devices intended for human use are classified as Class I, II, or III devices. Class I devices are considered to present the least risk to human safety and are subject to "general controls;" Class II devices present more risks to human safety than Class I devices and are subject to special controls; and Class III devices present the most risk to human safety and are subject to "premarket approval," which is designed to provide a "reasonable assurance of ... safety and effectiveness" for the most dangerous medical devices. See 21 U.S.C. §§ 360c(a)(1)(C), 360e(e) and 360i(a). Premarket approval under the MDA requires applicants to submit an application detailing: 1) extensive safety testing data; 2) the contents and operation of the device; 3) a description of methods used to manufacture, process, package, and install the device; 4) samples of the device; 5) proposed labeling for the device; and 6)...
To continue reading
Request your trial
-
Larkin v. Pfizer, Inc., No. 2002-SC-0746-CL.
...law); Ehlis v. Shire Richwood, Inc., 233 F.Supp.2d 1189, 1196 (D.N.D.2002) (interpreting North Dakota law); Menges v. Depuy Motech, Inc., 61 F.Supp.2d 817, 830 (N.D.Ind.1999) (interpreting Wisconsin law); Pumphrey v. C.R. Bard, Inc., 906 F.Supp. 334, 337-38 (N.D.W.Va.1995) (interpreting Wes......
-
Guinan v. A.I. Dupont Hosp. for Children
...the device is defective."); Minisan v. Danek Med., Inc., 79 F.Supp.2d 970, 977 (N.D.Ind.1999) (holding same); Menges v. Depuy Motech, Inc., 61 F.Supp.2d 817, 828 (N.D.Ind.1999) (holding 3. Breach of the Implied Warranty of Fitness for a Particular Purpose Plaintiff's final warranty claim, b......
-
Minisan v. Danek Medical, Inc.
...Sept.9, 1999); Lawrence v. Sofamor, S.N.C., No. 95-CV-1507, 1999 WL 592689 slip op. (N.D.N.Y. Aug. 2 1999); Menges v. Depuy Motech, Inc., 61 F.Supp.2d 817 (N.D.Ind.1999); McCollin v. Synthes, Inc., 50 F.Supp.2d 1119 (D.Utah 1999); Wheat v. Sofamor, S.N.C., 46 F.Supp.2d 1351 (N.D.Ga.1999); H......
-
Marvin v. Zydus Pharm. (USA) Inc.
...a private cause of action for violation of the statute"). In an opinion issued in the same year as Valente , Menges v. Dupuy Motech, Inc. , 61 F.Supp.2d 817, 829 (N.D.Ind.1999), the court summarily rejected the decision in Cali and cited Valente as authority for allowing a negligence per se......