Skerl v. Arrow International, Inc.

202 F. Supp. 2d 748, 2001 U.S. Dist. LEXIS 23495, 2001 WL 1835563
CourtDistrict Court, N.D. Ohio
DecidedOctober 29, 2001
Docket1:99CV2832
StatusPublished
Cited by2 cases

This text of 202 F. Supp. 2d 748 (Skerl v. Arrow International, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Ohio primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Skerl v. Arrow International, Inc., 202 F. Supp. 2d 748, 2001 U.S. Dist. LEXIS 23495, 2001 WL 1835563 (N.D. Ohio 2001).

Opinion

MEMORANDUM OPINION

PERELMAN, United States Magistrate Judge.

Now before this Court is the motion of defendant Arrow International, Inc. (“Arrow”) for summary judgment pursuant to Rule 56(b) of the Federal Rules of Civil Procedure.

This action was initiated by plaintiffs Barbara J. Skerl and her husband, Bernard M. Skerl, in the- Cuyahoga County Common Pleas Court, and removed by defendant to this federal court on November 19, 1999 pursuant to 28 U.S.C. §§ 1332 and 1446 based upon diversity of citizenship. Plaintiffs are Ohio residents and Arrow is a corporation organized and existing under the laws of Pennsylvania.

In their amended complaint plaintiffs allege that defendant “designed, produced, created, made, manufactured, constructed and/or assembled” a defective product known as a “Constant Flow Implantable Pump” (“Pump”) bearing serial number 3955 which had been implanted into Barbara Skerl and caused her serious harm. Plaintiffs further allege that defendant failed “to provide adequate warnings, instructions, training and/or set-up” regarding the alleged defective product, which also resulted in injuries to the plaintiffs. Mr. Skerl alleges injury by reason of loss of the consortium of his wife.

Mrs. Skerl suffered a long history of chronic back, leg and hip pain, which caused her to undergo a number of surgeries including cervical disc surgery, carpel tunnel surgery, arthroscopic surgery of the right knee, rotator cuff surgery, hip replacement surgery with subsequent revision and several lumbar surgeries, including multiple discectomies, laminectomies and spinal fusions. She also dislocated her hip twice during a three month period.

As a result of plaintiffs chronic pain, Dr. Vinod Joshi, one of plaintiffs treating physicians, recommended that she have a morphine pump surgically implanted into her body.

On October 29, 1998 Dr. Louis Keppler implanted the Pump into plaintiff, at the lower left quadrant of her abdomen, between her ribs and the iliac crest. The Pump is a drug delivery system completely implanted beneath the skin, which provided a continuous flow of medication up to its reservoir capacity of 30cc.

Upon being sent to Dr. Keppler the Pump included the following instructions and warnings:

Arrow Model 300 Series Constant Flow Implantable Infusion Pumps Contraindications
The Arrow Model 3000 Series Constant Flow Pumps with Bolus Safety Valve are contraindicated for use in patients with:
1. Known or suspected infection, bac-teremia, septicemia or peritonitis.
2. Known to have experienced an allergic reaction or other signs of intolerance to implanted devices.
3. Emotional or psychiatric problems.
*750 4. Patients whose body size is insufficient to accommodate the physical size of the Pump.
5. FUdR should be used with added caution in patients with impaired hepatic or renal function.
6. Patients with known disease extending beyond an area capable of infusion should be considered for systemic therapy with other chemotherapeutic agents.
Contraindications relating to the specific drug to be used should be observed and followed per the approved drug labeling.
Adverse Effects
Possible adverse effects of the Pump are those potential risks associated with any implanted drug delivery device and include: catheter thrombosis [blockage], bolus path occlusion [blockage], vessel thrombosis [blockage], Pump dislodgement, seroma, or recurrent hematoma, infection, extra-vasation, catheter shear, dislodgement or leakage, and migration. Drug ex-travasation may result if the instructions for use are not followed correctly during a Pump refill or bolus procedure (see the Instructions for Use pamphlet). It is important that an Arrow Refill Kit (Cat.# AP-07001) be utilized for Pump refill and that the refill procedure be carried out in accordance with the instructions provided in the pamphlet and in the Refill Kit. An Arrow Special Bolus Needle (Cat.# AP-04013) must be utilized to successfully perform a bolus procedure.

(Emphasis added.)

Mrs. Skerl testified upon deposition that she received the aforementioned information regarding the Pump and that both Drs. Keppler and Joshi reviewed the information with her. She also signed a consent form prior to the surgery indicating that she had been informed of the procedure and its risks, as well as potential problems related to recuperation.

After the surgery plaintiff made arrangements to return to Dr. Joshi to have the Pump filled as needed. Dr. Joshi subsequently saw plaintiff on November 23 and December 23, 1998, each time refilling the Pump to its capacity of 30 cc of morphine, although the infused volumes (amounts released into Mrs. Skerl since the prior visits) were only 20 cc and 11 cc, respectively.

On February 15, 1999 Mrs. Skerl once again returned to Dr. Joshi, this time complaining that the Pump was not alleviating her pain. Dr. Joshi extracted the entire 30 cc of morphine remaining in the Pump and did not refill the Pump. Instead, he gave Mrs. Skerl a bolus injection of 2cc of morphine, using the Pump as a conduit to do so by injecting the morphine into the catheter connected to the Pump which in turn allowed the medication to pass into her system.

Mrs. Skerl then left the office of Dr. Joshi, returned home, made dinner and went to bed at about 9:00 that evening. She stated during her deposition testimony that she remembers nothing more about that night, but does recall waking in the morning and finding herself in the intensive care unit of Parma Hospital. She also testified that upon going to bed that evening she may have been under the influence of Percocet, Prozac, Fioricet, Desyrel, Nolvadex, Librax, Tamoxifen, Percodan, Corgard, Paxil, and Azulfidine. 1

Mr. Skerl testified upon deposition that after sleeping on the living room couch he was awakened at about 8:00 the next morning by the sound of his wife calling *751 him. He went to her bedroom, found her lying on the floor between the night stand and the bed, and then called 9-1-1.

The Parma Fire Department responded and took Mrs. Skerl to Parma Hospital, where she underwent a closed reduction of a dislocated right hip and was treated with medication to prevent blood clots. She was also administered a charcoal absorption drink to soak up and neutralize the oral medications in her stomach.

During deposition questioning by plaintiffs’ counsel Mr. Skerl opined:

Q. What do you think happened, then?
A. What do I think happened?
MR.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Roberts v. RMB Enterprises, Inc.
967 N.E.2d 1263 (Ohio Court of Appeals, 2011)
Boettcher v. Gradall Co., Ca2008-02-051 (11-3-2008)
2008 Ohio 5664 (Ohio Court of Appeals, 2008)

Cite This Page — Counsel Stack

Bluebook (online)
202 F. Supp. 2d 748, 2001 U.S. Dist. LEXIS 23495, 2001 WL 1835563, Counsel Stack Legal Research, https://law.counselstack.com/opinion/skerl-v-arrow-international-inc-ohnd-2001.